Daridorexant
As of the edition of 20 October 2026, Daridorexant is a small molecule: marketed, first approved in 2022 (US); acts on HCRTR1 and HCRTR2; US protection ends in 2034.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Quviviq
- First approved
- 7 April 2022 (US)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Nexera Pharma Co., Ltd.; 3 holders in all
- Registered trials
- 48, 0 stopped early
- Disease areas
- Mental health; Nervous system; Lungs and airways; Chemically induced; Digestive system; Nutrition and metabolism
US protection
US protection ends in 2034.
The last listed US drug-substance patent ends in 2034. The application that gives this date is held by Idorsia 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 product10 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 10 listings behind itRequest access. Nothing is shown until you do.
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 Daridorexant.
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 not stated | 5 | 2 | 3 | 0 |
| Phase 1 | 24 | 24 | 0 | 0 |
| Phase 2 | 8 | 4 | 4 | 0 |
| Phase 3 | 5 | 5 | 0 | 0 |
| Phase 4 | 6 | 1 | 5 | 0 |
| All trials | 48 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Idorsia Pharmaceuticals | Originator and Lead sponsor of trials | 2015 to now |
| Idorsia Pharmaceuticals Deutschland | Applicant | 2022 to now |