Ulotaront hydrochloride is under clinical development by Sumitomo Pharma America 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.

Sumitomo Pharma America overview

Sumitomo Pharma America (Sumitomo Pharma), formerly Sunovion Pharmaceuticals Inc, is a research-based pharmaceutical company. It discovers, develops, and marketize therapeutic products that focus on the treatment of the central nervous system and respiratory disorders. Its major products include eslicarbazepine acetate tablets, lurasidone HCl tablets, relugolix, estradiol, and norethindrone acetate tablets, vibegron tablets, relugolix tablets, and allogeneic processed thymus tissue–agdc. The company’s product candidates are intended for the treatment of schizophrenia, neuropathic pain, bipolar depression, treatment-resistant depression, agitation in Alzheimer’s disease, and women’s healthcare products among others. It has partnerships with various pharmaceutical companies such as Psychogenics and others. Sumitomo Pharma is headquartered in Marlborough, Massachusetts, the US.

For a complete picture of Ulotaront hydrochloride’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 20 February 2024

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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.