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    Chemistry

    Click the arrow to open the dropdown
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    Also known as: Linzess, 851199-59-2, Chebi:68551, Md-1100, Constella, Cys cys glu tyr cys cys asn pro ala cys thr gly cys tyr (disulfide bridge: 1-6; 2-10; 5-13)
    Molecular Formula
    C59H79N15O21S6
    Molecular Weight
    1526.8  g/mol
    InChI Key
    KXGCNMMJRFDFNR-WDRJZQOASA-N
    Linaclotide
    Linaclotide is a synthetic, fourteen amino acid peptide and agonist of intestinal guanylate cyclase type C (GC-C), which is structurally related to the guanylin peptide family, with secretagogue, analgesic and laxative activities. Upon oral administration, linaclotide binds to and activates GC-C receptors located on the luminal surface of the intestinal epithelium. This increases the concentration of intracellular cyclic guanosine monophosphate (cGMP), which is derived from guanosine triphosphate (GTP). cGMP activates the cystic fibrosis transmembrane conductance regulator (CFTR) and stimulates the secretion of chloride and bicarbonate into the intestinal lumen. This promotes sodium excretion into the lumen and results in increased intestinal fluid secretion. This ultimately accelerates GI transit of intestinal contents, improves bowel movement and relieves constipation. Increased extracellular cGMP levels may also exert an antinociceptive effect, through an as of yet not fully elucidated mechanism, that may involve modulation of nociceptors found on colonic afferent pain fibers. Linaclotide is minimally absorbed from the GI tract.
    1 2D Structure

    Linaclotide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S)-2-[[(1R,4S,7S,13S,16R,21R,24R,27S,30S,33R,38R,44S)-21-amino-13-(2-amino-2-oxoethyl)-27-(2-carboxyethyl)-44-[(1R)-1-hydroxyethyl]-30-[(4-hydroxyphenyl)methyl]-4-methyl-3,6,12,15,22,25,28,31,40,43,46,51-dodecaoxo-18,19,35,36,48,49-hexathia-2,5,11,14,23,26,29,32,39,42,45,52-dodecazatetracyclo[22.22.4.216,33.07,11]dopentacontane-38-carbonyl]amino]-3-(4-hydroxyphenyl)propanoic acid
    2.1.2 InChI
    InChI=1S/C59H79N15O21S6/c1-26-47(82)69-41-25-101-99-22-38-52(87)65-33(13-14-45(80)81)49(84)66-34(16-28-5-9-30(76)10-6-28)50(85)71-40(54(89)72-39(23-97-96-20-32(60)48(83)70-38)53(88)67-35(18-43(61)78)58(93)74-15-3-4-42(74)56(91)63-26)24-100-98-21-37(64-44(79)19-62-57(92)46(27(2)75)73-55(41)90)51(86)68-36(59(94)95)17-29-7-11-31(77)12-8-29/h5-12,26-27,32-42,46,75-77H,3-4,13-25,60H2,1-2H3,(H2,61,78)(H,62,92)(H,63,91)(H,64,79)(H,65,87)(H,66,84)(H,67,88)(H,68,86)(H,69,82)(H,70,83)(H,71,85)(H,72,89)(H,73,90)(H,80,81)(H,94,95)/t26-,27+,32-,33-,34-,35-,36-,37-,38-,39-,40-,41-,42-,46-/m0/s1
    2.1.3 InChI Key
    KXGCNMMJRFDFNR-WDRJZQOASA-N
    2.1.4 Canonical SMILES
    CC1C(=O)NC2CSSCC3C(=O)NC(C(=O)NC(C(=O)NC(CSSCC(NC(=O)CNC(=O)C(NC2=O)C(C)O)C(=O)NC(CC4=CC=C(C=C4)O)C(=O)O)C(=O)NC(CSSCC(C(=O)N3)N)C(=O)NC(C(=O)N5CCCC5C(=O)N1)CC(=O)N)CC6=CC=C(C=C6)O)CCC(=O)O
    2.1.5 Isomeric SMILES
    C[C@H]1C(=O)N[C@H]2CSSC[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@@H](CSSC[C@H](NC(=O)CNC(=O)[C@@H](NC2=O)[C@@H](C)O)C(=O)N[C@@H](CC4=CC=C(C=C4)O)C(=O)O)C(=O)N[C@@H](CSSC[C@@H](C(=O)N3)N)C(=O)N[C@H](C(=O)N5CCC[C@H]5C(=O)N1)CC(=O)N)CC6=CC=C(C=C6)O)CCC(=O)O
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Asp-0456

    2. Asp0456

    3. Linaclotide Acetate

    4. Linzess

    5. Md-1100

    6. Md-1100 Acetate

    2.2.2 Depositor-Supplied Synonyms

    1. Linzess

    2. 851199-59-2

    3. Chebi:68551

    4. Md-1100

    5. Constella

    6. Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (disulfide Bridge: 1-6; 2-10; 5-13)

    7. Unii-n0txr0xr5x

    8. Linaclotide [usan:inn]

    9. Hsdb 8224

    10. Asp0456

    11. Constella (tn)

    12. Asp 0456

    13. Asp-0456

    14. Linzess (tn)

    15. Linzess Ammonium Salt

    16. Linaclotide Ammonium Salt

    17. Linaclotide (jan/usan)

    18. N0txr0xr5x

    19. Gtpl5017

    20. Chembl3301675

    21. Schembl13114620

    22. Dtxsid90234256

    23. Glxc-13151

    24. Ex-a6257

    25. Db08890

    26. Ncgc00389841-01

    27. L-tyrosine, L-cysteinyl-l-cysteinyl-l-alpha-glutamyl-l-tyrosyl-l-cysteinyl-l-cysteinyl-l-asparaginyl-l-prolyl-l-alanyl-l-cysteinyl-l-threonylglycyl-l-cysteinyl-, Cyclic (1->6),(2->10),(5->13)-tris(disulfide)

    28. D09355

    29. Q3832559

    30. L-cysteinyl-l-cysteinyl-l-alpha-glutamyl-l-tyrosyl-l-cysteinyl-l-cysteinyl-l-asparaginyl-l-prolyl-l-alanyl-l-cysteinyl-l-threonylglycyl-l-cysteinyl-l-tyrosine Cyclic (1->6),(2->10),(5->13)-tris(disulfide)

    2.3 Create Date
    2007-07-04
    3 Chemical and Physical Properties
    Molecular Weight 1526.8 g/mol
    Molecular Formula C59H79N15O21S6
    XLogP3-6.8
    Hydrogen Bond Donor Count19
    Hydrogen Bond Acceptor Count28
    Rotatable Bond Count13
    Exact Mass1525.3899216 g/mol
    Monoisotopic Mass1525.3899216 g/mol
    Topological Polar Surface Area726 Ų
    Heavy Atom Count101
    Formal Charge0
    Complexity3030
    Isotope Atom Count0
    Defined Atom Stereocenter Count14
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameLinzess
    PubMed HealthLinaclotide (By mouth)
    Drug ClassesGastrointestinal Agent
    Drug LabelLINZESS (linaclotide) is a guanylate cyclase-C agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threon...
    Active IngredientLinaclotide
    Dosage FormCapsule
    RouteOral
    Strength290mcg; 145mcg
    Market StatusPrescription
    CompanyForest Labs

    2 of 2  
    Drug NameLinzess
    PubMed HealthLinaclotide (By mouth)
    Drug ClassesGastrointestinal Agent
    Drug LabelLINZESS (linaclotide) is a guanylate cyclase-C agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threon...
    Active IngredientLinaclotide
    Dosage FormCapsule
    RouteOral
    Strength290mcg; 145mcg
    Market StatusPrescription
    CompanyForest Labs

    4.2 Therapeutic Uses

    Linzess (linaclotide) is indicated in adults for the treatment of irritable bowel syndrome with constipation (IBS-C). /Included in US product label/

    NIH; DailyMed. Current Medication Information for Linzess (Linaclotide) Capsule, Gelatin Coated (Revised: July 2014). Available from, as of March 19, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3

    Linzess is indicated in adults for the treatment of chronic idiopathic constipation (CIC). /Included in US product label/

    NIH; DailyMed. Current Medication Information for Linzess (Linaclotide) Capsule, Gelatin Coated (Revised: July 2014). Available from, as of March 19, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3

    4.3 Drug Warning

    /BOXED WARNING/ WARNING: PEDIATRIC RISK. Linzess is contraindicated in pediatric patients up to 6 years of age; in nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration in young juvenile mice. Avoid use of Linzess in pediatric patients 6 through 17 years of age. The safety and efficacy of Linzess has not been established in pediatric patients under 18 years of age.

    NIH; DailyMed. Current Medication Information for Linzess (Linaclotide) Capsule, Gelatin Coated (Revised: July 2014). Available from, as of March 19, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3

    Linaclotide is contraindicated in infants and children younger than 6 years of age and should be avoided in children and adolescents 6-17 years of age. Safety and efficacy of linaclotide in pediatric patients have not been established, and the drug has caused deaths in toxicology studies in juvenile mice 1-3 weeks of age (approximately equivalent to infants younger than 2 years of age). The deaths in young juvenile mice occurred following 1 or 2 doses of linaclotide 10 ug/kg administered once daily beginning on postnatal day 7, single oral doses of 100 ug/kg on day 14, and single oral doses of 600 ug/kg on day 21. Although no deaths occurred in juvenile mice 6 weeks of age (approximately equivalent to adolescents 12-17 years of age) receiving linaclotide 20,000 ug/kg daily for 28 days, use of the drug in children and adolescents 6-17 years of age should be avoided because of the deaths reported in younger mice and the lack of safety and efficacy data in pediatric patients.1 No data are available for mice between 3 and 6 weeks of age.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2988

    Severe diarrhea was reported in clinical trials in 2% of patients receiving linaclotide for treatment of either irritable bowel syndrome (IBS) with constipation or chronic idiopathic constipation. If severe diarrhea occurs, treatment with the drug should be interrupted or discontinued.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2988

    It is not known whether linaclotide is distributed into human milk. Although plasma concentrations of linaclotide and its active metabolite are not measurable following oral administration at recommended dosages, caution is advised when linaclotide is administered to nursing women.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2988

    For more Drug Warnings (Complete) data for Linaclotide (10 total), please visit the HSDB record page.

    4.4 Drug Indication

    Treatment of irritable bowel syndrome (IBS) with constipation and chronic idiopathic constipation.

    FDA Label

    Constella is indicated for the symptomatic treatment of moderate to severe irritable-bowel syndrome with constipation (IBS-C) in adults.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Changes in the appearance and consistency of stools as measured by the Bristol Stool Form Scale (BSFS) have been noted after taking linaclotide.

    5.2 MeSH Pharmacological Classification

    Guanylyl Cyclase C Agonists

    Compunds that bind to and activate GUANYLYL CYCLASE-C RECEPTORS. (See all compounds classified as Guanylyl Cyclase C Agonists.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Guanylate Cyclase-C Agonist [EPC]; Guanylate Cyclase Activators [MoA]
    5.4 ATC Code

    A06AX04

    A06AX04

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    A - Alimentary tract and metabolism

    A06 - Drugs for constipation

    A06A - Drugs for constipation

    A06AX - Other drugs for constipation

    A06AX04 - Linaclotide

    5.5 Absorption, Distribution and Excretion

    Absorption

    When taken orally, linaclotide is not absorbed into the systemic. No detectable levels of linaclotide or its active metabolite were noted after doses of 125 mcg or 290 mcg were administered.

    Route of Elimination

    Linaclotide is eliminated fecally (3 - 5% as active metabolites). However most of the dose undergoes proteolysis (processes include reduction of disulfide bonds) in the intestine before being excreted via feces.

    Volume of Distribution

    Given that linaclotide plasma concentrations following therapeutic oral doses are not measurable, linaclotide is expected to be minimally distributed to tissues.

    Given that linaclotide plasma concentrations following therapeutic oral doses are not measurable, linaclotide is expected to be minimally distributed to tissues.

    NIH; DailyMed. Current Medication Information for Linzess (Linaclotide) Capsule, Gelatin Coated (Revised: July 2014). Available from, as of March 19, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3

    Active peptide recovery in the stool samples of fed and fasted subjects following the daily administration of 290 mcg of Linzess for seven days averaged about 5% (fasted) and about 3% (fed) and virtually all as the active metabolite.

    NIH; DailyMed. Current Medication Information for Linzess (Linaclotide) Capsule, Gelatin Coated (Revised: July 2014). Available from, as of March 19, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3

    Linzess is minimally absorbed with low systemic availability following oral administration. Concentrations of linaclotide and its active metabolite in plasma are below the limit of quantitation after oral doses of 145 ug or 290 ug were administered. Therefore, standard pharmacokinetic parameters such as area under the curve (AUC), maximum concentration (Cmax), and half-life cannot be calculated.

    NIH; DailyMed. Current Medication Information for Linzess (Linaclotide) Capsule, Gelatin Coated (Revised: July 2014). Available from, as of March 19, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3

    It is not known whether linaclotide is distributed into human milk.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2988

    For more Absorption, Distribution and Excretion (Complete) data for Linaclotide (8 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Linaclotide is metabolized within the gastrointestinal tract to its principal, active metabolite, MM-419447, by loss of the terminal tyrosine moiety. Both linaclotide and the metabolite are proteolytically degraded within the intestinal lumen to smaller peptides and naturally occurring amino acids.

    The metabolism of linaclotide was investigated in a set of experiments, predominantly in rodents. Linaclotide is metabolised in the intestine by immediate break down of the disulfide bridges which prone linaclotide to further digestion by the enzymes present in the gastrointestinal environment. Several breakdown products containing 3-13 amino acids have been identified. Only one metabolite, MM-419447, was shown to be pharmacodynamic active.

    European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), European Public Assessment Report (EPAR): Constella (Linaclotide) p.18 (2012). Available from, as of March 18, 2015: https://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002490/WC500135624.pdf

    Linaclotide is metabolized within the gastrointestinal tract to its principal, active metabolite by loss of the terminal tyrosine moiety. Both linaclotide and the metabolite are proteolytically degraded within the intestinal lumen to smaller peptides and naturally occurring amino acids.

    NIH; DailyMed. Current Medication Information for Linzess (Linaclotide) Capsule, Gelatin Coated (Revised: July 2014). Available from, as of March 19, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3

    ... We examined the metabolic stability of linaclotide in conditions that mimic the gastrointestinal tract and characterized the metabolite MM-419447 (CCEYCCNPACTGC), which contributes to the pharmacologic effects of linaclotide. Systemic exposure to these active peptides is low in rats and humans, and the low systemic and portal vein concentrations of linaclotide and MM-419447 observed in the rat confirmed both peptides are minimally absorbed after oral administration. Linaclotide is stable in the acidic environment of the stomach and is converted to MM-419447 in the small intestine. The disulfide bonds of both peptides are reduced in the small intestine, where they are subsequently proteolyzed and degraded. After oral administration of linaclotide, <1% of the dose was excreted as active peptide in rat feces and a mean of 3-5% in human feces; in both cases MM-419447 was the predominant peptide recovered. MM-419447 exhibits high-affinity binding in vitro to T84 cells, resulting in a significant, concentration-dependent accumulation of intracellular cyclic guanosine-3',5'-monophosphate (cGMP). In rat models of gastrointestinal function, orally dosed MM-419447 significantly increased fluid secretion into small intestinal loops, increased intraluminal cGMP, and caused a dose-dependent acceleration in gastrointestinal transit. These results demonstrate the importance of the active metabolite in contributing to linaclotide's pharmacology.

    PMID:23090647 Busby RW et al; J Pharmacol Exp Ther 344 (1): 196-206 (2013)

    5.7 Biological Half-Life

    Because linaclotide is not systemically absorbed, half life cannot be calculated.

    Two male and two female monkeys were intravenously dosed for seven consecutive days with 15 mg/kg/day linaclotide. ... /The/ mean half life was approximately 1.5 hr on day 1 and 7 for both genders.

    European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), European Public Assessment Report (EPAR): Constella (Linaclotide) p.19 (2012). Available from, as of March 18, 2015: https://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002490/WC500135624.pdf

    5.8 Mechanism of Action

    Linaclotide is an agonist of guanylate cyclase-C (GC-C). Once linaclotide and its active metabolite binds to GC-C, it has local effect on the luminal surface of the intestinal epithelium. Activation of GC-C by linaclotide results in the intra- and extracellular increase of cyclic guanosine monophosphate concentrations (cGMP). This elevation of cGMP levels stimulates the secretion of chloride and bicarbonate into the intestinal lumen via activation of cystic fibrosis transmembrane conductance regulator (CFTR) ion channel. Ultimately, linaclotide helps patients with IBS (especially with constipation) as GI transit is accelerated and the release of intestinal fluid is increased. In animal models, a decrease in visceral pain after administration of linaclotide may be observed. A decrease in the activity of pain-sensing nerves occurs as a result of an increase in extracellular cGMP.

    Activation of guanylate cyclase-C (GC-C) expressed predominantly on intestinal epithelial cells by guanylin, uroguanylin or the closely related GC-C agonist peptide, linaclotide, stimulates generation, and release of cyclic guanosine-3',5'-monophosphate (cGMP). Evidence that the visceral analgesic effects of linaclotide are mediated by a novel, GC-C-dependent peripheral sensory mechanism was first demonstrated in animal models of visceral pain. Subsequent studies with uroguanylin or linaclotide have confirmed the activation of a GC-C/cGMP pathway leading to increased submucosal cGMP mediated by cGMP efflux pumps, which modulates intestinal nociceptor function resulting in peripheral analgesia. These effects can be reproduced by the addition of exogenous cGMP and support a role for GC-C/cGMP signaling in the regulation of visceral sensation, a physiological function that has not previously been linked to the GC-C/cGMP pathway. Notably, targeting the GC-C/cGMP pathway for treatment of gastrointestinal pain and abdominal sensory symptoms has now been validated in the clinic. ...

    PMID:24795564 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3997039 Hannig G et al; Front Mol Neurosci 7: 31 (2014)

    Linaclotide, a synthetic 14-amino acid peptide, is a potent and selective guanylate cyclase-C (GC-C) agonist with visceral analgesic and secretory activities. This first-in-class orally active peptide is structurally related to the guanylin peptide family, which is involved in the regulation of fluid homeostasis and bowel function of the GI tract. Both linaclotide and its active metabolite bind to GC-C and act locally on the luminal surface of the intestinal epithelium. Activation of GC-C results in an increase in both intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP). Elevation in intracellular cGMP stimulates secretion of chloride and bicarbonate into the intestinal lumen, through activation of the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel, resulting in increased intestinal fluid and accelerated transit. Linaclotide has been shown to both accelerate GI transit and reduce intestinal pain. The linaclotide-induced reduction in visceral pain is thought to be mediated by increased extracellular cGMP, which was shown to decrease the activity of pain-sensing nerves.

    Health Canada; Product Monograph for Constella (Linaclotide), Drug Identification Number (DIN): 02417162 p.12 (Date of Preparation: May 12, 2014). Available from, as of March 18, 2015: https://webprod5.hc-sc.gc.ca/dpd-bdpp/start-debuter.do?lang=eng

    Linaclotide is a minimally absorbed agonist of guanylate cyclase-C (GUCY2C or GC-C) that reduces symptoms associated with irritable bowel syndrome with constipation (IBS-C). Little is known about the mechanism by which linaclotide reduces abdominal pain in patients with IBS-C. We determined the effects of linaclotide on colonic sensory afferents in healthy mice and those with chronic visceral hypersensitivity. We assessed pain transmission by measuring activation of dorsal horn neurons in the spinal cord in response to noxious colorectal distention. Levels of Gucy2c messenger RNA were measured in tissues from mice using quantitative reverse transcription polymerase chain reaction and in situ hybridization. We used human intestinal cell lines to measure release of cyclic guanosine-3',5'-monophosphate (cGMP) by linaclotide. We performed a post-hoc analysis of data from a phase III, double-blind, parallel-group study in which 805 patients with IBS-C were randomly assigned to groups given an oral placebo or 290 ug linaclotide once daily for 26 weeks. We quantified changes in IBS-C symptoms, including abdominal pain. In mice, linaclotide inhibited colonic nociceptors with greater efficacy during chronic visceral hypersensitivity. Intra-colonic administration of linaclotide reduced signaling of noxious colorectal distention to the spinal cord. The colonic mucosa, but not neurons, was found to express linaclotide's target, GC-C. The downstream effector of GC-C, cGMP, was released after administration of linaclotide and also inhibited nociceptors. The effects of linaclotide were lost in Gucy2c(-/-) mice and prevented by inhibiting cGMP transporters or removing the mucosa. During 26 weeks of linaclotide administration, a significantly greater percentage of patients (70%) had at least a 30% reduction in abdominal pain compared with patients given placebo (50%). We have identified an analgesic mechanism of linaclotide: it activates GC-C expressed on mucosal epithelial cells, resulting in the production and release of cGMP. This extracellular cGMP acts on and inhibits nociceptors, thereby reducing nociception. We also found that linaclotide reduces chronic abdominal pain in patients with IBS-C.

    PMID:23958540 Castro J et al; Gastroenterology 145 (6): 1334-46.e1-11 (2013)

    Linaclotide is a guanlylate cyclase-C (GC-C) receptor agonist. GC-C receptor is found in the luminal aspect of intestinal epithelium and dopamine neurons in the brain, and is a key receptor for heat-stable enterotoxins that are responsible for acute secretory diarrhea. Linaclotide is structurally related to the guanylin peptide family, which is involved in the regulation of intestinal fluid homeostasis and bowel function, and includes the hormones guanylin and uroguanlyin. Linaclotide, similarly to guanylin and uroguanylin, is able to increase intracellular concentrations of the second messenger cyclic guanosine monophosphate (cGMP) through activation of the GC-C receptor, located on the apical surface of epithelial cells throughout the intestine. The presence of intracellular cGMP triggers a signal transduction cascade that leads to the activation of the cystic fibrosis transmembrane conductance regulator (CFTR) through its cGMP-dependent phosphorylation by protein kinase G II (PKG II). CFTR activation causes secretion of chloride and bicarbonate into the intestinal lumen, causing an increase in fluid secretion and acceleration of GI transit. cGMP is also transported out of the cell into the intestinal lumen and submucosa, modulating the activity of local afferent nerve fibers and causing a reduced visceral pain.

    European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), European Public Assessment Report (EPAR): Constella (Linaclotide) p.16 (2012). Available from, as of March 18, 2015: https://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002490/WC500135624.pdf

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I. B. L.","customerCountry":"BANGLADESH","quantity":"2.90","actualQuantity":"2.9","unit":"KGS","unitRateFc":"2466.8","totalValueFC":"7093.3","currency":"USD","unitRateINR":207831.89655172414,"date":"20-Dec-2024","totalValueINR":"602712.5","totalValueInUsd":"7093.3","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"6628634","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pellets","supplierPort":"Bombay Air","supplierAddress":"102,TITAN HOUSE,60 FEET RD,, MUMBAI, MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734633000,"product":"LINACLOTIDE IR PELLETS 0.09% W\/W","address":"102,TITAN HOUSE,60 FEET RD,","city":"MUMBAI, MAHARASHTRA","supplier":"TITAN LABORATORIES","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"S. I. B. L.","customerCountry":"BANGLADESH","quantity":"2.90","actualQuantity":"2.9","unit":"KGS","unitRateFc":"2466.8","totalValueFC":"7093.3","currency":"USD","unitRateINR":207831.89655172414,"date":"20-Dec-2024","totalValueINR":"602712.5","totalValueInUsd":"7093.3","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"6632584","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pellets","supplierPort":"Bombay Air","supplierAddress":"102,TITAN HOUSE,60 FEET RD,, MUMBAI, MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734892200,"product":"LINACLOTIDE (LE)","address":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL","city":"HYDERABAD, AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"DUBAI","customer":"GULF AGENCY COMPANY DUBAI LLC","customerCountry":"UNITED ARAB EMIRATES","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"871.2","totalValueFC":"86305","currency":"USD","unitRateINR":73332.519400000005,"date":"23-Dec-2024","totalValueINR":"7333251.94","totalValueInUsd":"86305","indian_port":"Hyderabad Air","hs_no":"29379020","bill_no":"6688482","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"UNITED ARAB EMIRATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL, HYDERABAD, AP","customerAddress":""}]
    19-Feb-2021
    23-Dec-2024
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    Drugs in Development

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    AbbVie Submits Supplemental New Drug Application to U.S. FDA to Support New Indication of LINZESS® (linaclotide) for Functional Constipation in Childre...

    Details:

    Linaclotide is a guanylate cyclase-C (GC-C) agonist that is thought to work in two ways based on nonclinical studies. Linaclotide binds to the GC-C receptor locally within the intestinal epithelium.


    Lead Product(s): Linaclotide

    Therapeutic Area: Gastroenterology Brand Name: Linzess

    Study Phase: Phase IIIProduct Type: Peptide

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 16, 2022

    Abbvie Company Banner

    01

    AbbVie Inc

    U.S.A
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    Lead Product(s) : Linaclotide

    Therapeutic Area : Gastroenterology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    AbbVie Submits Supplemental New Drug Application to U.S. FDA to Support New Indication of LINZESSÂ...

    Details : Linaclotide is a guanylate cyclase-C (GC-C) agonist that is thought to work in two ways based on nonclinical studies. Linaclotide binds to the GC-C receptor locally within the intestinal epithelium.

    Product Name : Linzess

    Product Type : Peptide

    Upfront Cash : Not Applicable

    December 16, 2022

    Abbvie Company Banner

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    AbbVie to Showcase Depth of Gastroenterology Portfolio and Pipeline at Digestive Disease Week®

    Details:

    Total of 27 abstracts AbbVie leadership in advancing research and standard of care across multiple gastroenterological condition, also presentations include analyses of Phase 3 study programs for RINVOQ (upadacitinib) in ulcerative colitis and risankizumab in Crohn's disease.


    Lead Product(s): Linaclotide

    Therapeutic Area: Gastroenterology Brand Name: Linzess

    Study Phase: ApprovedProduct Type: Peptide

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 16, 2022

    Abbvie Company Banner

    02

    AbbVie Inc

    U.S.A
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    Lead Product(s) : Linaclotide

    Therapeutic Area : Gastroenterology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    AbbVie to Showcase Depth of Gastroenterology Portfolio and Pipeline at Digestive Disease Week®

    Details : Total of 27 abstracts AbbVie leadership in advancing research and standard of care across multiple gastroenterological condition, also presentations include analyses of Phase 3 study programs for RINVOQ (upadacitinib) in ulcerative colitis and risankizum...

    Product Name : Linzess

    Product Type : Peptide

    Upfront Cash : Not Applicable

    May 16, 2022

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    Allergan keeps Linzess generics out until 2029 with Teva settlement

    Details:

    Pursuant to the terms of the settlement, Ironwood and Allergan will grant Teva a license to market its 145 mcg and 290 mcg generic version of LINZESS in U.S.


    Lead Product(s): Linaclotide

    Therapeutic Area: Gastroenterology Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Peptide

    Sponsor: Teva Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement January 23, 2020

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    Allergan Aesthetics

    U.S.A
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    Lead Product(s) : Linaclotide

    Therapeutic Area : Gastroenterology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Teva Pharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Allergan keeps Linzess generics out until 2029 with Teva settlement

    Details : Pursuant to the terms of the settlement, Ironwood and Allergan will grant Teva a license to market its 145 mcg and 290 mcg generic version of LINZESS in U.S.

    Product Name : Undisclosed

    Product Type : Peptide

    Upfront Cash : Undisclosed

    January 23, 2020

    Abbvie CB

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    Ironwood Pharmaceuticals Announces FDA Approval Of New Indication For Linzess (Linaclotide) For The Treatment Of Functional Constipation In Pediatric Pa...

    Details:

    Linzess (linaclotide) is the first and only FDA-approved prescription therapy for irritable bowel syndrome with constipation and chronic idiopathic constipation (CIC) in adults and functional constipation (FC) in children and adolescents 6 to 17 years of age.


    Lead Product(s): Linaclotide

    Therapeutic Area: Gastroenterology Brand Name: Linzess

    Study Phase: ApprovedProduct Type: Peptide

    Sponsor: AbbVie Inc

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 12, 2023

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    Ironwood Pharmaceuticals

    U.S.A
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    Ironwood Pharmaceuticals

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    Lead Product(s) : Linaclotide

    Therapeutic Area : Gastroenterology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : AbbVie Inc

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Ironwood Pharmaceuticals Announces FDA Approval Of New Indication For Linzess (Linaclotide) For Th...

    Details : Linzess (linaclotide) is the first and only FDA-approved prescription therapy for irritable bowel syndrome with constipation and chronic idiopathic constipation (CIC) in adults and functional constipation (FC) in children and adolescents 6 to 17 years of...

    Product Name : Linzess

    Product Type : Peptide

    Upfront Cash : Not Applicable

    June 12, 2023

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    Ironwood Pharmaceuticals Announces FDA Filing Acceptance and Priority Review of Supplemental New Drug Application for Linzess® (linaclotide) for Functi...

    Details:

    Linzess (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Activation of GC-C results in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. It is being developed for IBS-C or CIC.


    Lead Product(s): Linaclotide

    Therapeutic Area: Gastroenterology Brand Name: Linzess

    Study Phase: Phase IIIProduct Type: Peptide

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 13, 2023

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    Ironwood Pharmaceuticals

    U.S.A
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    Ironwood Pharmaceuticals

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    Lead Product(s) : Linaclotide

    Therapeutic Area : Gastroenterology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Ironwood Pharmaceuticals Announces FDA Filing Acceptance and Priority Review of Supplemental New D...

    Details : Linzess (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Activation of GC-C results in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. It is being developed for IB...

    Product Name : Linzess

    Product Type : Peptide

    Upfront Cash : Not Applicable

    February 13, 2023

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    Ironwood Pharmaceuticals Reports Positive Topline Data from Phase III Trial of LINZESS® (linaclotide) in Pediatric Patients Aged 6-17 with Functional C...

    Details:

    The trial met its primary and secondary endpoints, demonstrating that Linzess (linaclotide) improved frequency of spontaneous bowl movements (SBM) and stool consistency.


    Lead Product(s): Linaclotide

    Therapeutic Area: Gastroenterology Brand Name: Linzess

    Study Phase: Phase IIIProduct Type: Peptide

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 06, 2022

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    06

    Ironwood Pharmaceuticals

    U.S.A
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    Ironwood Pharmaceuticals

    U.S.A
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    Lead Product(s) : Linaclotide

    Therapeutic Area : Gastroenterology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Ironwood Pharmaceuticals Reports Positive Topline Data from Phase III Trial of LINZESS® (linaclot...

    Details : The trial met its primary and secondary endpoints, demonstrating that Linzess (linaclotide) improved frequency of spontaneous bowl movements (SBM) and stool consistency.

    Product Name : Linzess

    Product Type : Peptide

    Upfront Cash : Not Applicable

    September 06, 2022

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    Ironwood Pharmaceuticals to Present New IW-3300 and Linaclotide Data at Digestive Disease Week® 2022

    Details:

    Linzess (linaclotide) is a guanylate cyclase-C (GC-C) agonist that is thought to work in two ways based on nonclinical studies. Linaclotide binds to the GC-C receptor locally, within the intestinal epithelium.


    Lead Product(s): Linaclotide

    Therapeutic Area: Gastroenterology Brand Name: Linzess

    Study Phase: ApprovedProduct Type: Peptide

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 09, 2022

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    07

    Ironwood Pharmaceuticals

    U.S.A
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    Organic Process R&D
    Not Confirmed

    Ironwood Pharmaceuticals

    U.S.A
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    Lead Product(s) : Linaclotide

    Therapeutic Area : Gastroenterology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Ironwood Pharmaceuticals to Present New IW-3300 and Linaclotide Data at Digestive Disease Week® 2...

    Details : Linzess (linaclotide) is a guanylate cyclase-C (GC-C) agonist that is thought to work in two ways based on nonclinical studies. Linaclotide binds to the GC-C receptor locally, within the intestinal epithelium.

    Product Name : Linzess

    Product Type : Peptide

    Upfront Cash : Not Applicable

    May 09, 2022

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    Ironwood Pharmaceuticals Announces Agreement with Teva Involving LINZESS® (linaclotide) 72 mcg Dosage Strength

    Details:

    Ironwood and AbbVie have reached an agreement with Teva Pharmaceuticals providing a license to Teva's abbreviated new drug application seeking approval to market a generic version of 72 mcg LINZESS® (linaclotide) prior to the expiration of the companies' applicable patents.


    Lead Product(s): Linaclotide

    Therapeutic Area: Gastroenterology Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Peptide

    Sponsor: Teva Pharmaceutical Industries

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement May 26, 2021

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    08

    Ironwood Pharmaceuticals

    U.S.A
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    Not Confirmed

    Ironwood Pharmaceuticals

    U.S.A
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    Lead Product(s) : Linaclotide

    Therapeutic Area : Gastroenterology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Teva Pharmaceutical Industries

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Ironwood Pharmaceuticals Announces Agreement with Teva Involving LINZESS® (linaclotide) 72 mcg Do...

    Details : Ironwood and AbbVie have reached an agreement with Teva Pharmaceuticals providing a license to Teva's abbreviated new drug application seeking approval to market a generic version of 72 mcg LINZESS® (linaclotide) prior to the expiration of the companies...

    Product Name : Undisclosed

    Product Type : Peptide

    Upfront Cash : Undisclosed

    May 26, 2021

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    More Than a Third of Surveyed IBS-C Patient's Symptoms Worsened During COVID-19 According Findings Presented by Ironwood Pharma

    Details:

    Linaclotide binds to the GC-C receptor locally, within the intestinal epithelium. Activation of GC-C results in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine.


    Lead Product(s): Linaclotide

    Therapeutic Area: Gastroenterology Brand Name: Linzess

    Study Phase: ApprovedProduct Type: Peptide

    Sponsor: Allergan Aesthetics

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 24, 2021

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    Ironwood Pharmaceuticals

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    Lead Product(s) : Linaclotide

    Therapeutic Area : Gastroenterology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Allergan Aesthetics

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    More Than a Third of Surveyed IBS-C Patient's Symptoms Worsened During COVID-19 According Findings...

    Details : Linaclotide binds to the GC-C receptor locally, within the intestinal epithelium. Activation of GC-C results in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine.

    Product Name : Linzess

    Product Type : Peptide

    Upfront Cash : Not Applicable

    May 24, 2021

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    Ironwood and AbbVie Report Top-line Phase II Data for MD-7246 in Patients with Abdominal Pain Associated with IBS-D

    Details:

    The Phase II trial did not meet its primary or key secondary endpoints. Based on these findings, Ironwood and AbbVie plan to discontinue the development of MD-7246.


    Lead Product(s): Linaclotide

    Therapeutic Area: Neurology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 27, 2020

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    Ironwood Pharmaceuticals

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    Lead Product(s) : Linaclotide

    Therapeutic Area : Neurology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Ironwood and AbbVie Report Top-line Phase II Data for MD-7246 in Patients with Abdominal Pain Asso...

    Details : The Phase II trial did not meet its primary or key secondary endpoints. Based on these findings, Ironwood and AbbVie plan to discontinue the development of MD-7246.

    Product Name : Undisclosed

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    May 27, 2020

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - CAPSULE;ORAL - 145MCG

    USFDA APPLICATION NUMBER - 202811

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    DOSAGE - CAPSULE;ORAL - 290MCG

    USFDA APPLICATION NUMBER - 202811

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    DOSAGE - CAPSULE;ORAL - 72MCG

    USFDA APPLICATION NUMBER - 202811

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    ABOUT THIS PAGE

    Looking for 851199-59-2 / Linaclotide API manufacturers, exporters & distributors?

    Linaclotide manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Linaclotide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Linaclotide manufacturer or Linaclotide supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Linaclotide manufacturer or Linaclotide supplier.

    PharmaCompass also assists you with knowing the Linaclotide API Price utilized in the formulation of products. Linaclotide API Price is not always fixed or binding as the Linaclotide Price is obtained through a variety of data sources. The Linaclotide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Linaclotide

    Synonyms

    Linzess, 851199-59-2, Chebi:68551, Md-1100, Constella, Cys cys glu tyr cys cys asn pro ala cys thr gly cys tyr (disulfide bridge: 1-6; 2-10; 5-13)

    Cas Number

    851199-59-2

    About Linaclotide

    Linaclotide is a synthetic, fourteen amino acid peptide and agonist of intestinal guanylate cyclase type C (GC-C), which is structurally related to the guanylin peptide family, with secretagogue, analgesic and laxative activities. Upon oral administration, linaclotide binds to and activates GC-C receptors located on the luminal surface of the intestinal epithelium. This increases the concentration of intracellular cyclic guanosine monophosphate (cGMP), which is derived from guanosine triphosphate (GTP). cGMP activates the cystic fibrosis transmembrane conductance regulator (CFTR) and stimulates the secretion of chloride and bicarbonate into the intestinal lumen. This promotes sodium excretion into the lumen and results in increased intestinal fluid secretion. This ultimately accelerates GI transit of intestinal contents, improves bowel movement and relieves constipation. Increased extracellular cGMP levels may also exert an antinociceptive effect, through an as of yet not fully elucidated mechanism, that may involve modulation of nociceptors found on colonic afferent pain fibers. Linaclotide is minimally absorbed from the GI tract.

    Linaclotide Manufacturers

    A Linaclotide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Linaclotide, including repackagers and relabelers. The FDA regulates Linaclotide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Linaclotide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Linaclotide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Linaclotide Suppliers

    A Linaclotide supplier is an individual or a company that provides Linaclotide active pharmaceutical ingredient (API) or Linaclotide finished formulations upon request. The Linaclotide suppliers may include Linaclotide API manufacturers, exporters, distributors and traders.

    click here to find a list of Linaclotide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Linaclotide USDMF

    A Linaclotide DMF (Drug Master File) is a document detailing the whole manufacturing process of Linaclotide active pharmaceutical ingredient (API) in detail. Different forms of Linaclotide DMFs exist exist since differing nations have different regulations, such as Linaclotide USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Linaclotide DMF submitted to regulatory agencies in the US is known as a USDMF. Linaclotide USDMF includes data on Linaclotide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Linaclotide USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Linaclotide suppliers with USDMF on PharmaCompass.

    Linaclotide JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Linaclotide Drug Master File in Japan (Linaclotide JDMF) empowers Linaclotide API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Linaclotide JDMF during the approval evaluation for pharmaceutical products. At the time of Linaclotide JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Linaclotide suppliers with JDMF on PharmaCompass.

    Linaclotide WC

    A Linaclotide written confirmation (Linaclotide WC) is an official document issued by a regulatory agency to a Linaclotide manufacturer, verifying that the manufacturing facility of a Linaclotide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Linaclotide APIs or Linaclotide finished pharmaceutical products to another nation, regulatory agencies frequently require a Linaclotide WC (written confirmation) as part of the regulatory process.

    click here to find a list of Linaclotide suppliers with Written Confirmation (WC) on PharmaCompass.

    Linaclotide NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Linaclotide as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Linaclotide API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Linaclotide as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Linaclotide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Linaclotide NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Linaclotide suppliers with NDC on PharmaCompass.

    Linaclotide GMP

    Linaclotide Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Linaclotide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Linaclotide GMP manufacturer or Linaclotide GMP API supplier for your needs.

    Linaclotide CoA

    A Linaclotide CoA (Certificate of Analysis) is a formal document that attests to Linaclotide's compliance with Linaclotide specifications and serves as a tool for batch-level quality control.

    Linaclotide CoA mostly includes findings from lab analyses of a specific batch. For each Linaclotide CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Linaclotide may be tested according to a variety of international standards, such as European Pharmacopoeia (Linaclotide EP), Linaclotide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Linaclotide USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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