Roducitabine is under clinical development by Processa Pharmaceuticals and currently in Phase II for Non-Small Cell Lung Cancer. According to GlobalData, Phase II drugs for Non-Small Cell Lung Cancer have a 38% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Roducitabine’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.

Roducitabine overview

Roducitabine is under development for the treatment of solid tumors such as refractory metastatic pancreatic cancer (third-line therapy), biliary cancer,gallbladder cancer, non-small cell lung cancer and breast cancer. The drug candidate is administered through oral route. The drug candidate is a  cytidine analog. It is a small molecule (fluorocyclopentenylcytosine), a prodrug, next-generation nucleoside compound. It acts by targeting DNA, RNA, and DNA methyltransferase 1. It was also under development for colorectal cancer, muscle-invasive bladder cancer (MIBC), small cell lung cancer, colon cancer, relapsed and renal cell carcinoma, ovarian cancer, advanced malignancies, metastatic bladder cancer resistant to gemcitabine and cervical cancer.

Processa Pharmaceuticals overview

Processa Pharmaceuticals is a biopharmaceutical company that develops and commercializes drugs for the treatment of skin diseases and various cancer types. It is investigating its lead product candidate: PCS499 to treat necrobiosis lipoidica (NL), a chronic, disfiguring skin disorder and to treat the side effects of radiation in patients with head and neck cancer. The company’s PCS499 holds an Orphan Drug designation for the treatment of NL. It operates through its subsidiaries in Delaware, the US. Processa Pharmaceuticals is headquartered in Hanover, Maryland, the US.

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

This content was updated on 7 February 2024

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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.