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Osphena, Senshio(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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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
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 Application2023-04-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
atrophy—D001284—
dyspareuniaHP_0030016D004414N94.1
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
10 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Physiological sexual dysfunctionD012735———1—1
DyspareuniaD004414HP_0030016N94.1———1—1
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)
Structure (InChI/SMILES or Protein Sequence)
OCCOc1ccc(/C(=C(/CCCl)c2ccccc2)c2ccccc2)cc1
Identifiers
PDB—
CAS-ID128607-22-7
RxCUI1370971
ChEMBL IDCHEMBL2105395
ChEBI ID73275
PubChem CID3036505
DrugBankDB04938
UNII IDB0P231ILBK (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:
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Additional graphs summarizing 371 documents
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Safety
Black-box Warning
Black-box warning for: Osphena
Adverse Events
Top Adverse Reactions
Mock data
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25,826 adverse events reported
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