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 · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 · a red edge is where a trial was stopped
| 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 | Jul 2026 → Jul 2028 expected | schizophrenia | Anxo Pharmaceutical Co., Ltd. | Not yet 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 | ||||||
| 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| Phase 2 | NCT04965272 | Aug 2021 | generalized anxiety disorder | AbbVie | Withdrawn | No outcome recorded |
| Phase 2 | NCT03430544 | Apr 2018 → Sep 2020 | substance-related disorder | Anna Rose Childress, Ph.D. | Terminated | No outcome recorded |
| Phase 2 | NCT01469377 | Dec 2011 → Dec 2013 | major depressive disorder | Forest Laboratories | Completed | No outcome recorded |
| Phase 2 | NCT01396447 | Jul 2011 → Jan 2014 | bipolar depression | Forest Laboratories | Completed | No outcome recorded |
| Phase 2 | NCT00852202 | Jun 2009 → Jun 2010 | bipolar depression | Forest Laboratories | Completed | No outcome recorded |
| Phase 2 | NCT00854100 | Jun 2009 → Dec 2010 | major depressive disorder | Forest Laboratories | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 | 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 2/3 | NCT01626859 | May 2012 → Aug 2013 | schizophrenia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 321 trials | ||||||
| Phase 3 | NCT05368558 | Aug 2022 → Sep 2024 | schizophrenia | AbbVie | Terminated | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT03738215 | Nov 2018 → Sep 2021 | major depressive disorder | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03593213 | Jul 2018 → Feb 2021 | schizophrenia | AbbVie | Terminated | No outcome recorded |
| Phase 3 | NCT03573297 | Jun 2018 → Sep 2022 | bipolar I disorder, depressive disorder, manic bipolar affective disorder | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02670538 | Mar 2016 → Jan 2018 | bipolar disorder, depressive disorder | Forest Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT02670551 | Mar 2016 → Jul 2017 | bipolar disorder, depressive disorder | Forest Laboratories | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT01412060 | Sep 2011 → Sep 2014 | schizophrenia | Forest Laboratories | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT01104766 | Apr 2010 → Dec 2011 | schizophrenia | Forest Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT01059539 | Feb 2010 → Feb 2012 | bipolar I disorder | Forest Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT01058096 | Feb 2010 → Jul 2011 | manic bipolar affective disorder | Forest Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT01058668 | Feb 2010 → Dec 2011 | bipolar I disorder, manic bipolar affective disorder | Forest Laboratories | Completed | No outcome recorded |
| 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 |
| 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 |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT04771299 Comparator | Jul 2021 → Sep 2024 | bipolar I disorder, cognitive disorder | Lakshmi N Yatham | Terminated | No outcome recorded |
| Phase 43 trials | ||||||
| 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 |
Press releases naming this drug 8 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-12-16 | AbbVie | U.S. FDA Approves VRAYLAR® (cariprazine) as an Adjunctive Treatment for Major Depressive Disorder abbvie.com ↗ |
| 2022-05-23 | AbbVie | 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 ↗ |
| 2022-02-22 | AbbVie | AbbVie Submits Supplemental New Drug Application to U.S. FDA for cariprazine (VRAYLAR®) for the Adjunctive Treatment of Major Depressive Disorder abbvie.com ↗ |
| 2021-10-29 | AbbVie | AbbVie's Cariprazine (VRAYLAR®) Met Primary Endpoint in Phase 3 Study as an Adjunctive Treatment for Major Depressive Disorder abbvie.com ↗ |
| 2019-05-28 | AbbVie | Allergan and Gedeon Richter Receive U.S. FDA Approval For Expanded Use of VRAYLAR® (cariprazine) in the Treatment of Bipolar Depression abbvie.com ↗ |
| 2019-05-15 | AbbVie | Allergan to Present VRAYLAR® (cariprazine) Data at the American Psychiatric Association (APA) 2019 Annual Meeting Highlighting Continued Commitment to Mental Health abbvie.com ↗ |
| 2018-09-26 | AbbVie | Allergan Announces FDA Acceptance of Supplemental New Drug Application For VRAYLAR® (cariprazine) abbvie.com ↗ |
| 2018-04-03 | AbbVie | Allergan and Richter Announce Positive Topline Results from Third of Three Pivotal Trials of Cariprazine in Bipolar I Depression abbvie.com ↗ |
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 ↗48“Cariprazine 45 mg” NCT07484204 ↗ |
| 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 NCT01626859 ↗ |
| 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 ↗ |