Updated May 2026 · ClinicalTrials.gov
Otsuka Pharmaceutical Development & Commercialization, Inc.
5 clinical trials · 5 recruiting · INDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc. has 5 clinical trials registered on ClinicalTrials.gov, with 5 actively recruiting participants. The trials listed below cover 4 conditions across the phases listed in the sidebar. Always discuss any specific trial with your physician before contacting a study site.
About Otsuka Pharmaceutical Development & Commercialization, Inc.\'s Trial Portfolio
Otsuka Pharmaceutical Development & Commercialization, Inc. is an industry sponsor — typically a pharmaceutical, biotechnology, or medical device company. Industry sponsors fund and run the largest share of registered trials in the United States and are subject to FDA registration requirements under the FDA Amendments Act (FDAAA 801) for most drug and device studies.
5 of Otsuka Pharmaceutical Development & Commercialization, Inc.'s 5 registered trials are currently recruiting — roughly 100% of the portfolio. A high recruiting share usually points to an active research pipeline with multiple programs at the enrollment stage.
Otsuka Pharmaceutical Development & Commercialization, Inc.'s research footprint spans Phenylketonuria (pku) (2 trials), Schizophrenia (1), and Healthy Volunteers (1) as the top three conditions. The full condition list, sorted by trial count, is in the sidebar.
Otsuka Pharmaceutical Development & Commercialization, Inc.'s portfolio is weighted toward later-stage research — Phase 3 accounts for 60% of registered trials. Later-stage trials are the ones most likely to lead directly to FDA approval decisions, and they typically enroll the largest patient cohorts.
Trials by Otsuka Pharmaceutical Development & Commercialization, Inc.
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine,...
The purpose of this study is to assess the drug-drug interaction (DDI) of repinatrabit with ethinyl estradiol/norethindrone or norethisterone (EE/NE), metformin, rosuvastatin,...
A Phase 2 Study of JNT-517 in Adolescent Participants With Phenylketonuria
The goal of this Phase 2, randomized study is to assess the safety, tolerability, and pharmacokinetics (PK) of oral JNT-517 in adolescents (12 to less than 18 years of age) with...
A Study of JNT-517 in Participants With Phenylketonuria (PKU)
The goal of this Phase 3, randomized study is to assess the safety, efficacy, tolerability, and pharmacokinetics (PK) of oral JNT-517 in adults (18 years of age or older) with...
A Long-Term Study of JNT-517 in Participants With Phenylketonuria
The goal of this Phase 3, open-label study is to evaluate the long-term safety of JNT-517 in pediatric and adult participants with Phenylketonuria (PKU) after completion of either...
How to Approach a Trial Listing
Each trial card above links to a dedicated page with the official ClinicalTrials.gov data plus a plain-English translation of the eligibility criteria. We translate technical terminology (ECOG performance status, hepatic function values, exclusionary lab thresholds) into language that a patient or caregiver can understand, but the original clinical text and the live ClinicalTrials.gov record always govern any actual eligibility decision.
Before contacting a trial site, write down questions for your treating physician using the framework on our 25 Questions guide. Discuss whether the trial fits your treatment plan, what the time commitment looks like, and whether your insurance will cover the standard-of-care portions. Trials are not a substitute for a treatment plan — they are an addition that needs medical guidance to evaluate.
Authoritative Resources
Verify any trial registration directly on ClinicalTrials.gov. For background on the FDA approval pathway that Phase 3 trials feed into, see the FDA drug approval process. For cancer-specific trial guidance, the National Cancer Institute publishes patient-oriented overviews. For global trial registrations beyond the U.S., the WHO ICTRP aggregates registries from around the world.
Frequently Asked Questions
How many clinical trials does Otsuka Pharmaceutical Development & Commercialization, Inc. have on ClinicalTrials.gov?
Otsuka Pharmaceutical Development & Commercialization, Inc. has 5 clinical trials registered on the federal ClinicalTrials.gov registry, of which 5 are actively recruiting participants right now. These counts come directly from the ClinicalTrials.gov API and are updated as the registry changes.
What conditions does Otsuka Pharmaceutical Development & Commercialization, Inc. study?
Otsuka Pharmaceutical Development & Commercialization, Inc.'s registered trials cover 4 conditions on ClinicalTrials.gov, led by Phenylketonuria (pku) (2 trials), Schizophrenia (1 trial), Healthy Volunteers (1 trial), Phenylketonuria (1 trial). The complete condition list appears in the sidebar of this page; each condition links to a page listing every recruiting trial in that area, regardless of sponsor.
How do I join a Otsuka Pharmaceutical Development & Commercialization, Inc. clinical trial?
Joining a clinical trial is a medical decision that should always involve your treating physician. Each trial page on this site includes the eligibility criteria translated into plain English alongside the official clinical text, plus the contact information that the sponsor has registered with ClinicalTrials.gov. Bring the trial information to your doctor before reaching out — they can review the full inclusion and exclusion criteria against your medical history and help you decide whether to pursue screening.
What does the trial phase mean?
Phase 1 trials test safety and dosing in small groups (often 20–80 healthy volunteers or patients). Phase 2 trials evaluate efficacy and side effects in larger groups (100–300 patients with the target condition). Phase 3 trials confirm efficacy and monitor safety in the largest groups (300–3,000+ patients) and form the basis of an FDA approval submission. Phase 4 studies happen after a treatment is approved, monitoring long-term safety and effectiveness in real-world use. Some trials register without a phase — common for device, behavioral, or observational studies.
Where does this trial data come from?
All trial data is pulled directly from the ClinicalTrials.gov API v2, the official federal trial registry maintained by the National Library of Medicine at NIH. Under FDAAA 801, most U.S. drug and device trials are required to register, making ClinicalTrials.gov the most comprehensive source. Sponsors are responsible for keeping their listings current; trial status can shift between data refreshes.
How This Sponsor Page Is Built
Every count on this page is derived directly from ClinicalTrials.gov API v2 records. Trial counts include all trials currently registered to this sponsor; the recruiting count reflects trials with status "Recruiting" or equivalent. Plain-English eligibility translations on each linked trial page preserve the original clinical text alongside an accessible version. Read the full methodology for the data pipeline and limitations.
Source: ClinicalTrials.gov API v2, maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. Data: ClinicalTrials.gov."
Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.
Last updated 2026-05-08 · 5 trials tracked for Otsuka Pharmaceutical Development & Commercialization, Inc..
For this entity, the underlying data on this page comes from the NIH ClinicalTrials.gov registry. The breakdown above is the federal record; the paragraphs below add the per-entity context that makes the headline numbers usable for a real decision rather than just a data lookup.
Every number on this page links back to the NIH ClinicalTrials.gov registry; the methodology page describes the inputs, refresh cadence, and known limitations of the underlying data product.
For readers using this page as a decision input, the related-entity pages elsewhere on the site provide the comparison set. The most useful comparison for this entity is typically a peer within active and historical clinical trials with similar size, similar exposure, or similar geography — not the national-level summary alone.