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vibegron

Trade name: Gemtesa

Small moleculeapproved

Approved

Dec 23, 2020

Clinical trial activity

17 trials · 10 clinical orgs · 3 marketing orgs

Phase 1
5
Phase 2
8
Phase 3
7
Phase 4
2

Earliest trial started Mar 1, 2011 (NCT01314872)

Timeline

2010s

  1. Jan 1, 2011

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2011

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2018

    Urovant Sciences Ltd. — Earliest Phase 3 Sponsor(trial)

2020s

  1. Dec 23, 2020

    Sumitomo Dainippon — Earliest FDA Approval

  2. Dec 23, 2020

    Urovant Sciences Ltd. — Marketing Organization

  3. Dec 23, 2020

    Sumitomo Dainippon — NDA Secondary Org

  4. Dec 23, 2020

    Sumitomo Dainippon — NDA Organization

  5. Dec 23, 2020

    Sumitomo — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 23, 2020

Chemistry & pharmacology

Loading structure…

SMILES

O=C(Nc1ccc(C[C@@H]2CC[C@H]([C@H](O)c3ccccc3)N2)cc1)[C@@H]1CCc2nccc(=O)n21
Mol. weight
444.54 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • krp-114v
  • krp-114v
  • mk-4618
  • mk-4618
  • mk-4618
  • mk-4618
  • n-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide
  • vibegron
  • vibegron
  • vibegron
  • vibegron

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06987383Phase 3Aug 31, 2026Wake Forest University
NCT06438861N/AApr 30, 2025University of Alabama, Birmingham
NCT05806164Phase 4Jun 6, 2023Brown University, Howard University, Patient-Centered Outcomes Research Institute, University of Alabama, Birmingham, University of California, San Diego, University of New Mexico
NCT05491525Phase 2/Phase 3 (Phase 3)Aug 31, 2022Urovant Sciences Ltd.
NCT05067478Phase 4Oct 1, 2021Urovant Sciences Ltd.
NCT04914221Phase 1Mar 13, 2021Jeil Pharmaceutical Co., Ltd.
NCT04917315Phase 3May 21, 2020Jeil Pharmaceutical Co., Ltd.
NCT04103450Phase 3Sep 19, 2019Urovant Sciences Ltd.
NCT03902080Phase 3Mar 26, 2019Urovant Sciences Ltd.
NCT03806127Phase 2Dec 31, 2018Urovant Sciences Ltd.
NCT03583372Phase 3Jun 14, 2018Urovant Sciences Ltd.
NCT03492281Phase 3Feb 28, 2018Urovant Sciences Ltd.
NCT01737684Phase 1Jan 1, 2013Merck
NCT01628042Phase 1Jul 1, 2012Merck
NCT01500382Phase 1Feb 1, 2012Merck
NCT01337674Phase 1Apr 1, 2011Merck
NCT01314872Phase 2Mar 1, 2011Merck
Showing 17 of 17 trials
Page 1 / 1

Organizations

Research & Development (10)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Urovant Sciences Ltd.For profit7732018
MerckFor profit5522011
Jeil Pharmaceutical Co., Ltd.For profit2222020
University of Alabama, BirminghamAcademic/Hospital2122023
Brown UniversityAcademic/Hospital1112023
Howard UniversityAcademic/Hospital1012023
Patient-Centered Outcomes Research InstituteAcademic/Hospital1012023
University of California, San DiegoAcademic/Hospital1012023
University of New MexicoAcademic/Hospital1012023
Wake Forest UniversityAcademic/Hospital1112026
10 organizations
Page 1 / 1

Marketing (5)

OrganizationOrg typeRelationshipDate
SumitomoFor profitMKTGDec 23, 2020
Sumitomo DainipponFor profitNDA2Dec 23, 2020
Sumitomo DainipponFor profitNDADec 23, 2020
Urovant Sciences Ltd.For profitMKTGDec 23, 2020
Urovant Sciences Ltd.For profitMKTGDec 23, 2020