Crofelemer DR is under clinical development by Napo Pharmaceuticals and currently in Phase II for Irritable Bowel Syndrome. According to GlobalData, Phase II drugs for Irritable Bowel Syndrome have a 33% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Crofelemer DR’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.
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 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 pharmaceutical company that develops and commercializes novel gastrointestinal prescription products. The company’s product portfolio includes Crofelemer (delayed-release tablets), Crofelemer (powder for oral solution), NP-300, NCT03898856 and others. Its Crofelemer is an anti-diarrheal drug indicated for symptomatic relief of non-infectious diarrhea in adults living with HIV/AIDS who are on antiretroviral therapy (ART). It operates in the US. 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.
