Levoketoconazole
As of the edition of 20 October 2026, Levoketoconazole is a small molecule: marketed, first approved in 2021 (US); acts on CYP11A1, CYP11B1 and CYP11B2 and 1 more; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Recorlev
- First approved
- 30 December 2021 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Cortendo
- Registered trials
- 9, 2 stopped early
- Disease areas
- Hormones; Nutrition and metabolism; Nervous system
US protection
US protection ends in 2028.
The last listed US exclusivity ends in 2028. The application that gives this date is held by Cortendo.
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
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Levoketoconazole.
See the 4 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 | 3 | 3 | 0 | 0 |
| Phase 2 | 2 | 1 | 0 | 1 |
| Phase 3 | 4 | 3 | 0 | 1 |
| All trials | 9 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Cortendo | Originator and Lead sponsor of trials | 2014 to now |