Drugs / Cariprazine
Cariprazine
also known as
MP-214 · RGH-188 · Vraylar · Cariprazina · Cariprazine Depot · cariprazine HCl · CARIPRAZINE HYDROCHLORIDE · cariprazine hydrochloride (HCl) · +6 more
Small molecule targets DRD2, DRD3
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed schizophrenia 1 milestone | |||||
| Filed | EU (EMA) | — | schizophrenia | — | “The European Medicines Agency (EMA) started the evaluation of Richter’s marketing authorisation application for cariprazine for the treatment of schizophrenia in March 2016.” recordati.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (4) | US (FDA) | VRAYLAR | — | 2017-11-09 – 2025-12-18 | fda.gov ↗ |
| Approved | EU (EMA) | Reagila | — | 2017-07-13 | europa.eu ↗ |
| Approved | US (FDA) | VRAYLAR | — | 2015-09-17 | fda.gov ↗ |
Trials 51
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT07715253 | Dec 2026 → Aug 2030 expected | schizoaffective disorder, schizophrenia, schizophreniform disorder | New York State Psychiatric Institute | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07484204 | Sep 2026 → Jul 2028 expected | schizophrenia | Anxo Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT04382885 | Jun 2020 → Dec 2021 | autism spectrum disorder | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT02165098 | Jun 2014 → Feb 2016 | — | Gedeon Richter Plc. | Completed | No outcome recorded |
| Phase 1 | NCT01376076 | Jun 2011 → Feb 2012 | schizophrenia | Forest Laboratories | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07185815 | Aug 2025 → Dec 2026 expected | bipolar I disorder, major depressive disorder, schizophrenia | Mapi Pharma Ltd. | Recruiting | No outcome recorded |
| Phase 212 trials · 3 met primary · 2 missed | ||||||
| Phase 2 | NCT05063201 | Aug 2022 → Dec 2025 | opiate dependence | Kyle Kampman | Completed | No outcome recorded |
| Phase 2 | NCT04965272 | Aug 2021 | generalized anxiety disorder | AbbVie | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT03430544 | Apr 2018 → Sep 2020 | substance-related disorder | Anna Rose Childress, Ph.D. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01469377 | Dec 2011 → Dec 2013 | major depressive disorder | Forest Laboratories | Completed | Mixed |
| Phase 2 | NCT01396447 | Jul 2011 → Jan 2014 | bipolar depression | Forest Laboratories | Completed | Met primary |
| Phase 2 | NCT00852202 | Jun 2009 → Jun 2010 | bipolar depression | Forest Laboratories | Completed | Missed primary |
| Phase 2 | NCT00854100 | Jun 2009 → Dec 2010 | major depressive disorder | Forest Laboratories | Completed | Missed primary |
| Phase 2 | NCT00839852 | May 2009 → Aug 2010 | schizophrenia | Forest Laboratories | Completed | No outcome recorded |
| Phase 2 | NCT00694707 | Jun 2008 → Aug 2009 | schizophrenia | Forest Laboratories | Completed | Met primary |
| Phase 2 | NCT00862992 | Apr 2008 → Sep 2009 | schizophrenia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 2 | NCT00488618 | Jun 2007 → Jul 2008 | bipolar disorder | Forest Laboratories | Completed | Met primary |
| Phase 2 | NCT00404573 | Nov 2006 → Aug 2007 | schizophrenia | Forest Laboratories | Completed | No outcome recorded |
| Phase 2/35 trials | ||||||
| Phase 2/3 | NCT01626872 | Sep 2012 → Oct 2016 | schizophrenia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 2/3 | NCT01626859 | May 2012 → Aug 2013 | schizophrenia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 2/3 | NCT01625000 | May 2012 → Aug 2015 | schizophrenia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 2/3 | NCT01626885 | May 2012 → Jun 2014 | schizophrenia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 2/3 | NCT01625897 | May 2012 → Mar 2015 | schizophrenia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 321 trials · 9 met primary · 4 missed | ||||||
| Phase 3 | NCT05368558 | Aug 2022 → Sep 2024 | schizophrenia | AbbVie | Terminated | Met primary Stop: Business |
| Phase 3 | NCT05439616 | Jul 2022 → Oct 2024 | autism spectrum disorder | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT05168007 | Nov 2021 → Jul 2023 | schizophrenia | Whanin Pharmaceutical Company | Unknown | No outcome recorded |
| Phase 3 | NCT04777357 | Apr 2021 → Mar 2027 expected | bipolar I disorder, depressive disorder | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT04578756 | Feb 2021 → Oct 2025 | autism spectrum disorder, bipolar I disorder, schizophrenia | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03817502 | Jun 2019 → Dec 2026 expected | schizophrenia | Gedeon Richter Plc. | Recruiting | No outcome recorded |
| Phase 3 | NCT03739203 | Nov 2018 → Sep 2021 | major depressive disorder | AbbVie | Completed | Missed primary |
| Phase 3 | NCT03738215 | Nov 2018 → Sep 2021 | major depressive disorder | AbbVie | Completed | Met primary |
| Phase 3 | NCT03593213 | Jul 2018 → Feb 2021 | schizophrenia | AbbVie | Terminated | Missed primary |
| Phase 3 | NCT03573297 | Jun 2018 → Sep 2022 | bipolar I disorder, depressive disorder, manic bipolar affective disorder | AbbVie | Completed | Missed primary |
| Phase 3 | NCT02670538 | Mar 2016 → Jan 2018 | bipolar disorder, depressive disorder | Forest Laboratories | Completed | Met primary |
| Phase 3 | NCT02670551 | Mar 2016 → Jul 2017 | bipolar disorder, depressive disorder | Forest Laboratories | Completed | Met primary |
| Phase 3 | NCT01838876 | Apr 2013 → Jul 2015 | major depressive disorder | Forest Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT01715805 | Nov 2012 → Jun 2016 | major depressive disorder | Forest Laboratories | Completed | Missed primary |
| Phase 3 | NCT01412060 | Sep 2011 → Sep 2014 | schizophrenia | Forest Laboratories | Completed | Met primary |
| Phase 3 | NCT01104792 | May 2010 → Jan 2013 | schizophrenia | Forest Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT01104779 | Apr 2010 → Dec 2011 | schizophrenia | Forest Laboratories | Completed | Met primary |
| Phase 3 | NCT01104766 | Apr 2010 → Dec 2011 | schizophrenia | Forest Laboratories | Completed | Met primary |
| Phase 3 | NCT01059539 | Feb 2010 → Feb 2012 | bipolar I disorder | Forest Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT01058668 | Feb 2010 → Dec 2011 | bipolar I disorder, manic bipolar affective disorder | Forest Laboratories | Completed | Met primary |
| Phase 3 | NCT01058096 | Feb 2010 → Jul 2011 | manic bipolar affective disorder | Forest Laboratories | Completed | Met primary |
| Phase 47 trials | ||||||
| Phase 4 | NCT07266545 | Feb 2026 → Dec 2028 expected | bipolar depression, major depressive disorder | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 4 | NCT05060549 | Jan 2026 → May 2027 | bipolar depression | New York State Psychiatric Institute | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT06433635 | Oct 2024 → Feb 2030 expected | bipolar I disorder, depressive disorder | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05933538 | Aug 2024 → Aug 2030 expected | major depressive disorder | Sultan Qaboos University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05913947 | Dec 2022 → Sep 2028 expected | bipolar depression | Aalborg University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05384483 | Jul 2022 → Apr 2024 | social phobia | The Medical Research Network | Completed | No outcome recorded |
| Phase 4 | NCT04843423 | Dec 2021 → Dec 2022 | attention deficit-hyperactivity disorder | Dr. Martin A. Katzman | Unknown | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 3 | NCT04771299 Comparator | Jul 2021 → Sep 2024 | bipolar I disorder, cognitive disorder | Lakshmi N Yatham | Terminated | No outcome recorded |
| Phase 4 | NCT07665073 Comparator | Jun 2027 → Jun 2028 expected | bipolar I disorder | Pakistan Institute of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07676669 Comparator | Dec 2026 → Mar 2027 expected | bipolar depression | Watim Medical & Dental College | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05741502 Comparator | Aug 2023 → Jan 2026 | schizophrenia | Ohio State University | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2026-09-18 | AbbVie | Results AbbVie Highlights New Real-World Data Supporting the Effectiveness of VRAYLAR® (cariprazine) at Psych Congress 2026 abbvie.com ↗
In ProACt, a real-world study of adjunctive VRAYLAR in MDD, interim findings showed improvements not only in depressive symptoms, but also in outcomes that affect day-to-day life and matter most to patients, including functioning, motivation, energy and anhedonia. |
| 2026-08-12 | Mapi Pharma Ltd. | Results Mapi Pharma Announces Initial Phase I/IIa Clinical Results Supporting Continued Development of Once-Monthly Cariprazine Depot mapi-pharma.com ↗
Mapi Pharma Ltd. (“Mapi” or the “Company”), a late-stage clinical biopharmaceutical company specializing in long-acting injectable therapies, today announced initial clinical results from its on-going Phase I/IIa trial that support continued development of once-monthly Cariprazine Depot. |
| 2025-02-28 | Tanabe Pharma Corporation | Regulatory Regulatory Approval of Cariprazine (MP-214) For Adjunctive therapy for major depressive disorder in Thailand tanabe-pharma.com ↗ |
| 2024-04-11 | Gedeon Richter Ltd. | Results Gedeon Richter: Cariprazine shows effectiveness in the treatment for dual disorder gedeonrichter.com ↗
The first Gedeon Richter poster at the 2024 EPA Congress provided evidence that cariprazine is effective in treating patients with late-stage schizophrenia (having an illness-duration of more than 15 years). |
| 2022-12-19 | Gedeon Richter Ltd. | Regulatory U.S. FDA Approves VRAYLAR® (cariprazine) as an Adjunctive Treatment for Major Depressive Disorder gedeonrichter.com ↗
Richter Gedeon’s (’Richter’) partner AbbVie (’AbbVie’) today announced that the U.S. Food and Drug Administration (FDA) has approved VRAYLAR® (cariprazine) as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. |
| 2022-12-16 | AbbVie | Regulatory U.S. FDA Approves VRAYLAR® (cariprazine) as an Adjunctive Treatment for Major Depressive Disorder abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved VRAYLAR ® (cariprazine) as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. |
| 2022-09-12 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval and 180 days shared exclusivity from the USFDA for Cariprazine Capsules zyduslife.com ↗
Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received final approval from the United States Food and Drug Administration (USFDA) to market Cariprazine Capsules, USP 1.5 mg, 3 mg, 4.5 mg, and 6 mg (USRLD: VRAYLAR®). |
| 2022-05-23 | AbbVie | Results AbbVie Presents Positive Data from Phase 3 Study of Cariprazine (VRAYLAR®) for the Adjunctive Treatment of Major Depressive Disorder at 2022 APA Annual Meeting abbvie.com ↗
The study met its primary endpoint of statistically significant improvement using the Montgomery -Åsberg Depression Rating Scale (MADRS) total score in patients compared with placebo. |
| 2022-04-29 | AbbVie | Regulatory AbbVie Reports First-Quarter 2022 Financial Results abbvie.com ↗
AbbVie announced that it submitted a supplemental New Drug Application (sNDA) to the FDA for Vraylar (cariprazine) for the adjunctive treatment of major depressive disorder (MDD). |
| 2022-04-27 | Gedeon Richter Ltd. | Regulatory Health Canada Approves VRAYLAR® for the Treatment of Bipolar l Disorder and Schizophrenia in Adults gedeonrichter.com ↗ |
| 2022-02-22 | Gedeon Richter Ltd. | Regulatory AbbVie Submits Supplemental New Drug Application to U.S. FDA gedeonrichter.com ↗
Richter’s partner, AbbVie today announced that it has submitted a supplemental New Drug Application (sNDA) for cariprazine (VRAYLAR®) to the U.S. Food and Drug Administration (FDA) for the adjunctive treatment of major depressive disorder (MDD) in patients who are receiving ongoing antidepressant therapy. |
| 2022-02-22 | AbbVie | Regulatory AbbVie Submits Supplemental New Drug Application to U.S. FDA for cariprazine (VRAYLAR®) for the Adjunctive Treatment of Major Depressive Disorder abbvie.com ↗ |
| 2021-12-10 | Zydus Lifesciences Limited | Regulatory Zydus Cadila receives tentative approval from USFDA for Cariprazine Capsules zyduslife.com ↗ |
| 2021-10-29 | Gedeon Richter Ltd. | Results Cariprazine Met Primary Endpoint in Phase 3 Study as an Adjunctive Treatment for MDD gedeonrichter.com ↗
In Study 3111-301-001, cariprazine showed a statistically significant change from baseline to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared with placebo. |
| 2021-10-29 | AbbVie | Results AbbVie's Cariprazine (VRAYLAR®) Met Primary Endpoint in Phase 3 Study as an Adjunctive Treatment for Major Depressive Disorder abbvie.com ↗
In Study 3111-301-001, cariprazine showed a statistically significant change from baseline to week six in the Montgomery -Åsberg Depression Rating Scale (MADRS) total score compared with placebo. |
| 2019-05-28 | AbbVie | Regulatory Allergan and Gedeon Richter Receive U.S. FDA Approval For Expanded Use of VRAYLAR® (cariprazine) in the Treatment of Bipolar Depression abbvie.com ↗
Allergan plc (NYSE: AGN) and Gedeon Richter Plc. today announced that the U.S. Food and Drug Administration ( FDA ) has approved a supplemental New Drug Application (sNDA) for VRAYLAR® (cariprazine) for expanded use to treat depressive episodes associated with bipolar I disorder (bipolar depression) in adults. |
| 2018-09-26 | AbbVie | Regulatory Allergan Announces FDA Acceptance of Supplemental New Drug Application For VRAYLAR® (cariprazine) abbvie.com ↗ |
| 2018-04-03 | AbbVie | Results Allergan and Richter Announce Positive Topline Results from Third of Three Pivotal Trials of Cariprazine in Bipolar I Depression abbvie.com ↗ |
| 2017-05-19 | RECORDATI GROUP | Regulatory European CHMP Issues Positive Opinion for Cariprazine for the Treatment of Schizophrenia, recordati.com ↗ |
All press releases naming this drug 25 releases
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 57 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cariprazine | “Including Olanzapine, Risperidone, Paliperidone, Quetiapine, Aripiprazole, Ziprasidone, Lurasidone, Cariprazine, and all Typical antipsychotics” NCT05741502 ↗ |
| Known as | Cariprazina | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028019 ↗ |
| Known as | Cariprazine Depot | “injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine” NCT07185815 ↗ |
| Known as | cariprazine HCl | “Each hard gelatin capsule contains a white to off-white powder of cariprazine HCl, which is equivalent to either 1.5, 3, 4.5, or 6 mg of cariprazine base.” NCT04843423 ↗ |
| Known as | CARIPRAZINE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028019 ↗ |
| Known as | cariprazine hydrochloride (HCl) | “Cariprazine is an atypical antipsychotic where the active ingredient is cariprazine hydrochloride (HCl).” NCT04843423 ↗ |
| Known as | Cariprazine(INN) | “Cariprazine(INN)” NCT00862992 ↗ |
| Known as | Fri-7000188 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028019 ↗ |
| Known as | GED-129 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028019 ↗ |
| Known as | MP-214 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01625897 ↗ |
| Known as | Reagila | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028019 ↗ |
| Known as | RGH-188 | “A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) As Adjunctive Therapy In Major Depressive Disorder” NCT00854100 ↗ |
| Known as | RGH-188 HCL | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028019 ↗ |
| Known as | Vraylar | “Vraylar® (cariprazine) in the Treatment of Social Anxiety Disorder” NCT05384483 ↗1“Cariprazine Oral Capsule [Vraylar]” NCT03430544 ↗ |
| Known as | WID-RGC20 | “Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia” NCT05168007 ↗ |
| Action | Activate | “Cariprazine is a dopamine D3 receptor-preferring D3/D2 partial agonist antipsychotic” PMID 34091867 ↗ Jun 2021 |
| Modality | Small molecule | — CHEMBL2028019 ↗ |
| Route | Oral | “Cariprazine 3 mg - 12 mg oral administration, once per day.” NCT00488618 ↗ |
| Target | DRD2 | “Dopamine D2 receptor modulator” CHEMBL2028019 ↗ |
| Target | DRD3 | “Dopamine D3 receptor modulator” CHEMBL2028019 ↗ |