Drugs / Vibegron
Vibegron
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | GEMTESA | — | 2024-12-18 | fda.gov ↗ |
| Approved | EU (EMA) | Obgemsa | — | 2024-06-27 | europa.eu ↗ |
| Approved | US (FDA) | GEMTESA | — | 2020-12-23 | fda.gov ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT07674680 | Jul 2026 → May 2028 expected | — | University of Missouri-Columbia | Recruiting | No outcome recorded |
| Phase 0 | NCT06417177 | Jun 2024 → Dec 2026 expected | — | University of Missouri-Columbia | Recruiting | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT01737684 | Jan → Jun 2013 | overactive bladder | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01628042 | Jul 2012 → Jan 2013 | overactive bladder | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01500382 | Feb 2012 → Jan 2013 | overactive bladder | Merck Sharp & Dohme LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT03806127 | Dec 2018 → Sep 2020 | irritable bowel syndrome | Urovant Sciences GmbH | Completed | No outcome recorded |
| Phase 2 | NCT01314872 | Mar 2011 → Oct 2012 | overactive bladder | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05491525 | Oct 2022 → Mar 2030 expected | overactive bladder | Urovant Sciences GmbH | Recruiting | No outcome recorded |
| Phase 35 trials · 2 met primary | ||||||
| Phase 3 | NCT06987383 | Nov 2026 → Jul 2028 expected | obesity disorder | Wake Forest University Health Sciences | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04103450 | Sep 2019 → Jul 2022 | overactive bladder | Urovant Sciences GmbH | Completed | No outcome recorded |
| Phase 3 | NCT03902080 | Mar 2019 → Jun 2023 | overactive bladder | Urovant Sciences GmbH | Completed | Met primary |
| Phase 3 | NCT03583372 | Jun 2018 → Jun 2019 | overactive bladder | Urovant Sciences GmbH | Completed | No outcome recorded |
| Phase 3 | NCT03492281 | Mar 2018 → Jan 2019 | overactive bladder | Urovant Sciences GmbH | Completed | Met primary |
| Comparator or background therapy2 trials | ||||||
| Phase 4 | NCT05806164 Comparator | Jun 2023 → Aug 2026 overdue | overactive bladder | Women and Infants Hospital of Rhode Island | Active not recruiting | No outcome recorded |
| — | NCT06438861 Comparator | Jan → Dec 2025 | overactive bladder | University of Alabama at Birmingham | Withdrawn | No outcome recorded Stop: Business |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-03-06 | Sumitomo Pharma America, Inc. | KYORIN and Sumitomo Pharma Enter into License Agreement of Vibegron in Taiwan and Other Asian Countries sumitomo-pharma.com ↗ |
| 2016-03-30 | Kissei Pharmaceutical Co., Ltd. | 過活動膀胱治療薬「KRP-114V」の国内における共同開発および共同販売に関する契約締結について kissei.co.jp ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vibegron | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01737684 ↗ |
| Known as | Gemtesa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07674680 ↗ |
| Known as | KRP-114V | “Vibegron (RVT-901/MK-4618/KRP-114V) Administered Once Daily as Monotherapy or” PMID 30661513 ↗ Oct 2018 |
| Known as | MK-4618 | “This study will investigate the pharmacokinetics of a single oral dose of vibegron (MK-4618) administered to participants with moderate hepatic insufficiency and healthy...” NCT01737684 ↗ |
| Known as | RVT-901 | “Vibegron (RVT-901/MK-4618/KRP-114V) Administered Once Daily as Monotherapy or” PMID 30661513 ↗ Oct 2018 |
| Action | Activate | “Efficacy of vibegron, a new β3-adrenergic receptor agonist, for OAB is unknown.” PMID 30661513 ↗ Oct 2018 |
| Route | Oral | “Participants received vibegron oral tablets at dosages of 3 mg, 15 mg, 50 mg, or 100 mg depending on their vibegron arm assignment, taken orally each morning.” NCT01314872 ↗ |