Otsuka Pharmaceutical Development & Commercialization, Inc.

This study tested the safety and tolerability of aripiprazole (Abilify) in 21 children and adolescents aged 10 to 17 with schizophrenia or mania. Participants took daily doses of 2 to 30 mg for 14 days. The main goals were to see how many could tolerate the highest dose without s…

This Phase 3 trial tested an investigational drug called SEP-363856 in 464 people with schizophrenia who were experiencing acute psychosis. Participants received either the drug or a placebo daily for up to 9 weeks. The study measured changes in symptoms like hallucinations and d…

This study tested whether a once-monthly injection of aripiprazole can help people with schizophrenia avoid a relapse of symptoms. Over 900 adults took part, first switching to oral aripiprazole, then receiving either the long-acting shot or another treatment for up to 38 weeks. …

This Phase 3 trial tested sibeprenlimab, a drug given as a shot under the skin, in 530 adults with IgA nephropathy, a kidney disease. The study compared the drug to a placebo to see if it could reduce protein in the urine and protect kidney function over time. Participants were a…

This study tested an investigational drug called SEP-363856 in 463 people with schizophrenia who were having severe symptoms. Participants received either the drug or a placebo for 6 weeks. The main goal was to see if the drug reduced symptoms like hallucinations and emotional wi…

This trial tested a new 4-month combination of three drugs (OPC-167832, delamanid, and bedaquiline) against the standard 6-month treatment for drug-susceptible pulmonary tuberculosis. 122 adults with newly diagnosed TB took part. The goal was to see if the shorter regimen is safe…

This study tested the long-term safety of a daily medication called centanafadine in 680 children and teens (ages 4-17) with ADHD. The drug is a non-stimulant capsule taken once a day. Researchers tracked side effects over time to see if it is safe for extended use. The trial is …

This study tested a new drug called JNT-517 in 14 teenagers with phenylketonuria (PKU). Participants took either JNT-517 or a placebo twice daily for 28 days. The main goal was to check safety and how the drug moves through the body, while also measuring changes in blood phenylal…

This study tested a combination of two drugs, busulfan and bortezomib, given before a second stem cell transplant in 30 patients with multiple myeloma that had returned after a previous transplant. The goal was to see if this approach could control the disease. Results showed tha…

This study tested whether adding aripiprazole (Abilify) to the standard mood stabilizer lamotrigine helps prevent relapse in people with bipolar I disorder who recently had a manic or mixed episode. Over 1,100 adults took part, receiving either the combination or lamotrigine alon…

This Phase 3 trial tested a once-daily extended-release capsule called centanafadine in 315 adults with both ADHD and anxiety (generalized or social anxiety). For 8 weeks, participants received either the drug or a placebo. The study measured changes in ADHD symptoms using a clin…

This early-stage study tested an experimental oral drug called JNT-517 in healthy volunteers and people with phenylketonuria (PKU), a genetic condition that causes harmful buildup of the amino acid phenylalanine. The main goals were to check safety and how the body processes the …

This early-phase trial tested the safety of a new drug called VIS649 in 51 healthy volunteers. VIS649 is an antibody that blocks a protein called APRIL, which is thought to play a role in IgA nephropathy, a kidney disease. The study gave single doses of the drug or a placebo and …

This study tested a new drug called VIS649 in 155 adults with IgA nephropathy, a kidney disease. The goal was to see if the drug is safe and can reduce protein in the urine, a sign of kidney damage. Participants received either the drug or a placebo, and researchers monitored sid…

This early-phase trial tested a new drug called VIS171 in 61 people: first in healthy volunteers, then in patients with autoimmune diseases. The main goal was to check safety and how the body processes the drug. No results on whether it actually helps the disease are available ye…

This completed Phase 3 trial tested the long-term safety of the drug brexpiprazole in 295 adolescents aged 13-17 with schizophrenia. Participants took flexible daily doses of the oral tablet for up to several months. The main goal was to track side effects and see how many teens …

This study tested an experimental drug called SEP-363856 to see if it is safe to take for a long time by people with schizophrenia. 305 adults aged 18 to 65 took part for about 57 weeks. The main goal was to track any side effects or serious health problems that happened while on…

This study looked at the safety of a new drug called SEP-363856 for people with schizophrenia who switched from their usual antipsychotic medication. 75 participants who completed a prior study were followed for up to 25 weeks. The main goal was to track any side effects or serio…

This study looked at how well a new drug, SEP-363856, works and how safe it is for people with schizophrenia who switch from their current antipsychotic medication. About 101 adults with stable schizophrenia took part over 8 weeks. The main goal was to see how many stopped the st…

This Phase 3 trial tested rebamipide eye drops in 762 people with dry eye lasting at least 6 months. Participants received either rebamipide or placebo drops for 26 weeks. The goal was to see if the drops could reduce eye surface damage and discomfort better than placebo.

This Phase 3 trial tested rebamipide eye drops in 755 people with dry eye for at least 6 months. Participants received either rebamipide or placebo drops for up to 52 weeks. The goal was to see if the drops could reduce eye surface damage and ease discomfort.

This Phase 2 trial tested a new drug called EB-1020 SR (centanafadine) in 45 adult men with ADHD. The goal was to see if it could reduce symptoms like inattention and hyperactivity. Participants took the drug or a placebo for a few weeks, and researchers measured changes using a …

This study tested whether aripiprazole (Abilify) can reduce serious behavioral problems in children and teens aged 6 to 17 with autistic disorder. 98 participants received either the drug or a placebo for 8 weeks. Researchers measured changes in irritability and overall improveme…

This Phase 2 trial tested whether AVP-786, a combination of two drugs, can reduce negative symptoms (like lack of emotion or motivation) in people with schizophrenia. 145 adults on stable antipsychotics received either AVP-786 or a placebo for 12 weeks. The study measured changes…

This study tested a new drug, centanafadine, in 337 adults with major depression who hadn't responded well to at least one prior treatment. Some participants took the drug alone, others added it to their current antidepressant. The main goal was to see if it reduced depression sy…

This study tested whether aripiprazole (Abilify) can reduce serious behavioral problems in children and adolescents with autistic disorder. 218 participants aged 6 to 17 received either a fixed dose of aripiprazole or a placebo daily for 8 weeks. The main goal was to see if the d…

This early-stage study tested the safety and how the body processes the drug brexpiprazole in 43 teenagers aged 13-17 with schizophrenia. Researchers monitored side effects and changes in vital signs over 17 days. The goal was to find a safe dose for future studies, not to measur…

This study tested whether a once-daily capsule called centanafadine helps reduce ADHD symptoms in children aged 4 to 12. Over 500 children took either the drug or a placebo for 6 weeks. Researchers measured changes in ADHD rating scales to see if the drug works better than a suga…

This study tested whether adding an experimental drug called SEP-363856 to standard antidepressants can better reduce depression symptoms in adults who didn't respond well to prior treatments. About 929 participants took either the drug or a placebo alongside their usual medicati…

This early-stage study tested a new drug called CAN10, an antibody that blocks a protein involved in inflammation. Researchers gave single doses to 80 healthy adults and repeated doses to people with mild to moderate plaque psoriasis to see if it is safe and how the body processe…

This study tested an experimental drug called AVP-786 in 168 people with traumatic brain injury who had symptoms like aggression, agitation, and irritability. The goal was to see if the drug could safely reduce these difficult behaviors. Participants received either the drug or a…

This study tested a new medication called SEP-363856 in 434 adults with generalized anxiety disorder. Participants took either the drug or a placebo for up to 12 weeks. Researchers measured changes in anxiety symptoms using standard rating scales to see if the drug was safe and e…

This Phase 2 trial tested two doses of centanafadine sustained-release tablets against a placebo in 147 adults with moderate to severe binge eating disorder. The main goal was to see if the drug could reduce the number of binge eating days per week. Researchers also looked at cha…

This study looked at how a new drug called OPC-167832 is processed by the liver when taken with other common medicines. Twenty-four healthy adults took part to see if certain drugs slow down or speed up the breakdown of OPC-167832. The goal was to gather safety information, not t…

This early-stage study tested the safety of a new drug called VIS954 in 24 healthy adults aged 18 to 55. Participants received either the drug or a placebo, and researchers monitored side effects and how the drug moved through the body. The goal was not to treat any disease, but …

This study looked at how healthy men absorb, break down, and get rid of a drug called JNT-517. Eight men took a single dose with a radioactive tracer so scientists could track it in blood, urine, and stool. The goal was to understand the drug's path through the body, not to treat…

This study looked at how centanafadine, a potential ADHD treatment, affects the body when taken with common stimulant medicines. Forty healthy adults took part to measure changes in blood pressure, heart rate, and drug levels. The goal was to understand possible interactions, not…

This early-stage study tested the safety and how the body processes an experimental drug called AVP-786. 48 healthy adult men took single or multiple doses of the drug or a placebo. The goal was to measure drug levels in the blood and check for side effects, not to treat any dise…

This early-stage study enrolled 62 healthy adults to compare how two drugs, AVP-786 and AVP-923, are processed in the body. Participants received both drugs at different times to measure drug levels and safety. The goal was purely to gather information, not to treat any disease.

This early-stage trial tested a new drug, AVP-786, in 56 healthy adult men to see how the body processes it and whether it is safe. The drug is a modified version of dextromethorphan combined with quinidine. Because this is a Phase 1 study in healthy people, it does not test whet…

This study followed over 3,400 people with autosomal dominant polycystic kidney disease (ADPKD) to learn how the disease progresses. Researchers measured kidney size, symptoms, quality of life, and healthcare costs. The goal was to identify factors that predict faster disease pro…

This early-stage study looked at how a common antifungal drug (itraconazole) changes the levels of two experimental drugs, AVP-923 and AVP-786, in the blood. Twenty-four healthy adults took part to help researchers understand potential drug interactions. The goal was to gather sa…

This study was the first time a new drug, VIS954, was given to humans. The main goal was to see if it is safe and how the body handles it. 54 healthy adults received either the drug or a placebo. Researchers monitored for side effects and measured drug levels in the blood.

This early-stage study tested a new oral drug, SEP-380135, in 43 adults with schizophrenia or major depression (including bipolar disorder). The main goal was to check its safety and how the body processes it. Participants took multiple doses and were monitored for side effects, …

This early-stage study looked at how a new drug, EB-1020, behaves in the body when taken with or without food. It involved 54 healthy adults aged 18 to 45. The main goals were to check safety, tolerability, and how food changes drug levels in the blood.

This study looked at whether a new drug called EB-1020 has abuse potential in 80 healthy adults who use stimulants recreationally. Participants received single doses of EB-1020, d-amphetamine, or placebo, and rated how much they liked the drug. The goal was to see if EB-1020 prod…

This study looked at whether taking two smaller capsules of centanafadine (a potential ADHD medication) works the same as taking one larger capsule. 44 healthy adults took both versions at different times to compare how the drug enters the blood. The goal was to confirm the doses…

This study compared two different pill forms of the drug centanafadine in 62 healthy adults. The goal was to see how well each form releases the drug into the body. Results will help decide which version to use in future studies.

This completed phase 1 trial enrolled 12 healthy adults to see how a single dose of the experimental schizophrenia drug SEP-380135 interacts with quinidine, a medicine that blocks a key liver enzyme. Researchers measured drug levels in the blood and monitored safety. The goal is …

This completed Phase 1 trial studied how a single dose of the experimental drug OPC-167832 is eliminated from the body. Eight healthy men took the drug, which was tagged with a tiny amount of radioactivity, and researchers measured how much came out in urine and stool. The goal w…

This study tested how different capsule versions of the ADHD drug centanafadine are absorbed in the body. 174 healthy adults took part to see if a single high-dose capsule works the same as two lower-dose capsules, and whether food changes absorption. No treatment was given; the …