Elafibranor
As of the edition of 20 October 2026, Elafibranor is a small molecule: marketed, first approved in 2024 (US); acts on PPARA and PPARD; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Iqirvo
- First approved
- 10 June 2024 (US)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- BEAUFOUR IPSEN FARMACĂUTICA LTDA; 2 holders in all
- Registered trials
- 22, 3 stopped early
- Disease areas
- Digestive system; Nutrition and metabolism; Heart and blood vessels; Hormones; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ends in 2031.
The last listed US exclusivity ends in 2031. The application that gives this date is held by Ipsen.
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 product2 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 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Elafibranor.
See the 2 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 8 | 8 | 0 | 0 |
| Phase 2 | 8 | 5 | 1 | 2 |
| Phase 3 | 6 | 1 | 4 | 1 |
| All trials | 22 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Ipsen | Originator | 2024 to now |