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Drug

Aripiprazole

Approved · EMA
ClassSerotonin 2a (5-HT2a) receptor antagonistEmerging researchLate-stage developmentSteady momentum

Also known as Abilify, Opipza, Aripiprazol, Aripiprazolum.

6
Research papers
7
Active clinical trials
3
Protein targets
8
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Dopamine and Sensorimotor Function in Stuttering

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

A Phase II Study to Test PK Tolerability in Children and Adolescents

Clinical trial2026-06-22Results posted · ClinicalTrials.gov

Biomarkers to Enhance Early Schizophrenia Treatment

Clinical trial2026-06-12Results expected Q3 2030 · ClinicalTrials.gov

Recall (Class II): ARIPIPRAZOLE

Regulatory2026-05-27FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Aripiprazole
Aliases & brands
AbilifyOpipzaAripiprazolAripiprazolum
RxNorm CUI
89013
ChEMBL ID
CHEMBL1112
ATC codes
N05AX12
UNII
82VFR53I78
Primary mechanism
Serotonin 2a (5-HT2a) receptor antagonist
Regulatory jurisdictions
emamhrafda

Pharmacology & targets

3 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

ANTAGONISTSerotonin 2a (5-HT2a) receptor antagonist
PARTIAL AGONISTDopamine D2 receptor partial agonist
PARTIAL AGONISTSerotonin 1a (5-HT1a) receptor partial agonist

Regulatory timeline

8 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2004-06-04
Latest approval
2015-11-15
Authorities
FDA · EMA · MHRA
Total events
8
fdaU.S. Food and Drug Administration· 1 event
2026-05-27RecallSafety
Recall (Class II): ARIPIPRAZOLE
Evidence ↗
emaEuropean Medicines Agency· 6 events
2015-11-15Approval
Approval: Aripiprazole Accord (EMA)
Indication: Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Accord is indicated for the treatment ofShow full indication

Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Accord is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Aripiprazole Accord is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.

Evidence ↗
2015-08-20Approval
Approval: Aripiprazole Sandoz (EMA)
Indication: Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Sandoz is indicated for the treatment ofShow full indication

Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Sandoz is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Aripiprazole Sandoz is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.

Evidence ↗
2015-06-30Approval
Approval: Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) (EMA)
Indication: Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Mylan Pharma is indicated for theShow full indication

Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Mylan Pharma is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Aripiprazole Mylan Pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2023-12-18Safety communicationSafety
Drug Safety Update: Aripiprazole (Abilify and generic brands): risk of pathological gambling
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

190 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
190
registered trials across all phases
LATEST COMPLETION 2026
7
Active studies
7
Recruiting
159
Late-stage (III+)
136
Completed
47
Discontinued
PHASE DISTRIBUTIONn = 190
Early Phase 11Phase 112Phase 1 / 22Phase 216Phase 2 / 33Phase 363Phase 472Phase N / A21

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

6 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20112025
Most influential
Recent papers
Major research themes4
Antipsychotic Agents1Mental Disorders1Methamphetamine1Outcome Assessment, Health Care1
Journals, researchers & institutions
Top journals
  • The Journal of clinical psychiatry2
  • Addiction (Abingdon, England)1
  • Annals of clinical psychiatry : official journal of the American Academy of Clinical Psychiatrists1
  • Journal of child and adolescent psychopharmacology1
  • Journal of clinical psychopharmacology1
Leading researchers
  • Adegbite C1
  • Barnett M1
  • Calabrese JR1
  • Calarge C1
  • Clark C1
  • Coffin PO1
  • Colfax GN1
  • Cutler AJ1
Leading institutions
free-text, unnormalised
  • Clinical Development1
  • Stanford University Medical Center1
  • University Hospitals1
  • University of Iowa1
  • University of Pittsburgh School of Pharmacy1
  • UPMC Western Psychiatric Hospital1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Acts on the same molecular target as Aripiprazole, with an overlapping disease area.

2 shared targets1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.