Gemcitabine is under clinical development by Johnson & Johnson and currently in Phase III for Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer). According to GlobalData, Phase III drugs for Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) have a 67% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Gemcitabine’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.

Gemcitabine overview

Gemcitabine (TAR-200) is under development for the treatment of upper tract urothelial carcinomas including non-muscle invasive bladder cancer (NMIBC), muscle-invasive transitional cell carcinoma of the bladder. It is administered intravesically. The therapeutic candidate is a drug-device combination product designed to release gemcitabine continuously into the bladder over 7 days. It is an anticancer nucleoside analog. The drug candidate acts by targeting ribonucleoside diphosphate reductase subunit M1.

Johnson & Johnson overview

Johnson & Johnson (J&J) researches, develops, manufactures, and sells pharmaceutical products, medical devices, and consumer products. The company provides pharmaceuticals for immune diseases, cancer, neurological disorders, infectious, cardiovascular, and metabolic diseases; consumer products in oral care, baby care, beauty, over the counter (OTC) medicines, women’s health and wound care categories; and medical devices for use in the cardiovascular, orthopaedic, neurovascular care, general surgery and vision care fields. J&J distributes pharmaceutical and medical products to retailers, wholesalers, health care professionals and hospitals; and offers consumer products through retail outlets and distributors. The company offers its products in the US; Europe; Asia-Pacific and Africa; and Western Hemisphere (excluding the US). J&J is headquartered in New Brunswick, New Jersey, the US.

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

This content was updated on 20 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.