Vortioxetine
As of the edition of 20 October 2026, Vortioxetine is a small molecule: marketed, first approved in 2013 (US); acts on HTR1A, HTR3A and SLC6A4; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Trintellix
- First approved
- 30 September 2013 (US)
- Approvals on record
- 12 in 5 regions
- Holder of the most recent approval
- Pharmapath S.A.; 4 holders in all
- Registered trials
- 100, 8 stopped early
- Disease areas
- Mental health; Nervous system; Cancer; Nutrition and metabolism; Hormones; Heart and blood vessels
US protection
US protection ends in 2031.
The last listed US drug-substance patent ends in 2031. The application that gives this date is held by Takeda.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product16 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
5 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product5 company-target rows are on route B because of Vortioxetine.
See the 5 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 4 | 0 | 0 |
| Phase 1 | 12 | 10 | 0 | 1 |
| Phase 2 | 14 | 10 | 3 | 0 |
| Phase 3 | 44 | 35 | 1 | 4 |
| Phase 4 | 24 | 16 | 2 | 3 |
| All trials | 100 |