Mobocertinib is under clinical development by Takeda Pharmaceutical and currently in Phase II for Urinary Tract Cancer. According to GlobalData, Phase II drugs for Urinary Tract Cancer have a 28% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Mobocertinib’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.

Mobocertinib overview

Mobocertinib Succinate (Exkivity) is an oral tyrosine kinase inhibitor that acts as antineoplastic agent. It is formulated as hard gelatin capsules for oral route of administration. Exkivity is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

mobocertinib (TAK-788, AP-32788) is under development for the treatment of sarcoma, refractory non-small cell lung cancer, biliary tract cancer, bladder/urinary tract cancer, breast cancer, gastric/esophageal cancer, head and neck cancer and liver failure. It is a small molecule administered orally. It acts by targeting tyrosine kinase including EGFR, HER2, HER4 and BLK specific Exon-20 mutations. The drug candidate is a new molecular entity.

Takeda Pharmaceutical overview

Takeda Pharmaceutical (Takeda) is a research-based pharmaceutical company which focuses on the discovery, development, manufacturing, marketing, commercialization, import and export of pharmaceutical drugs. The company offers products in the areas of rare diseases, gastrointestinal, oncology, neuroscience, vaccines, and plasma-derived therapies. Takeda has facilities in Japan, Argentina, Brazil, Mexico, the US, Denmark, Norway, Europe, Poland, Russia, Spain, Switzerland, China, India, and Canada among others. It markets products directly and through a network of wholesale distributors, retail chains and other purchasing groups worldwide. Takeda has partnership with academic institutions, small biotech, and large pharmaceutical companies. It has presence in the Americas, Europe, and Asia, among others. Takeda is headquartered in Tokyo, Japan.

For a complete picture of Mobocertinib’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.