Developer · Japan
Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd. is a Tokyo-based pharmaceutical company with a major central nervous system franchise, known for antipsychotics such as aripiprazole (ABILIFY) and brexpiprazole (REXULTI). It is the principal operating subsidiary of the publicly listed Otsuka Holdings Co., Ltd. (Tokyo Stock Exchange: 4578).
Pipeline (4)
- Post-traumatic stress disorderFiled (NDA)Discontinued
- Attention-deficit/hyperactivity disorderFiled (NDA)Active
- Generalized anxiety disorderPhase 2/3Completed
- Major depressive disorderPhase 2/3Completed
- Major depressive disorderDiscontinuedDiscontinued
Deals & partnerships
- BrexpiprazolePartner H. Lundbeck A/S
- CentanafadineLicensor Neurovance, Inc.
- Ulotaront (SEP-363856)Licensor Sumitomo Pharma Co., Ltd.Licensor Sunovion Pharmaceuticals Inc.
- Mar 15, 2024Licensing dealOtsuka and Sumitomo revise the license agreement; Otsuka gains exclusive worldwide rights to ulotarontRevised agreement between Otsuka and Sumitomo Pharma (and its U.S. subsidiary Sumitomo Pharma America). Otsuka holds exclusive worldwide rights to develop, manufacture, and commercialize ulotaront (SEP-363856) and SEP-380135; SEP-4199 and SEP-378614 were excluded. No upfront payment; Otsuka to pay up to USD 30 million total in milestones for both compounds plus sales-based royalties, and bears the full cost of studies from January 2024 onward.
- Sep 30, 2021Licensing dealOtsuka in-licenses ulotaront (SEP-363856) in a worldwide collaboration with Sumitomo Dainippon Pharma and SunovionSumitomo Dainippon Pharma and its U.S. subsidiary Sunovion granted Otsuka rights to jointly develop and commercialize four psychiatry/neurology compounds worldwide: SEP-363856 (ulotaront, for schizophrenia), SEP-4199, SEP-378614, and SEP-380135. Otsuka paid Sunovion a USD 270 million upfront payment, with up to USD 620 million in development milestones plus sales milestones and royalties.
- Q2 2017AcquisitionOtsuka acquires Neurovance, gaining centanafadine (CTN / EB-1020) for ADHDOtsuka America agreed to acquire Neurovance, Inc., a privately held clinical-stage company developing centanafadine (CTN, formerly EB-1020), a non-stimulant triple reuptake inhibitor (norepinephrine/dopamine/serotonin) for ADHD. Terms: an estimated USD 100 million upfront at closing, up to USD 150 million in development/approval milestones, plus future sales milestones. Announced March 3, 2017; closing expected in Q2 2017 (exact close date not separately disclosed, anchored to quarter end).
- Nov 11, 2011PartnershipOtsuka and Lundbeck sign global development and commercialization alliance covering brexpiprazole (OPC-34712)Otsuka and Lundbeck entered a development and commercialization agreement for up to five products in psychiatry. Lundbeck was granted co-development and co-commercialization rights to OPC-34712 (brexpiprazole), a serotonin-dopamine activity modulator (SDAM) discovered by Otsuka that had recently entered Phase 3 in schizophrenia and major depressive disorder. Lundbeck paid Otsuka an upfront of USD 200 million, with the broader alliance worth up to USD 1.8 billion including development, regulatory and sales milestones. Otsuka remains the originator/developer of brexpiprazole.
Catalysts · 1 upcoming · 7 reported
- July 24, 2026Anticipated
CentanafadineforAttention-deficit/hyperactivity disorderRegulatory
FDA PDUFA target action date for the centanafadine ADHD NDA (children, adolescents, and adults).
Recently reported
- 2025-09-20missed
BrexpiprazoleforPost-traumatic stress disorderRegulatory
FDA issues Complete Response Letter for brexpiprazole + sertraline sNDA in PTSD
- 2024-09-19missed
OPC-64005forMajor depressive disorderFull results
OPC-64005 Phase 2 MDD trial (NCT04244253, Japan, n=273) missed its primary MADRS endpoint at Week 6 (20 mg vs placebo p=0.288).
- 2023-10-27met
CentanafadineforAttention-deficit/hyperactivity disorderTopline data
Pediatric Phase 3 trial (children 4-12) met ADHD-RS-5 primary endpoint at week 6; positive topline announced Oct 27, 2023.
- 2023-10-27met
CentanafadineforAttention-deficit/hyperactivity disorderTopline data
Adolescent Phase 3 trial (13-17) met ADHD-RS-5 primary endpoint at week 6 (high dose); positive topline announced Oct 27, 2023.
- 2022-05-01met
CentanafadineforAttention-deficit/hyperactivity disorderFull results
Adult Phase 3 trial (NCT03605680) met AISRS primary endpoint at both doses; published Adler et al. 2022, J Clin Psychopharmacol.
- 2022-05-01met
CentanafadineforAttention-deficit/hyperactivity disorderFull results
Adult Phase 3 trial (NCT03605836) met AISRS primary endpoint at both doses; published Adler et al. 2022, J Clin Psychopharmacol.
- 2021-10-29met
OPC-64005forMajor depressive disorderFull results
OPC-64005 Phase 2 adult ADHD trial (NCT03324581, n=239) met its primary CAARS-O:SV endpoint vs placebo (p=0.0101); ADHD development later discontinued.
Recent activity
- Jan 27, 2026Phase changeCentanafadine·Attention-deficit/hyperactivity disorderFiled (NDA)FDA accepted the NDA and granted priority review; PDUFA target action date set for July 24, 2026.source ↗
- Nov 25, 2025Phase changeCentanafadine·Attention-deficit/hyperactivity disorderFiled (NDA)Otsuka submitted the NDA to the U.S. FDA for centanafadine for the treatment of ADHD in children, adolescents, and adults.source ↗
- Nov 6, 2025Phase changeUlotaront (SEP-363856)·Major depressive disorderPhase 2/3Phase 2/3 adjunctive MDD study reached completion; topline results not yet disclosed.source ↗
- Sep 26, 2025Phase changeUlotaront (SEP-363856)·Generalized anxiety disorderPhase 2/3Phase 2/3 GAD study (NCT05729373) reached completion; topline results not yet disclosed.source ↗
- Sep 20, 2025ReadoutBrexpiprazole·Post-traumatic stress disordermissedFDA issues Complete Response Letter for brexpiprazole + sertraline sNDA in PTSDsource ↗
- Sep 19, 2024ReadoutOPC-64005·Major depressive disordermissedOPC-64005 Phase 2 MDD trial (NCT04244253, Japan, n=273) missed its primary MADRS endpoint at Week 6 (20 mg vs placebo p=0.288).source ↗
- Jun 25, 2024Phase changeBrexpiprazole·Post-traumatic stress disorderFiled (NDA)FDA accepted the sNDA for brexpiprazole in combination with sertraline for adult PTSD; PDUFA target action date 8 Feb 2025.source ↗
- Mar 15, 2024Phase changeUlotaront (SEP-363856)·Generalized anxiety disorderPhase 2/3Sumitomo Pharma amended its worldwide license; Otsuka took over ulotaront (incl. GAD/MDD) and decided to continue development.source ↗
- Oct 27, 2023ReadoutCentanafadine·Attention-deficit/hyperactivity disordermetPediatric Phase 3 trial (children 4-12) met ADHD-RS-5 primary endpoint at week 6; positive topline announced Oct 27, 2023.source ↗
- Oct 27, 2023ReadoutCentanafadine·Attention-deficit/hyperactivity disordermetAdolescent Phase 3 trial (13-17) met ADHD-RS-5 primary endpoint at week 6 (high dose); positive topline announced Oct 27, 2023.source ↗
- Aug 15, 2023Phase changeBrexpiprazole·Post-traumatic stress disorderPhase 3Both Phase 3 PTSD trials of brexpiprazole + sertraline completed in August 2023 (Trial 071 / NCT04124614 completed 8 Aug 2023; Trial 072 / NCT04174170 completed 15 Aug 2023). Trial 071 met its primary CAPS-5 endpoint; Trial 072 did not.source ↗
- Mar 8, 2023Phase changeUlotaront (SEP-363856)·Generalized anxiety disorderPhase 2/3First patient randomized in the Phase 2/3 GAD study (NCT05729373).source ↗
Competitive landscape
Other companies developing against Otsuka Pharmaceutical Co., Ltd.'s targets or indications.
- Definium Therapeutics, Inc.2 compoundsSERTPost-traumatic stress disorderAttention-deficit/hyperactivity disorderMajor depressive disorderGeneralized anxiety disorder
- Axsome Therapeutics, Inc.3 compoundsNETAttention-deficit/hyperactivity disorderMajor depressive disorder
- COMPASS Pathways plc1 compoundPost-traumatic stress disorderMajor depressive disorder
- Engrail Therapeutics, Inc.1 compoundD2Major depressive disorder
- Helus Pharma2 compoundsMajor depressive disorderGeneralized anxiety disorder
- Intra-Cellular Therapies, Inc.2 compoundsMajor depressive disorderGeneralized anxiety disorder
- LB Pharmaceuticals Inc.1 compoundD2Major depressive disorder
- Tonix Pharmaceuticals Holding Corp.1 compoundPost-traumatic stress disorderMajor depressive disorder
- Transcend Therapeutics, Inc.1 compoundSERTPost-traumatic stress disorder
- Alkermes plc1 compoundD2
- Alto Neuroscience, Inc.2 compoundsMajor depressive disorder
- Autobahn Therapeutics, Inc.1 compoundMajor depressive disorder
