TheraRadar
Data updated: Jun 28, 2026

OSPEMIFENE · HETERO LABS LTD V

Generic · see OSPHENA Trial Activity: Mature
Women's Health Approved 2013-02-26

OSPEMIFENE is FDA-approved to treat 3 conditions (same as OSPHENA).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Shionogi conducting 1 trials (33%)
4 indications explored (Focused)
→ vaginal dryness (1 trials)
→ vulvovaginal atrophy (1 trials)
→ dyspareunia (1 trials)
1
Indication
--
Phase 3 Trials
13
Years on Market

Details

Status
Prescription
First Approved
2013-02-26
Routes
ORAL
Dosage Forms
TABLET

Companies

HETERO LABS LTD V
Active Ingredient: OSPEMIFENE

OSPEMIFENE Approval History

2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2024 to 2025
Jul 2025 SUPPL
Label · Labeling
Jul 2024 SUPPL
Label · Labeling
Feb 2024 ORIGINAL
Update
FDA Letter

What OSPEMIFENE Treats

3 indications

OSPEMIFENE is approved for 3 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as OSPHENA (same active ingredient).

Source: FDA Label
📋

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

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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

Indications & Usage

OSPEMIFENE is FDA-approved to treat 3 conditions — same approved indications as OSPHENA.

Looking for the branded version?

OSPHENA

Full clinical data, patents, trials, and competitive landscape for ospemifene.

See OSPHENA

Data Sources

FDA Approval: ANDA215574 → Trials: ClinicalTrials.gov →

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