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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Commercial
Trade Name
FDA
EMA
Ospemifene, Osphena
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| osphena | New Drug Application | 2024-02-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| dyspareunia | HP_0030016 | D004414 | — |
| atrophy | — | D001284 | — |
| menopause | EFO_0003922 | D008593 | N95 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Ospemifene, Osphena, Duchesnay | |||
| 8642079 | 2028-07-09 | DP | |
| 8236861 | 2026-08-11 | U-905, U-1369, U-1370 | |
| 6245819 | 2025-07-21 | U-905, U-1370 | |
| 8470890 | 2024-02-13 | U-905, U-1369, U-1370 | |
| 8772353 | 2024-02-13 | U-905, U-1369, U-1370 | |
| 9241915 | 2024-02-13 | U-905, U-1369, U-1370 | |
| 9855224 | 2024-02-13 | U-905, U-1369, U-1370 | |
HCPCS
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Clinical
Clinical Trials
11 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atrophy | D001284 | — | — | — | 1 | 5 | 1 | — | 7 |
| Physiological sexual dysfunction | D012735 | — | — | — | — | — | 1 | — | 1 |
| Dyspareunia | D004414 | HP_0030016 | — | — | — | — | 1 | — | 1 |
| Atrophic vaginitis | D059268 | EFO_1001271 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vaginal diseases | D014623 | — | — | — | 1 | 5 | — | — | 6 |
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Menopause | D008593 | EFO_0003922 | N95 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ospemifene |
| INN | ospemifene |
| 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 class | antiestrogens 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-ID | 128607-22-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2105395 |
| ChEBI ID | 73275 |
| PubChem CID | 3036505 |
| DrugBank | DB04938 |
| UNII ID | B0P231ILBK (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Safety
Black-box Warning
Black-box warning for: Osphena
Adverse Events
Top Adverse Reactions
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2,321 adverse events reported
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