Cariprazine
Also known as Vraylar, Cariprazine hydrochloride
AbbVie Inc. ABBV · Bipolar I Disorder; Schizophrenia; Depression; Major Depressive Disorder; Autism Spectrum Disorder
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
8
From ClinicalTrials.gov
Latest FDA action
Approved
NDA204370,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- AbbVie Inc. ABBV Source: Company record for AbbVie Inc. (opens in a new tab)
- Indications
- Bipolar I Disorder; Schizophrenia; Depression; Major Depressive Disorder; Autism Spectrum Disorder Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- NDA 204370 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 204370 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 15 Jun 20188 linked trials
- Filed Completed
- Approved Current stageFirst approval 17 Sep 2015
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Cariprazine. Editors add each one with its source.
Filed application
No filed application is on record for Cariprazine. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Cariprazine.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT05368558ClinicalTrials.gov record for NCT05368558 (opens in a new tab)509 JPN Schz | Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia | Phase 3 | Terminated | 34 (actual) | 20 Sep 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT05368558 (opens in a new tab) |
Posted results on ClinicalTrials.gov for 509 JPN Schz
Serious adverse events (All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.): DBP Placebo 0 of 16; DBP Cariprazine 3 mg 0 of 5; DBP Cariprazine 6 mg 0 of 13; BEP Cariprazine 1.5 mg 1 of 10; BEP Cariprazine 3 mg 1 of 4; BEP Cariprazine 6 mg 0 of 10; SF DBP Placebo 0 of 5; SF DBP Cariprazine 3 mg 0 of 1; SF DBP Cariprazine 6 mg 1 of 4; SF BEP Cariprazine 1.5 mg 0 of 10; SF BEP Cariprazine 3 mg 1 of 4; SF BEP Cariprazine 6 mg 0 of 10 Source: ClinicalTrials.gov results for NCT05368558 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
| NCT05439616ClinicalTrials.gov record for NCT05439616 (opens in a new tab) | Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD | Phase 3 | Completed | 161 (actual) | 4 Oct 2024 (actual) | No |
| NCT04777357ClinicalTrials.gov record for NCT04777357 (opens in a new tab)3112 Ped BPD | A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder. | Phase 3 | Recruiting | 380 (estimated) | Mar 2027 (estimated) | No |
| NCT04578756ClinicalTrials.gov record for NCT04578756 (opens in a new tab)3070 Ped OLE | Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder | Phase 3 | Completed | 310 (actual) | 6 Oct 2025 (actual) | No |
| NCT03739203ClinicalTrials.gov record for NCT03739203 (opens in a new tab) | The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone | Phase 3 | Completed | 752 (actual) | 6 Sep 2021 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03739203 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT03739203
Serious adverse events (First dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)): Placebo + ADT 2 of 250; Cariprazine 1.5 mg/Day + ADT 3 of 250; Cariprazine 3 mg/Day + ADT 1 of 251 Source: ClinicalTrials.gov results for NCT03739203 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing NCT03739203 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT03738215ClinicalTrials.gov record for NCT03738215 (opens in a new tab) | Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone | Phase 3 | Completed | 759 (actual) | 30 Sep 2021 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03738215 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT03738215
Serious adverse events (First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)): Placebo + ADT 2 of 253; Cariprazine 1.5 mg/Day + ADT 3 of 252; Cariprazine 3 mg/Day + ADT 3 of 252 Source: ClinicalTrials.gov results for NCT03738215 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing NCT03738215 (2), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT03593213ClinicalTrials.gov record for NCT03593213 (opens in a new tab) | Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia | Phase 3 | Terminated | 587 (actual) | 11 Feb 2021 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03593213 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT03593213
Serious adverse events (First dose to last dose + 30 days in the Open-label Treatment Period (Up to 23 weeks); First dose to last dose + 30 days in the Double-blind Treatment Period (Up to 35 weeks)): Cariprazine 4.5 mg/Day (Open-label Treatment Period) 20 of 587; Cariprazine 4.5 mg/Day (Open-label Safety Follow-up) 7 of 273; Placebo (Double-blind Treatment Period) 5 of 53; Cariprazine 3.0 mg/Day (Double-blind Treatment Period) 0 of 49; Cariprazine 4.5 mg/Day (Double-blind Treatment Period) 1 of 54; Placebo (Double-blind Safety Follow-up) 0 of 53; Cariprazine 3.0 mg/Day (Double-blind Safety Follow-up) 0 of 49; Cariprazine 4.5 mg/Day (Double-blind Safety Follow-up) 2 of 54 Source: ClinicalTrials.gov results for NCT03593213 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
| NCT03573297ClinicalTrials.gov record for NCT03573297 (opens in a new tab) | A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features | Phase 3 | Completed | 901 (actual) | 5 Sep 2022 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03573297 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT03573297
Serious adverse events (Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).): Open Label Treatment Period 19 of 896; Double-Blind Placebo QD 5 of 145; Double-Blind Cariprazine 1.5 mg QD 7 of 144; Double-Blind Cariprazine 3.0 mg QD 3 of 147 Source: ClinicalTrials.gov results for NCT03573297 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
Authorised
Reagila (EMEA/H/C/002770)
- Authorised
- Therapeutic area
- Schizophrenia
- Marketing authorisation holder
- Gedeon Richter
- Active substance (INN)
- cariprazine
- ATC code
- N05AX15
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Reagila (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 204370 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT05368558 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05439616 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04777357 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04578756 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03739203 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03738215 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03593213 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03573297 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA204370 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.