Gynorest

(Dydrogesterone)

ApprovedSmall molecule

Gynorest is a small molecule that works as a Progesterone Receptor Agonist.[2] It is being used across 13 indications, with its most advanced program in Approved.[1]

Gynorest is one of 198 small molecule programs targeting Premature Birth. It is currently in Approved.

Indications

Total Trials

Active Trials

197

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Premature BirthApproved

Endometrial PolypActive, not recruiting

Female InfertilityApproved

AbortionActive, not recruiting

Ovarian CystActive, not recruiting

MiscarriageActive, not recruiting

Pregnancy DisorderApproved

Habitual AbortionActive, not recruiting

Polycystic Ovary SyndromeApproved

Menstrual DisorderActive, not recruiting

Premature BirthApproved

Approved

Endometrial PolypApproved

Active, not recruiting

Female InfertilityApproved

Approved

AbortionApproved

Active, not recruiting

Ovarian CystPhase 1

Active, not recruiting

MiscarriagePhase 3

Active, not recruiting

Pregnancy DisorderApproved

Approved

Habitual AbortionPhase 3

Active, not recruiting

Polycystic Ovary SyndromeApproved

Approved

Menstrual DisorderApproved

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

199 competitors in Endometriosis

#DrugCompanyPhaseTrials

Orilissa

AbbVie

Phase 3

16 2

Gynorest

SSolvay Pharmaceuticals

Approved

3 3

Lupron

AbbVie

Phase 3

1 4

Revia

Teva

Phase 3

1 5

Leuprorelin

Takeda

Phase 3

8 6

Lupron

EEastern Cooperative Oncology Group

Phase 3

1 7

Trental

VValidus Pharmaceuticals

Phase 3

1 8

Firmagon

Ferring

Phase 3

1 9

Esketamine Hydrochloride

TThe Second Hospital of Anhui Medical University

Phase 3

1 10

EE20/DRSP(BAY86-5300)

Bayer

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

N/AActive, not recruiting

Ovarian Stimulation

NCT06378268

Q4 2026

Phase 3Recruiting

Luteal Phase Support

NCT03859921

Clinical

Trials by Indication[1]

Luteal Phase Support6 trials

Oral Dydrogesterone as Luteal Phase Support in Natural Cycle FET

Recruiting·TThe University of Hong Kong·Phase 3·NCT03859921·716 enrolled

Oral Dydrogesterone vs. Vaginal Micronized Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer

Unknown status·WWolfson Medical Center·N/A·NCT03832699·100 enrolled

Oral Dydrogesterone (OD) Versus Micronized Vaginal Progesterone (MVP) for Luteal Phase Support (LPS) in IVF/ICSI

Completed·CCRG UZ Brussel·Phase 4·NCT03677336·30 enrolled

Show 3 more trials

Oral Dydrogesterone vs. Micronized Vaginal Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles

Unknown status·MMemorial Sisli Hospital, Istanbul·Phase 4·NCT04124913·140 enrolled

Dydrogesterone Versus Intravaginal Progesterone in the Luteal Phase Support

Completed·UUniversity of Zagreb·N/A·NCT01178931·853 enrolled

Addition of Dydrogesterone to the Luteal Phase Support After Fresh Embryo Transfer

Unknown status·LLaniado Hospital·N/A·NCT04408144·300 enrolled

Miscarriage4 trials

Use of Cyclosporin A for the Treatment of Recurrent Miscarriage

Unknown status·FFudan University·Phase 2/3·NCT02706470·384 enrolled

Oral Progesterone for Prevention of Miscarriage in Threatened Abortion

Completed·—·Phase 4·NCT04788108·100 enrolled

Non-interventional Study of Therapy for Threatened Miscarriage

Completed·BBesins Healthcare··NCT03309735·1,241 enrolled

Show 1 more trial

Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Threatened Miscarriage

Completed·TThe University of Hong Kong·Phase 3·NCT02128685·406 enrolled

Preterm Labor4 trials

Efficacy of Oral Progesterone and Vaginal Progesterone After Tocolytic Therapy in Threatened Preterm Labor

Completed·—·Phase 3·NCT02989519·231 enrolled

Oral Dydrogesterone in the Management of Preterm Labor

Completed·—·Phase 4·NCT03935152·48 enrolled

Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor

Completed·—·N/A·NCT02262481·48 enrolled

Show 1 more trial

Different Types of Progesterone in the Prevention of Preterm Labor

Unknown status·—·Phase 2·NCT03537287·140 enrolled

Endometriosis3 trials

Study of the Effectiveness of Dydrogesterone in the Treatment of Endometriosis-related Pain

Not yet recruiting·AAbbott··NCT06952296·250 enrolled

A Survey on Efficacy and Safety in Patients With Endometriosis

Completed·MMylan Inc.··NCT02921763·60 enrolled

The Effect of Dydrogesterone on Sexual Function in Women With Endometriosis

Completed·KKanuni Sultan Suleyman Training and Research Hospital·N/A·NCT04287205·79 enrolled

Ovarian Stimulation3 trials

Comparison of 3 Different Protocols for Preventing Premature Ovulation in Ovarian Stimulation Cycles

Completed·—·N/A·NCT05767086·297 enrolled

Dydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in ICSI

Unknown status·ZZagazig University·N/A·NCT05751681·79 enrolled

PPOS vs GnRH Antagonist in Ovarian Stimulation (ProGanOS Study)

Active, not recruiting·MMỹ Đức Hospital·N/A·NCT06378268·626 enrolled

17 more indications

Progesterone2 trials

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)

Completed·AAbbott·Phase 3·NCT02491437·1,034 enrolled

A Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization

Completed·AAbbott·Phase 3·NCT01850030·1,070 enrolled

Outcome1 trial

Dydrogesterone, Cetrorelix Acetate and Triptorelin in Intra Cytoplasmic Sperm Injection Outcomes

Unknown status·—·Phase 3·NCT05972902·387 enrolled

Pregnancy1 trial

The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss

Unknown status·SShanghai First Maternity and Infant Hospital·Phase 4·NCT02990403·500 enrolled

Menopausal Women1 trial

The Effect of Different Types of Progestin on Sleeping of Menopausal Women

Completed·—·N/A·NCT02086032·100 enrolled

Oocyte1 trial

DYG Versus Cetrorelix in Oocyte Donation

Completed·CClinica de la Mujer Medicina Reproductiva, Chile··NCT05577806·202 enrolled

Habitual Abortion1 trial

Habitual Abortion Study: Oral Dydrogesterone Treatment During Pregnancy in Women With Recurrent Miscarriage

Completed·AAbbott Products·Phase 3·NCT00193674·71 enrolled

Endometrial Polyp1 trial

Dydrogesterone in the Treatment of Endometrial Polyps

Completed·PPeking Union Medical College Hospital·Phase 4·NCT03790215·60 enrolled

Polycystic Ovary Syndrome1 trial

Progestin-primed Ovarian Stimulation Protocol Versus GnRH Antagonist Protocol in Polycystic Ovary Syndrome Patients Undergoing IVF/ICSI Cycles

Unknown status·MMansoura University·N/A·NCT05112692·200 enrolled

Efficacy1 trial

Comparing the Efficacy of Two Methods for the Therapy of Uterine Adhesion

Unknown status·—·N/A·NCT03329898·200 enrolled

Endometrial Hyperplasia without Atypia1 trial

MPA Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia

Completed·XXiaojun Chen·Phase 3·NCT03675139·471 enrolled

In Vitro Fertilization1 trial

Progesterone Primed Ovarian Stimulation Versus GnRH Antagonist in With Expected High Ovarian Response Undergoing in Vitro Fertilization

Unknown status·—·Phase 2/3·NCT05951400·200 enrolled

Clinical Trial1 trial

PPOS Protocol Versus GnRH Anatagonist for Expected Normal Responder Patients Undergoing ART : a Randomized Clinical Trial

Completed·KKasr El Aini Hospital·Phase 3·NCT06868576·328 enrolled

Ovarian cyst1 trial

The Efficacy of Progestins in Treatment of Functional Ovarian Cyst

Unknown status·—·Phase 1·NCT03456570·90 enrolled

Embryo Transfer1 trial

Luteal Support in Frozen-Thawed Embryo Transfer Cycles

Completed·CCentrum Clinic IVF Center·Phase 4·NCT03948022·151 enrolled

Abortion1 trial

Progesterone and Doppler in Recurrent Abortion

Unknown status·—·Phase 4·NCT03267771·50 enrolled

Preterm Delivery1 trial

Progesterone to Prevent Preterm Delivery

Unknown status·TThe University of Hong Kong·Phase 2/3·NCT03428685·1,714 enrolled

Frozen Embryo Transfer1 trial

Oral Versus Vaginal Progesterone for Luteal Phase Supplementation in Frozen Embryo Transfer Cycles

Completed·CCRG UZ Brussel·Phase 4·NCT04758871·150 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

GYNOREST

NDA NDA017388

Sources

References

[1]
ClinicalTrials.gov — 38 trial records for Dydrogesterone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Dydrogesterone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Dydrogesterone. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA017388). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Solvay Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Progesterone Receptor Agonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: SSolvay Pharmaceuticals

Gynorest

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Trials by Indication[1]

Luteal Phase Support6 trials

Miscarriage4 trials

Preterm Labor4 trials

Endometriosis3 trials

Ovarian Stimulation3 trials

Progesterone2 trials

Outcome1 trial

Pregnancy1 trial

Menopausal Women1 trial

Oocyte1 trial

Habitual Abortion1 trial

Endometrial Polyp1 trial

Polycystic Ovary Syndrome1 trial

Efficacy1 trial

Endometrial Hyperplasia without Atypia1 trial

In Vitro Fertilization1 trial

Clinical Trial1 trial

Ovarian cyst1 trial

Embryo Transfer1 trial

Abortion1 trial

Preterm Delivery1 trial

Frozen Embryo Transfer1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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