Tianeptine
As of the edition of 20 October 2026, Tianeptine is a small molecule: marketed, first approved in 1987 (FR).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1987
- Kind
- Small molecule
- Brand name
- Stablon
- First approved
- 6 February 1987 (FR)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Servier
- Registered trials
- 8, 1 stopped early
- Disease areas
- Mental health; Infections; Lungs and airways; Nervous 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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 0 | 0 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 2 | 1 | 1 | 0 |
| Phase 4 | 2 | 1 | 0 | 1 |
| All trials | 8 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Lead sponsor of trials | 2009 to now |
| Pfizer | Lead sponsor of trials | 2022 to now |
| Tonix Pharmaceuticals | Lead sponsor of trials | 2023 to now |