Lurasidone hydrochloride is under clinical development by Sumitomo Pharma and currently in Phase III for Autism Spectrum Disorder (ASD). According to GlobalData, Phase III drugs for Autism Spectrum Disorder (ASD) have a 13% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Lurasidone 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.

Lurasidone hydrochloride overview

Lurasidone hydrochloride (Latuda, SM-13496) is an atypical psychotropic agent belonging to the chemical class of benzisothiazole derivatives. It is formulated as film-coated tablets for oral route of administration and also administered through intramuscular route. Latuda is indicated for the treatment of patients with schizophrenia, as monotherapy for the treatment of patients with major depressive episodes associated with bipolar I disorder (bipolar depression), as adjunctive therapy with either lithium or valproate for the treatment of patients with major depressive episodes associated with bipolar I disorder (bipolar depression). It is also indicated for the treatment of schizophrenia in adults aged 18 years and over, for the treatment of schizophrenia in adolescents aged 13 to 17 years, for the treatment of major depressive episode associated with bipolar I disorder (bipolar depression) in pediatric patients (10 to 17 years of age).

Lurasidone hydrochloride is under development for the treatment of schizophrenia, autism and major depressive disorder with mixed features. It is under development for the treatment of autism, schizophrenia in pediatric patients. The drug candidate was also under development for the treatment of the major depressive disorder, bipolar disorder (manic depression) as depot formulation. It was under development for bipolar I disorder.

Sumitomo Pharma overview

Sumitomo Pharma, a subsidiary of Sumitomo Chemical Co Ltd develops, manufactures, sells, imports and exports pharmaceutical products. The company drugs are focused on major therapeutic areas which include regenerative diseases, oncology, psychiatry and neurology and infectious diseases. It also offers veterinary medicines for companion animals, primarily dogs, and cats, as well as for livestock such as cattle, swine, poultry, horses, and aquacultured fish. It also offers food additives, chemical product materials, food ingredients, and other products. Sumitomo Dainippon has research laboratories and manufacturing and distribution facilities in Japan. The company operates through subsidiaries and offices in North America, Europe, and Asia Pacific. Sumitomo Pharma is headquartered in Osaka, Japan.

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

This content was updated on 2 September 2023

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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.