Dienogest
drugOn this page
Also known as Dienogest component of nataziaEndometrionM 18575M-18575MJR-35STS 557STS-557ZK 37659ZK-37659DienogestÊDienogestÂ
Summary
Dienogest (CHEMBL1201864) is an approved small-molecule progesterone receptor agonist (ATC G03DB08); indicated across 6 conditions including endometriosis and anorexia nervosa.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Small molecule
- ATC class: G03DB08
- Indications: 6 conditions
- Clinical trials: 36
- Chemistry: 311.4 Da · C20H25NO2
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL1201864 |
| Name | Dienogest |
| Type | Small molecule |
| Max phase | 4 |
| FDA approved | no |
| PubChem CID | 68861 |
| ChEBI | CHEBI:70708 |
| ATC | G03DB08 |
| Molecular formula | C20H25NO2 |
| Molecular weight | 311.4 |
| InChIKey | AZFLJNIPTRTECV-FUMNGEBKSA-N |
SMILES: C[C@]12CCC3=C4CCC(=O)C=C4CC[C@H]3[C@@H]1CC[C@]2(CC#N)O
IUPAC name: 2-[(8S,13S,14S,17R)-17-hydroxy-13-methyl-3-oxo-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-17-yl]acetonitrile
ChEBI definition: A steroid hormone that is 17β-hydroxy-3-oxoestra-4,9-diene substituted at position 17 by a cyanomethyl group. Used as an oral contraceptive.
Pharmacological roles (ChEBI): synthetic oral contraceptive, progesterone receptor agonist, progestin.
Also known as: Dienogest, Dienogest component of natazia, Endometrion, M 18575, M-18575, MJR-35, STS 557, STS-557, ZK 37659, ZK-37659, DIENOGEST, dienogest
Patent coverage: 1,067 distinct patent families (3,891 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
6 indications (1 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| endometriosis | 3 | MONDO:0005133 | EFO:0001065 |
| anorexia nervosa | 2 | MONDO:0005351 | MONDO:0005351 |
| uterine corpus leiomyoma | 2 | MONDO:0007886 | EFO:0000731 |
3 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 36.
Phase distribution
| Phase | Trials |
|---|---|
| Not specified | 14 |
| PHASE4 | 11 |
| PHASE3 | 5 |
| PHASE2/PHASE3 | 2 |
| PHASE1 | 2 |
| PHASE2 | 1 |
| EARLY_PHASE1 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT06543550 | PHASE4 | RECRUITING | Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis |
| NCT01738724 | PHASE4 | TERMINATED | Study of the Efficacy of Dienogest in the Treatment of Uterine Leiomyomas When Compared to Desogestrel and Goserelin |
| NCT02352090 | PHASE4 | COMPLETED | Synthetic vs Natural Estrogen in Combined Oral Contraception |
| NCT02385448 | PHASE4 | UNKNOWN | Comparing the Use of Dienogest and Combined Oral Contraceptive Pills (Microgynon) to Reduce the Risk of Recurrence of Endometriotic Cyst After Conservative Surgery |
| NCT02440750 | PHASE4 | UNKNOWN | Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women |
| NCT02575248 | PHASE4 | UNKNOWN | Induction of Ovulation by Clomiphene Citrate Following Laparoscopic Surgery for Endometriosis Stage 1 and Stage 2 With and Without Suppression by Dienogest |
| NCT03124524 | PHASE4 | COMPLETED | Treatment Choice in Primary Dysmenorrhea |
| NCT03654144 | PHASE4 | UNKNOWN | Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis |
| NCT03789123 | PHASE4 | UNKNOWN | Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma |
| NCT06316206 | PHASE4 | COMPLETED | The Use of Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation |
| NCT06324851 | PHASE4 | COMPLETED | The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation |
| NCT07164183 | PHASE3 | RECRUITING | Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules and Visanne 2 mg Tablets in Treatment of Endometriosis |
| NCT01697111 | PHASE3 | COMPLETED | Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis |
| NCT02427334 | PHASE3 | UNKNOWN | Dienogest Versus Luteal Phase Fluoxetine in the Management of Premenstrual Syndrome |
| NCT02599077 | PHASE2/PHASE3 | SUSPENDED | Impact vs. Dienogest: A Combined Oral Contraceptive in the Size of Endometriomas |
| NCT05697471 | PHASE3 | UNKNOWN | Comparisons of the Therapeutic Effects of Dienogest and Danazol on Endometriosis |
| NCT06115408 | PHASE2/PHASE3 | COMPLETED | Evaluation of Using Dienogest and N-Acetyl Cysteine on the Volume of Uterine Leiomyoma |
| NCT06145438 | PHASE3 | COMPLETED | Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery |
| NCT02728245 | PHASE2 | WITHDRAWN | Trial Comparing Preoperative Dienogest Therapy Followed by Surgery vs. Upfront Surgery to Save Ovarian Reserve in Young Women With Ovarian Endometrioma |
| NCT00754871 | PHASE1 | COMPLETED | Pharmacodynamic Characterization of Dienogest |
| NCT03353857 | PHASE1 | COMPLETED | Drug-drug Interaction Between Rifampicin and Progestins/Ethinylestradiol and Midazolam |
| NCT04374006 | EARLY_PHASE1 | COMPLETED | Effects of Sulawesi Propolis Extract on Lesion Growth, Apoptotic and Inflammatory Activity of the Rat Endometriosis Tissue |
| NCT06414720 | Not specified | RECRUITING | Salivary microRNA in Endometriosis: Correlation With Response to Progestin Therapy |
| NCT02400801 | Not specified | COMPLETED | Gonadotropin-releasing Hormone (GnRH) Downregulation Versus Oral Anticonception Prior to ART in Postoperative Endometriosis Patients |
| NCT03142035 | Not specified | UNKNOWN | Dienogest Versus GnRH-a Pre-treatment in Women With Endometriosis Undergoing IVF |
| NCT03778359 | Not specified | COMPLETED | Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis |
| NCT03890042 | Not specified | COMPLETED | Dienogest for Treatment of Adenomyotic Uteri |
| NCT04306276 | Not specified | COMPLETED | Pretreatment With Dienogest in Women With Endometriosis Undergoing in Vitro-fertilization After a Previous Failed Cycle |
| NCT04495855 | Not specified | COMPLETED | A Study to Learn More About Using Dienogest to Treat Endometriosis in Chinese Participants |
| NCT04500743 | Not specified | COMPLETED | Role of Suppression of Endometriosis With Progestins Before IVF-ET |
| NCT04808843 | Not specified | COMPLETED | A Study to Learn More About How Safe Dienogest is and How Well it Works Under Real World Conditions in Indian Women With Endometriosis |
| NCT04901377 | Not specified | COMPLETED | A Study to Gather Information About User Satisfaction in Women in Russia Who Take Estradiol Valerate/Dienogest |
| NCT05272930 | Not specified | COMPLETED | The Effect of Dionegest Use on the Frequency of Fibromyalgia in Endometriosis |
| NCT05476172 | Not specified | COMPLETED | The Effect of Dienogest vs. Norethindrone Acetate Treatment in Endometriosis |
| NCT05637073 | Not specified | UNKNOWN | Effect of Management of the Endometrioma on Ovarian Reserve |
| NCT05751876 | Not specified | COMPLETED | Dienogest in Perimenopausal Women With Adenomyosis |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).
Related Atlas pages
- Diseases: endometriosis