Otsuka Pharmaceutical Development & Commercialization, Inc.

This phase 3 trial is testing whether an experimental oral medication called SEP-363856 (ulotaront) can reduce anxiety symptoms in adults with generalized anxiety disorder. Participants will receive one of two fixed doses of the drug or a placebo for 8 weeks. The main goal is to …

This trial tests the safety of tolvaptan, a drug that helps the body remove extra water, in 20 children aged 28 days to 18 years with autosomal recessive polycystic kidney disease (ARPKD). The goal is to see if the drug can slow kidney function decline and reduce the need for dia…

This early-stage trial tests a daily capsule called NDI-5001 in 24 adult men with a rare inherited kidney condition (X-linked congenital nephrogenic diabetes insipidus) that causes extreme thirst and frequent urination. The study's main goal is to check the drug's safety and how …

This study tests a new drug called Ulotaront (SEP-363856) to see if it can reduce symptoms like hallucinations and delusions in people with schizophrenia. About 522 adults experiencing an acute episode will receive either the drug or a placebo for 6 weeks. The main goal is to mea…

This study tests an experimental oral drug, JNT-517, for adults with phenylketonuria (PKU), a genetic condition that causes harmful buildup of phenylalanine (Phe). About 120 adults will receive either JNT-517 or a placebo for 6 weeks, then all will receive JNT-517 for nearly a ye…

This study tests whether a new drug called quabodepistat can shorten treatment for drug-resistant tuberculosis (TB) from 6 months to 4 months. About 532 adults and teens with rifampicin-resistant or multidrug-resistant TB will be randomly assigned to receive either the new shorte…

This Phase 3 study is testing the long-term safety of an oral drug called JNT-517 in 240 children and adults with phenylketonuria (PKU). All participants will receive the drug twice daily, with doses based on age and weight. The goal is to see if JNT-517 is safe to use over time …

This early-stage trial is testing how the experimental drug repinatrabit interacts with several common medications, including birth control pills, metformin, and methotrexate. The study involves 48 healthy volunteers and will measure drug levels in the blood to see if combining t…

This study looks at how the body processes repinatrabit (JNT-517), an oral tablet for phenylketonuria, in people with moderate liver impairment or severe kidney impairment. It compares these results to those from healthy volunteers of similar age, weight, and sex. The goal is to …

This early-stage study involves 18 healthy men to see how well the experimental drug MSP-2020 attaches to serotonin receptors in the brain. Researchers will also measure how much drug stays in the blood and check for side effects. The goal is to understand the drug's activity in …