ospemifene
Trade name: osphena
Approved
Feb 26, 2013
Ospemifene (commercial name Osphena produced by Shionogi) is anoral medication indicated for the treatment of dyspareunia – pain during sexual intercourse – encountered by some women, more often in those who are post-menopausal. Ospemifene is a selective estrogen receptor modulator (SERM) that selectively binds to estrogen receptors and either stimulates or blocks estrogen's activity in different tissue types. It has an agonistic effect on the endometrium. It’s building vaginal wall thickness which in turn reduces the pain associated with dyspareunia. Dyspareunia is most commonly caused by "vulval and vaginal atrophy”. — NCATS
Clinical trial activity
10 trials · 6 clinical orgs · 3 marketing orgs
Earliest trial started Jan 1, 2006 (NCT00276094)
Timeline
2000s
2010s
- Feb 26, 2013
Shionogi — Earliest FDA Approval
- Feb 26, 2013
Shionogi — NDA Organization
- Feb 26, 2013
Duchesnay Inc. — NDA Secondary Org
2020s
- Jun 23, 2023
Hetero Labs Ltd — Marketing Organization
Indications
Approved for
Mechanism of action
- Estrogen receptorMODULATOR
Estrogen receptor modulator
Mixed agonist/antagonist
Approval history
- approvedFeb 26, 2013
Chemistry & pharmacology
SMILES
OCCOC1=CC=C(C=C1)C(=C(\CCCl)C2=CC=CC=C2)\C3=CC=CC=C3- Mol. weight
- 378.891 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaOspemifene ↗
- NCATSB0P231ILBK ↗
- ChEMBLCHEMBL2105395 ↗
Also known as
- 2-(4-(4-chloro-1,2-diphenyl-but-1-enyl)phenoxy)ethanol
- 2-(4-(4-chloro-1,2-diphenyl-but-1-enyl)phenoxy)ethanol
- 2-(p-((z)-4-chloro-1,2-diphenyl-1-butenyl)phenoxy)ethanol
- 2-(p-((z)-4-chloro-1,2-diphenyl-1-butenyl)phenoxy)ethanol
- deamino-hydroxytoremifene
- deamino-hydroxytoremifene
- fc-1271
- fc-1271
- fc-1271a
- fc-1271a
- fc-1271a
- fc-1271a
- ospemifene
- ospemifene
- ospemifene
- ospemifene
- ospemifene
- ospemifene
- ospemifene
- ospemifene
- ospemifene
- ospemifene
- ospemifene
- osphena
- osphena
- osphena
- osphena
- osphena
- osphena
- osphena
- senshio
- z-2-(4-(4-chloro-1,2-diphenyl-but-1-enyl)phenoxy)ethanol
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04677491 | Phase 4 | Nov 1, 2020 | University of Barcelona |
| NCT03018106 | Phase 4 | Jan 1, 2017 | Emory University |
| NCT02638337 | Phase 3 | Dec 1, 2015 | Shionogi |
| NCT02784613 | Phase 4 | Jul 1, 2015 | San Diego Sexual Medicine |
| NCT00729469 | Phase 3 | Jul 1, 2008 | Hormos Medical, Quatrx Pharmaceuticals Co, Shionogi |
| NCT00566982 | Phase 3 | Oct 1, 2007 | Hormos Medical, Quatrx Pharmaceuticals Co, Shionogi |
| NCT00630539 | Phase 2 | Aug 1, 2007 | Hormos Medical, Quatrx Pharmaceuticals Co, Shionogi |
| NCT01586364 | Phase 3 | May 1, 2006 | Quatrx Pharmaceuticals Co, Shionogi |
| NCT01585558 | Phase 3 | May 1, 2006 | Quatrx Pharmaceuticals Co, Shionogi |
| NCT00276094 | Phase 3 | Jan 1, 2006 | Hormos Medical, Quatrx Pharmaceuticals Co, Shionogi |
Organizations
Research & Development (6)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Shionogi | For profit | 7 | 7 | 2 | 2006 |
| Quatrx Pharmaceuticals Co | For profit | 6 | 0 | 2 | 2006 |
| Hormos Medical | For profit | 4 | 0 | 2 | 2006 |
| Emory University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| San Diego Sexual Medicine | Academic/Hospital | 1 | 1 | 1 | 2015 |
| University of Barcelona | Academic/Hospital | 1 | 1 | 1 | 2020 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Duchesnay Inc. | For profit | NDA2 | Feb 26, 2013 |
| Hetero Labs Ltd | For profit | MKTG | Jun 23, 2023 |
| Shionogi | For profit | NDA | Feb 26, 2013 |