OSPHENA (ospemifene)
Osphena treats moderate to severe vaginal dryness and pain during intercourse, which are common symptoms of vulvar and vaginal atrophy in menopausal women. It is used to help patients manage these specific physical changes that occur as a result of menopause. This medication provides a targeted approach for those experiencing significant discomfort during sexual activity or general vaginal dryness.
How OSPHENA Works
Osphena works by binding to estrogen receptors throughout the body, acting as a tissue-selective estrogen receptor agonist/antagonist. This binding triggers estrogenic pathways in certain tissues while blocking those same pathways in others. By selectively activating these receptors, the drug produces specific biological actions to address symptoms of atrophy.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2013-02-26
- Patent Cliff
- 2028
- Routes
- ORAL
- Dosage Forms
- TABLET
OSPHENA Approval History
What OSPHENA Treats
3 indicationsOSPHENA is approved for 3 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Dyspareunia
- Vulvar and Vaginal Atrophy
- Vaginal Dryness
OSPHENA Boxed Warning
ENDOMETRIAL CANCER and CARDIOVASCULAR DISORDERS WARNING: ENDOMETRIAL CANCER and CARDIOVASCULAR DISORDERS See full prescribing information for complete boxed warning. OSPHENA is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, OSPHENA has estrogen agonistic effects. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Perform adequate diagnostic measures, including directed and random endometrial sampling when ind...
WARNING: ENDOMETRIAL CANCER and CARDIOVASCULAR DISORDERS WARNING: ENDOMETRIAL CANCER and CARDIOVASCULAR DISORDERS See full prescribing information for complete boxed warning. OSPHENA is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, OSPHENA has estrogen agonistic effects. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Perform adequate diagnostic measures, including directed and random endometrial sampling when indicated, to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.2) ]. Estrogen-alone therapy has an increased risk of stroke and deep vein thrombosis (DVT). OSPHENA 60 mg had cerebral thromboembolic and hemorrhagic stroke incidence rates of 1.13 and 3.39 per thousand women years, respectively vs. 3.15 and 0 per thousand women years, respectively with placebo. For deep vein thrombosis, the incidence rate for OSPHENA 60 mg is 2.26 per thousand women years (2 reported cases) vs. 3.15 per thousand women years (1 reported case) with placebo [see Warnings and Precautions (5.1) ]. Endometrial Cancer OSPHENA is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, OSPHENA has estrogen agonistic effects. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Perform adequate diagnostic measures, including directed and random endometrial sampling when indicated, to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.2) ]. Cardiovascular Disorders In the clinical trials for OSPHENA (duration of treatment up to 15 months), the incidence rates of thromboembolic and hemorrhagic stroke were 1.13 and 3.39 per thousand women years, respectively in the OSPHENA 60 mg treatment group and 3.15 and 0 with placebo [see Warnings and Pr
OSPHENA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to OSPHENA
3 of 15FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
OSPHENA FDA Label Details
Indications & Usage
FDA Label (PDF)OSPHENA is indicated for the treatment of Dyspareunia; Vulvar and Vaginal Atrophy; Vaginal Dryness.
WARNING: ENDOMETRIAL CANCER and CARDIOVASCULAR DISORDERS WARNING: ENDOMETRIAL CANCER and CARDIOVASCULAR DISORDERS See full prescribing information for complete boxed warning. OSPHENA is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, OSPHENA has estrogen agonistic e...
Pro Intelligence Preview
Deep insights for OSPHENA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 4 active patents
Trial Analysis
- • 3 total trials
- • Stage: Mature
Competitive Landscape
- • 15 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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