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    Chemistry

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    Also known as: Exenatide, Exendin-4, Exendin 4, 141758-74-9, Chebi:64073, Heloderma suspectum gila monster exendin-4
    Molecular Formula
    C184H282N50O60S
    Molecular Weight
    4187  g/mol
    InChI Key
    HTQBXNHDCUEHJF-URRANESESA-N
    Exenatide
    A synthetic form of exendin-4, a 39-amino acid peptide isolated from the venom of the Gila monster lizard (Heloderma suspectum). Exenatide increases CYCLIC AMP levels in pancreatic acinar cells and acts as a GLUCAGON-LIKE PEPTIDE-1 RECEPTOR (GLP-1) agonist and incretin mimetic, enhancing insulin secretion in response to increased glucose levels; it also suppresses inappropriate glucagon secretion and slows gastric emptying. It is used an anti-diabetic and anti-obesity agent.
    1 2D Structure

    Exenatide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (4S)-5-[[2-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-6-amino-1-[[(2S)-5-amino-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-6-amino-1-[[(2S)-4-amino-1-[[2-[[2-[(2S)-2-[[(2S)-1-[[(2S)-1-[[2-[[(2S)-1-[(2S)-2-[(2S)-2-[(2S)-2-[[(2S)-1-amino-3-hydroxy-1-oxopropan-2-yl]carbamoyl]pyrrolidine-1-carbonyl]pyrrolidine-1-carbonyl]pyrrolidin-1-yl]-1-oxopropan-2-yl]amino]-2-oxoethyl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-3-hydroxy-1-oxopropan-2-yl]carbamoyl]pyrrolidin-1-yl]-2-oxoethyl]amino]-2-oxoethyl]amino]-1,4-dioxobutan-2-yl]amino]-1-oxohexan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-4-carboxy-1-oxobutan-2-yl]amino]-3-methyl-1-oxopentan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-5-carbamimidamido-1-oxopentan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-1-oxopropan-2-yl]amino]-4-carboxy-1-oxobutan-2-yl]amino]-4-carboxy-1-oxobutan-2-yl]amino]-4-carboxy-1-oxobutan-2-yl]amino]-4-methylsulfanyl-1-oxobutan-2-yl]amino]-1,5-dioxopentan-2-yl]amino]-1-oxohexan-2-yl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-carboxy-1-oxopropan-2-yl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-3-hydroxy-1-oxobutan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-3-hydroxy-1-oxobutan-2-yl]amino]-2-oxoethyl]amino]-4-[[2-[[(2S)-2-amino-3-(1H-imidazol-4-yl)propanoyl]amino]acetyl]amino]-5-oxopentanoic acid
    2.1.2 InChI
    InChI=1S/C184H282N50O60S/c1-16-94(10)147(178(289)213-114(52-58-144(257)258)163(274)218-121(73-101-77-195-105-39-24-23-38-103(101)105)168(279)215-116(68-90(2)3)165(276)205-107(41-26-28-61-186)158(269)219-122(75-134(189)243)154(265)198-79-135(244)196-83-139(248)231-63-30-43-129(231)175(286)225-127(87-238)174(285)223-125(85-236)155(266)200-80-136(245)202-96(12)181(292)233-65-32-45-131(233)183(294)234-66-33-46-132(234)182(293)232-64-31-44-130(232)176(287)222-124(84-235)150(190)261)229-170(281)119(71-99-34-19-17-20-35-99)217-166(277)117(69-91(4)5)214-159(270)108(42-29-62-194-184(191)192)212-177(288)146(93(8)9)228-151(262)95(11)203-156(267)111(49-55-141(251)252)208-161(272)112(50-56-142(253)254)209-162(273)113(51-57-143(255)256)210-164(275)115(59-67-295-15)211-160(271)110(47-53-133(188)242)207-157(268)106(40-25-27-60-185)206-172(283)126(86-237)224-167(278)118(70-92(6)7)216-169(280)123(76-145(259)260)220-173(284)128(88-239)226-180(291)149(98(14)241)230-171(282)120(72-100-36-21-18-22-37-100)221-179(290)148(97(13)240)227-138(247)82-199-153(264)109(48-54-140(249)250)204-137(246)81-197-152(263)104(187)74-102-78-193-89-201-102/h17-24,34-39,77-78,89-98,104,106-132,146-149,195,235-241H,16,25-33,40-76,79-88,185-187H2,1-15H3,(H2,188,242)(H2,189,243)(H2,190,261)(H,193,201)(H,196,244)(H,197,263)(H,198,265)(H,199,264)(H,200,266)(H,202,245)(H,203,267)(H,204,246)(H,205,276)(H,206,283)(H,207,268)(H,208,272)(H,209,273)(H,210,275)(H,211,271)(H,212,288)(H,213,289)(H,214,270)(H,215,279)(H,216,280)(H,217,277)(H,218,274)(H,219,269)(H,220,284)(H,221,290)(H,222,287)(H,223,285)(H,224,278)(H,225,286)(H,226,291)(H,227,247)(H,228,262)(H,229,281)(H,230,282)(H,249,250)(H,251,252)(H,253,254)(H,255,256)(H,257,258)(H,259,260)(H4,191,192,194)/t94?,95-,96-,97?,98?,104-,106-,107-,108-,109-,110-,111-,112-,113-,114-,115-,116-,117-,118-,119-,120-,121-,122-,123-,124-,125-,126-,127-,128-,129-,130-,131-,132-,146-,147-,148-,149-/m0/s1
    2.1.3 InChI Key
    HTQBXNHDCUEHJF-URRANESESA-N
    2.1.4 Canonical SMILES
    CCC(C)C(C(=O)NC(CCC(=O)O)C(=O)NC(CC1=CNC2=CC=CC=C21)C(=O)NC(CC(C)C)C(=O)NC(CCCCN)C(=O)NC(CC(=O)N)C(=O)NCC(=O)NCC(=O)N3CCCC3C(=O)NC(CO)C(=O)NC(CO)C(=O)NCC(=O)NC(C)C(=O)N4CCCC4C(=O)N5CCCC5C(=O)N6CCCC6C(=O)NC(CO)C(=O)N)NC(=O)C(CC7=CC=CC=C7)NC(=O)C(CC(C)C)NC(=O)C(CCCNC(=N)N)NC(=O)C(C(C)C)NC(=O)C(C)NC(=O)C(CCC(=O)O)NC(=O)C(CCC(=O)O)NC(=O)C(CCC(=O)O)NC(=O)C(CCSC)NC(=O)C(CCC(=O)N)NC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(CC(C)C)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CC8=CC=CC=C8)NC(=O)C(C(C)O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)CNC(=O)C(CC9=CNC=N9)N
    2.1.5 Isomeric SMILES
    CCC(C)[C@@H](C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CC1=CNC2=CC=CC=C21)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(=O)N)C(=O)NCC(=O)NCC(=O)N3CCC[C@H]3C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N4CCC[C@H]4C(=O)N5CCC[C@H]5C(=O)N6CCC[C@H]6C(=O)N[C@@H](CO)C(=O)N)NC(=O)[C@H](CC7=CC=CC=C7)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](C(C)C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(=O)N)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@H](C(C)O)NC(=O)[C@H](CC8=CC=CC=C8)NC(=O)[C@H](C(C)O)NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@H](CC9=CNC=N9)N
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Ac 2993

    2. Ac 2993 Lar

    3. Bydureon

    4. Byetta

    5. Ex4 Peptide

    6. Exenatide

    7. Exendin 4

    8. Exendin-4

    9. Itca 650

    10. Peptide, Ex4

    2.2.2 Depositor-Supplied Synonyms

    1. Exenatide

    2. Exendin-4

    3. Exendin 4

    4. 141758-74-9

    5. Chebi:64073

    6. Heloderma Suspectum Gila Monster Exendin-4

    7. H-his-gly-glu-gly-xithr-phe-xithr-ser-asp-leu-ser-lys-gln-met-glu-glu-glu-ala-val-arg-leu-phe-xiile-glu-trp-leu-lys-asn-gly-gly-pro-ser-ser-gly-ala-pro-pro-pro-ser-nh2

    8. His-gly-glu-gly-thr-phe-thr-ser-asp-leu-ser-lys-gln-met-glu-glu-glu-ala-val-arg-leu-phe-ile-glu-trp-leu-lys-asn-gly-gly-pro-ser-ser-gly-ala-pro-pro-pro-ser-nh2

    2.3 Create Date
    2012-04-02
    3 Chemical and Physical Properties
    Molecular Weight 4187 g/mol
    Molecular Formula C184H282N50O60S
    XLogP3-21
    Hydrogen Bond Donor Count58
    Hydrogen Bond Acceptor Count66
    Rotatable Bond Count135
    Exact Mass4185.0306624 g/mol
    Monoisotopic Mass4184.0273075 g/mol
    Topological Polar Surface Area1780 Ų
    Heavy Atom Count295
    Formal Charge0
    Complexity10300
    Isotope Atom Count0
    Defined Atom Stereocenter Count34
    Undefined Atom Stereocenter Count3
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Therapeutic Uses

    Hypoglycemic Agents

    National Library of Medicine's Medical Subject Headings. Exenatide. Online file (MeSH, 2014). Available from, as of April 30 2014: https://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html

    Byetta is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus /Included in US product label/

    NIH; DailyMed. Current Medication Information for Byetta (Exenatide) Injection (Revised: February 2013). Available from, as of July 18, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=751747da-7c1f-41ad-b1a6-a6d920f70599

    Bydureon is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Bydureon is an extended-release formulation of exenatide. Do not coadminister with Byetta. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Bydureon (Exenatide Extended-release for Injectable Suspension) (Revised: May 2014). Available from, as of July 18, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a1c8ee2a-6a76-435e-ad38-8a9c99046ad9

    Prior treatment with Byetta is not required when initiating Bydureon therapy. If the decision is made to start Bydureon in an appropriate patient already taking Byetta, Byetta should be discontinued. Patients changing from Byetta to Bydureon may experience transient (approximately 2 weeks) elevations in blood glucose concentrations.

    NIH; DailyMed. Current Medication Information for Bydureon (Exenatide Extended-release for Injectable Suspension) (Revised: May 2014). Available from, as of July 18, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a1c8ee2a-6a76-435e-ad38-8a9c99046ad9

    For more Therapeutic Uses (Complete) data for Exenatide (8 total), please visit the HSDB record page.

    4.2 Drug Warning

    /BOXED WARNING/ WARNING: RISK OF THYROID C-CELL TUMORS. Exenatide extended-release causes thyroid C-cell tumors at clinically relevant exposures in rats. It is unknown whether Bydureon causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be determined by clinical or nonclinical studies. Bydureon is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2.

    NIH; DailyMed. Current Medication Information for Bydureon (Exenatide Extended-release for Injectable Suspension) (Revised: May 2014). Available from, as of July 18, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a1c8ee2a-6a76-435e-ad38-8a9c99046ad9

    Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis requiring hospitalization, has been reported during postmarketing experience with exenatide. Persistent, severe abdominal pain, which may be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Most patients who have developed pancreatitis have had at least one other risk factor for acute pancreatitis (e.g., gallstones, severe hypertriglyceridemia, alcohol use) and have required hospitalization. Some patients have developed serious complications including dehydration and renal failure, suspected ileus, phlegmon, and ascites. Acute or worsening pancreatitis has been associated temporally with an increase in exenatide dosage from 5 ug to 10 ug twice daily, the maximum recommended dosage, in some patients. Symptoms of acute pancreatitis (e.g., nausea, vomiting, abdominal pain) recurred upon rechallenge with the drug in several patients; abdominal pain abated after permanent discontinuance of the drug in one patient. Most patients have improved upon discontinuance of exenatide.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014, p. 3214

    The US Food and Drug Administration (FDA) is evaluating unpublished findings suggesting an increased risk of pancreatitis and precancerous cellular changes (pancreatic duct metaplasia) in patients with type 2 diabetes mellitus receiving incretin mimetics (exenatide, liraglutide, sitagliptin, saxagliptin, alogliptin, or linagliptin). These findings are based on examination of a small number of pancreatic tissue specimens taken from patients who died from unspecified causes while receiving an incretin mimetic. FDA has not yet reached any new conclusions about safety risks with incretin mimetics. FDA will notify healthcare professionals of its conclusions and recommendations when the review is complete, or when the agency has additional information to report. FDA states that at this time clinicians should continue to follow the recommendations in the prescribing information for incretin mimetics. The manufacturer states that after initiation of exenatide, and after increases in dosage, patients should be observed carefully for signs and symptoms of acute pancreatitis (e.g., unexplained, persistent severe abdominal pain that may radiate to the back; nausea; vomiting; elevated serum amylase or lipase concentrations). If pancreatitis is suspected, therapy with exenatide and other potentially suspect drugs should be promptly discontinued, confirmatory tests performed (e.g., serum amylase or lipase concentrations, radiologic imaging), and appropriate therapy initiated. Exenatide should not be resumed if pancreatitis is confirmed. Exenatide has not been studied in patients with a history of pancreatitis; other antidiabetic therapies should be considered in such patients.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014, p. 3214

    Deterioration of renal function (e.g., increased serum creatinine concentrations, renal impairment/insufficiency, worsened chronic renal failure, acute renal failure sometimes requiring hemodialysis or kidney transplantation) has been reported rarely with exenatide. Some of these events occurred in patients experiencing nausea, vomiting, and/or diarrhea with or without dehydration; these adverse effects may have contributed to development of altered renal function in these patients. Some of these events also occurred in patients receiving exenatide in combination with other agents known to affect renal function or hydration status (e.g., angiotensin-converting enzyme inhibitors, nonsteroidal anti-inflammatory agents, diuretics). Exenatide has not been found to be directly nephrotoxic in preclinical or clinical studies. Renal effects usually have been reversible with supportive treatment and discontinuance of potentially causative agents, including exenatide. Altered renal function may be a consequence of diabetes mellitus, independent of any risk associated with exenatide therapy. Clinicians should closely monitor patients receiving exenatide for signs and symptoms of renal dysfunction and consider discontinuance of the drug if renal dysfunction is suspected and cannot be explained by other causes.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014, p. 3214

    For more Drug Warnings (Complete) data for Exenatide (15 total), please visit the HSDB record page.

    4.3 Drug Indication

    Exenatide is indicated for improving glycemic control in adults with type 2 diabetes mellitus along with diet and exercise.

    FDA Label

    Byetta is indicated for treatment of type-2 diabetes mellitus in combination with:

    - metformin;

    - sulphonylureas;

    - thiazolidinediones;

    - metformin and a sulphonylurea;

    - metformin and a thiazolidinedione;

    in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. Byetta is also indicated as adjunctive therapy to basal insulin with or without metformin and / or pioglitazone in adults who have not achieved adequate glycaemic control with these agents.

    Bydureon is indicated in adults 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control (see section 4. 4, 4. 5 and 5. 1 for available data on different combinations).

    Bydureon is indicated for treatment of type 2 diabetes mellitus in combination with:

    MetforminSulphonylureaThiazolidinedioneMetformin and sulphonylureaMetformin and thiazolidinedionein adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.

    Treatment of type II diabetes mellitus

    Treatment of type II diabetes mellitus

    Treatment of type II diabetes mellitus

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    When patients take exenatide the body's natural response to glucose is modulated. More insulin and less glucagon are released in response to glucose, though in cases of hypoglycemia a normal amount of glucagon is released. Exenatide also slows gastric emptying, leading to a slower and prolonged release of glucose into the systemic circulation. Together these effects prevent hyper and hypoglycemia.

    5.2 MeSH Pharmacological Classification

    Anti-Obesity Agents

    Agents that increase energy expenditure and weight loss by neural and metabolic regulation. (See all compounds classified as Anti-Obesity Agents.)

    Hypoglycemic Agents

    Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)

    Incretins

    Peptides which stimulate INSULIN release from the PANCREATIC BETA CELLS following oral nutrient ingestion, or postprandially. (See all compounds classified as Incretins.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Glucagon-Like Peptide 1 [CS]; Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]; GLP-1 Receptor Agonist [EPC]
    5.4 ATC Code

    A10BJ01

    A10BJ01

    A - Alimentary tract and metabolism

    A10 - Drugs used in diabetes

    A10B - Blood glucose lowering drugs, excl. insulins

    A10BJ - Glucagon-like peptide-1 (glp-1) analogues

    A10BJ01 - Exenatide

    5.5 Absorption, Distribution and Excretion

    Absorption

    Exenatide reaches a peak plasma concentration in 2.1 hours. Because exenatide is administerd subcutaneously, the bioavailability is 1.

    Route of Elimination

    Exenatide is mainly eliminated by glomerular filtration followed by proteolysis before finally being eliminated in the urine.

    Volume of Distribution

    28.3L.

    Clearance

    9.1 L/hour.

    Following a single dose of Bydureon, exenatide is released from the microspheres over approximately 10 weeks. There is an initial period of release of surface-bound exenatide followed by a gradual release of exenatide from the microspheres, which results in two subsequent peaks of exenatide in plasma at around week 2 and week 6 to 7, respectively, representing the hydration and erosion of the microspheres. Following initiation of once every 7 days (weekly) administration of 2 mg Bydureon, gradual increase in the plasma exenatide concentration is observed over 6 to 7 weeks. After 6 to 7 weeks, mean exenatide concentrations of approximately 300 pg/mL were maintained over once every 7 days (weekly) dosing intervals indicating that steady state was achieved.

    NIH; DailyMed. Current Medication Information for Bydureon (Exenatide Extended-release for Injectable Suspension) (Revised: May 2014). Available from, as of July 18, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a1c8ee2a-6a76-435e-ad38-8a9c99046ad9

    Nonclinical studies have shown that exenatide is predominantly eliminated by glomerular filtration with subsequent proteolytic degradation. The mean apparent clearance of exenatide in humans is 9.1 L/hr and the mean terminal half-life is 2.4 hr. These pharmacokinetic characteristics of exenatide are independent of the dose. In most individuals, exenatide concentrations are measurable for approximately 10 hr post-dose.

    NIH; DailyMed. Current Medication Information for Byetta (Exenatide) Injection (Revised: February 2013). Available from, as of July 21, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=751747da-7c1f-41ad-b1a6-a6d920f70599

    The mean apparent volume of distribution of exenatide following SC administration of a single dose of Byetta is 28.3 L.

    NIH; DailyMed. Current Medication Information for Byetta (Exenatide) Injection (Revised: February 2013). Available from, as of July 21, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=751747da-7c1f-41ad-b1a6-a6d920f70599

    Following SC administration to patients with type 2 diabetes, exenatide reaches median peak plasma concentrations in 2.1 hr. The mean peak exenatide concentration (Cmax) was 211 pg/mL and overall mean area under the time-concentration curve (AUC0-inf) was 1036 pg hr/mL following SC administration of a 10 ug dose of Byetta. Exenatide exposure (AUC) increased proportionally over the therapeutic dose range of 5 ug to 10 ug. The Cmax values increased less than proportionally over the same range. Similar exposure is achieved with SC administration of Byetta in the abdomen, thigh, or upper arm.

    NIH; DailyMed. Current Medication Information for Byetta (Exenatide) Injection (Revised: February 2013). Available from, as of July 21, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=751747da-7c1f-41ad-b1a6-a6d920f70599

    For more Absorption, Distribution and Excretion (Complete) data for Exenatide (6 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Exenatide is filtered through the glomerulus before being degraded to smaller peptides and amino acids by dipeptidyl peptidase-4, metalloproteases, endopeptidase 24-11, amino proteases, and serine proteases. It is currently believed that the metalloproteases are responsible for most of the degradation of exenatide. Exenatide is metabolised to small peptides <3 amino acids in length by enzymes in the kidney.

    5.7 Biological Half-Life

    2.4 hours

    Terminal half life varied from 18 minutes in mice up to 114 minutes in rats.

    European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), European Public Assessment Report (EPAR): Byetta (Exenatide), Scientific Discussion p.7 (2006). Available from, as of July 22, 2014: https://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000698/WC500051842.pdf

    Mean terminal half-life /in humans/ is 2.4 hr

    NIH; DailyMed. Current Medication Information for Byetta (Exenatide) Injection (Revised: February 2013). Available from, as of July 21, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=751747da-7c1f-41ad-b1a6-a6d920f70599

    5.8 Mechanism of Action

    Exenatide is a human glucacon-like peptide-1(GLP-1) receptor agonist. By activating this receptor, insulin secretion is increased and glucagon secretion is decreased in a glucose dependant manner. Exenatide also slows gastric emptying and decreases food intake. These effects work synergistically to improve glycemic control by reducing the likelihood of hyper and hypoglycemia.

    Islet amyloid, formed by aggregation of human islet amyloid polypeptide (hIAPP), is associated with beta cell death in type 2 diabetes as well as in cultured and transplanted human islets. Impaired prohIAPP processing due to beta cell dysfunction is implicated in hIAPP aggregation. We examined whether the glucagon-like peptide-1 receptor (GLP-1R) agonist exenatide can restore impaired prohIAPP processing and reduce hIAPP aggregation in cultured human islets and preserve beta cell function/mass during culture conditions used in clinical islet transplantation. METHODS: Isolated human islets (n = 10 donors) were cultured with or without exenatide in normal or elevated glucose for 2 or 7 days. Beta cell apoptosis, proliferation, mass, function, cJUN N-terminal kinase (JNK) and protein kinase B (PKB) activation and amyloid formation were assessed. ProhIAPP, its intermediates and mature hIAPP were detected. Exenatide-treated islets had markedly lower JNK and caspase-3 activation and beta cell apoptosis, resulting in higher beta/alpha cell ratio and beta cell area than non-treated cultured islets. Exenatide improved beta cell function, manifested as higher insulin response to glucose and insulin content, compared with non-treated cultured islets. Phospho-PKB immunoreactivity was detectable in exenatide-treated but not untreated cultured islets. Islet culture caused impaired prohIAPP processing with decreased mature hIAPP and increased NH(2)-terminally unprocessed prohIAPP levels resulting in higher release of immature hIAPP. Exenatide restored prohIAPP processing and reduced hIAPP aggregation in cultured islets. Exenatide treatment enhances survival and function of cultured human islets and restores impaired prohIAPP processing in normal and elevated glucose conditions thereby reducing hIAPP aggregation. GLP-1R agonists may preserve beta cells in conditions associated with islet amyloid formation.

    PMID:23262664 Park YJ et al; Diabetologia 56 (3): 508-19 (2013)

    Incretins, such as glucagon-like peptide-1 (GLP-1), enhance glucose-dependent insulin secretion and exhibit other antihyperglycemic actions following their release into the circulation from the gut. Byetta is a GLP-1 receptor agonist that enhances glucose-dependent insulin secretion by the pancreatic beta-cell, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying. The amino acid sequence of exenatide partially overlaps that of human GLP-1. Exenatide has been shown to bind and activate the human GLP-1 receptor in vitro. This leads to an increase in both glucose-dependent synthesis of insulin, and in vivo secretion of insulin from pancreatic beta cells, by mechanisms involving cyclic AMP and/or other intracellular signaling pathways.

    NIH; DailyMed. Current Medication Information for Byetta (Exenatide) Injection (Revised: February 2013). Available from, as of July 21, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=751747da-7c1f-41ad-b1a6-a6d920f70599

    It has been reported that GLP-1 agonist exenatide (exendin-4) decreases blood pressure. The dose-dependent vasodilator effect of exendin-4 has previously been demonstrated, although the precise mechanism is not thoroughly described. /The aim of this study is/ to provide in vitro evidence for the hypothesis that exenatide may decrease central (aortic) blood pressure involving three gasotransmitters, namely nitric oxide (NO) carbon monoxide (CO), and hydrogen sulfide (H2S). ... The vasoactive effect of exenatide on isolated thoracic aortic rings of adult rats /was determined/. Two millimetre-long vessel segments were placed in a wire myograph and preincubated with inhibitors of the enzymes producing the three gasotransmitters, with inhibitors of reactive oxygen species formation, prostaglandin synthesis, inhibitors of protein kinases, potassium channels or with an inhibitor of the Na+/Ca2+-exchanger. Exenatide caused dose-dependent relaxation of rat thoracic aorta, which was evoked via the GLP-1 receptor and was mediated mainly by H2S but also by NO and CO. Prostaglandins and superoxide free radical also play a part in the relaxation. Inhibition of soluble guanylyl cyclase significantly diminished vasorelaxation. We found that ATP-sensitive-, voltage-gated- and calcium-activated large-conductance potassium channels are also involved in the vasodilation, but that seemingly the inhibition of the KCNQ-type voltage-gated potassium channels resulted in the most remarkable decrease in the rate of vasorelaxation. Inhibition of the Na+/Ca2+-exchanger abolished most of the vasodilation. Exenatide induces vasodilation in rat thoracic aorta with the contribution of all three gasotransmitters. /This provides/ in vitro evidence for the potential ability of exenatide to lower central (aortic) blood pressure, which could have relevant clinical importance.

    PMID:24693878 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3976540 Selley E et al; Cardiovasc Diabetol. 2014 Apr 2;13:69. doi: 10.1186/1475-2840-13-69

    Glucagon-like peptide-1 receptor (GLP-1R) activation in the nucleus accumbens (NAc) core is pharmacologically and physiologically relevant for regulating palatable food intake. /An assessment was made/ whether GLP-1R signaling in the NAc core of rats modulates GABAergic medium spiny neurons (MSNs) through presynaptic-glutamatergic and/or presynaptic-dopaminergic signaling to control feeding. First, ex vivo fast-scan cyclic voltammetry showed that the GLP-1R agonist exendin-4 (Ex-4) does not alter dopamine release in the NAc core. Instead, support for a glutamatergic mechanism was provided by ex vivo electrophysiological analyses showing that Ex-4 activates presynaptic GLP-1Rs in the NAc core to increase the activity of MSNs via a glutamatergic, AMPA/kainate receptor-mediated mechanism, indicated by increased mEPSC frequency and decreased paired pulse ratio in core MSNs. Only a small, direct excitatory effect on MSNs by Ex-4 was observed, suggesting that the contribution of postsynaptic GLP-1R to MSN activity is minimal. The behavioral relevance of the electrophysiological data was confirmed by the finding that intracore injection of the AMPA/kainate receptor antagonist CNQX attenuated the ability of NAc core GLP-1R activation by Ex-4 microinjection to suppress food intake and body weight gain; in contrast, intracore NMDA receptor blockade by AP-5 did not inhibit the energy balance effects of NAc core Ex-4. Together, these data provide evidence for a novel glutamatergic, but not dopaminergic, mechanism by which NAc core GLP-1Rs promote negative energy balance.

    PMID:24828651 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4019807 Mietlicki-Baase EG et al; J Neurosci 34 (20): 6985-92 (2014)

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    ABOUT THIS PAGE

    Exenatide Manufacturers

    A Exenatide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Exenatide, including repackagers and relabelers. The FDA regulates Exenatide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Exenatide 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 Exenatide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Exenatide Suppliers

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

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

    Exenatide USDMF

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

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

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

    Exenatide 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 Exenatide Drug Master File in Japan (Exenatide JDMF) empowers Exenatide 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 Exenatide JDMF during the approval evaluation for pharmaceutical products. At the time of Exenatide 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 Exenatide suppliers with JDMF on PharmaCompass.

    Exenatide KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Exenatide Drug Master File in Korea (Exenatide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Exenatide. The MFDS reviews the Exenatide KDMF as part of the drug registration process and uses the information provided in the Exenatide KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Exenatide KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Exenatide API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Exenatide suppliers with KDMF on PharmaCompass.

    Exenatide WC

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

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

    Exenatide 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 Exenatide as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Exenatide 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 Exenatide 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 Exenatide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Exenatide NDC to their finished compounded human drug products, they may choose to do so.

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

    Exenatide GMP

    Exenatide 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 Exenatide 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 Exenatide GMP manufacturer or Exenatide GMP API supplier for your needs.

    Exenatide CoA

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

    Exenatide CoA mostly includes findings from lab analyses of a specific batch. For each Exenatide 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.

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