Palovarotene
As of the edition of 20 October 2026, Palovarotene is a small molecule: marketed, first approved in 2022 (CA); acts on RARG; US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Sohonos
- First approved
- 21 January 2022 (CA)
- Approvals on record
- 11 in 3 regions
- Holder of the most recent approval
- Ipsen
- Registered trials
- 10, 2 stopped early
- Disease areas
- Bones, joints and muscles; Cancer; Eye; Inherited and neonatal
US protection
US protection ends in 2030.
The last listed US exclusivity ends in 2030. 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 product10 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
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 Palovarotene.
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 |
|---|---|---|
| RARG | Retinoic acid receptor gamma | P13631 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 4 | 4 | 0 | 0 |
| Phase 2 | 4 | 2 | 0 | 2 |
| Phase 3 | 2 | 2 | 0 | 0 |
| All trials | 10 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Ipsen | Applicant and Lead sponsor of trials | 2014 to now |