Amitriptyline
As of the edition of 20 October 2026, Amitriptyline is a small molecule: marketed, first approved in 1961 (ES); acts on SLC6A4.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1986
- Kind
- Small molecule
- Brand name
- Elavil
- First approved
- 1 December 1961 (ES)
- Approvals on record
- 21 in 4 regions
- Holder of the most recent approval
- TEOFARMA; 7 holders in all
- Registered trials
- 59, 12 stopped early
- Disease areas
- Nervous system; Mental health; Bones, joints and muscles; Immune system; Urinary and reproductive; Digestive system
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| SLC6A4 | Sodium-dependent serotonin transporter | P31645 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 14 | 6 | 1 | 2 |
| Phase 1 | 7 | 4 | 2 | 0 |
| Phase 2 | 14 | 7 | 4 | 2 |
| Phase 3 | 14 | 5 | 2 | 5 |
| Phase 4 | 10 | 5 | 1 | 3 |
| All trials | 59 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Acquired holder, Later holder and Lead sponsor of trials | 2003 to now |
| Merck & Co. | Earlier holder |