Sertraline
As of the edition of 20 October 2026, Sertraline is a small molecule: marketed, first approved in 1991 (US); acts on SLC6A4; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1996
- Kind
- Small molecule
- Brand name
- Zoloft
- First approved
- 30 December 1991 (US)
- Approvals on record
- 11 in 4 regions
- Holder of the most recent approval
- Almatica Pharma; 5 holders in all
- Registered trials
- 210, 24 stopped early
- Disease areas
- Mental health; Nervous system; Chemically induced; Injuries; Heart and blood vessels; Infections
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.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Sertraline.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| SLC6A4 | Sodium-dependent serotonin transporter | P31645 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 58 | 37 | 6 | 8 |
| Phase 1 | 25 | 22 | 1 | 1 |
| Phase 2 | 33 | 22 | 4 | 4 |
| Phase 3 | 40 | 31 | 3 | 5 |
| Phase 4 | 54 | 39 | 4 | 6 |
| All trials | 210 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator and Lead sponsor of trials | 1991 to now |
| Viatris | Acquired holder and Lead sponsor of trials | 2002 to now |
| Almatica Pharma | Later holder | 2021 to now |