Lurasidone
As of the edition of 20 October 2026, Lurasidone is a small molecule: marketed, first approved in 2010 (US); acts on DRD2 and HTR2A; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Latuda
- First approved
- 28 October 2010 (US)
- Approvals on record
- 9 in 4 regions
- Holder of the most recent approval
- Exeltis Healthcare S.L.; 4 holders in all
- Registered trials
- 72, 6 stopped early
- Disease areas
- Mental health; Nervous system; Nutrition and metabolism; Infections; Inherited and neonatal; Pregnancy and women's health
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
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Lurasidone.
See the 4 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 | 9 | 6 | 1 | 2 |
| Phase 1 | 12 | 12 | 0 | 0 |
| Phase 2 | 7 | 6 | 0 | 0 |
| Phase 3 | 34 | 31 | 1 | 2 |
| Phase 4 | 10 | 5 | 2 | 2 |
| All trials | 72 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sumitomo Pharma | Originator and Lead sponsor of trials | 2002 to now |
| Aziende Chimiche Riunite Angelini Francesco | Applicant and Lead sponsor of trials | 2014 to now |