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.
Estetrol overview
Esterol (E-4) is under development for the treatment of breast cancer, prostate cancer, vasomotor symptoms of menopause (menopausal hot flashes), genitourinary syndrome of menopause, female sexual arousal disorder (FSAD), vulvovaginal atrophy of menopause, post-menopausal disorders, neonatal hypoxic-ischemic encephalopathy, neuroprotection and coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The drug candidate is administered through oral route in the form of tablet and capsule and intravenous route. The drug candidate is a new generation of hormonal replacement therapy. It was also under development for the treatment of osteoporosis, autoimmune disorders and migraine.
Mithra Pharmaceuticals overview
Mithra Pharmaceuticals (Mithra) is a biotech company that develops and manufactures over the counter products for women’s health and other applications. The company offers various drug products including Donesta, Estelle, tibelia, myring and zoreline. Mithra offers its products in polymeric forms, hormonal tablets, and sterile injectable products. The company also provides CDMO services such as drug development and supporting services. It offers its products under various brands including Tibelia, Estelle and Donesta. Its products are used in the treatment of contraception and fertility, gynecological infections, menopause and osteoporosis and cancers. The company offers its products through a network of distributors in Belgium, France, Germany, Luxemburg and Brazil. Mithra is headquartered in Liege, Belgium.
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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.