(Estradiol + norethindrone acetate + relugolix) is under clinical development by Sumitomo Pharma America and currently in Phase III for Female Contraception. According to GlobalData, Phase III drugs for Female Contraception have a 67% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how (Estradiol + norethindrone acetate + relugolix)’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.
(Estradiol + norethindrone acetate + relugolix) overview
Estradiol, Norethindrone acetate and Relugolix (Myfembree, Ryeqo) is a fixed dose combination product. It is formulated as film coated tablets and tablets for oral route of administration. It is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. It is also indicated for treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, management of moderate to severe pain associated with endometriosis.
A fixed-dose combination of estradiol, norethindrone acetate and relugolix is under development for the treatment of heavy menstrual bleeding and pain associated with uterine fibroids, pain associated with endometriosis and female contraception. It is administered through oral route as tablet. Relugolix acts by targeting gonadotropin-releasing hormone receptor (GNRHR), estradiol acts by targeting estrogen receptor and norethindrone acetate acts by targeting progesterone receptor.
Sumitomo Pharma America overview
Sumitomo Pharma America (Sumitomo Pharma), formerly Sunovion Pharmaceuticals Inc, is a research-based pharmaceutical company. It discovers, develops, and marketize therapeutic products that focus on the treatment of the central nervous system and respiratory disorders. Its major products include eslicarbazepine acetate tablets, lurasidone HCl tablets, relugolix, estradiol, and norethindrone acetate tablets, vibegron tablets, relugolix tablets, and allogeneic processed thymus tissue–agdc. The company’s product candidates are intended for the treatment of schizophrenia, neuropathic pain, bipolar depression, treatment-resistant depression, agitation in Alzheimer’s disease, and women’s healthcare products among others. It has partnerships with various pharmaceutical companies such as Psychogenics and others. Sumitomo Pharma is headquartered in Marlborough, Massachusetts, the US.
For a complete picture of (Estradiol + norethindrone acetate + relugolix)’s drug-specific PTSR and LoA scores, buy the report here.
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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.
