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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 diseasesD000091642
Trade Name
FDA
EMA
Combinations
Natazia
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dienogest
+
Estradiol valerate
Tradename
Company
Number
Date
Products
NATAZIABayerN-022252 RX2010-05-06
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
nataziaNew Drug Application2010-10-05
nataziaNew Drug Application2015-08-21
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
endometriosisEFO_0001065D004715N80
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Dienogest / Estradiol Valerate, Natazia, Bayer Hlthcare
81536162028-01-30U-1240
80715772026-05-13DPU-1
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
Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDIENOGEST
INNdienogest
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 classProgestogen; 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-ID65928-58-7
RxCUI22968
ChEMBL IDCHEMBL1201864
ChEBI ID70708
PubChem CID68861
DrugBankDB09123
UNII ID46M3EV8HHE (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 1,125 documents
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Safety
Black-box Warning
Black-box warning for: Natazia, Natazia
Adverse Events
Top Adverse Reactions
Mock data
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1,279 adverse events reported
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