Lurasidone hydrochloride is under clinical development by Sumitomo Pharma and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Lurasidone hydrochloride’s likelihood of approval (LoA) and phase transition for Autism took place on 18 Mar 2021, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Lurasidone hydrochloride Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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.

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.

Quick View Lurasidone hydrochloride LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Lurasidone hydrochloride
Administration Pathway
  • Intramuscular
  • Oral
Therapeutic Areas
  • Central Nervous System
Key Developers
Highest Development Stage
  • Marketed

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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.