aripiprazole: clinical trials recruiting now
4
Recruiting trials
6
Conditions studied
9
US states with sites
3
Countries
FDA drug label
- FDA-approved
- Yes. aripiprazole appears in the FDA drug-label database. Marketed as Aripiprazole.
- Drug class
- Atypical Antipsychotic (FDA established pharmacologic class)
- Boxed warning
- The FDA label for aripiprazole carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Aripiprazole is indicated for the treatment of: • Schizophrenia • Irritability Associated with Autistic Disorder • Treatment of Tourette’s Disorder Aripiprazole is an atypical antipsychotic. The oral formulations are indicated for: • Schizophrenia (14.1) • Irritability Associated with Autistic Disorder (14.4) • Treatment of Tourette’s disorder (14.5)
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications. — Hetero Labs, Ltd. - Unit III | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2018-01-10 |
| CGMP Deviations: recalling drug products following an FDA inspection. — Accord Healthcare, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2023-02-07 |
| CGMP Deviations: recalling drug products following an FDA inspection. — Accord Healthcare, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2023-02-07 |
| CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed. — Bristol Myers Squibb Manufacturing Company | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2012-11-02 |
| Cross Contamination with Other Products — Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. | Class III (FDA: unlikely to cause harm) | Ongoing | 2024-04-09 |
Phase breakdown
Phase 1 1
Phase 2 1
Phase 3 1
Phase 4 2
Conditions being studied
| Condition | Trials |
|---|---|
| Schizophrenia · aripiprazole for Schizophrenia | 3 |
| Depression | 1 |
| Negative Symptoms of Schizophrenia | 1 |
| Psychosis; Acute | 1 |
| Schizophenia Disorder | 1 |
| Sequestra | 1 |
Recruiting trials involving aripiprazole
- Biomarkers to Enhance Early Schizophrenia Treatment
- Cerebellum-based Imaging Neural Markers for Antipsychotic Response
- Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)
- Study to Evaluate Efficacy and Safety of Roluperidone in Adult Subjects With Negative Symptoms and Stable Positive Symptoms of Schizophrenia and to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications
Common questions
Is aripiprazole FDA-approved?
Yes, marketed as Aripiprazole. Its FDA label carries a boxed warning.
How many recruiting trials involve aripiprazole?
4 recruiting trials across 6 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.