Data completeness
2/8 — Basic
Drug data last refreshed 3h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GYNOREST is an oral tablet formulation of dydrogesterone, a synthetic progestin indicated for women's health conditions. The product is in pre-launch phase under Sanofi sponsorship, representing a novel oral delivery of a well-established active pharmaceutical ingredient. Dydrogesterone acts as a progesterone receptor agonist to support reproductive and endocrine health.
Growth
Pre-launch stage indicates team building and market entry preparation; small linked job count (4) suggests focused, core-team positioning rather than full commercial scale.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
Study of the Effectiveness of Dydrogesterone in the Treatment of Endometriosis-related Pain
Started Apr 2025
250 enrolled
Endometriosis
Oral Dydrogesterone (OD) Versus Micronized Vaginal Progesterone (MVP) for Luteal Phase Support (LPS) in IVF/ICSI
Started May 2019
30 enrolled
Infertility, FemaleInfertilityGenital Diseases, Male+7 more
Dydrogesterone in the Treatment of Endometrial Polyps
Started Feb 2019
60 enrolled
Endometrial Polyp
Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
Started Sep 2018
350 enrolled
Endometriosis
A Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Crinone 8% Intravaginal Progesterone Gel 90 mg Daily for Luteal Support in In-Vitro Fertilization (LOTUS II)
Started Jul 2015
1,034 enrolled
Female Infertility
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.