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 14 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT07674680 | Jul 2026 → May 2028 expected | — | University of Missouri-Columbia | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT06417177 | Jun 2024 → Jul 2026 overdue | — | University of Missouri-Columbia | Recruiting | No outcome recorded |
| Phase 14 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 |
| Phase 1 | NCT01337674 | Apr → Nov 2011 | hypertensive disorder | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| 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 | No outcome recorded |
| 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 | ||||||
| Phase 3 | NCT06987383 | Aug 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 | No outcome recorded |
| 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 | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 41 trial | ||||||
| Phase 4 | NCT05806164 Comparator | Jun 2023 → Aug 2026 overdue | overactive bladder | Women and Infants Hospital of Rhode Island | Active not recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06438861 Comparator | Jan → Dec 2025 | overactive bladder | University of Alabama at Birmingham | Withdrawn | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vibegron | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03583372 ↗ |
| 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 ↗ |