Progesterone is under clinical development by Besins Healthcare and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Progesterone’s likelihood of approval (LoA) and phase transition for Polycystic Ovarian Syndrome took place on 29 Sep 2021, which increased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Progesterone Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Progesterone overview

Progesterone (Utrogestan / Progestan / Progestogel / Prometrium / F-Meno) 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.

Quick View Progesterone LOA Data

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Progesterone
Administration Pathway
  • Oral
  • Topical
  • Vaginal
Therapeutic Areas
  • Central Nervous System
  • Hormonal Disorders
  • Women’s Health
Key Developers
Highest Development Stage
  • Marketed

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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.