Sponsor · clinical trials

Otsuka Pharmaceutical Development & Commercialization clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — current trials in our USA, Japan, Spain, Australia, Germany, Poland, UK, Canada, Belgium, India, China, France, Netherlands, Czechia, South Korea, Italy, Portugal, Brazil, Taiwan, Singapore and Israel registers with Otsuka Pharmaceutical Development & Commercialization as lead sponsor. Synced 10 Nov 2026

19Current trials

12Recruiting now

12Drugs in these trials

21Trial 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 · Synced 10 Nov 2026 · Editorial standards

At a glance

Otsuka Pharmaceutical Development & Commercialization is the lead sponsor of 19 current clinical trials in our USA, Japan, Spain, Australia, Germany, Poland, UK, Canada, Belgium, India, China, France, Netherlands, Czechia, South Korea, Italy, Portugal, Brazil, Taiwan, Singapore and Israel registers. 12 are recruiting patients now. The most common phase is Phase 3. The drugs named most often in its trials are Repinatrabit, Sibeprenlimab and Ulotaront. The most-studied condition is Generalized Anxiety Disorder.

ClinicalTrials.gov trials by status

Recruiting1263%
Not yet open15%
Active, closed526%
By invitation15%

Trials by phase

Phase 31053%
Phase 1632%
Phase 2211%
Phase 2/315%

Clinical trials sponsored by Otsuka Pharmaceutical Development & Commercialization

19 on ClinicalTrials.gov

Study	Phase	Status	Start	Registers
A Long-Term Study of JNT-517 in Participants With Phenylketonuria NCT06628128 · Phenylketonuria (PKU) Drug: Repinatrabit	Phase 3	Recruiting	2025-08	USA, Australia
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body NCT07649265 · ClinicalTrials.gov ↗ · Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis	Phase 1	Recruiting	2026-09	Australia
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis NCT07209761 · ClinicalTrials.gov ↗ · Rifampicin-Resistant Pulmonary Tuberculosis, Multidrug-Resistant Pulmonary Tuberculosis Drugs: Bedaquiline, Linezolid, Moxifloxacin	Phase 3	Recruiting	2025-10	India, China, Japan, South Korea
A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety Disorder NCT07759128 · Generalized Anxiety Disorder Drug: Ulotaront	Phase 3	Recruiting	2026-07	USA
A Study of JNT-517 in Participants With Phenylketonuria (PKU) NCT06971731 · Phenylketonuria Drug: Repinatrabit	Phase 3	Recruiting	2025-10	USA, Germany, France, Spain, Netherlands, Poland, Czechia, Canada, Japan, Australia
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 · Phenylketonuria Drug: Repinatrabit	Phase 1	Recruiting	2026-07	USA
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) Drug: Tolvaptan	Phase 3	Recruiting	2023-01	UK, USA, Germany, Spain, Belgium, Poland
A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together NCT07446400 · ClinicalTrials.gov ↗ · Healthy Volunteers Drugs: Carbamazepine, Metformin, Methotrexate	Phase 1	Recruiting	2026-03	Australia
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 · Generalized Anxiety Disorder Drug: Ulotaront	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 · Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation	Phase 3	Recruiting	2026-09	USA
A Trial of the Safety and Tolerability of SEP-363856 in Adults With Generalized Anxiety Disorder NCT07786454 · ClinicalTrials.gov ↗ · Generalized Anxiety Disorder Drug: Ulotaront	Phase 3	Recruiting	2026-10	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	2026-11	USA
Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN) NCT05248659 · Immunoglobulin A Nephropathy Drug: Sibeprenlimab	Phase 2/3	By invitation	2022-04	UK, USA, India, China, Germany, France, Spain, Italy, Netherlands, Belgium, Poland, Czechia, Portugal, Canada, Brazil, Japan, South Korea, Taiwan, Singapore, Australia, Israel
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia NCT06894212 · Schizophrenia Drug: Ulotaront	Phase 3	Active, closed	2025-02	USA, Japan
Phase 2b Open-Label Repeat Kidney Biopsy Study NCT06740526 · IgA Nephropathy Drug: Sibeprenlimab	Phase 2	Active, closed	2024-12	UK, USA, Canada, Japan
Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN) NCT05248646 · Immunoglobulin A Nephropathy Drug: Sibeprenlimab	Phase 3	Active, closed	2022-03	UK, USA, India, China, Germany, France, Spain, Italy, Netherlands, Belgium, Poland, Czechia, Portugal, Canada, Brazil, Japan, South Korea, Taiwan, Singapore, Australia, Israel
A Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of VIS171 in Participants With Autoimmune Disease(s) NCT06799520 · ClinicalTrials.gov ↗ · Systemic Lupus Erythematosus (SLE), Alopecia Areata (AA), Immune-mediated Focal Segmental Glomerulosclerosis (FSGS)	Phase 1	Active, closed	2025-03	Spain
A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's NCT06928142 · Sjogren Disease Drug: Sibeprenlimab	Phase 2	Active, closed	2025-04	USA, Germany, Spain, Poland

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.

Drugs in Otsuka Pharmaceutical Development & Commercialization trials

12 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.

Repinatrabit4 Sibeprenlimab4 Ulotaront4 Bedaquiline1 Carbamazepine1 Linezolid1 Metformin1 Methotrexate1 Moxifloxacin1 Pretomanid1 Rosuvastatin1 Tolvaptan1

Conditions in Otsuka Pharmaceutical Development & Commercialization trials

21 conditions

Generalized Anxiety Disorder3 Immunoglobulin A Nephropathy2Phenylketonuria2Schizophrenia2 IgA Nephropathy1Autosomal Recessive Polycystic Kidney (ARPKD)1Diabetes Insipidus1Phenylketonuria (PKU)1Attention-deficit/Hyperactivity Disorder1Emotional Dysregulation1Sjogren Disease1Rifampicin-Resistant Pulmonary Tuberculosis1Multidrug-Resistant Pulmonary Tuberculosis1Systemic Lupus Erythematosus (SLE)1Alopecia Areata (AA)1Immune-mediated Focal Segmental Glomerulosclerosis (FSGS)1Rheumatoid Arthritis1 Systemic Lupus Erythematosus1 Systemic Sclerosis1Sjögren's Disease1Healthy Volunteers1

By trial register

Register	Trials	Recruiting
Clinical trials in USA	15	9
Clinical trials in Japan	6	2
Clinical trials in Spain	6	2
Clinical trials in Australia	6	4
Clinical trials in Germany	5	2
Clinical trials in Poland	5	2
Clinical trials in UK	4	1
Clinical trials in Canada	4	1
Clinical trials in Belgium	3	1
Clinical trials in India	3	1
Clinical trials in China	3	1
Clinical trials in France	3	1
Clinical trials in Netherlands	3	1
Clinical trials in Czechia	3	1
Clinical trials in South Korea	3	1
Clinical trials in Italy	2	0
Clinical trials in Portugal	2	0
Clinical trials in Brazil	2	0
Clinical trials in Taiwan	2	0
Clinical trials in Singapore	2	0
Clinical trials in Israel	2	0

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

Other sponsors in Generalized Anxiety Disorder

Sponsor	Trials
Intra-Cellular Therapies	4
Beijing Union Pharmaceutical Factory	3
Definium Therapeutics US	2

Sponsors with the most current trials registered for this condition.

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 19 current trials on ClinicalTrials.gov in our USA, Japan, Spain, Australia, Germany, Poland, UK, Canada, Belgium, India, China, France, Netherlands, Czechia, South Korea, Italy, Portugal, Brazil, Taiwan, Singapore and Israel registers, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.

Are Otsuka Pharmaceutical Development & Commercialization trials recruiting?

Yes. 12 of its 19 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 12 drugs and biologicals as interventions. The most frequent are Repinatrabit (4), Sibeprenlimab (4), Ulotaront (4), Bedaquiline (1) and Carbamazepine (1). 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.

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.

ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, lead sponsor, phase, overall status, start date, conditions and intervention names
EU Clinical Trials Information System (CTIS) ↗ EU trial numbers, titles, sponsor, phase, status, therapeutic area and member-state countries

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 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

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.