Dydrogesterone
Gynorest (dydrogesterone) is a small molecule pharmaceutical. Dydrogesterone was first approved as Gynorest on 1982-01-01. It is used to treat menstruation disturbances in the USA. The pharmaceutical is active against progesterone receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| signs and symptoms pathological conditions | D013568 |
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Drug Products
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New Drug Application (NDA)
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Abbreviated New Drug Application (ANDA)
Dydrogesterone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| GYNOREST | Solvay Pharmaceuticals | N-017388 DISCN | 1982-01-01 | 2 products, RLD |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| menstruation disturbances | — | D008599 | N91.5 |
Agency Specific
FDA
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ATC Codes
G: Genito urinary system and sex hormones
— G03: Sex hormones and modulators of the genital system
— G03D: Progestogen sex hormones and modulators of the genital system
— G03DB: Pregnadien derivatives, progestogens
— G03DB01: Dydrogesterone
— G03F: Progestogens and estrogens in combination
— G03FA: Progestogens and estrogens, fixed combinations
— G03FA14: Dydrogesterone and estrogen
— G03FB: Progestogens and estrogens, sequential preparations
— G03FB08: Dydrogesterone and estrogen
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Clinical
Clinical Trials
112 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infertility | D007246 | EFO_0000545 | — | — | 2 | 4 | 6 | 13 | 25 |
| Female infertility | D007247 | EFO_0008560 | N97 | — | 1 | 3 | 3 | 3 | 10 |
| Spontaneous abortion | D000022 | EFO_1001255 | O00.1 | — | 1 | 3 | 4 | 2 | 9 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | 1 | 1 | 5 | 7 |
| Gynatresia | D006175 | EFO_1001335 | N85.6 | 2 | 1 | — | 1 | 2 | 5 |
| Threatened abortion | D000033 | — | O20.0 | — | — | 1 | 2 | 2 | 5 |
| Premature birth | D047928 | EFO_0003917 | O60 | — | 2 | 2 | 1 | 1 | 5 |
| Recurrence | D012008 | — | — | — | — | 1 | 1 | 2 | 4 |
| Habitual abortion | D000026 | EFO_1000954 | N96 | — | 1 | 2 | 1 | 1 | 4 |
| Syndrome | D013577 | — | — | — | 1 | 1 | 1 | 1 | 4 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Endometriosis | D004715 | EFO_0001065 | N80 | — | 1 | 1 | — | 6 | 8 |
| Postmenopause | D017698 | — | — | — | 1 | 3 | — | — | 3 |
| Pregnancy rate | D018873 | — | — | 1 | — | 1 | — | — | 2 |
| Preimplantation diagnosis | D019836 | — | — | — | — | 1 | — | — | 1 |
| Endometrial hyperplasia | D004714 | — | N85.0 | — | — | 1 | — | — | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tissue adhesions | D000267 | — | — | 1 | 1 | — | — | 5 | 6 |
| Ovarian hyperstimulation syndrome | D016471 | — | — | 1 | 1 | — | — | 1 | 3 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ovarian cysts | D010048 | — | N83.1 | 1 | — | — | — | 1 | 2 |
| Cysts | D003560 | — | — | 1 | — | — | — | — | 1 |
| Intracytoplasmic sperm injections | D020554 | — | — | 1 | — | — | — | — | 1 |
| Pregnancy complications | D011248 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 3 | 3 |
| Uterine hemorrhage | D014592 | — | — | — | — | — | — | 2 | 2 |
| Observational studies as topic | D064887 | — | — | — | — | — | — | 2 | 2 |
| Metrorrhagia | D008796 | — | N92.1 | — | — | — | — | 2 | 2 |
| Physiological sexual dysfunction | D012735 | — | — | — | — | — | — | 1 | 1 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 1 | 1 |
| Oocyte donation | D018587 | — | — | — | — | — | — | 1 | 1 |
| Hypogonadism | D007006 | — | E23.0 | — | — | — | — | 1 | 1 |
| Kallmann syndrome | D017436 | Orphanet_478 | E23.0 | — | — | — | — | 1 | 1 |
| Hemophilia b | D002836 | — | D67 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dydrogesterone |
| INN | dydrogesterone |
| Description | Dydrogesterone is a 3-oxo-Delta(4) steroid and a 20-oxo steroid. It has a role as a progestin. |
| Classification | Small molecule |
| Drug class | progestins; steroids (androgens, anabolics); antiandrogens |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)[C@H]1CC[C@H]2[C@@H]3C=CC4=CC(=O)CC[C@@]4(C)[C@@H]3CC[C@]12C |
Identifiers
| PDB | — |
| CAS-ID | 152-62-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200853 |
| ChEBI ID | 31527 |
| PubChem CID | 9051 |
| DrugBank | DB00378 |
| UNII ID | 90I02KLE8K (ChemIDplus, GSRS) |
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Safety
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495 adverse events reported
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