Dienogest

ApprovedSmall molecule

Bayer

Dienogest is one of 198 small molecule programs targeting Contraception. It is currently in Approved.

Indications

Total Trials

Active Trials

197

Competitors

Pipeline

Status by Indication[3][1]

Indication

ContraceptionUnknown

AdenomyosisActive, not recruiting

Uterine LeiomyomaActive, not recruiting

Anorexia NervosaActive, not recruiting

DysmenorrheaUnknown

Uterine FibroidActive, not recruiting

Ovarian ReserveActive, not recruiting

MetrorrhagiaActive, not recruiting

MenorrhagiaUnknown

EndometriosisUnknown

ContraceptionPreclinical

Unknown

AdenomyosisPhase 1

Active, not recruiting

Uterine LeiomyomaApproved

Active, not recruiting

Anorexia NervosaPhase 2

Active, not recruiting

DysmenorrheaPreclinical

Unknown

Uterine FibroidPhase 2

Active, not recruiting

Ovarian ReservePhase 2

Active, not recruiting

MetrorrhagiaPhase 3

Active, not recruiting

MenorrhagiaPreclinical

Unknown

EndometriosisPreclinical

Unknown

Competition

Competitive Landscape

199 competitors in Endometriosis

#DrugCompanyPhaseTrials

Dienogest

Bayer

Approved

19 2

Lupron

AbbVie

Phase 3

1 3

Orgovyx

Sumitomo Pharma America, Inc.

Phase 3

3 4

Lupron

EEastern Cooperative Oncology Group

Phase 3

1 5

Trental

VValidus Pharmaceuticals

Phase 3

1 6

Firmagon

Ferring

Phase 3

1 7

Estradiol/norethindrone Acetate

AbbVie

Phase 3

5 8

Add-Back

KKissei Pharmaceutical Co., Ltd.

Phase 3

4 9

Triptorelin Acetate PR 1-Month

Ipsen

Phase 3

1 10

Merional

CCairo University

Phase 3

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

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Endometriosis

NCT07164183

Clinical

Trials by Indication[1]

Endometriosis19 trials

Effects of Sulawesi Propolis Extract on Lesion Growth, Apoptotic and Inflammatory Activity of the Rat Endometriosis Tissue

Completed·IIndonesia University·Phase 1·NCT04374006·120 enrolled

The Effect of Dionegest Use on the Frequency of Fibromyalgia in Endometriosis

Completed·GGaziosmanpasa Research and Education Hospital··NCT05272930·61 enrolled

Role of Suppression of Endometriosis With Progestins Before IVF-ET

Completed·NNational Research Centre, Egypt·N/A·NCT04500743·134 enrolled

Show 16 more trials

Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis

Recruiting·BBio Meds Pharmaceutica Ltda·Phase 4·NCT06543550·70 enrolled

Ultra-Safe Hormonal Strategy: Transdermal Estradiol Added to Progestins for Endometriosis

Active, not recruiting·FFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico··NCT07204093·138 enrolled

Dienogest Versus GnRH-a Pre-treatment in Women With Endometriosis Undergoing IVF

Unknown status·—·N/A·NCT03142035·189 enrolled

Phase 3 Study of Dienogest for the Treatment of Endometriosis in Chinese Patients

Completed· Bayer logo

Bayer·Phase 3·NCT01822080·250 enrolled

A Study to Learn More About Using Dienogest to Treat Endometriosis in Chinese Participants

Completed· Bayer logo

Bayer··NCT04495855·968 enrolled

Salivary microRNA in Endometriosis: Correlation With Response to Progestin Therapy

Recruiting·UUniversity of Udine··NCT06414720·90 enrolled

Efficacy of Dienogest Versus Oral Contraceptive Pills on Pain Associated With Endometriosis

Unknown status·—·Phase 2/3·NCT04256200·100 enrolled

Pretreatment With Dienogest in Women With Endometriosis Undergoing in Vitro-fertilization After a Previous Failed Cycle

Completed·OOspedale Policlinico San Martino··NCT04306276·140 enrolled

A Study to Learn More About How Safe Dienogest is and How Well it Works Under Real World Conditions in Indian Women With Endometriosis

Completed· Bayer logo

Bayer··NCT04808843·160 enrolled

To Evaluate Effectiveness of Visanne in Improving Quality of Life in Asian Women With Endometriosis

Completed· Bayer logo

Bayer··NCT02425462·895 enrolled

Induction of Ovulation by Clomiphene Citrate Following Laparoscopic Surgery for Endometriosis Stage 1 and Stage 2 With and Without Suppression by Dienogest

Unknown status·—·Phase 4·NCT02575248·310 enrolled

Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules and Visanne 2 mg Tablets in Treatment of Endometriosis

Recruiting·AAlcea·Phase 3·NCT07164183·290 enrolled

Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis

Completed· Bayer logo

Bayer·Phase 3·NCT01697111·312 enrolled

Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery

Completed·UUniversitas Diponegoro·Phase 3·NCT06145438·80 enrolled

Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis

Completed·TTaipei Veterans General Hospital, Taiwan··NCT03778359·5,000 enrolled

Comparisons of the Therapeutic Effects of Dienogest and Danazol on Endometriosis

Unknown status·FFar Eastern Memorial Hospital·Phase 3·NCT05697471·120 enrolled

Adenomyosis4 trials

Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis

Unknown status·—·Phase 4·NCT03654144·100 enrolled

Adenomyosis and ART

Unknown status·AAzienda Ospedaliero-Universitaria di Modena·Phase 4·NCT05937490·500 enrolled

Ttt of Adenomyosis

Not yet recruiting·—·Phase 1·NCT06719934·100 enrolled

Show 1 more trial

Dienogest in Perimenopausal Women With Adenomyosis

Completed·NNational Taiwan University Hospital··NCT05751876·87 enrolled

Endometrioma2 trials

Impact vs. Dienogest: A Combined Oral Contraceptive in the Size of Endometriomas

Suspended·FFundación Santa Fe de Bogota·Phase 2/3·NCT02599077·50 enrolled

Impact of the Type of Treatment of the Endometrioma on Ovarian Reserve

Withdrawn·UUniversity of Valencia··NCT05637073

Uterine leiomyoma2 trials

Study of the Efficacy of Dienogest in the Treatment of Uterine Leiomyomas When Compared to Desogestrel and Goserelin

Terminated·UUniversity of Sao Paulo·Phase 4·NCT01738724·14 enrolled

Evaluation of Using Dienogest and N-Acetyl Cysteine on the Volume of Uterine Leiomyoma

Completed·—·Phase 2/3·NCT06115408·40 enrolled

Age1 trial

Dienogest Versus Luteal Phase Fluoxetine in the Management of Premenstrual Syndrome

Unknown status·—·Phase 3·NCT02427334·210 enrolled

6 more indications

Ovarian Reserve1 trial

Trial Comparing Preoperative Dienogest Therapy Followed by Surgery vs. Upfront Surgery to Save Ovarian Reserve in Young Women With Ovarian Endometrioma

Withdrawn·SSeoul National University Hospital·Phase 2·NCT02728245

Adolescent1 trial

Visanne Study to Assess Safety in Adolescents

Completed· Bayer logo

Bayer·Phase 2·NCT01283724·111 enrolled

Menopausal Women1 trial

Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women

Unknown status·UUniversity of Cagliari·Phase 4·NCT02440750·50 enrolled

Contraception1 trial

Synthetic vs Natural Estrogen in Combined Oral Contraception

Completed·HHelsinki University Central Hospital·Phase 4·NCT02352090·59 enrolled

Recurrence1 trial

Comparing the Use of Dienogest and Combined Oral Contraceptive Pills (Microgynon) to Reduce the Risk of Recurrence of Endometriotic Cyst After Conservative Surgery

Unknown status·TThe University of Hong Kong·Phase 4·NCT02385448·144 enrolled

Unspecified2 trials

Pharmacodynamic Characterization of Dienogest

Completed· Bayer logo

Bayer·Phase 1·NCT00754871·102 enrolled

Regulatory Post Marketing Surveillance Study in Korea

Completed· Bayer logo

Bayer··NCT01788722·3,223 enrolled

Sources

References

[1]
ClinicalTrials.gov — 35 trial records for Dienogest. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Dienogest compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Dienogest. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Bayer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Bayer

Dienogest

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Endometriosis19 trials

Adenomyosis4 trials

Endometrioma2 trials

Uterine leiomyoma2 trials

Age1 trial

Ovarian Reserve1 trial

Adolescent1 trial

Menopausal Women1 trial

Contraception1 trial

Recurrence1 trial

Unspecified2 trials

References

Drug Info

Quick Facts

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