Vibegron
As of the edition of 20 October 2026, Vibegron is a small molecule: marketed, first approved in 2018 (JP); acts on ADRB3; US protection ends in 2034.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Gemtesa
- First approved
- 21 September 2018 (JP)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Pierre Fabre; 3 holders in all
- Registered trials
- 15, 1 stopped early
- Disease areas
- Pregnancy and women's health; Urinary and reproductive; Heart and blood vessels; Cancer; Digestive system; Immune system
US protection
US protection ends in 2034.
The last listed US drug-substance patent ends in 2034. The application that gives this date is held by Sumitomo Pharma.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product5 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Vibegron.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ADRB3 | Beta-3 adrenergic receptor | P13945 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 6 | 3 | 2 | 1 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 6 | 4 | 2 | 0 |
| All trials | 15 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sumitomo Pharma | Applicant, Acquired holder and Lead sponsor of trials | 2018 to now |
| Kyorin Pharmaceutical | Applicant | 2018 to now |
| Pierre Fabre | Applicant | 2024 to now |