Osilodrostat
As of the edition of 20 October 2026, Osilodrostat is a small molecule: marketed, first approved in 2020 (EU); acts on CYP11B1; US protection ends in 2033.
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
- Isturisa
- First approved
- 9 January 2020 (EU)
- Approvals on record
- 9 in 4 regions
- Holder of the most recent approval
- Recordati Rare Diseases
- Registered trials
- 19, 0 stopped early
- Disease areas
- Hormones; Heart and blood vessels; Cancer; Nervous system; Nutrition and metabolism; Pregnancy and women's health
US protection
US protection ends in 2033.
The last listed US drug-substance patent ends in 2033. The application that gives this date is held by Recordati Rare Diseases.
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 product15 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 15 listings behind itRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CYP11B1 | Cytochrome P450 11B1, mitochondrial | P15538 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 1 | 2 | 0 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 9 | 7 | 2 | 0 |
| Phase 3 | 2 | 2 | 0 | 0 |
| Phase 4 | 3 | 0 | 3 | 0 |
| All trials | 19 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Recordati Rare Diseases | Applicant | 2020 to now |