Clinical Trials

Cariprazine hydrochloride is evaluated across numerous early- to late-phase clinical trials targeting schizophrenia, bipolar I disorder, acute mania, major depressive disorder, and autism spectrum disorder. Sponsored by academic institutions and pharmaceutical companies, these studies encompass active, recruiting, completed, terminated, and not yet recruiting statuses. Collectively, these investigations assess cariprazine's therapeutic efficacy, safety, pharmacokinetic profile, and functional outcomes across diverse clinical populations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07715253 NOT_YET_RECRUITING
Schizoaffective Disorder; Schizophreniform Disorder; Schizophrenia
New York State Psychiatric Institute
 2026-12-01 PHASE1
NCT05933538 NOT_YET_RECRUITING
Depressive Disorder, Major
Sultan Qaboos University
 2024-08 PHASE4
NCT06433635 ACTIVE_NOT_RECRUITING
Bipolar I Disorder; Depression
Massachusetts General Hospital
 2024-10-01 PHASE4
NCT07266545 RECRUITING
Unipolar Depression; Bipolar Depression
Mayo Clinic
 2026-02-17 PHASE4
NCT05913947 RECRUITING
Depression, Bipolar
Aalborg University Hospital
 2022-12-13 PHASE4
NCT07665073 NOT_YET_RECRUITING
Bipolar 1 Disorder
Pakistan Institute of Medical Sciences
 2027-06 PHASE4
NCT05060549 WITHDRAWN
Bipolar Depression
New York State Psychiatric Institute
 2026-01-06 PHASE4
NCT07676669 NOT_YET_RECRUITING
Bipolar 1 Depression
Watim Medical & Dental College
 2026-12 PHASE4
NCT04777357 RECRUITING
Depression; Bipolar I Disorder
AbbVie
 2021-04-28 PHASE3
NCT07185815 RECRUITING
Schizophrenia; Bipolar I Disorder; Major Depressive Disorder
Mapi Pharma Ltd.
 2025-08-01 PHASE1; PHASE2
NCT03817502 RECRUITING
Schizophrenia
Gedeon Richter Plc.
 2019-06-06 PHASE3
NCT07691190 COMPLETED
SCHIZOPHRENIA 1 (Disorder)
Humanis Saglık Anonim Sirketi
 2026-03-05 PHASE1
NCT05063201 COMPLETED
Opioid-use Disorder; Cocaine Use Disorder
Kyle Kampman
 2022-08-05 PHASE2
NCT04578756 COMPLETED
Schizophrenia; Bipolar I Disorder; Autism Spectrum Disorder (ASD)
AbbVie
 2021-02-01 PHASE3
NCT07121868 COMPLETED
Bioequivalence Study in Healthy Subjects
Aya Mohammed Abdel Magid Abdel Hamid
 2024-08-03 PHASE1
NCT05439616 COMPLETED
Autism Spectrum Disorder
AbbVie
 2022-07-07 PHASE3
NCT05368558 TERMINATED
Schizophrenia
AbbVie
 2022-08-18 PHASE3
NCT04771299 TERMINATED
Bipolar I Disorder; Cognitive Impairment
Lakshmi N Yatham
 2021-07-07 PHASE3
NCT05384483 COMPLETED
Social Anxiety Disorder
The Medical Research Network
 2022-07-18 PHASE4
NCT05168007 UNKNOWN
Schizophrenia
Whanin Pharmaceutical Company
 2021-11-19 PHASE3
NCT04843423 UNKNOWN
Attention Deficit Hyperactivity Disorder
Dr. Martin A. Katzman
 2021-12-01 PHASE4
NCT03573297 COMPLETED
Bipolar I Disorder; Mania; Depression
AbbVie
 2018-06-15 PHASE3
NCT04382885 COMPLETED
Autism Spectrum Disorder
AbbVie
 2020-06-26 PHASE1
NCT03738215 COMPLETED
Major Depressive Disorder
AbbVie
 2018-11-09 PHASE3
NCT03739203 COMPLETED
Major Depressive Disorder
AbbVie
 2018-11-10 PHASE3
NCT04965272 WITHDRAWN
Generalized Anxiety Disorder
AbbVie
 2021-08-18 PHASE2
NCT03593213 TERMINATED
Schizophrenia
AbbVie
 2018-07-30 PHASE3
NCT03430544 TERMINATED
Cocaine Use Disorder
Anna Rose Childress, Ph.D.
 2018-04-04 PHASE2
NCT02670538 COMPLETED
Bipolar Disorder; Depression
Forest Laboratories
 2016-03-31 PHASE3
NCT02670551 COMPLETED
Bipolar Disorder; Depression
Forest Laboratories
 2016-03-17 PHASE3
NCT01715805 COMPLETED
Major Depressive Disorder
Forest Laboratories
 2012-11-15 PHASE3
NCT02165098 COMPLETED
Pharmacokinetic Profile
Gedeon Richter Plc.
 2014-06 PHASE1
NCT01838876 COMPLETED
Major Depressive Disorder
Forest Laboratories
 2013-04-29 PHASE3
NCT01412060 COMPLETED
Schizophrenia
Forest Laboratories
 2011-09-27 PHASE3
NCT01396447 COMPLETED
Depression, Bipolar
Forest Laboratories
 2011-07-26 PHASE2
NCT01469377 COMPLETED
Major Depressive Disorder
Forest Laboratories
 2011-12-15 PHASE2
NCT01104792 COMPLETED
Schizophrenia
Forest Laboratories
 2010-05-31 PHASE3
NCT01059539 COMPLETED
Bipolar I Disorder
Forest Laboratories
 2010-02-28 PHASE3
NCT01376076 COMPLETED
Schizophrenia
Forest Laboratories
 2011-06 PHASE1
NCT01104766 COMPLETED
Schizophrenia
Forest Laboratories
 2010-04-23 PHASE3
NCT01104779 COMPLETED
Schizophrenia
Forest Laboratories
 2010-04-27 PHASE3
NCT01058668 COMPLETED
Mania; Bipolar I Disorder
Forest Laboratories
 2010-02 PHASE3
NCT01058096 COMPLETED
Bipolar Disorder; Mania
Forest Laboratories
 2010-02 PHASE3
NCT00854100 COMPLETED
Major Depressive Disorder
Forest Laboratories
 2009-06-30 PHASE2
NCT00839852 COMPLETED
Schizophrenia
Forest Laboratories
 2009-05-31 PHASE2
NCT00852202 COMPLETED
Bipolar Depression
Forest Laboratories
 2009-06-30 PHASE2
NCT00862992 COMPLETED
Schizophrenia
Tanabe Pharma Corporation
 2008-04 PHASE2
NCT00694707 COMPLETED
Schizophrenia
Forest Laboratories
 2008-06-30 PHASE2
NCT00488618 COMPLETED
Bipolar Disorder
Forest Laboratories
 2007-06 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-20)

Check the Cariprazine hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cariprazine hydrochloride acts as a highly selective partial agonist of dopamine D2 and D3 receptors with preferential binding affinity for D3 receptors (Ki = 0.085 nM), while also exhibiting moderate partial agonist activity at serotonin 5-HT1A receptors (Ki = 2.6 nM). By modulating dopaminergic and serotonergic neurotransmission in central neuronal pathways, it normalizes monoaminergic signaling to provide therapeutic efficacy across clinical indications such as schizophrenia, bipolar disorder, and major depressive disorder.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.