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Chemistry

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Also known as: 1190389-15-1, Krp-114v, Gemtesa, Mk-4618, (s)-n-(4-(((2s,5r)-5-((r)-hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo[1,2-a]pyrimidine-6-carboxamide, M5tse03w5u
Molecular Formula
C26H28N4O3
Molecular Weight
444.5  g/mol
InChI Key
DJXRIQMCROIRCZ-XOEOCAAJSA-N
FDA UNII
M5TSE03W5U

Vibegron
Vibegron is a potent, selective beta-3 adrenergic receptor (3) agonist that relaxes the detrusor smooth muscle of the bladder, thereby increasing bladder capacity. Vibegron was first approved in Japan in September 2018 for the treatment of overactive bladder, a condition associated with distressing symptoms of urge urinary incontinence, urgency, and urinary frequency, and reduced quality of life of patients. On December 23, 2020, vibegron was approved for the same indication in adults. It is available as oral tablets under the market name GEMTESA. Vibegron is the second beta-3 adrenergic agonist approved for the treatment of overactive bladder following [mirabegron], which was approved in 2012. Unlike mirabegron, vibegron is less likely to be associated with drug-drug interactions involving the CYP3A4, 2D6, or 2C9 enzymes.
1 2D Structure

Vibegron

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(6S)-N-[4-[[(2S,5R)-5-[(R)-hydroxy(phenyl)methyl]pyrrolidin-2-yl]methyl]phenyl]-4-oxo-7,8-dihydro-6H-pyrrolo[1,2-a]pyrimidine-6-carboxamide
2.1.2 InChI
InChI=1S/C26H28N4O3/c31-24-14-15-27-23-13-12-22(30(23)24)26(33)29-19-8-6-17(7-9-19)16-20-10-11-21(28-20)25(32)18-4-2-1-3-5-18/h1-9,14-15,20-22,25,28,32H,10-13,16H2,(H,29,33)/t20-,21+,22-,25+/m0/s1
2.1.3 InChI Key
DJXRIQMCROIRCZ-XOEOCAAJSA-N
2.1.4 Canonical SMILES
C1CC(NC1CC2=CC=C(C=C2)NC(=O)C3CCC4=NC=CC(=O)N34)C(C5=CC=CC=C5)O
2.1.5 Isomeric SMILES
C1C[C@@H](N[C@@H]1CC2=CC=C(C=C2)NC(=O)[C@@H]3CCC4=NC=CC(=O)N34)[C@@H](C5=CC=CC=C5)O
2.2 Other Identifiers
2.2.1 UNII
M5TSE03W5U
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Mk-4618

2. N-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide

2.3.2 Depositor-Supplied Synonyms

1. 1190389-15-1

2. Krp-114v

3. Gemtesa

4. Mk-4618

5. (s)-n-(4-(((2s,5r)-5-((r)-hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo[1,2-a]pyrimidine-6-carboxamide

6. M5tse03w5u

7. C26h28n4o3

8. Mk4618

9. (6s)-n-(4-(((2s,5r)-5-((r)-hydroxyphenylmethyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide

10. Pyrrolo(1,2-a)pyrimidine-6-carboxamide, 4,6,7,8-tetrahydro-n-(4-(((2s,5r)-5-((r)-hydroxyphenylmethyl)-2-pyrrolidinyl)methyl)phenyl)-4-oxo-, (6s)-

11. Beova

12. Pyrrolo[1,2-a]pyrimidine-6-carboxamide, 4,6,7,8-tetrahydro-n-[4-[[(2s,5r)-5-[(r)-hydroxyphenylmethyl]-2-pyrrolidinyl]methyl]phenyl]-4-oxo-, (6s)-

13. Vibegron [usan]

14. Vibegron [usan:inn]

15. Unii-m5tse03w5u

16. Vibegronum

17. Beova (tn)

18. Mk 4618

19. Vibegron (jan/usan)

20. Vibegron [inn]

21. Vibegron [jan]

22. Vibegron [who-dd]

23. Vibegron [orange Book]

24. Chembl2107826

25. Schembl11985457

26. Gtpl10100

27. Dtxsid40152299

28. Chebi:142418

29. Ex-a3390

30. Bdbm50146154

31. Mfcd28502057

32. At23148

33. Compound 7 [pmid: 26709102]

34. Db14895

35. Hy-19933

36. Cs-0016926

37. D10433

38. A903957

39. Q27283524

40. (6s)-4,6,7,8-tetrahydro-n-[4-[[(2s,5r)-5-[(r)-hydroxyphenylmethyl]-2-pyrrolidinyl]methyl]phenyl]-4-oxo-pyrrolo[1,2-a]pyrimidine-6-carboxamide

41. (6s)-4,6,7,8-tetrahydro-n-[4-[[(2s,5r)-5-[(r)-hydroxyphenylmethyl]-2-pyrrolidinyl]methyl]phenyl]-4-oxopyrrolo[1,2-a]pyrimidine-6-carboxamide

42. (6s)-n-(4-(((2s,5r)-5-((r)-hydroxy(phenyl)methyl)pyrrolidin-2-yl(methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-

43. (6s)-n-[4-({(2s,5r)-5-[(r)-hydroxy(phenyl)methyl]pyrrolidin-2-yl}methyl)phenyl]-4-oxo-4,6,7,8-tetrahydropyrrolo[1,2-a]pyrimidine-6-carboxamide

44. (6s)-n-[4-[[(2s,5r)-5-[(r)-hydroxy(phenyl)methyl]pyrrolidin-2-yl]methyl]phenyl]-4-oxo-7,8-dihydro-6h-pyrrolo[1,2-a]pyrimidine-6-carboxamide

2.4 Create Date
2009-11-30
3 Chemical and Physical Properties
Molecular Weight 444.5 g/mol
Molecular Formula C26H28N4O3
XLogP31.8
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count5
Rotatable Bond Count6
Exact Mass444.21614077 g/mol
Monoisotopic Mass444.21614077 g/mol
Topological Polar Surface Area94 Ų
Heavy Atom Count33
Formal Charge0
Complexity782
Isotope Atom Count0
Defined Atom Stereocenter Count4
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

Vibegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Vibegron selectivity for beta-3 adrenergic receptors is >9000 times higher than for 1AR or 2AR. Vibegron improves clinical symptoms of overactive bladder by increasing bladder capacity without affecting bladder contraction. It significantly increases the functional bladder volume in a dose-dependent manner, which results in prolongation of the interval between voids. In clinical studies, vibegron inhibited detrusor bladder contractions in a concentration-dependent manner, reduced voiding pressure, and increased bladder compliance. In Japanese clinical studies comprising patients with overactive bladder, vibegron significantly improved the frequency of micturition, urgency, and urgency incontinence episodes.


5.2 Absorption, Distribution and Excretion

Absorption

The mean Tmax is 1-3 hours. Steady-state concentrations are achieved within 7 days of once-daily dosing.


Route of Elimination

In a radiolabeled drug study, approximately 59% of the radiolabeled dose was recovered in feces, in which 54% of that amount was in the unchanged parent drug form. About 20% of the radioactivity was recovered in urine, in which 19% of the amount was in the unchanged form.


Volume of Distribution

The mean apparent volume of distribution is 6304 L. The average blood-to-plasma concentration ratio is 0.9. According to tissue distribution studies in animals, vibegron does not penetrate the blood-brain barrier, suggesting limited potential for CNS toxicity in humans.


Clearance

There is limited information on the clearance rate of vibegron.


5.3 Metabolism/Metabolites

In vitro, CYP3A4 is the main enzyme responsible for the metabolism of vibegron, which plays a minor role in the elimination of vibegron. Two predominant metabolic pathways are oxidation and glucuronidation to form two oxidative metabolites and three glucuronide metabolites. Metabolites have not been fully characterized.


5.4 Biological Half-Life

The terminal plasma half-life ranges from 60 to 70 hours. The effective half-life is 30.8 hours.


5.5 Mechanism of Action

Overactive bladder is characterized by symptoms of urge urinary incontinence, urgency, and urinary frequency. Bladder filling and emptying are regulated by the coordinated communication between sympathetic and parasympathetic systems. Bladder filling occurs via parasympathetic inhibition and the sympathetic hypogastric nerve releasing norepinephrine, which acts on beta-adrenergic receptors responsible for mediating detrusor muscle relaxation. Symptoms of overactive bladder are thought to be caused by the deterioration of the sensory connections between the bladder, spinal cord and brain, leading to changes in the lower urinary tract and abnormal bladder sensations of the urge to void at small bladder volumes. Beta-3 adrenergic receptors (3ARs) are expressed in the kidneys and lower urinary tract, including ureters, urethra, prostate, and bladder. Vibegron is a selective agonist at 3AR. One vibegron binds to the receptor, 3AR is stimulated and undergoes a conformation change and activates adenylyl cyclases (AC), which promotes the formation of cyclic adenosine monophosphate (cAMP). Increased intracellular cAMP concentration leads to the activation of cAMP-dependent protein kinase A (PKA), which subsequently phosphorylates myosin light chains that are responsible for inhibiting the interaction of actin with myosin dependent on calcium calmodulin complex. In clinical trials, vibegron increased cAMP levels in a dose-proportional manner. There is evidence that 3AR agonists may also work via sensory mechanisms without directly affecting detrusor muscle motor function.


API Reference Price

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15-Jun-2022
28-Dec-2024
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Vibegron manufacturers, exporters & distributors 1

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API | Excipient name

Vibegron

Synonyms

1190389-15-1, Krp-114v, Gemtesa, Mk-4618, (s)-n-(4-(((2s,5r)-5-((r)-hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo[1,2-a]pyrimidine-6-carboxamide, M5tse03w5u

Cas Number

1190389-15-1

Unique Ingredient Identifier (UNII)

M5TSE03W5U

About Vibegron

Vibegron is a potent, selective beta-3 adrenergic receptor (3) agonist that relaxes the detrusor smooth muscle of the bladder, thereby increasing bladder capacity. Vibegron was first approved in Japan in September 2018 for the treatment of overactive bladder, a condition associated with distressing symptoms of urge urinary incontinence, urgency, and urinary frequency, and reduced quality of life of patients. On December 23, 2020, vibegron was approved for the same indication in adults. It is available as oral tablets under the market name GEMTESA. Vibegron is the second beta-3 adrenergic agonist approved for the treatment of overactive bladder following [mirabegron], which was approved in 2012. Unlike mirabegron, vibegron is less likely to be associated with drug-drug interactions involving the CYP3A4, 2D6, or 2C9 enzymes.

Vibegron Manufacturers

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

Vibegron Suppliers

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

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

Vibegron USDMF

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

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

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

Vibegron KDMF

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

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

After submitting a Vibegron 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 Vibegron API can apply through the Korea Drug Master File (KDMF).

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

Vibegron 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 Vibegron as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Vibegron GMP

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

Vibegron CoA

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

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

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