Crofelemer DR by Napo Pharmaceuticals for Chemotherapy-Induced Diarrhea (CID): Likelihood of Approval


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.

Crofelemer DR overview

Crofelemer (Fulyzaq, Mytesi) is an anti diarrheal agent. It is formulated as delayed release tablets for oral route of administration. Crofelemer is indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy.

The drug is under development for the treatment of chronic idiopathic diarrhea in non-HIV patients, acute infectious diarrhea including chemotherapy-induced diarrhea, rare congenital diarrheal disorder called microvillus inclusion disease (MVID), cholera, predominant irritable bowel syndrome, short bowel syndrome, congenital diarrheal disorders, pediatric diarrhea, travelers’ diarrhea and COVID associated diarrhea. It is a proanthocyanidin oligomer.

Napo Pharmaceuticals overview

Napo Pharmaceuticals, a subsidiary of Jaguar Health Inc, is a company focused on developing and commercializing proprietary, plant-based gastrointestinal pharmaceuticals. The company provides the research, development, and commercialization of prescription medicines aimed at alleviating gastrointestinal distress. Its major products include Crofelemer which treats non-infectious diarrhea in adults with HIV/AIDS on antiretroviral therapy; NP-300 for treating diarrhea from infectious pathogens. Napo Pharmaceuticals serves patients undergoing treatment for diseases such as cancer, with applications in managing chemotherapy-induced overactive bowel and other gastrointestinal disorders. The company supports investigator-initiated trials and collaborates with external researchers. Napo Pharmaceuticals is headquartered in San Francisco, California, the US.

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

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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.






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