Endoxifen is under clinical development by Atossa Therapeutics and currently in Phase II for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer). According to GlobalData, Phase II drugs for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer) have a 49% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. 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.

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 the treatment of HER2 negative breast cancer, mammographic breast density for women and breast cancer for men, recurrent ovarian cancer. It is administered through oral and topical route. The drug candidate is an active metabolite of tamoxifen. It acts by targeting estrogen receptor.

It was also under development for gynecomastia.

Atossa Therapeutics overview

Atossa Therapeutics (Atossa), formerly Atossa Genetics is a clinical-stage biopharmaceutical company. It develops proprietary therapeutics and delivery methods for breast cancer and other breast conditions. The company’s pipeline pharmaceutical programs include endoxifen, an active metabolite of tamoxifen, used for the treatment of breast density and other breast health conditions. Atossa is developing patented microcatheter technology to deliver fulvestrant as a potential treatment of ductal carcinoma through the nipple to site of early breast cancer. The company also uses its proprietary intraductal microcatheter technology to deliver CAR-T cells into the ducts of the breast for the treatment of breast cancer. The company has operational presence in Australia, the US and the UK. Atossa is headquartered in Seattle, Washington, the US.

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

This content was updated on 2 September 2023

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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.