Brexpiprazole
As of the edition of 20 October 2026, Brexpiprazole is a small molecule: marketed, first approved in 2015 (US); acts on DRD2, HTR1A and HTR2A; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Rexulti
- First approved
- 10 July 2015 (US)
- Approvals on record
- 18 in 5 regions
- Holder of the most recent approval
- LUNDBECK BRASIL LTDA; 3 holders in all
- Registered trials
- 80, 8 stopped early
- Disease areas
- Mental health; Nervous system; Chemically induced
US protection
US protection ends in 2028.
The last listed US drug-substance patent ends in 2028. The application that gives this date is held by Otsuka.
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 product36 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
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Brexpiprazole.
See the 2 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 | 4 | 1 | 2 | 0 |
| Phase 1 | 11 | 9 | 2 | 0 |
| Phase 2 | 11 | 10 | 0 | 1 |
| Phase 3 | 50 | 42 | 2 | 6 |
| Phase 4 | 4 | 3 | 0 | 1 |
| All trials | 80 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Otsuka | Originator, Applicant and Lead sponsor of trials | 2008 to now |