Elacestrant hydrochloride is under clinical development by Stemline Therapeutics and currently in Phase III for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer). According to GlobalData, Phase III drugs for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer) have a 52% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Elacestrant hydrochloride’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.
Elacestrant hydrochloride overview
Elacestrant dihydrochloride (Orserdu) is a selective estrogen receptor degrader. It is formulated as film coated tablets for oral route of administration. Orserdu is indicated for the treatment of postmenopausal women or adult men with estrogen receptor(ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
Elacestrant hydrochloride is under development for the treatment of breast cancer, estrogen receptor positive and HER2 negative metastatic breast cancer, breast cancer brain metastases (BCBM). RAD-1901 is administered orally in the form of film-coated tablet and targets estrogen receptors.
The drug candidate was also under development for the treatment of vasomotor symptoms in postmenopausal women and ovarian cancer.
Stemline Therapeutics overview
Stemline Therapeutics (Stemline), a subsidiary of A. Menarini Industrie Farmaceutiche Riunite Srl, is a clinical stage biopharmaceutical company that develops therapeutics to treat cancer stem cells. The company pipeline products include TAGRAXOFUSP, ELACESTRANT, SL-701, MEN1611, MEN1611, MEN1309, FELEZONEXOR and SL-901. Stemline products treat blastic plasmacytoid dendritic cell neoplasm (BPDCN), chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), breast cancer, acute myeloid leukemia (AML), colorectal cancer (CRC) and solid tumors. It also carries out the development and commercialization of novel oncology therapeutics. The company has operations across Europe. Stemline is headquartered in New York, the US.
For a complete picture of Elacestrant hydrochloride’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.
