Endoxifen is under clinical development by Jina Pharmaceuticals and currently in Phase III for Bipolar I Disorder. According to GlobalData, Phase III drugs for Bipolar I Disorder have an 80% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Endoxifen’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.

Endoxifen overview

Endoxifen is under development for treatment of bipolar 1 disorder. The drug candidate is formulated as tablet for oral administration and is also administered through topical route. Endoxifen is an active metabolite of tamoxifen. It has anti-estrogen and antineoplastic activity. Endoxifen is based on the Nanoaqualip Technology. The drug candidate was also under development for metastatic breast cancer.

Jina Pharmaceuticals overview

Jina Pharmaceuticals (Jina Pharma) is a biopharmaceutical company engaged in research, development and commercialization of novel lipid molecules, lipid-drug conjugates, and new functional lipid molecules for the treatment of cancer, infectious diseases, and acute medical emergencies. The company’s products portfolio include Amphotericin B-Lipid Suspension (Amfy), an antifungal product indicated for the treatment of severe systemic and or deep mycoses; Endoxifen, a metabolite of Tamoxifen, used for treating breast cancer; Lipid based MorrF against Alopecia; Tacrolimus Lipid Suspension (Tacrolimus) an immunosuppressant product indicated for the prophylaxis of transplant rejection in liver, heart and kidney allograft recipients. The company is also conducting research on developing lipids that delivers nucleic acids such as antisense oligonucleotides, siRNA and miRNA. Jina Pharma is headquartered in Libertyville, Illinois, the US.

For a complete picture of Endoxifen’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.