Big pharma · OTSKY · 590 trials led

Otsuka clinical trial pipeline

590 trials as lead sponsor, 19 recruiting now, 243 in phase 3. Live from ClinicalTrials.gov, updated daily.

  • Status changeStatus moved to completedWas recruiting · always alerts
  • Completion date movePrimary completion slipped 210 daysSlips and pull-ins of 30+ days
  • New trialNew trial registered in your scopeFirst posted within 30 days
  • Enrollment changeEnrollment grew to 1,200Moves of 15%+ or count finalised
  • Substantive record editPrimary endpoint redefined from 24 to 52 weeksRead overnight and flagged in plain English
View trials

Archive historyOct 2022 to Jun 2026

124 recorded changes across Otsuka trials

Every status move, completion date shift and enrollment change ComplyRx has recorded across 30 of these trials. One is shown below.

Completion date movePrimary completion confirmed actual at 2025-07-14NCT05781399 · recorded 1 Jun 2026
Track to read them

+120 more recorded changes · Track a drug to see every change the night it lands

Start tracking drugs

Most active programmes

The drugs appearing most often across Otsuka's recently active trials. Comparator arms are excluded.

  • SEP-3638566 trials
  • AVP-7866 trials
  • JNT-517 Tablet5 trials
  • Aripiprazole5 trials
  • Centanafadine5 trials
  • Tolvaptan4 trials

Upcoming readouts

Next primary completion dates among Otsuka's active phase 2 and phase 3 trials. Dates are registry estimates and move often, which is exactly what the tracker watches.

Top therapeutic areas

Conditions studied most often across Otsuka's recently active trials.

  • Schizophrenia17 trials
  • Immunoglobulin A Nephropathy4 trials
  • Phenylketonuria3 trials
  • Major Depressive Disorder3 trials
  • Atopic Dermatitis (AD)3 trials
  • Keratoconjunctivitis Sicca2 trials

Otsuka trials

The 50 most significant of Otsuka's recently active trials, soonest estimated readout first.
Select any row for the full record; the change timeline unlocks with tracking.

TrialPhaseStabilityStatusEnrollmentEst. readout
Specified Drug Use Survey on AJOVY Subcutaneous Injection for Long-term UseNCT05342493Fremanezumab 225 Mg/1.5 mL Subcutaneous SolutionNot yet scoredOngoingRecruiting1,000 est.30 Sept 2026
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With SchizophreniaNCT06894212SEP-363856Phase 3Locked · track to revealOngoingRecruiting522 est.20 Oct 2026
A Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of VIS171 in Participants With Autoimmune Disease(s)NCT06799520VIS171Phase 1Locked · track to revealOngoingRecruiting30 est.1 Dec 2026
A Phase 3 Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic DermatitisNCT07173478OPA-15406Phase 3Locked · track to revealOngoingNot yet recruiting156 est.Dec 2026
A Brain Imaging Study to Assess the Binding of MSP-2020 to Serotonin 5-HT2A Receptors in Healthy Male AdultsNCT07329621MSP-2020Phase 1Locked · track to revealOngoingRecruiting18 est.29 Jan 2027
A Trial to Examine if Repinatrabit is Processed Differently in Adults With Reduced Liver or Kidney Function Compared to Adults With Normal Liver and Kidney FunctionNCT07713758RepinatrabitPhase 1Not yet scoredOngoingNot yet recruiting32 est.9 Feb 2027
A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic DermatitisNCT07184645OPA-15406Phase 3Locked · track to revealOngoingNot yet recruiting198 est.Feb 2027
EnVISageA Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren'sNCT06928142SibeprenlimabPhase 2Locked · track to revealOngoingActive, not recruiting83 est.13 Mar 2027
QUANTUM-TBA Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary TuberculosisNCT07209761BPaQMPhase 3Locked · track to revealOngoingRecruiting532 est.28 May 2027
A Long-term Trial of EB-1020 in Pediatric Patients With ADHDNCT07087327EB-1020 (Centanafadine) low dosePhase 3Locked · track to revealOngoingRecruiting180 est.Aug 2027
A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHDNCT07086313EB-1020 (Centanafadine) low dosePhase 2Locked · track to revealOngoingRecruiting315 est.Aug 2027
A Study in Adult Males With X-linked Congenital Nephrogenic Diabetes Insipidus to Test the Effects of NDI-5001 Given for Multiple Days and to Test How NDI-5001 is Tolerated and Taken up in the BodyNCT07525960NDI-5001Phase 1Locked · track to revealOngoingActive, not recruiting24 est.25 Aug 2027
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 Due to Alzheimer's Disease)NCT06875986Brexpiprazole (Rexulti)Not yet scoredOngoingRecruiting200 est.30 Sept 2027
A Long-Term Study of JNT-517 in Participants With PhenylketonuriaNCT06628128JNT-517Phase 3Locked · track to revealOngoingRecruiting240 est.1 Nov 2027
A Long-term Trial of EB-1020 in Adult Patients With ADHDNCT06926829EB-1020 (Centanafadine) 164.4 mgPhase 3Locked · track to revealOngoingRecruiting180 est.Dec 2027
Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD PatientsNCT06931080EB-1020 (Centanafadine) 164.4 mgPhase 2Locked · track to revealOngoingRecruiting630 est.Dec 2027
A Study of JNT-517 in Participants With Phenylketonuria (PKU)NCT06971731JNT-517 TabletPhase 3Locked · track to revealOngoingRecruiting120 est.1 Mar 2028
A Long-term Administration Trial of SEP-363856 in Patients With SchizophreniaNCT07225712SEP-363856Phase 3Locked · track to revealOngoingRecruiting100 est.Mar 2028
A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)NCT04782258Tolvaptan SuspensionPhase 3Locked · track to revealOngoingRecruiting20 est.31 Jul 2028
A Trial in Healthy Adult Participants and Adults With Autoimmune Disease to Test How HBM7020 is Tolerated and Absorbed in the BodyNCT07649265HBM7020Phase 1Not yet scoredOngoingNot yet recruiting63 est.20 Nov 2028
Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)NCT05248659Sibeprenlimab 400 mg s.c. Q4weeksPhase 2Locked · track to revealOngoingEnrolling by invitation600 est.28 Dec 2028
LUPKYNIS Drug-use Results SurveyNCT07053891Voclosporin (LUPKYNIS)Not yet scoredOngoingRecruiting400 est.30 Jun 2031
A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered TogetherNCT07446400RepinatrabitPhase 1Locked · track to revealOngoingRecruiting48 est.9 Jun 2026
PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic SyndromesNCT06091267IV DecitabinePhase 1Locked · track to revealOngoingActive, not recruiting72 est.31 May 2026
Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)NCT05248646Sibeprenlimab 400 mgPhase 3Locked · track to revealOngoingActive, not recruiting530 est.13 May 2026
A Phase 2 Study of JNT-517 in Adolescent Participants With PhenylketonuriaNCT06637514JNT-517 TabletPhase 2Locked · track to revealCompleted14 est.8 May 2026
Samtasu Post-marketing General Drug Use-results Survey in Patients With Volume Overload in Heart Failure.NCT05712746Samtasu for I.V. infusionNot yet scoredOngoingActive, not recruiting1,600 est.7 May 2026
A Trial of Centanafadine Long-term Safety in Children and Adolescents With Attention-deficit/Hyperactivity Disorder.NCT05279313Centanafadine HydrochloridePhase 3Locked · track to revealCompleted680 est.24 Apr 2026
P3b Short-term Study of CTN in Patients With ADHD and Comorbid AnxietyNCT06973577CentanafadinePhase 3Locked · track to revealCompleted315 est.22 Apr 2026
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male AdultsNCT0745508414C-SEP-380135Phase 1Locked · track to revealOngoingNot yet recruiting8 est.10 Apr 2026
A Trial to Assess How Centanafadine Interacts With Stimulants in the BodyNCT07314333CentanafadinePhase 1Locked · track to revealCompleted40 est.30 Mar 2026
A Study to Evaluate Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Multiple Doses of VIS954NCT06937593VIS954Phase 1Locked · track to revealCompleted24 est.3 Feb 2026
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADHNCT04790175Tolvaptan (SAMSCA)Not yet scoredOngoingActive, not recruiting300 est.19 Jan 2026
A Study to See if Tolvaptan Can Delay Dialysis in Infants and Children Who at Enrollment Are 28 Days to Less Than 12 Weeks Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)NCT04786574Tolvaptan (OPC-41061)Phase 3Locked · track to revealStoppedWithdrawn0 est.10 Dec 2025
A Study to Investigate the Safety and Tolerability of CAN10 Antibody in Healthy Subjects and in Subjects With Plaque Psoriasis.NCT06143371CAN10Phase 1Locked · track to revealCompleted80 est.10 Nov 2025
A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive DisorderNCT05593029SEP-363856Phase 2Locked · track to revealCompleted929 est.6 Nov 2025
A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety DisorderNCT05729373SEP-363856Phase 2Locked · track to revealCompleted434 est.26 Sept 2025
A Study of SEP-380135 in Adults With Schizophrenia or Major Depressive EpisodeNCT07549581SEP-380135Phase 1Locked · track to revealCompleted43 est.12 Sept 2025
First-in-Human, Multiple Part Clinical Study of JNT-517 in Healthy Participants and in Participants With PhenylketonuriaNCT05781399JNT-517 SuspensionPhase 1Locked · track to revealCompleted163 est.29 Jul 2025
A Proof-of-concept Trial for OPC 131461 in Patients Hospitalized for Worsening Heart FailureNCT06795399OPC-131461Phase 2Locked · track to revealStoppedWithdrawn0 est.25 May 2025
JUNIPERTrial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive DisorderNCT05536414CentanafadinePhase 2Locked · track to revealCompleted337 est.16 May 2025
A Trial to Test the Effects of Other Drugs on SEP-380135 in Healthy Men and WomenNCT07305779SEP-380135Phase 1Locked · track to revealCompleted12 est.3 May 2025
Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With SchizophreniaNCT03238326BrexpiprazolePhase 3Locked · track to revealCompleted295 est.22 Apr 2025
A Phase 1 Trial of OPB-111077 in Combination With Bendamustine and Rituximab in Patients With r/r DLBCLNCT04049825OPB-111077Phase 1Locked · track to revealCompleted36 est.25 Mar 2025
Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With SchizophreniaNCT06036108OPC-34712FUM/ Brexpiprazole fumaratePhase 1Locked · track to revealCompleted59 est.18 Mar 2025
A Trial of Centanafadine Efficacy and Safety in Children With Attention-deficit/ Hyperactivity Disorder (ADHD)NCT05428033centanafadine capsulePhase 3Locked · track to revealCompleted574 est.17 Mar 2025
How [14C]-JNT-517 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Healthy Male ParticipantsNCT07573449[14C]-JNT-517Phase 1Locked · track to revealCompleted8 est.22 Jan 2025
A Trial to Characterize Differences in Blood Levels of Different Lots of Centanafadine QD XR and to Understand the Effect of Food on Blood LevelsNCT07253441CTN XR (TBM)Phase 1Locked · track to revealCompleted174 est.30 Dec 2024
Samsca PMS in ADPKD PatientsNCT03406286TolvaptanNot yet scoredCompleted2,067 est.Dec 2024
A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell LymphomaNCT04362007ASTX660Phase 1Locked · track to revealStoppedTerminated8 est.30 Nov 2024
View all trials590

Track your drug now for free

We check every one of its trials daily and tell you what moved.

  • Status changeStatus moved to completedWas recruiting · always alerts
  • Completion date movePrimary completion slipped 210 daysSlips and pull-ins of 30+ days
  • New trialNew trial registered in your scopeFirst posted within 30 days
  • Enrollment changeEnrollment grew to 1,200Moves of 15%+ or count finalised
  • Substantive record editPrimary endpoint redefined from 24 to 52 weeksRead overnight and flagged in plain English
US registryClinicalTrials.gov
EU registryCTIS · Soon
590

Trials as lead sponsor

19

Recruiting now

243

Phase 3 trials

143

Phase 2 trials

147

Phase 1 trials

46

Phase 4 trials