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COMPANY

Otsuka

otsuka-us.com ↗ · Mid-Atlantic

Clinical Phase 3

Keywords: psychiatry neurology immunology kidney disease Schizophrenia Atopic Dermatitis Major Depressive Disorder Migraine Congestive Heart Failure Hyper-low-density Lipoprotein (LDL) Cholesterolemia Attention-Deficit Hyperactivity Disorder Attention Deficit Hyperactivity Disorder Agitation Associated With Dementia of the Alzheimer's Type Acute Schizophrenia Multiple Myeloma Heart Failure Inappropriate Secretion Antidiuretic Hormone Migraine Disorders Relapsed or Refractory Diffuse Large B-cell Lymphoma Autosomal Dominant Polycystic Kidney Cardiac Edema (CHF) Lupus Nephritis Alzheimer Disease Alcohol Dependence Bipolar Disorder I Lower-risk Myelodysplastic Autistic Disorder Hypercholesterolemia Head and Neck Cancer Autism Ulcerative Colitis Dry Eye Syndromes ASTX660 OPA-15406 ASTX727 Brexpiprazole TEV-48125 OPB-111077

Profile checked Oct 10, 2026

143Trials (company is sponsor)

Raises and deals from press releases

From the company’s own releases; this list is partial. All raises and deals

Timeline

  1. Trial start Phase 3: A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia source ↗
  2. Trial start —: LUPKYNIS Drug-use Results Survey source ↗
  3. Trial start Phase 3: A Long-term Trial of EB-1020 in Pediatric Patients With ADHD source ↗
  4. Trial start Phase 2/Phase 3: A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD source ↗
  5. Trial start Phase 3: A Long-term Trial of EB-1020 in Adult Patients With ADHD source ↗
  6. Trial start Phase 2/Phase 3: Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD Patients source ↗
  7. Trial start —: REXULTI Drug General Use-results Survey (Excessive Motor Activity or Physically/Verbally Aggressive Behavior Due to Rapid Changes in Mood, Irritability, and/or Outbursts Associated With Dementia Du source ↗
  8. Trial start Phase 1: Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia source ↗
  9. Trial start —: Samtasu Post-marketing General Drug Use-results Survey in Patients With Volume Overload in Heart Failure. source ↗
  10. Trial start Phase 3: A Long-term Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia source ↗
  11. Trial start Phase 3: A Confirmatory Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia source ↗
  12. Trial start Phase 2: A Dose-ranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF]) source ↗
  13. Trial start Phase 3: Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia source ↗
  14. Trial start Phase 3: A Long-term Administration Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia source ↗
  15. Trial start Phase 3: A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis source ↗
  16. Trial start —: Specified Drug Use Survey on AJOVY Subcutaneous Injection for Long-term Use source ↗
  17. Trial start Phase 1: A Clinical Pharmacology Trial of Brexpiprazole Long Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia source ↗
  18. Trial start —: Specified Drug-use Survey on Abilify Prolonged Release Aqueous Suspension for IM Injection (Prevention of Relapse of Mood Episodes in BP) source ↗
  19. Trial start —: Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH source ↗
  20. Trial start Phase 2: A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With Hypercholesterolemia source ↗
  21. Trial start Phase 1/Phase 2: Safety and Efficacy Study of OPC-415 in Patients With Relapsed and/or Refractory Multiple Myeloma source ↗
  22. Trial start I: A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell Lymphoma source ↗
  23. Trial start Phase 3: A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients source ↗
  24. Trial start 3: A Phase 3 Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic Dermatitis source ↗
  25. Trial start 3: A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis source ↗

Showing 25 of 50 dated events.

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) Showing 50 of 143

RecordTitlePhaseStatusStartPrimary completion
NCT05325645Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute SchizophreniaPhase 3RecruitingJul 21, 20222027-09 (estimated)
NCT04649073Safety and Efficacy Study of OPC-415 in Patients With Relapsed and/or Refractory Multiple MyelomaPhase 1/Phase 2TerminatedFeb 18, 2021Apr 9, 2025 (actual)
NCT05326347A Long-term Administration Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With SchizophreniaPhase 3CompletedMay 31, 2022Aug 26, 2025 (actual)
NCT05712746Samtasu Post-marketing General Drug Use-results Survey in Patients With Volume Overload in Heart Failure.Not listedActive, not recruitingMar 3, 2023May 7, 2026 (actual)
NCT04790175Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADHNot listedActive, not recruitingMar 29, 2021Jan 19, 2026 (actual)
NCT05342493Specified Drug Use Survey on AJOVY Subcutaneous Injection for Long-term UseNot listedRecruitingApr 20, 2022Sep 30, 2026 (estimated)
NCT04049825A Phase 1 Trial of OPB-111077 in Combination With Bendamustine and Rituximab in Patients With r/r DLBCL1CompletedNov 22, 2019Mar 25, 2025 (actual)
NCT04362007A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell LymphomaITerminatedJul 14, 2020Nov 30, 2024 (actual)
NCT05687071A Long-term Trial of ETC-1002 in Patients With Hyper-LDL CholesterolemiaPhase 3CompletedFeb 27, 2023Oct 5, 2024 (actual)
NCT06036108Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With SchizophreniaPhase 1CompletedOct 3, 2023Mar 18, 2025 (actual)
NCT07225712A Long-term Administration Trial of SEP-363856 in Patients With SchizophreniaPhase 3RecruitingDec 22, 20252028-03 (estimated)
NCT07087327A Long-term Trial of EB-1020 in Pediatric Patients With ADHDPhase 3RecruitingSep 16, 20252027-08 (estimated)
NCT07086313A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHDPhase 2/Phase 3RecruitingSep 3, 20252027-08 (estimated)
NCT02847624Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKDNot listedCompletedMar 24, 2014Sep 20, 2022 (actual)
NCT05615363A Dose-ranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])Phase 2CompletedJan 10, 2023Oct 21, 2024 (actual)
NCT07184645A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis3Not yet recruiting2025-092027-02 (estimated)
NCT07053891LUPKYNIS Drug-use Results SurveyNot listedRecruitingSep 17, 2025Jun 30, 2031 (estimated)
NCT07173478A Phase 3 Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic Dermatitis3Not yet recruiting2025-102026-12 (estimated)
NCT06926829A Long-term Trial of EB-1020 in Adult Patients With ADHDPhase 3RecruitingJun 25, 20252027-12 (estimated)
NCT06931080Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD PatientsPhase 2/Phase 3RecruitingApr 30, 20252027-12 (estimated)
NCT06875986REXULTI Drug General Use-results Survey (Excessive Motor Activity or Physically/Verbally Aggressive Behavior Due to Rapid Changes in Mood, Irritability, and/or Outbursts Associated With Dementia Due to Alzheimer's Disease)Not listedRecruitingApr 17, 2025Sep 30, 2027 (estimated)
NCT05372653A Long-term Trial of OPA-15406 in Infants With Atopic DermatitisPhase 3CompletedMay 23, 2022Dec 29, 2022 (actual)
NCT04107051Post-Marketing Surveillance Study of Nalmefene Hydrochloride Hydrate in Patients with Alcohol DependenceNot listedCompletedOct 1, 2019Feb 7, 2023 (actual)
NCT04812379Specified Drug-use Survey on Abilify Prolonged Release Aqueous Suspension for IM Injection (Prevention of Relapse of Mood Episodes in BP)Not listedCompletedApr 7, 2021Sep 13, 2023 (actual)
NCT03906695Phase 1 Trial of ASTX727 in Subjects With Lower-risk Myelodysplastic Syndromes1Active, not recruitingMar 15, 2019Jan 31, 2026 (estimated)
NCT05683340A Confirmatory Trial of ETC-1002 in Patients With Hyper-LDL CholesterolemiaPhase 3CompletedFeb 13, 2023Feb 20, 2024 (actual)
NCT03620981Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's TypePhase 2/Phase 3CompletedAug 20, 2018Apr 21, 2023 (actual)
NCT03724942Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's TypePhase 3CompletedNov 9, 2018Dec 2, 2021 (actual)
NCT04244253A Phase 2 Trial of OPC-64005 for Major Depressive Disorder2CompletedMar 3, 2020Feb 8, 2022 (actual)
NCT03255226Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume OverloadPhase 3CompletedMar 7, 2018Jul 11, 2021 (actual)
NCT03697603A Study of Brexpiprazole in Patients With Major Depressive DisorderPhase 2/Phase 3CompletedJul 30, 2018Jun 6, 2022 (actual)
NCT01617460A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic DisorderPhase 3Completed2012-092016-10 (actual)
NCT04118127A Clinical Pharmacology Trial of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral DosesPhase 1CompletedOct 17, 2019Feb 16, 2021 (actual)
NCT04784442A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With HypercholesterolemiaPhase 2CompletedMar 24, 2021Apr 18, 2022 (actual)
NCT03737474A Long-Term Study of Brexpiprazole in Patients With Major Depressive DisorderPhase 3CompletedOct 4, 2018Mar 17, 2021 (actual)
NCT03303105Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of MigrainePhase 3CompletedDec 7, 2017Jun 16, 2020 (actual)
NCT05119894A Clinical Pharmacology Trial of Brexpiprazole Long Acting Injectable (LAI) Administered as a Single Dose in Patients With SchizophreniaPhase 1WithdrawnNov 22, 2021Dec 6, 2021 (actual)
NCT03961529Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic DermatitisPhase 3CompletedMay 14, 2019Nov 11, 2020 (actual)
NCT04355117A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine PatientsPhase 3CompletedJun 17, 2020Nov 11, 2020 (actual)
NCT02085460A Phase 2 Trial of Rebamipide Liquid to Determine the Effective Dose for Prevention of Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer2Completed2014-032015-08 (actual)
NCT02554721Pharmacodynamic Study of Cilostazol in Healthy VolunteersPhase 1Completed2015-08Mar 30, 2018 (actual)
NCT04182958A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese SubjectsICompletedNov 25, 2019Dec 19, 2019 (actual)
NCT03179787Post-Marketing Surveillance Study of Aripiprazole in Patients With AutismNot listedCompletedApr 1, 2017Mar 17, 2020 (actual)
NCT03962101Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral IntakePhase 3CompletedJun 17, 2019Jun 30, 2020 (actual)
NCT03772041Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart FailurePhase 3CompletedJan 16, 2019Jul 21, 2020 (actual)
NCT03303092Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Episodic MigrainePhase 2/Phase 3CompletedDec 19, 2017Nov 22, 2019 (actual)
NCT03254108Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart FailureNot phased (device or behavioral study)CompletedNov 6, 2017Apr 14, 2018 (actual)
NCT00463151An Exploratory Study of Rebamipide in Patients With Active Ulcerative ColitisPhase 2Completed2007-062008-08 (actual)
NCT03902574Bioequivalence Study of Brexpiprazole Orally Disintegrating Tablets (ODT) 2mgPhase 1CompletedMar 27, 2019Jun 18, 2019 (actual)
NCT01471093Safety Study of OPC-12759 Ophthalmic SolutionPhase 1Completed2011-112011-12 (actual)
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