Mirdametinib is under clinical development by SpringWorks Therapeutics and currently in Phase II for Solid Tumor. According to GlobalData, Phase II drugs for Solid Tumor have a 21% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Mirdametinib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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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.

Mirdametinib overview

mirdametinib (PD-0325901) is under development for the treatment of neurofibromatosis type-1 (NF1)-associated plexiform neurofibromas (PNs), non-small cell lung cancer, low-grade glioma, colorectal cancer, ovarian cancer, endometrial cancer, thyroid cancer, melanoma, pancreatic cancer, Langerhans cell histiocytosis, cutaneous neurofibromas and other solid tumors. The therapeutic candidate is administered through oral route. PD0325901 is a bioavailable, synthetic organic molecule targeting mitogen-activated protein kinase (MAPK/ERK kinase or MEK) with potential antineoplastic activity.  It was under development for the treatment of colon cancer, breast cancer, melanoma and non-small cell lung cancer. It is under development for the treatment of ER+ metastatic breast cancer and advanced solid tumors. It acts by targeting MEK1 or MEK2.

SpringWorks Therapeutics overview

SpringWorks Therapeutics is a drug development company that develops therapeutic medicines for various diseases. The company’s pipeline products include Nirogacestat, MEK ½ Inhibitor, Senicapoc and FAAH Inhibitor. Its Nirogacestat is a gamma-secretase inhibitor used for the treatment of Desmoid tumors. SpringWorks Therapeutics’ Senicapoc is a Gardos channel blocker used for the treatment of hereditary xerocytosis. The company’s FAAH Inhibitor is used for the treatment of post-traumatic stress disorder. It partners with biopharmaceutical companies, scientists, patient groups and philanthropists. SpringWorks Therapeutics is headquartered in Stamford, Connecticut, the US.

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

This content was updated on 7 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.