Dienogest
Natazia (dienogest) is a small molecule pharmaceutical. Dienogest was first approved as Natazia on 2010-05-06. It is used to treat endometriosis in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
Trade Name
FDA
EMA
Combinations
Natazia
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| natazia | New Drug Application | 2010-10-05 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
ATC Codes
G: Genito urinary system and sex hormones
— G03: Sex hormones and modulators of the genital system
— G03A: Hormonal contraceptives for systemic use
— G03AA: Progestogens and estrogen systemic contraceptives, fixed combinations
— G03AA16: Dienogest and ethinylestradiol
— G03AB: Progestogens and estrogens systemic contraceptives, sequential preparations
— G03AB08: Dienogest and estradiol
— G03D: Progestogen sex hormones and modulators of the genital system
— G03DB: Pregnadien derivatives, progestogens
— G03DB08: Dienogest
— G03F: Progestogens and estrogens in combination
— G03FA: Progestogens and estrogens, fixed combinations
— G03FA15: Dienogest and estrogen
HCPCS
No data
Clinical
Clinical Trials
81 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Endometriosis | D004715 | EFO_0001065 | N80 | 1 | 4 | 6 | 5 | 20 | 34 |
| Contraception | D003267 | — | — | — | 1 | 5 | 1 | 3 | 10 |
| Adenomyosis | D062788 | EFO_1001757 | N80.0 | — | — | — | 2 | 4 | 6 |
| Leiomyoma | D007889 | HP_0000131 | D25 | — | 1 | 1 | 2 | — | 3 |
| Dysmenorrhea | D004412 | HP_0100607 | N94.6 | — | — | 1 | 1 | 1 | 3 |
| Ovarian reserve | D065851 | EFO_0004770 | — | — | 1 | — | 1 | — | 2 |
| Infertility | D007246 | HP_0000789 | — | — | — | — | 1 | 1 | 2 |
| Myofibroma | D047708 | — | — | — | 1 | 1 | 1 | — | 2 |
| Uterine diseases | D014591 | — | N85.9 | — | — | — | 2 | — | 2 |
| Recurrence | D012008 | — | — | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | 4 | — | 1 | 5 |
| Metrorrhagia | D008796 | HP_0100608 | N92.1 | — | — | 4 | — | — | 4 |
| Pelvic pain | D017699 | — | — | — | — | 1 | — | 2 | 3 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | 1 | — | 1 | 2 |
| Uterine hemorrhage | D014592 | — | — | — | — | 2 | — | — | 2 |
| Headache | D006261 | HP_0002315 | R51 | — | — | 1 | — | — | 1 |
| Libido | D007989 | — | R68.82 | — | — | 1 | — | — | 1 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | — | — | 1 | — | — | 1 |
| Syndrome | D013577 | — | — | — | — | 1 | — | — | 1 |
| Premenstrual syndrome | D011293 | — | N94.3 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anorexia | D000855 | HP_0002039 | R63.0 | — | 1 | — | — | — | 1 |
| Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | — | 1 | — | — | — | 1 |
| Ovulation inhibition | D034445 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Therapeutic equivalency | D013810 | — | — | 3 | — | — | — | 1 | 4 |
| Biological availability | D001682 | — | — | 1 | — | — | — | — | 1 |
| Pharmacological phenomena | D000069437 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic pain | D059350 | HP_0012532 | — | — | — | — | — | 1 | 1 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | — | — | — | — | 1 | 1 |
| Thromboembolism | D013923 | HP_0001907 | — | — | — | — | — | 1 | 1 |
| Pregnancy rate | D018873 | — | — | — | — | — | — | 1 | 1 |
| Hormonal contraception | D000080282 | — | — | — | — | — | — | 1 | 1 |
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | — | — | — | — | 1 | 1 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | — | — | — | 1 | 1 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dienogest |
| INN | dienogest |
| Description | Dienogest is a steroid hormone that is 17beta-hydroxy-3-oxoestra-4,9-diene substituted at position 17 by a cyanomethyl group. Used as an oral contraceptive. It has a role as a synthetic oral contraceptive, a progesterone receptor agonist and a progestin. It is a 17beta-hydroxy steroid, a 3-oxo-Delta(4) steroid, a steroid hormone and an aliphatic nitrile. It derives from a hydride of an estrane. |
| Classification | Small molecule |
| Drug class | Progestogen; Progestin; Steroidal antiandrogen |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@]12CCC3=C4CCC(=O)C=C4CC[C@H]3[C@@H]1CC[C@@]2(O)CC#N |
Identifiers
| PDB | — |
| CAS-ID | 65928-58-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201864 |
| ChEBI ID | 70708 |
| PubChem CID | 68861 |
| DrugBank | DB09123 |
| UNII ID | 46M3EV8HHE (ChemIDplus, GSRS) |
Target
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Variants
No data
Financial
Revenue by drug
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Estimated US medical usage
Dienogest
+
Estradiol
Total medical expenditures per year (USD, in millions)
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Natazia
Adverse Events
Top Adverse Reactions
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1,131 adverse events reported
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