Aripiprazole
As of the edition of 20 October 2026, Aripiprazole is a small molecule: marketed, first approved in 2002 (US); acts on DRD2, HTR1A 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 2018
- Kind
- Small molecule
- Brand name
- Abilify
- First approved
- 15 November 2002 (US)
- Approvals on record
- 59 in 7 regions
- Holder of the most recent approval
- ZYDUS NIKKHO FARMACÊUTICA LTDA; 8 holders in all
- Registered trials
- 265, 30 stopped early
- Disease areas
- Mental health; Nervous system; Nutrition and metabolism; Chemically induced; Inherited and neonatal; Hormones
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
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Aripiprazole.
See the 3 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 | 50 | 28 | 2 | 10 |
| Phase 1 | 25 | 23 | 0 | 0 |
| Phase 2 | 20 | 14 | 3 | 1 |
| Phase 3 | 79 | 65 | 1 | 11 |
| Phase 4 | 91 | 65 | 4 | 8 |
| All trials | 265 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Otsuka | Originator, Applicant and Lead sponsor of trials | 1998 to now |
| Aché Laboratórios Farmacêuticos | Applicant | 2012 to now |
| CMG Pharmaceutical | Later holder and Lead sponsor of trials | 2015 to now |
| Xiamen Lp Pharmacuetical | Later holder | 2024 to now |