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Otsuka Pharmaceutical Development & Commercialization clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — current trials in our USA, UK, China and India registers with Otsuka Pharmaceutical Development & Commercialization as lead sponsor. Synced 26 Sep 2026
15Current trials
11Recruiting now
3Drugs in these trials
4Trial registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist
Compiled from ClinicalTrials.gov and CTIS registry records · Last verified · Editorial standards
At a glance

Otsuka Pharmaceutical Development & Commercialization is the lead sponsor of 15 current clinical trials in our USA, UK, China and India registers. 11 are recruiting patients now. The most common phase is Phase 3. The drugs named most often in its trials are SEP-363856, Sibeprenlimab and JNT-517. The most-studied condition is Immunoglobulin A Nephropathy.

ClinicalTrials.gov trials by status

  • Recruiting1173%
  • Not yet open17%
  • Active, closed213%
  • By invitation17%

Trials by phase

  • Phase 3960%
  • Phase 1320%
  • Phase 2213%
  • Phase 2/317%
01

Clinical trials sponsored by Otsuka Pharmaceutical Development & Commercialization

15 on ClinicalTrials.gov
StudyPhaseStatusStartRegisters
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)
NCT04782258 · Autosomal Recessive Polycystic Kidney (ARPKD)
Phase 3 Recruiting 2023-01 UK, USA
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
NCT07209761 · ClinicalTrials.gov ↗ · Pulmonary Tuberculosis
Phase 3 Recruiting 2025-10 China
A Long-Term Study of JNT-517 in Participants With Phenylketonuria
NCT06628128 · Phenylketonuria (PKU)
Drug: JNT-517
Phase 3 Recruiting 2025-08 USA
A Study of JNT-517 in Participants With Phenylketonuria (PKU)
NCT06971731 · ClinicalTrials.gov ↗ · Phenylketonuria
Drug: JNT-517
Phase 3 Recruiting 2025-10 USA
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 Body
NCT07525960 · ClinicalTrials.gov ↗ · Diabetes Insipidus
Phase 1 Recruiting 2026-07 USA
A Trial of the Efficacy and Safety of a Fixed Dose of SEP-363856 in Adults With Generalized Anxiety Disorder
NCT07767903 · ClinicalTrials.gov ↗ · Generalized Anxiety Disorder
Phase 3 Recruiting 2026-08 USA
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
NCT07759154 · ClinicalTrials.gov ↗ · Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation
Phase 3 Recruiting 2026-09 USA
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 Function
NCT07713758 · ClinicalTrials.gov ↗ · Phenylketonuria
Phase 1 Recruiting 2026-07 USA
A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety Disorder
NCT07759128 · ClinicalTrials.gov ↗ · Generalized Anxiety Disorder
Phase 3 Recruiting 2026-07 USA
Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue
NCT06740526 · ClinicalTrials.gov ↗ · IgA Nephropathy
Phase 2 Recruiting 2024-11 USA
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
NCT06894212 · ClinicalTrials.gov ↗ · Schizophrenia
Phase 3 Recruiting 2025-02 USA
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
NCT07455084 · ClinicalTrials.gov ↗ · Schizophrenia
Phase 1 Not yet open 2026-03 USA
Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)
NCT05248659 · ClinicalTrials.gov ↗ · Immunoglobulin A Nephropathy
Phase 2/3 By invitation 2022-04 UK, USA, India, China
Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)
NCT05248646 · Immunoglobulin A Nephropathy
Phase 3 Active, closed 2022-03 UK, USA, India, China
A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's
NCT06928142 · Sjogren Disease
Phase 2 Active, closed 2025-04 USA

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Titles and statuses are copied from the registry as published.

02

Drugs in Otsuka Pharmaceutical Development & Commercialization trials

3 compounds

Drugs and biologicals named as interventions in these trials, with the number of this sponsor's trials that name each one. Placebos and generic comparators are excluded.

03

Conditions in Otsuka Pharmaceutical Development & Commercialization trials

12 conditions
Immunoglobulin A Nephropathy2Phenylketonuria2Generalized Anxiety Disorder2Schizophrenia2Autosomal Recessive Polycystic Kidney (ARPKD)1Sjogren Disease1Phenylketonuria (PKU)1Diabetes Insipidus1Attention-deficit/Hyperactivity Disorder1Emotional Dysregulation1IgA Nephropathy1Pulmonary Tuberculosis1
04

By trial register

RegisterTrialsRecruiting
Clinical trials in USA1410
Clinical trials in UK31
Clinical trials in China31
Clinical trials in India20

A trial with sites in more than one country appears in each of those registers.

05

Other sponsors in Immunoglobulin A Nephropathy

SponsorTrials
Novartis Pharmaceuticals5
Travere Therapeutics2
Beijing Mabworks Biotech1

Sponsors with the most current trials registered for this condition.

06

Questions about Otsuka Pharmaceutical Development & Commercialization trials

How many clinical trials does Otsuka Pharmaceutical Development & Commercialization sponsor?

Otsuka Pharmaceutical Development & Commercialization is the lead sponsor of 15 current trials on ClinicalTrials.gov in our USA, UK, China and India registers, as of the registry sync on 26 September 2026. Completed and withdrawn studies are not counted.

Are Otsuka Pharmaceutical Development & Commercialization trials recruiting?

Yes. 11 of its 15 ClinicalTrials.gov trials are recruiting. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Which drugs is Otsuka Pharmaceutical Development & Commercialization testing?

Its current trials name 3 drugs and biologicals as interventions. The most frequent are SEP-363856 (3), Sibeprenlimab (3) and JNT-517 (2). The number in brackets is how many of its trials name each drug.

Where does this information come from?

Every trial, status, phase and condition on this page is copied from public ClinicalTrials.gov and EU CTIS records by a daily sync, grouped by the sponsor name each registry records. It says nothing about the organisation beyond its registered trials, and it is not medical advice.

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How this page is built

Everything on this page is copied from public registry records — it is not written from memory, and nothing here describes the organisation beyond its registered trials. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our trial registers and groups every current trial by its lead sponsor name, ignoring legal-form suffixes such as Inc. or Ltd. A small, hand-checked list joins the same organisation's different registry names (for example its EU legal entity). There is no AI drafting and no per-sponsor editorial pass. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The the registries data on this page was last retrieved on 26 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.