Agomelatine
As of the edition of 20 October 2026, Agomelatine is a small molecule: marketed, first approved in 2009 (EU); acts on HTR2C, MTNR1A and MTNR1B.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2009
- Kind
- Small molecule
- Brand name
- Valdoxan
- First approved
- 19 February 2009 (EU)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- LABORATÓRIOS SERVIER DO BRASIL LTDA; 2 holders in all
- Withdrawn from market
- 31 July 2022 (in some regions)
- Registered trials
- 19, 3 stopped early
- Disease areas
- Mental health; Nervous system; Bones, joints and muscles; Heart and blood vessels
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 2 | 0 | 1 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 8 | 6 | 0 | 2 |
| Phase 4 | 6 | 3 | 1 | 0 |
| All trials | 19 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Servier | Applicant | 2009 to now |