Ulotaront
As of the edition of 20 October 2026, Ulotaront is a small molecule: in active development; acts on TAAR1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Active, 2026
- Kind
- Small molecule
- Registered trials
- 30, 3 stopped early
- Disease areas
- Mental health; 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.
Companies that need a new molecule because of this drug
1 company on route A because of this drug.
Companies on route A for this drug
In the product1 company is on route A because of Ulotaront.
See the 1 company on route A for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| TAAR1 | Trace amine-associated receptor 1 | Q96RJ0 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 12 | 12 | 0 | 0 |
| Phase 2 | 4 | 4 | 0 | 0 |
| Phase 3 | 14 | 6 | 5 | 3 |
| All trials | 30 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Otsuka | Lead sponsor of trials | 2013 to now |
| Sumitomo Pharma | Lead sponsor of trials | 2017 to now |