Serdexmethylphenidate
As of the edition of 20 October 2026, Serdexmethylphenidate is a small molecule: marketed, first approved in 2021 (US); acts on SLC6A2 and SLC6A3; no US protection is listed.
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
- Azstarys
- First approved
- 7 May 2021 (US)
- Approvals on record
- 3 in 1 region
- Holder of the most recent approval
- Collegium Pharmaceutical
- Registered trials
- 6, 0 stopped early
- Disease areas
- Mental health; Nervous system
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 2 | 2 | 0 | 0 |
| Phase 4 | 3 | 3 | 0 | 0 |
| All trials | 6 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Zevra Therapeutics | Lead sponsor of trials | 2018 to now |