Dydrogesterone

Summary

Dydrogesterone (CHEMBL1200853) is an approved small-molecule progestin (ATC G03DB01) targeting PGR; indicated across 8 conditions including habitual spontaneous abortion and female infertility.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: G03DB01
• Targets: 1 (PGR)
• Indications: 8 conditions
• Clinical trials: 52
• Chemistry: 312.4 Da · C21H28O2

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1200853
Name	Dydrogesterone
Type	Small molecule
Max phase	4
FDA approved	no
PubChem CID	9051
ChEBI	CHEBI:31527
ATC	G03DB01
Molecular formula	C21H28O2
Molecular weight	312.4
InChIKey	JGMOKGBVKVMRFX-HQZYFCCVSA-N

SMILES: CC(=O)[C@H]1CC[C@@H]2[C@@]1(CC[C@@H]3[C@H]2C=CC4=CC(=O)CC[C@@]34C)C

IUPAC name: (8S,9R,10S,13S,14S,17S)-17-acetyl-10,13-dimethyl-1,2,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthren-3-one

Pharmacological roles (ChEBI): progestin.

Also known as: Didrogesterona, Duphaston, Duphaston-hrt, Dydrogesterone, Gynorest, Isopregnenone, NSC-92336, DYDROGESTERONE, SID56463092, SID144203980, SID170465104, dydrogesterone

Patent coverage: 1,352 distinct patent families (4,463 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

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
PGR	Progesterone receptor	Agonist	6.9	0.1%	P06401

Broader ChEMBL bioactivity targets: 5 (assay-derived). Sample: Androgen receptor, Thromboxane A2 receptor, Progesterone receptor, Muscarinic acetylcholine receptor M1, Alpha-1A adrenergic receptor.

Bioactivity

ChEMBL activities: 3 potent at pChembl ≥ 5 of 5 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
PGR	8.02	AC50	9.6	nM	CHEMBL_ACT_25204914
AR	6.92	AC50	120	nM	CHEMBL_ACT_25203981
CHRM1	5.3	AC50	5060	nM	CHEMBL_ACT_25210758

Target pathways

Aggregated over 1 target gene(s): PGR.

Top Reactome pathways

7 total, by targets touching each:

Pathway	Targets	Genes
Nuclear signaling by ERBB4	1	PGR
HSP90 chaperone cycle for steroid hormone receptors (SHR) in the presence of ligand	1	PGR
Nuclear Receptor transcription pathway	1	PGR
SUMOylation of intracellular receptors	1	PGR
Estrogen-dependent gene expression	1	PGR
Developmental Lineage of Mammary Gland Luminal Epithelial Cells	1	PGR
Developmental Lineage of Mammary Gland Alveolar Cells	1	PGR

Dominant GO biological processes

GO term	Targets
ovulation from ovarian follicle	1
glandular epithelial cell maturation	1
regulation of DNA-templated transcription	1
regulation of transcription by RNA polymerase II	1
signal transduction	1
cell-cell signaling	1
positive regulation of gene expression	1
negative regulation of gene expression	1
nuclear receptor-mediated steroid hormone signaling pathway	1
paracrine signaling	1
positive regulation of transcription by RNA polymerase II	1
lung alveolus development	1
regulation of epithelial cell proliferation	1
progesterone receptor signaling pathway	1
maintenance of protein location in nucleus	1

Indications & clinical

Indications

8 indications (0 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
habitual spontaneous abortion	3	MONDO:0006774	EFO:1000954
female infertility	3	MONDO:0021124	EFO:0008560
infertility disorder	3	MONDO:0005047	EFO:0000545
ovarian cyst	0	MONDO:0003282	HP:0000138
polycystic ovary syndrome	0	MONDO:0008487	EFO:0000660

3 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 52.

Phase distribution

Phase	Trials
Not specified	22
PHASE3	12
PHASE4	10
PHASE2/PHASE3	4
PHASE1	2
PHASE2	1
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00145522	PHASE4	COMPLETED	Study to Compare the Effect of Hormone Replacement Therapy (HRT) on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women
NCT02990403	PHASE4	UNKNOWN	The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss
NCT03267771	PHASE4	UNKNOWN	Progesterone and Doppler in Recurrent Abortion
NCT03436303	PHASE4	UNKNOWN	The Benefits and Risks of Different Menopausal Hormone Replacement Therapy Regimes in the Treatment of Menopause Syndrome
NCT03677336	PHASE4	COMPLETED	Oral Dydrogesterone (OD) Versus Micronized Vaginal Progesterone (MVP) for Luteal Phase Support (LPS) in IVF/ICSI
NCT03790215	PHASE4	COMPLETED	Dydrogesterone in the Treatment of Endometrial Polyps
NCT03858049	PHASE4	TERMINATED	Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)
NCT03935152	PHASE4	COMPLETED	Oral Dydrogesterone in the Management of Preterm Labor
NCT04788108	PHASE4	COMPLETED	Oral Progesterone for Prevention of Miscarriage in Threatened Abortion
NCT05156814	PHASE4	UNKNOWN	Comparative Study to Evaluate the Efficacy and Safety of the Fixed-dose Combination of Estradiol / Dydrogesterone in Perimenopausal Women
NCT03859921	PHASE3	RECRUITING	Oral Dydrogesterone as Luteal Phase Support in Natural Cycle FET
NCT00193674	PHASE3	COMPLETED	Habitual Abortion Study: Oral Dydrogesterone Treatment During Pregnancy in Women With Recurrent Miscarriage
NCT00251082	PHASE3	COMPLETED	Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination
NCT01850030	PHASE3	COMPLETED	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
NCT02128685	PHASE3	COMPLETED	Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Threatened Miscarriage
NCT02491437	PHASE3	COMPLETED	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)
NCT02706470	PHASE2/PHASE3	UNKNOWN	Use of Cyclosporin A for the Treatment of Recurrent Miscarriage
NCT02989519	PHASE3	COMPLETED	Efficacy of Oral Progesterone and Vaginal Progesterone After Tocolytic Therapy in Threatened Preterm Labor
NCT03428685	PHASE2/PHASE3	UNKNOWN	Progesterone to Prevent Preterm Delivery
NCT03675139	PHASE3	COMPLETED	MPA Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia
NCT04414748	PHASE3	COMPLETED	Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Patients Undergoing PGT-A
NCT04537078	PHASE3	COMPLETED	Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders
NCT05758064	PHASE2/PHASE3	UNKNOWN	The Rescue of Hormonal Replacement Frozen Embryo Transfer Cycle With Low Serum Progesterone.
NCT05951400	PHASE2/PHASE3	COMPLETED	Progesterone Primed Protocol Versus GnRH Antagonist in With PCO Undergoing ICSI
NCT05972902	PHASE3	UNKNOWN	Dydrogesterone, Cetrorelix Acetate and Triptorelin in Intra Cytoplasmic Sperm Injection Outcomes
NCT06868576	PHASE3	COMPLETED	PPOS Protocol Versus GnRH Anatagonist for Expected Normal Responder Patients Undergoing ART : a Randomized Clinical Trial
NCT03537287	PHASE2	UNKNOWN	Different Types of Progesterone in the Prevention of Preterm Labor
NCT06546397	PHASE1	RECRUITING	Study on the Effect of Combined Estrogen and Progestogen Therapy on Endometrial Repair After Induced Abortion
NCT04175990	PHASE1	COMPLETED	IVF Outcome Following Progestogen Ovarian Stimulation
NCT03456570	EARLY_PHASE1	UNKNOWN	The Efficacy of Progestins in Treatment of Functional Ovarian Cyst
NCT05569577	Not specified	RECRUITING	An Open Labeled RCT on the Effect of Additional hCG Injection for LPS on Pregnancy Outcomes in IHH Patients
NCT06378268	Not specified	ACTIVE_NOT_RECRUITING	PPOS vs GnRH Antagonist in Ovarian Stimulation (ProGanOS Study)
NCT06952296	Not specified	NOT_YET_RECRUITING	Study of the Effectiveness of Dydrogesterone in the Treatment of Endometriosis-related Pain
NCT07242131	Not specified	RECRUITING	Efficacy of Oral Contraceptive, Progesterone, and Inositol on Menstrual Regulation in PCOS
NCT01178931	Not specified	COMPLETED	Dydrogesterone Versus Intravaginal Progesterone in the Luteal Phase Support
NCT02086032	Not specified	COMPLETED	The Effect of Different Types of Progestin on Sleeping of Menopausal Women
NCT02262481	Not specified	COMPLETED	Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor
NCT02496052	Not specified	UNKNOWN	The Efficacy and Safety of the Dried Biological Amnion Graft in Patients With Intrauterine Adhesions
NCT02921763	Not specified	COMPLETED	A Survey on Efficacy and Safety in Patients With Endometriosis
NCT03309735	Not specified	COMPLETED	Non-interventional Study of Therapy for Threatened Miscarriage

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.

Related molecules

Related molecules

Molecules sharing ≥1 of this drug’s curated primary targets, merged from two biobtree sources and ranked by shared-target count, then clinical phase: ChEMBL clinical-stage candidates (development phase ≥2) and PubChem drug-class bioactivity (approved / known drugs acting on the target). Deduplicated by drug name; the drug’s own salt forms are excluded. Note: for a drug with few primary targets a shared-target match can reflect off-target / promiscuous binding rather than the same therapeutic mechanism — the phase ordering surfaces bona-fide therapeutics first.

290 molecules share ≥1 primary target. Top 60 by shared-target count:

Molecule	Source	Status	Shared targets
FIDAXOMICIN	ChEMBL + PubChem	Phase 4 (approved)	PGR
FULVESTRANT	ChEMBL + PubChem	Phase 4 (approved)	PGR
GENTIAN VIOLET	ChEMBL + PubChem	Phase 4 (approved)	PGR
ABIRATERONE	ChEMBL	Phase 4 (approved)	PGR
ACETYLCHOLINE	ChEMBL	Phase 4 (approved)	PGR
ADAPALENE	ChEMBL	Phase 4 (approved)	PGR
ALCLOMETASONE DIPROPIONATE	ChEMBL	Phase 4 (approved)	PGR
ALECTINIB	ChEMBL	Phase 4 (approved)	PGR
AMCINONIDE	ChEMBL	Phase 4 (approved)	PGR
APOMORPHINE	ChEMBL	Phase 4 (approved)	PGR
ARFORMOTEROL	ChEMBL	Phase 4 (approved)	PGR
ARIPIPRAZOLE	ChEMBL	Phase 4 (approved)	PGR
AZATHIOPRINE	ChEMBL	Phase 4 (approved)	PGR
BECLOMETHASONE DIPROPIONATE	ChEMBL	Phase 4 (approved)	PGR
BENPERIDOL	ChEMBL	Phase 4 (approved)	PGR
BENZBROMARONE	ChEMBL	Phase 4 (approved)	PGR
BENZIODARONE	ChEMBL	Phase 4 (approved)	PGR
BETAMETHASONE	ChEMBL	Phase 4 (approved)	PGR
BETAMETHASONE DIPROPIONATE	ChEMBL	Phase 4 (approved)	PGR
BETAMETHASONE VALERATE	ChEMBL	Phase 4 (approved)	PGR
BEXAROTENE	ChEMBL	Phase 4 (approved)	PGR
BICALUTAMIDE	ChEMBL	Phase 4 (approved)	PGR
BIFONAZOLE	ChEMBL	Phase 4 (approved)	PGR
BITHIONOL	ChEMBL	Phase 4 (approved)	PGR
BOSUTINIB	ChEMBL	Phase 4 (approved)	PGR
BUDESONIDE	ChEMBL	Phase 4 (approved)	PGR
BUTOCONAZOLE	ChEMBL	Phase 4 (approved)	PGR
CABOZANTINIB	ChEMBL	Phase 4 (approved)	PGR
CALCIPOTRIENE	ChEMBL	Phase 4 (approved)	PGR
CALCITRIOL	ChEMBL	Phase 4 (approved)	PGR
CANDESARTAN CILEXETIL	ChEMBL	Phase 4 (approved)	PGR
CANRENONE	ChEMBL	Phase 4 (approved)	PGR
CARBARIL	ChEMBL	Phase 4 (approved)	PGR
CASPOFUNGIN	ChEMBL	Phase 4 (approved)	PGR
CEFAMANDOLE	ChEMBL	Phase 4 (approved)	PGR
CEFMENOXIME	ChEMBL	Phase 4 (approved)	PGR
CEFTAZIDIME	ChEMBL	Phase 4 (approved)	PGR
CEFTIZOXIME	ChEMBL	Phase 4 (approved)	PGR
CEFTRIAXONE	ChEMBL	Phase 4 (approved)	PGR
CEFUROXIME	ChEMBL	Phase 4 (approved)	PGR
CEPHRADINE	ChEMBL	Phase 4 (approved)	PGR
CHLORHEXIDINE	ChEMBL	Phase 4 (approved)	PGR
CHLORMADINONE	ChEMBL	Phase 4 (approved)	PGR
CHOLECALCIFEROL	ChEMBL	Phase 4 (approved)	PGR
CICLESONIDE	ChEMBL	Phase 4 (approved)	PGR
CLOBETASOL PROPIONATE	ChEMBL	Phase 4 (approved)	PGR
CLOCORTOLONE PIVALATE	ChEMBL	Phase 4 (approved)	PGR
CLOMIPHENE	ChEMBL	Phase 4 (approved)	PGR
CYCLOFENIL	ChEMBL	Phase 4 (approved)	PGR
DANAZOL	ChEMBL	Phase 4 (approved)	PGR
DAUNORUBICIN	ChEMBL	Phase 4 (approved)	PGR
DEFLAZACORT	ChEMBL	Phase 4 (approved)	PGR
DEQUALINIUM	ChEMBL	Phase 4 (approved)	PGR
DESOGESTREL	ChEMBL	Phase 4 (approved)	PGR
DESONIDE	ChEMBL	Phase 4 (approved)	PGR
DESOXIMETASONE	ChEMBL	Phase 4 (approved)	PGR
DESOXYCORTICOSTERONE PIVALATE	ChEMBL	Phase 4 (approved)	PGR
DEXAMETHASONE	ChEMBL	Phase 4 (approved)	PGR
DIETHYLPROPION	ChEMBL	Phase 4 (approved)	PGR
DIETHYLSTILBESTROL	ChEMBL	Phase 4 (approved)	PGR