Ulotaront hydrochloride is under clinical development by Otsuka Pharmaceutical and currently in Phase III for Generalized Anxiety Disorder (GAD). According to GlobalData, Phase III drugs for Generalized Anxiety Disorder (GAD) have a 36% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Ulotaront hydrochloride’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Ulotaront hydrochloride overview
Ulotaront hydrochloride (SEP-363856, SEP-856) is under development for the treatment of schizophrenia, major depressive disorder, generalized anxiety disorder (GAD), Parkinson’s disease psychosis and substance drug abuse (cocaine). The drug candidate is administered orally. It is an anti-psychotic agent. It acts by targeting TAAR1 and serotonin 5-HT1A receptors. It is developed based on the PsychoGenics artificial intelligence (AI) technology.
It was also under development for the treatment of narcolepsy-cataplexy.
Otsuka Pharmaceutical overview
Otsuka Pharmaceutical (OPC), a subsidiary of Otsuka Holdings Co Ltd, is a manufacturer and supplier of pharmaceuticals, food products, clinical testing, and medical equipment. The company develops formulations for the diagnosis and treatment of central nervous system, oncology, cardiovascular and renal, gastrointestinal, ophthalmology disorders and infectious diseases through its pharmaceutical business. Its nutraceutical segment offers rehydration, nutrition, vitamin supplements and cosmetics. OPC is investigating drugs for psychiatry and neurology; oncology; cardiovascular and other therapeutic indications in collaboration with academia and venture companies. The company operates branch offices, research facilities and factories in Japan. OPC is headquartered in Chiyoda-ku, Tokyo, Japan.
For a complete picture of Ulotaront hydrochloride’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
