OSPEMIFENE
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2024-02-13
- Routes
- ORAL
- Dosage Forms
- TABLET
OSPEMIFENE Approval History
What OSPEMIFENE Treats
1 FDA approvalsOriginally approved for its first indication in 2024 .
- Other (1)
Other
(1 approval)- • Approved indication (Feb 2024)Letter
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02784613 results posted | SDSM-2015-02 | Ph 4 | completed | Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA |
| NCT02638337 results posted | 1517I0231 | Ph 3 | completed | Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause |
| NCT03018106 results posted | IRB00088077 | Ph 4 | terminated | Ospemifene vs. Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OSPEMIFENE FDA Label Details
Looking for the branded version?
OSPHENA
Full clinical data, patents, trials, and competitive landscape for ospemifene.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment