drug

Cariprazine (Vraylar)

CariprazineCariprazine Flexible DoseCariprazine 3 mgCariprazine 6 mgCariprazine 12.5 mgCariprazine DepotCariprazine Depot MTDOral Cariprazine 3 mg/day

MeSH C533287UNII F6RJL8B278RxCUI 1667655FDA_ApplNo NDA204370SPL_set_id 4b5f7c65-aa2d-452a-b3db-bc85c06ff12fFDA_sponsor ABBVIEOrangeBook_Appl A213932, A213982, A213984, N204370

as of 2026-07-01

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at a glance

small molecule · Atypical Antipsychotic [EPC]

US-approved (2015) as Vraylar

Developed by Forest Laboratories

Orange Book protection to 2030

15 trials in the graph

Synthesized from structured facts only — each point cited above.

Mechanism & identity

Modality

small molecule

FDA class

Atypical Antipsychotic [EPC]

Mechanism of action

12.1 Mechanism of Action The mechanism of action of cariprazine is unknown. However, the efficacy of cariprazine could be mediated through a combination of partial agonist activity at central dopamine D 2 and serotonin 5-HT 1A receptors and antagonist activity at serotonin 5-HT 2A receptors. Cariprazine forms two major metabolites, desmethylcariprazine (DCAR) and didesmethylcariprazine (DDCAR), that have in vitro receptor binding profiles similar to the parent drug.

RxCUI

1667655

Indications

Labeled

SchizophreniaBipolar depressionBipolar maniaMajor depressive disorder

Investigational (via trials)

Schizophrenia Autism Spectrum Disorder Autism Spectrum Disorder (ASD)Mental Disorders Schizophrenia Depressive Disorder, Major Major Depressive Disorder Bipolar I Disorder

Patents & exclusivity

Orange Book

patent 7737142*PED2030-03-17

patent RE49302*PED2030-01-16

patent RE47350*PED2030-01-16

patent RE49110*PED2030-01-16

patent 7737142 · U-25442029-09-17

patent RE49302 · U-25432029-07-16

patent RE49110 · U-25452029-07-16

patent RE47350 · U-17502029-07-16

patent 7943621*PED2029-06-20

patent 7943621*PED2029-06-16

patent 79436212028-12-20

patent 79436212028-12-16

exclusivity PED2029-06-18

exclusivity M-142028-12-18

exclusivity NPP2028-12-18

Adverse-event signal

FAERS spontaneous · within-drug share

Eps Akathisia13.5%

top term: AKATHISIA

Sedation5.1%

top term: FATIGUE

Gi5.0%

top term: NAUSEA

Weight Metabolic3.8%

top term: WEIGHT INCREASED

Mortality2.0%

top term: DEATH

Anticholinergic1.7%

top term: VISION BLURRED

Qt Cardiac1.0%

top term: PALPITATIONS

Nms0.4%

top term: NEUROLEPTIC MALIGNANT SYNDROME

Spontaneous reports — a signal of reporting share, not incidence.

Regulatory history

Drugs@FDA submissions

EfficacyNDA204370 s16PRIORITY

2025-12-18

EfficacyNDA204370 s17PRIORITY

2025-12-18

EfficacyNDA204370 s14STANDARD

2025-12-18

EfficacyNDA204370 s15PRIORITY

2025-12-18

LabelingNDA204370 s12STANDARD

2024-11-22

EfficacyNDA204370 s9STANDARD

2022-12-16

EfficacyNDA204370 s6STANDARD

2019-05-24

LabelingNDA204370 s5STANDARD

2018-11-28

LabelingNDA204370 s3STANDARD

2017-11-09

EfficacyNDA204370 s2STANDARD

2017-11-09

LabelingNDA204370 s1901 REQUIRED

2017-02-23

EfficacyNDA204370 s2STANDARD

2015-09-17

Type 1 - New Molecular EntityNDA204370 s1STANDARD

2015-09-17

Trials

Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine

NCT07185815Phase 1, Phase 2Recruiting

Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia

NCT03817502Phase 3Recruiting

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

NCT04578756Phase 3Completed

Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia

NCT05368558Phase 3Terminated

Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia

NCT05168007Phase 3Unknown

Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia

NCT03593213Phase 3Terminated

A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia

NCT01412060Phase 3Completed

Long-term Study of Cariprazine in Patients With Schizophrenia

NCT01104792Phase 3Completed

Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia

NCT01376076Phase 1Completed

Safety and Efficacy of Cariprazine in Patients With Schizophrenia

NCT01104766Phase 3Completed

Safety and Efficacy of Cariprazine in Schizophrenia

NCT01104779Phase 3Completed

A Study of Cariprazine in Patients With Chronic Stable Schizophrenia

NCT00839852Phase 2Completed

Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia

NCT00862992Phase 2Completed

Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia

NCT00694707Phase 2Completed

Study Evaluating RGH-188 in the Treatment of Patients With Schizophrenia

NCT00404573Phase 2Completed

KOLs & investigators

Suresh Durgam, MDKOL score 43

Willie EarleyKOL score 18

Raffaele Migliore, MA

Suneeta Ahuja, PhD

Teruhiko Higuchi, President

Publications & congress

Treatment of bipolar depression: results from a comprehensive network meta-analysis and updated systematic review.

European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · 2026 · high-value

Effect of cariprazine on metabolic parameters in patients with affective disorders: A systematic review and meta-analysis.

Journal of psychopharmacology (Oxford, England) · 2026 · high-value

Trajectories and predictors of depressive and anxiety symptom improvement with adjunctive cariprazine in antidepressant-treated adults with major depression: A Bayesian mega-analysis of two randomized trials.

Journal of affective disorders · 2026 · high-value

Effect of cariprazine versus aripiprazole on cardiometabolic profile in patients with schizophrenia switched from olanzapine due to weight gain: A randomized controlled trial.

Journal of psychiatric research · 2026 · high-value

Hospital-based management of predominant negative symptoms in schizophrenia: an observational study.

CNS spectrums · 2026 · high-value

Bioequivalence evaluation of two cariprazine hard capsule formulations.

Naunyn-Schmiedeberg's archives of pharmacology · 2026 · high-value

The Australian and New Zealand journal of psychiatry

The Australian and New Zealand journal of psychiatry · 2026 · high-value

Impact of selected second and third generation antipsychotics on cognitive dysfunction in schizophrenia-spectrum disorders. Systematic review and network meta-analysis.

International clinical psychopharmacology · 2026 · high-value

Safety and tolerability of cariprazine for the adjunctive treatment of major depressive disorder: a pooled analysis of phase 2b/phase 3 clinical trials.

International clinical psychopharmacology · 2025 · high-value

Effect of Cariprazine on Anhedonia in Patients with Bipolar I Depression: Post Hoc Analysis of Three Randomized Placebo-Controlled Clinical Trials.

Advances in therapy · 2025 · high-value

The effect of adjunctive cariprazine on symptoms of anhedonia in patients with major depressive disorder.

Journal of affective disorders · 2025 · high-value

Probiotics for adults with major depressive disorder compared with antidepressants: a systematic review and network meta-analysis.

Nutrition reviews · 2025 · high-value

Antipsychotic drug dosing and study discontinuation in schizophrenia: A systematic review and dose-response meta-analysis.

European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · 2025 · high-value

Efficacy of Adjunctive Cariprazine on Anxiety Symptoms in Patients With Major Depressive Disorder: Post Hoc Analysis of a Randomized Placebo-Controlled Trial.

The Journal of clinical psychiatry · 2025 · high-value

Pharmacological Treatment of Neuropsychiatric Symptoms in Huntington's Disease: A Systematic Review.

Movement disorders clinical practice · 2025 · high-value

Antipsychotic-Related Prolactin Changes: A Systematic Review and Dose-Response Meta-analysis.

CNS drugs · 2025 · high-value

Facts & assertions

30 sourced

Anda Generic Count

Available Strengths

cariprazine 1.5 MG Oral Capsule, cariprazine 3 MG Oral Capsule, cariprazine 4.5 MG Oral Capsule, cariprazine 6 MG Oral Capsule, cariprazine 0.5 MG Oral Capsule, cariprazine 0.75 MG Oral Capsule

Boxed Warning

present

Dose Forms

Oral Capsule

Dosing Frequency

once daily

Faers Share Anticholinergic

0.017

Faers Share Eps Akathisia

0.135

Faers Share Gi

0.05

Faers Share Mortality

0.02

Faers Share Nms

0.004

Faers Share Qt Cardiac

0.01

Faers Share Sedation

0.051

Faers Share Weight Metabolic

0.038

Fda Pharm Class Epc

Atypical Antipsychotic [EPC]

Has Generic Competition

yes

Label Expansions ApprovedCariprazine (Vraylar): 7 approved efficacy label-expansion supplements since launch on NDA204370. Higher count = more aggressive addressable-market broadening (competitive-threat velocity signal).

Latest Exclusivity Expiry

2029-06-18

Latest Patent Expiry

2030-03-17

Latest Protection Date

2030-03-17

Mechanism Of Action

Originator Company

Abbvie

Precise Ingredient

cariprazine hydrochloride

Rxcui