Gepirone
As of the edition of 20 October 2026, Gepirone is a small molecule: marketed, first approved in 2023 (US); acts on HTR1A; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Exxua
- First approved
- 22 September 2023 (US)
- Approvals on record
- 4 in 1 region
- Holder of the most recent approval
- Fabre Kramer Pharmaceuticals
- Registered trials
- 1, 0 stopped early
- Disease areas
- Chemically induced; Mental health
US protection
US protection ends in 2028.
The last listed US exclusivity ends in 2028. The application that gives this date is held by Fabre Kramer Pharmaceuticals.
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 product4 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 4 listings behind itRequest access. Nothing is shown until you do.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Gepirone.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| HTR1A | 5-hydroxytryptamine receptor 1A | P08908 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 2 | 1 | 1 | 0 | 0 |
| All trials | 1 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Fabre Kramer Pharmaceuticals | Originator | 2023 to now |