Brexpiprazole

also known as OPC-34712 · Brexpiprazole fumarate · OPC-34712FUM · Brexpiprazol · OPDC-34712 · Rexulti · Rxulti

Small molecule targets DRD2, HTR1A, HTR2A via activation / inhibition

Developed for: schizophrenia · major depressive disorder · post-traumatic stress disorder · Alzheimer disease · bipolar I disorder · borderline personality disorder · manic bipolar affective disorder · autism spectrum disorder
+8 more
· bipolar depression · schizoaffective disorder · anxiety · schizophreniform disorder · sleep disorder · substance-related disorder · alcohol-related disorders · depressive disorder
Investigated by: Otsuka Pharmaceutical Development & Commercialization, Inc. · H. Lundbeck A/S · Otsuka Pharmaceutical Co., Ltd. · Otsuka Beijing Research Institute · Otsuka America Pharmaceutical · Augusta University
+18 more
· Columbia University · Douglas Mental Health University Institute · Duke University · Jewish General Hospital · Lundbeck Canada Inc. · Massachusetts General Hospital · McMaster University · National Institute of Mental Health (NIMH) · New York State Psychiatric Institute · Otsuka Canada Pharmaceutical Inc. · Quintiles, Inc. · Sichuan Kelun Pharmaceutical Co.,Ltd. · Stony Brook Medicine · University of California, San Francisco · University of Chicago · University of Massachusetts, Worcester · University of North Carolina, Chapel Hill · University of Texas Southwestern Medical Center

Regulatory milestones approvals, filings & regulatory actions · 15 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed post-traumatic stress disorder 2 milestones
Filed	US (FDA)	—	post-traumatic stress disorder	2024-06-25	“brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) has been accepted and filed by the FDA.” otsuka.co.jp ↗ “brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) has been accepted and filed by the FDA.” lundbeck.com ↗ “Otsuka and Lundbeck submitted an sNDA for brexpiprazole in combination with sertraline for the treatment of adults with PTSD in April 2024.” otsuka-us.com ↗
Filed	US (FDA)	—	post-traumatic stress disorder	2024-04-04	“Otsuka and Lundbeck submit sNDA for FDA review of brexpiprazole and sertraline combination as potential treatment for PTSD” otsuka-us.com ↗
Filed schizoaffective depressive disorder 2 milestones
Filed	US (FDA)	—	schizoaffective depressive disorder	2015-05-12	“A New Drug Application for brexpiprazole has been filed with the U.S. Food and Drug Administration (FDA)” otsuka-us.com ↗
Filed	US (FDA)	—	schizoaffective depressive disorder	2014-09-09	“today announced the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for brexpiprazole” otsuka-us.com ↗
Filed schizophrenia 2 milestones
Filed	US (FDA)	Rexulti	schizophrenia	2021-10-13	“the U.S. Food and Drug Administration (FDA) has accepted a Supplemental New Drug Application (sNDA) for the treatment of schizophrenia in adolescents with Rexulti® (brexpiprazole)” lundbeck.com ↗
Filed	EU (EMA)	—	schizophrenia	2017-03-24	“the European Medicines Agency (EMA) has accepted for review a Marketing Authorization Application for brexpiprazole to treat schizophrenia in adults.” otsuka.co.jp ↗
Approved Indication not stated 5 milestones
Label expansions (5)	US (FDA)	REXULTI	—	2016-09-23 – 2025-05-09	fda.gov ↗
Filed	Japan (PMDA)	Rexulti	agitation associated with Alzheimer disease	2023-10-31	“has filed an application in Japan for an additional indication for Rexulti(generic name: brexpiprazole) in the treatment of agitation” otsuka.co.jp ↗
Filed	US (FDA)	—	agitation associated with Alzheimer’s dementia	2022-12-01	“The supplemental new drug application (sNDA) for brexpiprazole in the treatment of agitation associated with Alzheimer's dementia has been accepted and filed by the FDA” lundbeck.com ↗ “The supplemental new drug application (sNDA) for brexpiprazole in the treatment of agitation associated with Alzheimer’s dementia has been accepted and filed by the FDA” lundbeck.com ↗ “Otsuka and Lundbeck announce FDA acceptance and priority review of sNDA for brexpiprazole for the treatment of agitation associated with Alzheimer’s dementia” otsuka-us.com ↗
Approved	EU (EMA)	Rxulti	—	2018-07-26	europa.eu ↗
Approved	US (FDA)	REXULTI	—	2015-07-10	fda.gov ↗

Trials 80 · started per year

today

US approved 2015

EU approved 2018

20092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 114 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	NCT06674694	Apr 2024 → Jun 2026 overdue	schizophrenia	Sichuan Kelun Pharmaceutical Co.,Ltd.	Recruiting	No outcome recorded
Phase 1	NCT06036108	Oct 2023 → Mar 2025	schizophrenia	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 1	NCT05119894	Nov → Dec 2021	schizophrenia	Otsuka Pharmaceutical Co., Ltd.	Withdrawn	No outcome recorded Stop: Business
Phase 1	NCT04118127	Oct 2019 → Feb 2021	schizophrenia	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 1	NCT03734302	Apr 2019 → Jun 2020	—	Otsuka Beijing Research Institute	Completed	No outcome recorded
Phase 1	NCT03734354	Apr 2019 → May 2020	—	Otsuka Beijing Research Institute	Completed	No outcome recorded
Phase 1	NCT03292848	Oct 2017 → May 2018	attention deficit-hyperactivity disorder, autism, bipolar I disorder, conduct disorder +1	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 1	NCT02968121	Jan → Dec 2017	schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Terminated	No outcome recorded
Phase 1	NCT02875080	Sep → Nov 2016	—	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 1	NCT02411695	Mar 2015 → Jan 2017	schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 1	NCT01854944	Sep 2013 → Jul 2014	schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 1	NCT01670279	Jul 2012 → May 2013	major depressive disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 1	NCT00805454	Dec 2008 → Jul 2009	schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded

Phase 29 trials · 2 met primary · 3 missed
Phase 2	NCT04100096	Oct 2019 → Jun 2021	borderline personality disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Missed primary
Phase 2	NCT03418675	Nov 2018 → Dec 2020	borderline personality disorder	University of Chicago	Completed	No outcome recorded
Phase 2	NCT02934932	Apr 2017 → Apr 2018	post-traumatic stress disorder	Duke University	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT03033069	Jan 2017 → Nov 2018	post-traumatic stress disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Met primary
Phase 2	NCT01052077	Mar 2010 → Oct 2011	major depressive disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Missed primary
Phase 2	NCT01447576	Sep 2009 → Dec 2012	major depressive disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 2	NCT01649557	Aug 2009 → Aug 2011	schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 2	NCT00905307	Jul 2009 → Sep 2010	schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Missed primary
Phase 2	NCT00797966	May 2009 → Jun 2010	major depressive disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Met primary
Phase 2/34 trials · 2 met primary · 1 missed
Phase 2/3	NCT04186403	Jan 2020 → Sep 2021	borderline personality disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Missed primary
Phase 2/3	NCT03620981	Aug 2018 → Apr 2023	—	Otsuka Pharmaceutical Co., Ltd.	Completed	Met primary
Phase 2/3	NCT03697603	Jul 2018 → Jun 2022	major depressive disorder	Otsuka Pharmaceutical Co., Ltd.	Completed	Met primary
Phase 2/3	NCT01451164	Oct 2011 → Jun 2015	schizophrenia	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 348 trials · 9 met primary · 8 missed
Phase 3	NCT05325645	Jul 2022 → Sep 2027 expected	schizophrenia	Otsuka Pharmaceutical Co., Ltd.	Recruiting	No outcome recorded
Phase 3	NCT05326347	May 2022 → Aug 2025	schizophrenia	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 3	NCT04569448	May 2021 → Feb 2025 overdue	bipolar depression	Douglas Mental Health University Institute	Recruiting	No outcome recorded
Phase 3	NCT04258839	Jan 2020 → Mar 2023	autism spectrum disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT03874494	Nov 2019 → Aug 2021	schizophrenia	Otsuka Beijing Research Institute	Completed	No outcome recorded
Phase 3	NCT04174170	Oct 2019 → Jul 2023	post-traumatic stress disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Missed primary
Phase 3	NCT04174365	Oct 2019 → Aug 2022	autism spectrum disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Missed primary
Phase 3	NCT04124614	Oct 2019 → Jul 2023	post-traumatic stress disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Met primary
Phase 3	NCT03724942	Nov 2018 → Dec 2021	—	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 3	NCT03594123	Oct 2018 → Sep 2022	Alzheimer disease	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT03737474	Oct 2018 → Mar 2021	major depressive disorder	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 3	NCT03538691	Jul 2018 → Jul 2022	major depressive disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Missed primary
Phase 3	NCT03487198	May 2018 → May 2019	major depressive disorder	Otsuka Beijing Research Institute	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT03548584	May 2018 → May 2022	Alzheimer disease	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Met primary
Phase 3	NCT03287869	Oct 2017 → Jul 2019	bipolar I disorder, manic bipolar affective disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT03257865	Sep 2017 → Jan 2019	bipolar I disorder, manic bipolar affective disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Missed primary
Phase 3	NCT03259555	Sep 2017 → Jan 2019	bipolar I disorder, manic bipolar affective disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Missed primary
Phase 3	NCT03238326	Aug 2017 → Apr 2025	schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT03198078	Jun 2017 → Apr 2023	schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Met primary
Phase 3	NCT02758067	Jun 2016	schizophrenia	H. Lundbeck A/S	Withdrawn	No outcome recorded
Phase 3	NCT02400346	Mar 2015 → Jun 2016	major depressive disorder	H. Lundbeck A/S	Completed	No outcome recorded
Phase 3	NCT02194933	Feb 2015 → Apr 2016	schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Mixed
Phase 3	NCT02212613	Sep 2014 → Nov 2015	major depressive disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Withdrawn	No outcome recorded Stop: Enrollment
Phase 3	NCT02196506	Jul 2014 → Apr 2016	major depressive disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Met primary
Phase 3	NCT02054702	Feb → Jun 2014	schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT01987960	Dec 2013 → Oct 2015	post-traumatic stress disorder	H. Lundbeck A/S	Terminated	No outcome recorded
Phase 3	NCT02013609	Nov 2013 → Sep 2014	major depressive disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT02012218	Nov 2013 → Oct 2014	major depressive disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT02013622	Nov 2013 → Sep 2014	schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT02013531	Nov 2013 → May 2014	anxiety, major depressive disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT01944969	Oct 2013 → May 2014	major depressive disorder	H. Lundbeck A/S	Terminated	No outcome recorded
Phase 3	NCT01942785	Oct 2013 → Jul 2014	major depressive disorder	H. Lundbeck A/S	Completed	No outcome recorded
Phase 3	NCT01922258	Sep 2013 → Mar 2017	Alzheimer disease, mental disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Missed primary
Phase 3	NCT01942733	Sep 2013 → Aug 2014	sleep disorder	H. Lundbeck A/S	Completed	No outcome recorded
Phase 3	NCT01862640	Jul 2013 → Mar 2017	Alzheimer disease, mental disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Met primary
Phase 3	NCT01810783	Jul 2013 → Dec 2015	schizophrenia	H. Lundbeck A/S	Completed	No outcome recorded
Phase 3	NCT01838681	Jun 2013 → Jun 2016	major depressive disorder	H. Lundbeck A/S	Completed	Missed primary
Phase 3	NCT01837797	Apr 2013 → May 2014	major depressive disorder	H. Lundbeck A/S	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT01810380	Mar 2013 → Dec 2014	schizophrenia	H. Lundbeck A/S	Completed	Missed primary
Phase 3	NCT01727726	Dec 2012 → Oct 2016	major depressive disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT01668797	Oct 2012 → Jan 2015	schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Met primary
Phase 3	NCT01456897	Oct 2011 → May 2015	schizophrenia	Otsuka Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 3	NCT01360866	Oct 2011 → Apr 2017	major depressive disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT01397786	Sep 2011 → Jan 2016	schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT01396421	Jul 2011 → Jan 2014	schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Met primary
Phase 3	NCT01360645	Jul 2011 → May 2013	major depressive disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Met primary
Phase 3	NCT01393613	Jul 2011 → Feb 2014	schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Met primary
Phase 3	NCT01360632	Jun 2011 → Aug 2013	major depressive disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Mixed

Phase 45 trials
Phase 4	NCT06580041	Nov 2024 → Sep 2029 expected	major depressive disorder	University of California, San Francisco	Enrolling by invitation	No outcome recorded
Phase 4	NCT05504486	Aug 2022 → Mar 2023	major depressive disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Withdrawn	No outcome recorded Stop: Business
Phase 4	NCT04830215	Apr 2021 → May 2022	major depressive disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 4	NCT03526354	Jun 2018 → Feb 2024	schizoaffective disorder, schizophrenia, substance-related disorder	University of Massachusetts, Worcester	Completed	No outcome recorded
Phase 4	NCT03427892	Mar 2017 → Mar 2018	bipolar depression	University of Texas Southwestern Medical Center	Completed	No outcome recorded
Comparator or background therapy8 trials
Phase 1	NCT01423916 Comparator	Jul 2011 → Feb 2012	schizoaffective disorder, schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 1	NCT01289080 Comparator	Jan → Dec 2011	schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 1	NCT01299454 Comparator	Dec 2010 → Jun 2011	schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 2	NCT04066192 Comparator	Oct 2020 → Aug 2026 overdue	alcohol-related disorders	University of Colorado, Denver	Recruiting	No outcome recorded
Phase 2	NCT03557931 Background	Jul 2018 → Oct 2019	schizophrenia	Astellas Pharma Global Development, Inc.	Completed	Missed primary
Phase 3	NCT04162522 Comparator	Dec 2019 → Dec 2022	major depressive disorder	University Health Network, Toronto	Completed	No outcome recorded
Phase 4	NCT05017311 Comparator	Jan 2023 → Dec 2028 expected	major depressive disorder	Nova Scotia Health Authority	Recruiting	No outcome recorded
Phase 4	NCT03149991 Comparator	Sep 2017 → Mar 2019	depressive disorder	Massachusetts General Hospital	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 92

Date	Issuer	Release
2025-09-20	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck Receive Complete Response Letter from U.S. FDA for sNDA of REXULTI (brexpiprazole) in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD)® otsuka.co.jp ↗ The CRL states that the FDA has completed their review but cannot approve the application in the current form, further stating that the application does not provide substantial evidence of effectiveness to support the approval.
2025-09-20	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck Receive Complete Response Letter from U.S. FDA for sNDA of REXULTI® (brexpiprazole) in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) otsuka-us.com ↗ The CRL states that the FDA has completed their review but cannot approve the application in the current form, further stating that the application does not provide substantial evidence of effectiveness to support the approval.
2025-09-20	H. Lundbeck A/S	Regulatory Otsuka and Lundbeck Receive Complete Response Letter from U.S. FDA for sNDA of REXULTI® (brexpiprazole) in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) lundbeck.com ↗ The CRL states that the FDA has completed their review but cannot approve the application in the current form, further stating that the application does not provide substantial evidence of effectiveness to support the approval.
2025-07-19	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on REXULTI (brexpiprazole) in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD)® otsuka.co.jp ↗ The committee voted 1-10, concluding that the efficacy of brexpiprazole, when initiated concurrently with sertraline, has not been established for the treatment of PTSD based on the available data presented.
2025-07-18	H. Lundbeck A/S	Regulatory Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on REXULTI® (brexpiprazole) in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) lundbeck.com ↗ The committee voted 1-10, concluding that the efficacy of brexpiprazole, when initiated concurrently with sertraline, has not been established for the treatment of PTSD based on the available data presented.
2025-03-13	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Rxulti (brexpiprazole) approved in the European Union for the treatment of schizophrenia in adolescents aged 13 years and older® otsuka.co.jp ↗ Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced that the European Commission (EC) has approved Rxulti (brexpiprazole) for the treatment of schizophrenia in adolescents aged 13 years and older.
2025-01-10	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka Announces FDA Plans to Host an Advisory Committee Meeting to Discuss the sNDA for Brexpiprazole in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) otsuka.co.jp ↗ The FDA's decision to host a PDAC meeting does not reflect a final decision on the approvability.
2025-01-10	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka Announces FDA Plans to Host an Advisory Committee Meeting to Discuss the sNDA for Brexpiprazole in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) otsuka-us.com ↗ The FDA’s decision to host a PDAC meeting does not reflect a final decision on the approvability.
2025-01-01	Alembic Pharmaceuticals Ltd.	Regulatory 15th January, 2025 Vadodara, India alembicpharmaceuticals.com ↗ Alembic Pharmaceuticals Limited (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg.
2024-12-19	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results JAMA Psychiatry Publishes Results of Otsuka and Lundbeck's Phase 3 Trial of Brexpiprazole in Combination with Sertraline in Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults otsuka.co.jp ↗ rexpiprazole in combination with sertraline demonstrated a statistically significant reduction in overall PTSD symptoms compared to sertraline plus placebo, as measured by change in CAPS-5 total score from Week 1 to Week 10B1
2024-12-18	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results JAMA Psychiatry Publishes Results of Otsuka and Lundbeck's Phase 3 Trial of Brexpiprazole in Combination with Sertraline in Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults otsuka-us.com ↗
2024-12-18	H. Lundbeck A/S	Results JAMA Psychiatry Publishes Results of Otsuka and Lundbeck's Phase 3 Trial of Brexpiprazole in Combination with Sertraline in Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults lundbeck.com ↗ Brexpiprazole in combination with sertraline demonstrated a statistically significant reduction in overall PTSD symptoms compared to sertraline plus placebo, as measured by change in CAPS-5 total score from Week 1 to Week 101
2024-09-24	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka Obtains Additional Indication for Rexultiin Japan as an Adjunctive Treatment for Agitation Associated with Dementia due to Alzheimer's Disease® otsuka.co.jp ↗ This is the third treatment indication received by Rexulti in Japan, in addition to schizophrenia and adjunctive treatment of major depressive disorder.
2024-08-02	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka and Lundbeck Present New REXULTI (brexpiprazole) Post Hoc Efficacy Data Analyses for Agitation Associated with Dementia Due to Alzheimer's Disease at Alzheimer's Association International Conference (AAIC) 2024® otsuka.co.jp ↗ Long-term data analysis suggests that REXULTI was associated with a sustained, clinically meaningful response over 24 weeks with a consistent rate of improvement.
2024-07-31	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka and Lundbeck Present New REXULTI® (brexpiprazole) Post Hoc Efficacy Data Analyses for Agitation Associated with Dementia Due to Alzheimer’s Disease at Alzheimer’s Association International Conference (AAIC) 2024 otsuka-us.com ↗ Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) presented new post hoc pooled analyses of Phase 3 trials evaluating the safety and efficacy of REXULTI® (brexpiprazole) in patients with agitation associated with dementia due to Alzheimer’s disease.
2024-07-31	H. Lundbeck A/S	Results Otsuka and Lundbeck Present New REXULTI® (brexpiprazole) Post Hoc Efficacy Data Analyses for Agitation Associated with Dementia Due to Alzheimer’s Disease at Alzheimer’s Association International Conference (AAIC) 2024 lundbeck.com ↗ Long-term data analysis suggests that REXULTI was associated with a sustained, clinically meaningful response over 24 weeks with a consistent rate of improvement.
2024-06-25	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck announce FDA acceptance of sNDA filing for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) otsuka.co.jp ↗ The supplemental new drug application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) has been accepted and filed by the FDA.
2024-06-25	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck Announce FDA Acceptance of sNDA Filing for Brexpiprazole in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) otsuka-us.com ↗ The supplemental new drug application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) has been accepted and filed by the FDA.
2024-06-25	H. Lundbeck A/S	Regulatory Otsuka and Lundbeck announce FDA acceptance of sNDA filing for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) lundbeck.com ↗ The supplemental new drug application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) has been accepted and filed by the FDA.
2024-05-29	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka and Lundbeck Present Results from Three Clinical Trials of Brexpiprazole in Combination with Sertraline for the Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults otsuka.co.jp ↗ In Trial 072, while the primary endpoint was not met, reductions in PTSD symptom severity with brexpiprazole in combination with sertraline were consistent with Trials 061 and 071.
2024-05-28	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka and Lundbeck Present Results from Three Clinical Trials of Brexpiprazole in Combination with Sertraline for the Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults otsuka-us.com ↗ These data showed that brexpiprazole in combination with sertraline improved symptoms of PTSD in two out of the three studies, based on the primary endpoint of change in CAPS-5 total scores from Week 1 to Week 10 compared to sertraline plus placebo.
2024-05-28	H. Lundbeck A/S	Results Otsuka and Lundbeck Present Results from Three Clinical Trials of Brexpiprazole in Combination with Sertraline for the Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults lundbeck.com ↗ These data showed that brexpiprazole in combination with sertraline improved symptoms of PTSD in two out of the three studies, based on the primary endpoint of change in CAPS-5 total scores from Week 1 to Week 10 compared to sertraline plus placebo.
2024-04-10	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck submit sNDA for FDA review of brexpiprazole and sertraline combination as potential treatment for PTSD otsuka-us.com ↗ Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) have submitted a supplemental New Drug Application (sNDA) for U.S. Food and Drug Administration (FDA) review of brexpiprazole as combination therapy with sertraline for the treatment of post-traumatic stress disorder (PTSD) in adults.
2024-04-09	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck submit sNDA for FDA review of brexpiprazole and sertraline combination as potential treatment for PTSD otsuka.co.jp ↗ have submitted a supplemental New Drug Application (sNDA) for U.S. Food and Drug Administration (FDA) review of brexpiprazole as combination therapy with sertraline for the treatment of post-traumatic stress disorder (PTSD) in adults.
2024-03-22	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka and Lundbeck Presented New Data Analyses on the Efficacy of REXULTI (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer's Disease ® otsuka.co.jp ↗ New analyses suggest REXULTI was associated with reductions in overall neuropsychiatric symptoms and in agitation symptoms
2024-03-18	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka and Lundbeck Present New Data Analyses on the Efficacy of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease otsuka-us.com ↗ New analyses suggest REXULTI was associated with reductions in overall neuropsychiatric symptoms and in agitation symptoms
2023-12-22	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka Obtains the Additional Indication of Adjunctive Treatment of Major Depressive Disorder for Rexulti in Japan ® otsuka.co.jp ↗ Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that it has obtained approval in Japan for an additional indication for Rexulti (generic name: brexpiprazole) for the treatment of depression/depressive state.
2023-11-06	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results JAMA Neurology Publishes Complete Results of Positive Phase 3 Study of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease otsuka-us.com ↗ New efficacy data reported for pivotal Study 213 shows significant, clinically meaningful improvements in agitation symptoms.
2023-11-06	H. Lundbeck A/S	Results JAMA Neurology Publishes Complete Results of Positive Phase 3 Study of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease lundbeck.com ↗ Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Lundbeck Pharmaceuticals LLC (Lundbeck) announce that treatment with REXULTI® (brexpiprazole) resulted in statistically significant and clinically meaningful improvements in adult patients with agitation associated with dementia due to Alzheimer’s disease,
2023-10-31	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka Applies in Japan for the Additional Indication for Agitation Associated with Dementia due to Alzheimer's Disease for Rexulti (brexpiprazole) ® otsuka.co.jp ↗ Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that it has filed an application in Japan for an additional indication for Rexulti(generic name: brexpiprazole) in the treatment of agitation associated with dementia due to Alzheimer's disease.
2023-09-07	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka Pharmaceutical and Lundbeck Announce Topline Results from Two Phase 3 Trials of Brexpiprazole as Combination Therapy with Sertraline for the Treatment of Post-Traumatic Stress Disorder in Adults otsuka.co.jp ↗ The flexible dose phase 3 trial met its primary endpoint, while the fixed dose phase 3 trial missed its primary endpoint
2023-09-07	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka Pharmaceutical and Lundbeck Announce Topline Results from Two Phase 3 Trials of Brexpiprazole as Combination Therapy with Sertraline for the Treatment of Post-Traumatic Stress Disorder in Adults otsuka-us.com ↗ The first trial met its primary endpoint by demonstrating improvements from baseline on the primary endpoint of CAPS-5 for patients receiving brexpiprazole 2-3 mg/day + sertraline combination therapy being statistically significantly greater than for those receiving sertraline + placebo (p<0.05).
2023-06-27	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka Pharmaceutical announces positive results of phase III trial in Japan showingreduced agitation in patients with Alzheimer's dementia treated with brexpiprazole otsuka.co.jp ↗ Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces positive results from a phase III clinical trial in Japan for brexpiprazole in the treatment of agitation associated with Alzheimer's dementia.
2023-05-31	Hopstem Biotechnology Inc.	Regulatory 2023【五月精选】领域最新进展 hopstem.com ↗ 5月12日，美国FDA批准大塚制药和灵北联合开发的Rexulti (brexpiprazole) 用于治疗由阿尔茨海默病引起的痴呆所导致的激越症状，这是 FDA首次批准用于此适应症的治疗选择。
2023-05-11	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck Announce U.S. Food and Drug Administration (FDA) Approval of supplemental New Drug Application (sNDA) for REXULTI (brexpiprazole) for the Treatment of Agitation Associated with Dementia due to Alzheimer's Disease ® otsuka.co.jp ↗ Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of REXULTI (brexpiprazole) for use in the treatment of agitation associated with dementia due to Alzheimer's disease.
2023-05-11	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck Announce U.S. Food and Drug Administration (FDA) Approval of Supplemental New Drug Application (sNDA) for REXULTI® (brexpiprazole) for the Treatment of Agitation Associated with Dementia Due to Alzheimer’s Disease otsuka-us.com ↗
2023-05-10	H. Lundbeck A/S	Regulatory Otsuka and Lundbeck Announce U.S. Food and Drug Administration (FDA) Approval of Supplemental New Drug Application (sNDA) for REXULTI® (brexpiprazole) for the Treatment of Agitation Associated with Dementia Due to Alzheimer’s Disease lundbeck.com ↗ Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Lundbeck LLC (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of REXULTI® (brexpiprazole) for use in the treatment of agitation associated with dementia due to Alzheimer’s disease.
2023-04-28	Hopstem Biotechnology Inc.	Regulatory 2023【四月精选】领域最新进展 hopstem.com ↗ 治疗阿尔茨海默病常见症状，FDA咨询委员会投票支持新药批准
2023-04-17	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on brexpiprazole for the Treatment of Agitation Associated with Alzheimer's Dementia otsuka.co.jp ↗ The committee voted 9-1 that Otsuka and Lundbeck provided sufficient data to allow the identification of a population in whom the benefits of treating AAD with brexpiprazole outweigh its risks.
2023-04-16	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on REXULTI® (brexpiprazole) for the Treatment of Agitation Associated with Alzheimer’s Dementia otsuka-us.com ↗ The committee voted 9-1 that Otsuka and Lundbeck provided sufficient data to allow the identification of a population in whom the benefits of treating AAD with REXULTI outweigh its risks.
2023-04-16	H. Lundbeck A/S	Regulatory Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on REXULTI® (brexpiprazole) for the Treatment of Agitation Associated with Alzheimer’s Dementia lundbeck.com ↗ The committee voted 9-1 that Otsuka and Lundbeck provided sufficient data to allow the identification of a population in whom the benefits of treating AAD with REXULTI outweigh its risks.
2023-03-21	Lupin Limited	Regulatory Lupin Receives Approval from US FDA for Brexpiprazole Tablets lupin.com ↗ Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Brexpiprazole Tablets
2023-03-01	Alembic Pharmaceuticals Ltd.	Regulatory 9th March, 2023, Vadodara, India alembicpharmaceuticals.com ↗ Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg.
2023-01-30	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka Applies for the Additional Indication of Adjunctive Treatmentof Major Depressive Disorder for Rexulti (brexpiprazole) in Japan ® otsuka.co.jp ↗ Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that it has filed an application in Japan for an additional indication for Rexulti(generic name: brexpiprazole)
2023-01-10	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck announce FDA acceptance and priority review of sNDA for brexpiprazole for the treatment of agitation associated with Alzheimer's dementia otsuka.co.jp ↗ The supplemental new drug application (sNDA) for brexpiprazole in the treatment of agitation associated with Alzheimer's dementia has been accepted and filed by the FDA under Priority review
2023-01-07	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck announce FDA acceptance and priority review of sNDA for brexpiprazole for the treatment of agitation associated with Alzheimer’s dementia otsuka-us.com ↗ The FDA has assigned the application priority review and a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2023.
2023-01-07	H. Lundbeck A/S	Regulatory Otsuka and Lundbeck announce FDA acceptance and priority review of sNDA for brexpiprazole for the treatment of agitation associated with Alzheimer’s dementia lundbeck.com ↗ The supplemental new drug application (sNDA) for brexpiprazole in the treatment of agitation associated with Alzheimer’s dementia has been accepted and filed by the FDA under Priority review
2022-12-02	H. Lundbeck A/S	Results Otsuka Pharmaceutical And Lundbeck Present Positive Data From Multiple Phase 3 Studies Showing Brexpiprazole Significantly Improved Symptoms Of Agitation In Patients With Alzheimer’s Dementia At The 2022 Clinical Trials For Alzheimer’s Disease Congress lundbeck.com ↗ Data from two Phase 3 studies showed that brexpiprazole 2 mg or 3 mg doses significantly (p<0.05) improved symptoms of agitation in patients with Alzheimer’s dementia compared to placebo.
2022-12-01	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka Pharmaceutical and Lundbeck Present Positive Data From Multiple Phase 3 Studies Showing Brexpiprazole Significantly Improved Symptoms of Agitation in Patients with Alzheimer's Dementia at the 2022 Clinical Trials for Alzheimer’s Disease Congress otsuka-us.com ↗ Data from two Phase 3 studies showed that brexpiprazole 2 mg or 3 mg doses significantly (p<0.05) improved symptoms of agitation in patients with Alzheimer’s dementia compared to placebo.
2022-09-12	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka Pharmaceutical announces positive results of phase III trial in Japan for brexpiprazole in the treatment of major depressive disorder otsuka.co.jp ↗ Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces positive results from a phase III clinical trial in Japan of brexpiprazole in the treatment of major depressive disorder (ClinicalTrials.gov identifier NCT03697603).
2022-08-05	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka Pharmaceutical and Lundbeck present positive results showing reduced agitation in patients with Alzheimer's dementia treated with brexpiprazole at the 2022 Alzheimer's Association International Conference otsuka.co.jp ↗ Results from a Phase 3 clinical study for treatment of agitation in patients with Alzheimer's dementia showed that patients treated with brexpiprazole had a statistically significantly greater reduction in agitation compared to placebo
2022-08-04	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka Pharmaceutical and Lundbeck present positive results showing reduced agitation in patients with Alzheimer’s dementia treated with brexpiprazole at the 2022 Alzheimer's Association International Conference otsuka-us.com ↗ Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and H. Lundbeck A/S (Lundbeck) today presented positive results from a Phase 3 clinical trial of brexpiprazole in the treatment of agitation in patients with Alzheimer's dementia at the 2022 Alzheimer's Association International Conference.
2022-08-04	H. Lundbeck A/S	Results Otsuka Pharmaceutical and Lundbeck present positive results showing reduced agitation in patients with Alzheimer’s dementia treated with brexpiprazole at the 2022 Alzheimer's Association International Conference lundbeck.com ↗ Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and H. Lundbeck A/S (Lundbeck) today presented positive results from a Phase 3 clinical trial of brexpiprazole in the treatment of agitation in patients with Alzheimer's dementia at the 2022 Alzheimer's Association International Conference.
2022-06-27	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka Pharmaceutical and Lundbeck announce positive results showing reduced agitation in patients with Alzheimer's dementia treated with brexpiprazole otsuka.co.jp ↗ The analysis concluded that there is a statistically significant difference (p=0.0026) in the mean change from baseline to week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score between brexpiprazole and placebo.
2022-06-27	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka Pharmaceutical and Lundbeck announce positive results showing reduced agitation in patients with Alzheimer’s dementia treated with brexpiprazole otsuka-us.com ↗ The analysis concluded that there is a statistically significant difference (p=0.0026) in the mean change from baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score between brexpiprazole and placebo.
2022-06-27	H. Lundbeck A/S	Results Otsuka Pharmaceutical and Lundbeck announce positive results showing reduced agitation in patients with Alzheimer's dementia treated with brexpiprazole lundbeck.com ↗ Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce positive results of the Phase 3 clinical trial of brexpiprazole in the treatment of agitation in patients with Alzheimer's dementia (NCT03548584).
2022-01-07	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck Announce U.S. FDA Approval of Supplemental New Drug Application for REXULTI (brexpiprazole) to Treat Schizophrenia in Pediatric Patients® otsuka.co.jp ↗
2022-01-05	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck Announce FDA Approval of Supplemental New Drug Application for REXULTI® (brexpiprazole) to Treat Schizophrenia in Pediatric Patients Ages 13-17 otsuka-us.com ↗ Otsuka America Pharmaceutical, Inc., (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) of REXULTI® (brexpiprazole) for the treatment of schizophrenia in pediatric patients 13 to 17 years of age.
2022-01-05	H. Lundbeck A/S	Regulatory Otsuka and Lundbeck Announce FDA Approval of Supplemental New Drug Application for REXULTI® (brexpiprazole) to Treat Schizophrenia in Pediatric Patients Ages 13-17 lundbeck.com ↗ Otsuka America Pharmaceutical, Inc., (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) of REXULTI® (brexpiprazole) for the treatment of schizophrenia in pediatric patients 13 to 17 years of age.
2021-10-13	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck Announce FDA Acceptance of Supplemental New Drug Application; Receive Priority Review for Treatment of Schizophrenia in Adolescents otsuka-us.com ↗
2021-10-13	H. Lundbeck A/S	Regulatory Otsuka and Lundbeck Announce FDA Acceptance of Supplemental New Drug Application; Receive Priority Review for Treatment of Schizophrenia in Adolescents lundbeck.com ↗ Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) report that the U.S. Food and Drug Administration (FDA) has accepted a Supplemental New Drug Application (sNDA) for the treatment of schizophrenia in adolescents with Rexulti® (brexpiprazole) and has granted Otsuka and Lundbeck Priority Review.
2021-10-06	Lupin Limited	Regulatory Lupin Receives Tentative Approval from U.S. FDA for Brexpiprazole Tablets lupin.com ↗
2021-09-09	Zydus Lifesciences Limited	Regulatory Zydus Cadila receives tentative approval from USFDA for Brexpiprazole Tablets zyduslife.com ↗ Zydus Cadila has received tentative approval from the USFDA to market Brexpiprazole Tablets in the strength of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg.
2021-08-18	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka Obtains Approval in Japan for Orally-Disintegrating-Dose Form of REXULTI Tablets® otsuka.co.jp ↗ Otsuka Pharmaceutical Co., Ltd. announces that it has received regulatory approval in Japan for an orally-disintegrating-dose (OD) form of REXULTI(brexpiprazole) tablets.
2021-08-18	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka reports topline outcomes on a phase II trial that evaluated brexpiprazole for the treatment of borderline personality disorder otsuka.co.jp ↗ The trial did not meet the primary endpoint, change from baseline in the Zanarini Rating Scale for BPD.*
2019-02-15	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka and Lundbeck report phase III data evaluating brexpiprazole for the treatment of manic episodes associated with bipolar I disorder otsuka.co.jp ↗ The studies did not meet the primary endpoint of statistical separation from placebo as measured by the Young Mania Rating Scale (YMRS) at week three.
2018-11-30	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka and Lundbeck report positive phase II data for the combination treatment of brexpiprazole and sertraline for the treatment of Post-Traumatic Stress Disorder (PTSD) otsuka.co.jp ↗ Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced today the achievement of positive clinical results (in intention-to-treat population) as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score change from baseline compared to placebo, when brexpiprazole and sertraline was given as combination treatment (p<0.01).
2018-11-30	H. Lundbeck A/S	Results Lundbeck and Otsuka Report Positive Phase II Data for the Combination Treatment of Brexpiprazole and Sertraline for the Treatment of Post-Traumatic Stress Disorder (PTSD) lundbeck.com ↗ The combination treatment arm of brexpiprazole and sertraline demonstrated improvement in symptoms of PTSD versus placebo (p<0.01) on the primary efficacy endpoint
2018-10-26	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Data Demonstrate Safety and Efficacy of Brexpiprazole in Patients with Schizophrenia Experiencing Severe Psychotic Symptoms otsuka-us.com ↗ The study demonstrated that patients receiving brexpiprazole showed a mean improvement in PANSS Total score of 24.03 vs. 17.27 for patients receiving placebo (placebo-adjusted difference of 6.76, p<0.0001).
2018-07-31	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck's Rxulti (brexpiprazole) approved by the European Commission® otsuka.co.jp ↗ Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announce that the European Commission has approved Rxulti(brexpiprazole) for the treatment of schizophrenia in adults.
2018-06-04	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck's Rxulti® (brexpiprazole) receives positive opinion in EUfrom CHMP for the treatment of schizophrenia in adults otsuka.co.jp ↗ issued a positive opinion on Rxulti(brexpiprazole) for the treatment of schizophrenia in adult on June 1, 2018.
2018-01-19	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka Receives Approval in Japan for the Manufacture and Sale of New Antipsychotic Drug Rexulti Tablets for Schizophrenia ® otsuka.co.jp ↗ Otsuka Pharmaceutical Co., Ltd. announces that regulatory approval was received on January 19 for the manufacture and sale of Rexulti Tablets (generic name is brexpiprazole) in 1mg and 2 mg dosage sizes.
2017-05-02	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka and Lundbeck Announce Results of Brexpiprazole on Symptoms of Agitation Related to Alzheimer's-type Dementia otsuka.co.jp ↗ Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce top-line results from two phase III clinical trials evaluating the efficacy, safety and tolerability of brexpiprazole in the treatment of agitation in patients with dementia of the Alzheimer's type.
2017-05-02	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka and Lundbeck announce results of brexpiprazole on symptoms of agitation related to Alzheimer’s-type dementia otsuka-us.com ↗ Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce top-line results from two phase III clinical trials evaluating the efficacy, safety and tolerability of brexpiprazole in the treatment of agitation in patients with dementia of the Alzheimer’s type.
2017-03-24	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Lundbeck and Otsuka's Brexpiprazole for Adult Patients with Schizophrenia Accepted for Review by EMA otsuka.co.jp ↗ H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announce that the European Medicines Agency (EMA) has accepted for review a Marketing Authorization Application for brexpiprazole to treat schizophrenia in adults.
2017-02-20	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Health Canada Approves Otsuka and Lundbeck's REXULTI (brexpiprazole) as a Treatment for Schizophrenia in Adults otsuka.co.jp ↗ Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck Canada announce that Health Canada issued a Notice of Compliance for REXULTI(brexpiprazole) for the treatment of schizophrenia in adults.
2017-01-06	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka Submits New Drug Application in Japan for Brexpiprazole in the Treatment of Schizophrenia otsuka.co.jp ↗ Otsuka Pharmaceutical Co., Ltd. today announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare for the manufacture and sale in Japan of brexpiprazole in the treatment of schizophrenia.
2016-09-26	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory U.S. FDA Approves Labeling Update of REXULTI(brexpiprazole) for Maintenance Treatment of Schizophrenia in Patients in the U.S.® otsuka.co.jp ↗ Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and H. Lundbeck A/S (Lundbeck) announced today that the U.S. Food and Drug Administration (FDA) approved the labeling update of REXULTI (brexpiprazole) to reflect clinical data for maintenance treatment of schizophrenia in patients in the U.S.
2016-09-23	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory U.S. FDA Approves Labeling Update of REXULTI® (brexpiprazole) for Maintenance Treatment of Schizophrenia otsuka-us.com ↗ Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced today that the U.S. Food and Drug Administration (FDA) approved the labeling update of REXULTI®(brexpiprazole) to reflect clinical data for maintenance treatment of schizophrenia.
2016-02-08	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory U.S. FDA Accepts For Review Otsuka and Lundbeck’s sNDA Filing for Labeling Update of REXULTI® (brexpiprazole) for Maintenance Treatment of Schizophrenia otsuka-us.com ↗ Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the proposed labeling update ofREXULTI (brexpiprazole) for the maintenance treatment of adults with schizophrenia.
2015-07-13	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory U.S. FDA Approves Otsuka and Lundbeck's REXULTI (brexpiprazole) as Adjunctive Treatment for Adults with Major Depressive Disorder and as a Treatment for Adults with Schizophrenia® otsuka.co.jp ↗
2015-07-10	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory U.S. FDA Approves Otsuka and Lundbeck’s REXULTI® (Brexpiprazole) as Adjunctive Treatment for Adults with Major Depressive Disorder and as a Treatment for Adults with Schizophrenia otsuka-us.com ↗ Tokyo, Japan and Valby, Denmark – July 11, 2015 – Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced today that the U.S. Food and Drug Administration (FDA) approved REXULTI® (brexpiprazole) as an adjunctive therapy for the treatment of adults with major depressive disorder (MDD) and as a treatment for adults with schizophrenia.
2015-04-20	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Results of Phase III Study of Brexpiprazole in Adult Patients with Schizophrenia Published in American Journal of Psychiatry otsuka.co.jp ↗ Brexpiprazole demonstrated statistically significant efficacy vs. placebo in PANSS (Positive and Negative Syndrome Scale) Total Score in adult patients with schizophrenia.
2015-04-17	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Results of Phase III Study of Brexpiprazole in Adult Patients With Schizophrenia Published in American Journal of Psychiatry otsuka-us.com ↗ Brexpiprazole demonstrated statistically significant efficacy vs. placebo in PANSS (Positive and Negative Syndrome Scale) Total Score in adult patients with schizophrenia.
2014-12-11	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka And Lundbeck's Brexpiprazole Demonstrates Statistically Significant Effects In New Phase III Studies In Adult Patients With Schizophrenia Presented At The American College Of Neuropsychopharmacology Annual Meeting otsuka.co.jp ↗ Results from two Phase III clinical studies demonstrated the effects of brexpiprazole in adult patients with schizophrenia.
2014-12-10	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka And Lundbeck Present Phase III Data on Brexpiprazole As Adjunctive Therapy In Adult Patients With Major Depression At The American College Of Neuropsychopharmacology Annual Meeting otsuka.co.jp ↗ Results from two Phase III clinical studies demonstrated the effects of brexpiprazole as adjunctive treatment in patients with major depressive disorder (MDD) who had an inadequate response to monotherapy antidepressant treatments (ADT).
2014-09-24	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory U.S. FDA Accepts Otsuka and Lundbeck's Filing for Review of Brexpiprazole for the Treatment of Schizophrenia and as Adjunctive Therapy for the Treatment of Major Depression otsuka.co.jp ↗
2014-09-24	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory U.S. FDA accepts Otsuka and Lundbeck’s filing for review of brexpiprazole for the treatment of schizophrenia and as adjunctive therapy for the treatment of major depression. otsuka-us.com ↗
2014-07-14	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck Submit New Drug Application in The US for Brexpiprazole for The Treatment of Schizophrenia and as Adjunctive Therapy for The Treatment of Major Depressive Disorder otsuka.co.jp ↗ Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S, today announced the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for brexpiprazole for the treatment of schizophrenia and as adjunctive treatment of major depressive disorder (MDD).
2014-07-14	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck Submit New Drug Application in the US for Brexpiprazole for the Treatment of Schizophrenia and as Adjunctive Therapy for the Treatment of Major Depressive Disorder otsuka-us.com ↗ Tokyo, Japan and Copenhagen, Denmark – July 14, 2014 – Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S, today announced the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for brexpiprazole for the treatment of schizophrenia and as adjunctive treatment of major depressive disorder (MDD).
2014-01-24	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka and Lundbeck to present new data on brexpiprazole in major depressive disorder (MDD) at European Psychiatry Association 2014 Congress otsuka.co.jp ↗ Overall, brexpiprazole demonstrated efficacy and was well tolerated as an adjunctive treatment for MDD patients with an inadequate response to antidepressant treatment.
2011-05-16	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka Pharmaceutical Co., LTD. Announces Results from a Phase 2 Study of Investigational Product OPC-34712 as Adjunctive Therapy in Adults with Major Depressive Disorder otsuka.co.jp ↗ In a six-week, double-blind, randomized, placebo-controlled study, OPC-34712 (1.5 ± 0.5 mg), when added to antidepressant therapy (ADT) in adult patients with major depressive disorder (MDD), who had exhibited an inadequate response to ADT, demonstrated improvement in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score (p=0.0303), the primary endpoint of the study.

All press releases naming this drug 105 releases

Date	Issuer	Release
Show all 105 releases opens the full record — a long page

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 90 sources stand behind the page.

Field	Value	Cited text
Known as	brexpiprazole	“To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment...” NCT01360645 ↗ 73 “A post hoc analysis was performed using data obtained over eight weeks from 200 Japanese patients with schizophrenia who were switched to brexpiprazole monotherapy in a...” PMID 32297486 ↗ Apr 2020 “In each cohort, subjects will receive a brexpiprazole 2 mg conventional tablet on Day 1of Period 1, the QW formulation on Day 1 of Period 2 and 3, as single and multiple dose...” NCT04118127 ↗ “oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)” NCT01360866 ↗ “CAU plan modified to include a trial of phenelzine (or, if contraindicated: brexpiprazole).” NCT06580041 ↗ “OPC-34712 (brexpiprazole)” NCT01360632 ↗ NCT04174170 ↗ NCT01838681 ↗ NCT03557931 ↗ NCT03734302 ↗ NCT03427892 ↗ Show 63 more sources
Known as	Brexpiprazol	ChEMBL registry synonym — accepted as the source's own label CHEMBL2105760 ↗
Known as	Brexpiprazole fumarate	“OPC-34712FUM/ Brexpiprazole fumarate” NCT05325645 ↗ 2 “OPC-34712FUM/ Brexpiprazole fumarate” NCT06036108 ↗ “OPC-34712FUM/ Brexpiprazole fumarate” NCT05326347 ↗
Known as	OPC-34712	“A Phase 2/3 Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Evaluate the Efficacy and Safety of Brexpiprazole (OPC-34712) in the...” NCT03620981 ↗ 26 “Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress” NCT02196506 ↗ “To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment” NCT01360632 ↗ “Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia” NCT01668797 ↗ “Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms” NCT02013531 ↗ “Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia” NCT02013622 ↗ “OPC-34712 [Brexpiprazole] High Dose” NCT01396421 ↗ “Brexpiprazole (OPC-34712)” NCT02411695 ↗ “Brexpiprazole (OPC-34712)” NCT03198078 ↗ “Brexpiprazole, OPC-34712” NCT01922258 ↗ “Brexpiprazole, OPC-34712” NCT01862640 ↗ Show 16 more sources
Known as	OPC-34712FUM	“OPC-34712FUM/ Brexpiprazole fumarate” NCT05325645 ↗ 2 “OPC-34712FUM/ Brexpiprazole fumarate” NCT06036108 ↗ “OPC-34712FUM/ Brexpiprazole fumarate” NCT05326347 ↗
Known as	OPDC-34712	“Brexpiprazole, OPDC-34712” NCT02968121 ↗
Known as	Rexulti	ClinicalTrials.gov intervention name — accepted as the source's own label NCT03418675 ↗
Known as	Rxulti	ChEMBL registry synonym — accepted as the source's own label CHEMBL2105760 ↗
Action	Activate	“Serotonin 1a (5-HT1a) receptor partial agonist” CHEMBL2105760 ↗ 1 “Dopamine D2 receptor partial agonist” CHEMBL2105760 ↗
Action	Inhibit	“Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL2105760 ↗
Modality	Small molecule	— CHEMBL2105760 ↗
Route	Oral	“Tablets, Oral, 1 - 4 mg OPC-34712 variable dose once daily, 14 weeks” NCT00797966 ↗
Target	DRD2	“Dopamine D2 receptor partial agonist” CHEMBL2105760 ↗
Target	HTR1A	“Serotonin 1a (5-HT1a) receptor partial agonist” CHEMBL2105760 ↗
Target	HTR2A	“Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL2105760 ↗