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    Chemistry

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    Also known as: 179474-81-8, Motegrity, R093877, 4-amino-5-chloro-2,3-dihydro-n-[1-(3-methoxypropyl)-4-piperidinyl]-7-benzofurancarboxamide, 4-amino-5-chloro-n-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydro-1-benzofuran-7-carboxamide, 4-amino-5-chloro-n-(1-(3-methoxypropyl)piperidin-4-yl)-2,3-dihydrobenzofuran-7-carboxamide
    Molecular Formula
    C18H26ClN3O3
    Molecular Weight
    367.9  g/mol
    InChI Key
    ZPMNHBXQOOVQJL-UHFFFAOYSA-N
    FDA UNII
    0A09IUW5TP
    Prucalopride (USAN/INN)
    Prucalopride is a dihydrobenzofurancarboxamide derivative from the benzofurane family that selectively stimulates 5-HT4 receptors and thus, it presents enterokinetic properties. The high selectivity of prucalopride allowed further development as it prevented the cardiac adverse reactions observed due to non-target effects of precedent therapies. Prucalopride was developed by Shire Development LLC and approved for use in Europe in 2009, in Canada on December 7, 2011 and by the FDA on December 17, 2018.
    Prucalopride is a Serotonin-4 Receptor Agonist. The mechanism of action of prucalopride is as a Serotonin 4 Receptor Agonist.
    1 2D Structure

    Prucalopride (USAN/INN)

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    4-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydro-1-benzofuran-7-carboxamide
    2.1.2 InChI
    InChI=1S/C18H26ClN3O3/c1-24-9-2-6-22-7-3-12(4-8-22)21-18(23)14-11-15(19)16(20)13-5-10-25-17(13)14/h11-12H,2-10,20H2,1H3,(H,21,23)
    2.1.3 InChI Key
    ZPMNHBXQOOVQJL-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    COCCCN1CCC(CC1)NC(=O)C2=CC(=C(C3=C2OCC3)N)Cl
    2.2 Other Identifiers
    2.2.1 UNII
    0A09IUW5TP
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 4-amino-5-chloro-n-(1-(3-methoxypropyl)-4-piperidinyl)-2,3-dihydro-1-benzofuran-7-carboxamide

    2. Motegrity

    3. R 093877

    4. R093877

    5. Resolor

    6. Resotran

    7. Resotrans

    2.3.2 Depositor-Supplied Synonyms

    1. 179474-81-8

    2. Motegrity

    3. R093877

    4. 4-amino-5-chloro-2,3-dihydro-n-[1-(3-methoxypropyl)-4-piperidinyl]-7-benzofurancarboxamide

    5. 4-amino-5-chloro-n-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydro-1-benzofuran-7-carboxamide

    6. 4-amino-5-chloro-n-(1-(3-methoxypropyl)piperidin-4-yl)-2,3-dihydrobenzofuran-7-carboxamide

    7. R-093877

    8. 0a09iuw5tp

    9. Chembl117287

    10. 179474-81-8 (free Base)

    11. Resotrans

    12. Unii-0a09iuw5tp

    13. R-93877

    14. Prucalopride [usan:inn:ban]

    15. Prucalopride [mi]

    16. Prucalopride (usan/inn)

    17. Prucalopride [inn]

    18. Prucalopride [usan]

    19. Dsstox_cid_31459

    20. Dsstox_rid_97345

    21. Dsstox_gsid_57670

    22. Schembl16952

    23. Gtpl243

    24. Prucalopride [mart.]

    25. Prucalopride [who-dd]

    26. Prucalopride [ema Epar]

    27. Dtxsid5057670

    28. Chebi:135552

    29. Bcpp000099

    30. Hms3651f04

    31. Hms3748m09

    32. Hms3884p20

    33. Bcp02177

    34. Ex-a1333

    35. Zinc1891034

    36. Tox21_113885

    37. Bdbm50122872

    38. Mfcd09837787

    39. S2875

    40. Akos015951096

    41. Am84628

    42. Ccg-268257

    43. Db06480

    44. Pb31402

    45. 4-amino-5-chloro-2,3-dihydro-n-(1-(3-methoxypropyl)-4-piperidyl)-7-benzofurancarboxamide

    46. Ncgc00253867-01

    47. Ncgc00253867-02

    48. 4-amino-5-chloro-n-(1-(3-methoxypropyl)-4-piperidinyl)-2,3-dihydro-1-benzofuran-7-carboxamide

    49. Ac-23945

    50. As-19549

    51. Hy-14151

    52. Cas-179474-81-8

    53. Ft-0674128

    54. P2467

    55. Sw219198-2

    56. A25458

    57. D09205

    58. Q68484

    59. 474p818

    60. L000891

    61. Sr-01000945275

    62. Sr-01000945275-1

    63. 4-amino-5+k445-chloro-2,3-dihydro-benzofuran-7-carboxylic Acid [1-(3-methoxy-propyl)-piperidin-4-yl]-amide

    64. 4-amino-5-chloro-2,3-dihydro-benzofuran-7-carboxylic Acid [1-(3-methoxy-propyl)-piperidin-4-yl]-amide

    65. 7-benzofurancarboxamide, 4-amino-5-chloro-2,3-dihydro-n-[1-(3-methoxypropyl)-4-piperidinyl]-

    2.4 Create Date
    2005-08-09
    3 Chemical and Physical Properties
    Molecular Weight 367.9 g/mol
    Molecular Formula C18H26ClN3O3
    XLogP32
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count6
    Exact Mass367.1662694 g/mol
    Monoisotopic Mass367.1662694 g/mol
    Topological Polar Surface Area76.8 Ų
    Heavy Atom Count25
    Formal Charge0
    Complexity445
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Indication

    Prucalopride is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. CIC is one of the most common chronic functional gastrointestinal disorders worldwide. The diagnosis of this agent is very hard and it can be confirmed if the patient experience at least two of the following: -Straining during more than 25% of the bowel movements. -Lumpy or hard stools in 25% of the bowel movements. -Sensation of incomplete evacuation in more than 25% of all bowel movements. -Sensation of anorectal blockage or obstruction in more than 25% of the bowel movements. -Manual maneuvers required in more than 25% of the bowel movements. -Fewer than 3 bowel movements per week.

    FDA Label

    Resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    In animal studies, prucalopride induced a dose-dependent stimulation of contractile activity in the proximal colon and inhibition of the contractility in the distal colon. As well it has been shown that prucalopride stimulates and amplifies giant migratory contraction which is the high-amplitude type of contraction that initiates the urge to defecate. Thus, prucalopride not only accelerates the colonic transit but also accelerates gastric emptying and small bowel transit. In supratherapeutic concentrations, prucalopride can be observed to interact with hERG potassium channels and L-type calcium channels. In clinical trials, prucalopride showed to significantly increase the spontaneous bowel movements with a standardized mean difference of about 0.5 after the use of 1 mg when compared with the placebo group. In this studies as well, it was observed a numerical improvement in mean colonic transit time and a significant increase in spontaneous complete bowel movement without marked changes in the anorectal function. In phase III clinical trials, 86% of the tested individuals opted to continue with the open-label study and based on Patients Assessments, 67% of the patients increase more than one point improvement in their satisfaction. In the final set of clinical trials for approval, there was a significant increase in the number of patients that reached over 3 complete spontaneous bowel movements per week when compared with the placebo.

    5.2 MeSH Pharmacological Classification

    Laxatives

    Agents that produce a soft formed stool, and relax and loosen the bowels, typically used over a protracted period, to relieve CONSTIPATION. (See all compounds classified as Laxatives.)

    Serotonin 5-HT4 Receptor Agonists

    Endogenous compounds and drugs that specifically stimulate SEROTONIN 5-HT4 RECEPTORS. (See all compounds classified as Serotonin 5-HT4 Receptor Agonists.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    PRUCALOPRIDE
    5.3.2 FDA UNII
    0A09IUW5TP
    5.3.3 Pharmacological Classes
    Serotonin-4 Receptor Agonist [EPC]; Serotonin 4 Receptor Agonists [MoA]
    5.4 ATC Code

    A06AX05

    A06AX05

    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

    A06AX05 - Prucalopride

    5.5 Absorption, Distribution and Excretion

    Absorption

    Prucalopride is well absorbed and it reaches maximum plasma concentration of 3.79ng/ml with a tmax of 2.77 hours after initial administration. It presents an AUC of 96.5 mn.h/ml. The bioavailability of prucalopride is of over 90% and this bioavailability does not get influenced by the ingestion of food.

    Route of Elimination

    After maximum plasma concentration, prucalopride concentration decline in a biphasic manner. Prucalopride is mainly excreted by the urine, representing 84% of the administered dose while only 13% of the dose is recovered in feces.

    Volume of Distribution

    The mean volume of distribution of prucalopride is registered to be 623 L.

    Clearance

    Prucalopride renal clearance is reported to be of 17 L/h which actually exceeds the glomerular filtration rate of the kidney.

    5.6 Metabolism/Metabolites

    Prucalopride is not extensively metabolized in the body and does not interact with the enzymes of the family of the cytochrome P450 enzymes nor the P glycoprotein. The metabolism of prucalopride only represents 6% of the administered dose and the remaining 94% is found as the unchanged drug. From studies, it was reported the recovery of 8 metabolites being the major metabolite R107504 which is formed after the O-demethylation and oxidation of the resulting alcohol to a carboxylic acid.

    5.7 Biological Half-Life

    The reported half-life of prucalopride is of around 18-20 hours.

    5.8 Mechanism of Action

    Prucalopride acts as a selective stimulator of the 5-HT4 receptors while having no interaction with hERG channel or 5-HT1 receptors which reduces significantly the cardiovascular risk found in other similar drugs. 5-HT4 receptors can be found throughout the gastrointestinal tract primarily in smooth muscle cells, enterochromaffin cells, and myenteric plexus. Its activation produces the release of acetylcholine which is the major excitatory neurotransmitter in the GI tract. Hence, prucalopride stimulates motility by interacting specifically with 5-HT4 receptors in the GI tract which causes a release of acetylcholine and further contraction of the muscle layer of the colon and relaxation of the circular muscle layer leading to the propulsion of luminal content.

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    API | Excipient name

    Prucalopride (USAN/INN)

    Synonyms

    179474-81-8, Motegrity, R093877, 4-amino-5-chloro-2,3-dihydro-n-[1-(3-methoxypropyl)-4-piperidinyl]-7-benzofurancarboxamide, 4-amino-5-chloro-n-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydro-1-benzofuran-7-carboxamide, 4-amino-5-chloro-n-(1-(3-methoxypropyl)piperidin-4-yl)-2,3-dihydrobenzofuran-7-carboxamide

    Cas Number

    179474-81-8

    Unique Ingredient Identifier (UNII)

    0A09IUW5TP

    About Prucalopride (USAN/INN)

    Prucalopride is a dihydrobenzofurancarboxamide derivative from the benzofurane family that selectively stimulates 5-HT4 receptors and thus, it presents enterokinetic properties. The high selectivity of prucalopride allowed further development as it prevented the cardiac adverse reactions observed due to non-target effects of precedent therapies. Prucalopride was developed by Shire Development LLC and approved for use in Europe in 2009, in Canada on December 7, 2011 and by the FDA on December 17, 2018.

    Prucalopride (USAN/INN) Manufacturers

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

    Prucalopride (USAN/INN) Suppliers

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

    Prucalopride (USAN/INN) GMP

    Prucalopride (USAN/INN) 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 Prucalopride (USAN/INN) 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 Prucalopride (USAN/INN) GMP manufacturer or Prucalopride (USAN/INN) GMP API supplier for your needs.

    Prucalopride (USAN/INN) CoA

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

    Prucalopride (USAN/INN) CoA mostly includes findings from lab analyses of a specific batch. For each Prucalopride (USAN/INN) 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.

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