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Drug ReportsOspemifene
Osphena, Senshio(ospemifene)
Ospemifene, Osphena, Senshio (ospemifene) is a small molecule pharmaceutical. Ospemifene was first approved as Osphena on 2013-02-26. It is used to treat atrophy, dyspareunia, and menopause in the USA. It has been approved in Europe to treat postmenopause.
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YTD
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EMA approval date
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Last update post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
signs and symptoms pathological conditionsD013568
mental disordersD001523
reproductive and urinary physiological phenomenaD012101
Trade Name
FDA
EMA
Osphena (discontinued: Ospemifene)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ospemifene
Tradename
Company
Number
Date
Products
OSPHENADuchesnayN-203505 RX2013-02-26
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
osphenaNew Drug Application2025-02-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
dyspareunia—D004414N94.1
atrophy—D001284—
menopauseEFO_0003922D008593N95
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Ospemifene, Osphena, Duchesnay
86420792028-07-09DP
82368612026-08-11U-905, U-1369, U-1370
62458192025-07-21U-905, U-1370
84708902024-02-13U-905, U-1369, U-1370
87723532024-02-13U-905, U-1369, U-1370
92419152024-02-13U-905, U-1369, U-1370
98552242024-02-13U-905, U-1369, U-1370
ATC Codes
G: Genito urinary system and sex hormones
— G03: Sex hormones and modulators of the genital system
— G03X: Other sex hormones and modulators of the genital system in atc
— G03XC: Selective estrogen receptor modulators
— G03XC05: Ospemifene
HCPCS
No data
Clinical
Clinical Trials
11 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AtrophyD001284———15——6
Vaginal diseasesD014623———15——6
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 nameOspemifene
INNospemifene
Description
Ospemifene is an organochlorine compound that is a selective estrogen receptor modulator; used for treatment of dyspareunia. It has a role as an estrogen receptor modulator, an antineoplastic agent and an anti-inflammatory agent. It is an organochlorine compound, an aromatic ether and a primary alcohol. It derives from a hydride of a stilbene.
Classification
Small molecule
Drug classantiestrogens of the clomifene and tamoxifen groups
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
OCCOc1ccc(/C(=C(/CCCl)c2ccccc2)c2ccccc2)cc1
Identifiers
PDB—
CAS-ID128607-22-7
RxCUI—
ChEMBL IDCHEMBL2105395
ChEBI ID73275
PubChem CID3036505
DrugBankDB04938
UNII IDB0P231ILBK (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 8,704 documents
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Safety
Black-box Warning
Black-box warning for: Osphena
Adverse Events
Top Adverse Reactions
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2,338 adverse events reported
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