Apilimod mesylate is under clinical development by AI Therapeutics and currently in Phase I for Mantle Cell Lymphoma. According to GlobalData, Phase I drugs for Mantle Cell Lymphoma have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Apilimod mesylate’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.

Apilimod mesylate overview

Apilimod mesylate is under development for the treatment of follicular lymphoma, diffuse large b-cell lymphoma, mantle cell lymphoma, amyotrophic lateral sclerosis, marginal zone lymphoma, primary mediastinal b-cell lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), frontotemporal dementia and coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The drug candidate is administered through oral route. It acts by targeting 1 phosphatidylinositol 3 phosphate 5 kinase (PIKFYVE).

AI Therapeutics overview

AI Therapeutics, formerly LAM Therapeutics, is a biopharmaceutical company that identifies and develops treatments for neurological disease and cancers. It is investigating LAM-001 program against pulmonary sarcoidosis; and bronchiolitis obliterans disease caused after lung transplantation resulting in obstruction of the smallest airways of the lungs. The company is also evaluating AIT–101 drug to treat amyotrophic lateral sclerosis; and AIT-102 for rare diseases. AI Therapeutics is headquartered in Guilford, Connecticut, the US.

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


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.