Drugs / Ospemifene
Ospemifene
also known as
(deaminohydroxy) toremifene · FC-1271 · FC-1271A · Ospemifeno · Osphena · Senshio · Tore iii
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | OSPHENA | — | 2019-01-25 | fda.gov ↗ |
| Approved | EU (EMA) | Senshio | — | 2015-01-14 | europa.eu ↗ |
| Approved | US (FDA) | OSPHENA | — | 2013-02-26 | fda.gov ↗ |
Trials 9 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00630539 | Aug 2007 → Jan 2008 | muscular atrophy, vaginal disorder | Shionogi | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT02638337 | Jan 2016 → Jun 2017 | postmenopausal atrophic vaginitis | Shionogi | Completed | No outcome recorded |
| Phase 3 | NCT00729469 | Jul 2008 → Aug 2009 | vaginal disorder | Shionogi | Completed | No outcome recorded |
| Phase 3 | NCT00566982 | Oct 2007 → Jul 2009 | vaginal disorder | Shionogi | Completed | No outcome recorded |
| Phase 3 | NCT01585558 | May 2006 → Aug 2008 | vaginal disorder | Shionogi | Completed | No outcome recorded |
| Phase 3 | NCT01586364 | May 2006 → Nov 2008 | vaginal disorder | Shionogi | Completed | No outcome recorded |
| Phase 3 | NCT00276094 | Jan 2006 → Dec 2007 | muscular atrophy, vaginal disorder | Shionogi | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT03018106 | Jun → Sep 2017 | physiological sexual disorder | Emory University | Terminated | No outcome recorded |
| Phase 4 | NCT02784613 | Jul 2015 → Feb 2017 | postmenopausal atrophic vaginitis, psychologic dyspareunia | Sue Goldstein | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT04677491 Comparator | Nov 2021 → Nov 2022 | sexual disorder, vaginal disorder | Hospital Clinic of Barcelona | Completed | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ospemifene | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03018106 ↗ |
| Known as | (deaminohydroxy) toremifene | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105395 ↗ |
| Known as | FC-1271 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105395 ↗ |
| Known as | FC-1271A | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105395 ↗ |
| Known as | Ospemifeno | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105395 ↗ |
| Known as | Osphena | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105395 ↗ |
| Known as | Senshio | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105395 ↗ |
| Known as | Tore iii | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105395 ↗ |
| Modality | Other / unclassified | “Ospemifene is a non-estrogen selective estrogen receptor modulator (SERM)” NCT03018106 ↗ |
| Route | Oral | “1 tablet (dose 30 mg/day) taken each morning with food” NCT00276094 ↗ |