Progesterone is under clinical development by Besins Healthcare and currently in Phase II for Polycystic Ovarian Syndrome. According to GlobalData, Phase II drugs for Polycystic Ovarian Syndrome does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Progesterone LoA Report. 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.

Progesterone overview

Progesterone (Utrogestan / Progestan / Progestogel / Progestosol / Prometrium / F-Meno / Lugesteron) is a natural progestogen, the main hormone of the corpus luteum and the placenta. It is formulated as soft gelatin capsules and capsules for oral and vaginal route of administration and gel for topical application. Progesterone is indicated in adjunctive to estrogen in post-menopausal women with an intact uterus (HRT), for the supplementation of the luteal phase during Assisted Reproductive Technology (ART) cycles, mastodynia, secondary amenorrhea, menstrual irregularities, and pre-menstrual hormone replacement therapy, fibrocystic breast disease. F-Meno is indicated for the prevention of endometrial hyperplasia upon administration of estrogen drug for menopausal disorders and ovarian deficiency symptoms.  

Progesterone (FSN-011-01) is under development for the treatment of polycystic ovary syndrome and menopausal disorders. The drug candidate is administered through oral route. It acts by targeting progesterone receptor. It was also under development for premature labor (Tocolysis).

Besins Healthcare overview

Besins Healthcare (Besins) discovers, develops and commercializes pharmaceutical products to treat gynecology and andrology disorders. The company’s product range includes tablets and capsules for fertility and reduction of menopause symptoms; gels to treat benign breast pathologies, and hot flushes in postmenopausal women. It offers healthcare solutions for the treatment of male hypogonadism and genital dermatosis. Besins also develops complementary and alternative medicines (CAMs) to prevent pregnancy risks and promote the development of foetus and baby during conception, pregnancy, breastfeeding; and decrease the impact of free radicals attacks. The company works in partnership with Abbvie, Vifor Pharma, Capsugel, Takeda, and other companies. Besins is headquartered in Monaco.

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

This content was updated on 10 June 2024

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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.