Aripiprazole clinical trials
Aripiprazole is named as an intervention in 9 current clinical trials in our China, Canada, USA and Germany registers. 3 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Minerva Neurosciences (1). The most-studied condition is Major Depressive Disorder (MDD).
Where Aripiprazole is approved
All regulators →Of the three regulators tracked here, the first to approve Aripiprazole was the US, on 15 Nov 2002. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Aripiprazole patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Aripiprazole, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 14 listed patents; the last listed expires 15 Dec 2041 (US 11701352).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Aripiprazole
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Aripiprazole works
All drug targets →- Dopamine D2 receptor partial agonist Partial agonistTarget: DRD2 dopamine receptor D2✓ In ChEMBL and the Guide to Pharmacology
- Serotonin 1a (5-HT1a) receptor partial agonist Partial agonistTarget: HTR1A 5-hydroxytryptamine receptor 1A✓ In ChEMBL and the Guide to Pharmacology
- Serotonin 2a (5-HT2a) receptor antagonist AntagonistTarget: HTR2A 5-hydroxytryptamine receptor 2A✓ In ChEMBL and the Guide to Pharmacology
- Alzheimer diseasePhase 3
- Alcohol dependencePhase 3
- Anorexia nervosaPhase 3
- Chronic tic disorderPhase 3
- DementiaPhase 3
- Major depressive episodePhase 3
- Pervasive developmental disorderPhase 3
- Post-traumatic stress disorderPhase 3
- Postpartum depressionPhase 3
- Schizoaffective disorderPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1112, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 34, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Aripiprazole
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Aripiprazole. 2 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Aripiprazole for treating moderate to severe manic episodes in adolescents with bipolar I disorder NICE TA292 | Recommended | 24 Jul 2013 | Current |
| Aripiprazole for the treatment of schizophrenia in people aged 15 to 17 years NICE TA213 | Recommended | 26 Jan 2011 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Aripiprazole
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 55 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Abilify, Abilify Maintena, Aripiprazole Accord (generic), Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) (generic), Aripiprazole Sandoz (generic), Aripiprazole Zentiva (generic)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Aripiprazole
- ATC code
- N05AX12
- ChEMBL
- CHEMBL1112
- DrugBank
- DB01238
- PubChem CID
- 60795
- CAS number
- 129722-12-9
- FDA UNII
- 82VFR53I78
- Wikidata
- Q411188
- Wikipedia
- Aripiprazole
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Aripiprazole
9 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Aripiprazole across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
55 single-substance products containing Aripiprazole on the HPRA medicines list.
- Aripiprazole Clonmel 10 mg tabletsClonmel Healthcare Ltd · PA0126/266/002 · Marketed
- Aripiprazole Clonmel 15 mg tabletsClonmel Healthcare Ltd · PA0126/266/003 · Marketed
- Aripiprazole Clonmel 30 mg tabletsClonmel Healthcare Ltd · PA0126/266/004 · Marketed
- Aripiprazole Clonmel 5 mg tabletsClonmel Healthcare Ltd · PA0126/266/001 · Marketed
- Aripiprazole Krka 10mg TabletsKRKA, d.d., Novo mesto · PA1347/089/002 · Marketed
Supply shortages
No entry for Aripiprazole in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Aripiprazole
13 conditionsAll 13 conditions
| Condition (as registered) | Trials |
|---|---|
| Major Depressive Disorder (MDD) | 2 |
| Negative Symptoms of Schizophrenia | 1 |
| SCHIZOPHRENIA 1 (Disorder) | 1 |
| Schizophrenia | 1 |
| Depression | 1 |
| Sequestra | 1 |
| Rumination | 1 |
| Post-acute Infectious Syndrome (PAIS) | 1 |
| Post-COVID-19 Condition (PCC or Long COVID) | 1 |
| Schizophenia Disorder | 1 |
| Late Life Treatment Resistant Depression | 1 |
| Depression - Major Depressive Disorder | 1 |
| Treatment Resistant Depression | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Minerva Neurosciences | 1 |
| Jiangsu Hansoh Pharmaceutical Co., Ltd | 1 |
| Xinyu Zhou | 1 |
| Vigonvita Life Sciences | 1 |
| First Affiliated Hospital of Chongqing Medical University | 1 |
| Central South University | 1 |
| Christiana Franke | 1 |
| Northwell Health | 1 |
| Washington University School of Medicine | 1 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in China | 5 | 1 |
| Clinical trials in Canada | 2 | 1 |
| Clinical trials in USA | 1 | 1 |
| Clinical trials in Germany | 1 | 0 |
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Aripiprazole trials
How many clinical trials are testing Aripiprazole?
9 current trials in our China, Canada, USA and Germany registers name Aripiprazole as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Aripiprazole trials recruiting patients?
Yes. 3 of the 9 trials are recruiting: 1 with sites in China, 1 with sites in Canada and 1 with sites in USA. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Aripiprazole clinical trials?
Minerva Neurosciences (1), Jiangsu Hansoh Pharmaceutical Co., Ltd (1), Xinyu Zhou (1) and Vigonvita Life Sciences (1), among 9 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Aripiprazole licensed in Ireland?
Yes. The HPRA medicines list includes 55 single-substance products containing Aripiprazole, for example Aripiprazole Clonmel 10 mg tablets (Clonmel Healthcare Ltd). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Aripiprazole shortage?
Not in the lists we track: Aripiprazole has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Aripiprazole works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Aripiprazole works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Aripiprazole (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.