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Ospemifene (Dose 1)
Ospemifene (Dose 1) is a Selective estrogen receptor modulator (SERM) Small molecule drug developed by Shionogi. It is currently in Phase 3 development for Moderate to severe dyspareunia due to genitourinary syndrome of menopause (GSM).
Ospemifene is a selective estrogen receptor modulator (SERM) that acts as an estrogen agonist in vaginal tissue to treat moderate to severe dyspareunia caused by genitourinary syndrome of menopause.
Ospemifene is a small molecule that modulates the estrogen receptor, classified as a modulator. It is being studied for the treatment of vulvar and vaginal atrophy in postmenopausal women, with a dose of 60 mg being evaluated in clinical trials.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Ospemifene (Dose 1) |
|---|---|
| Sponsor | Shionogi |
| Drug class | Selective estrogen receptor modulator (SERM) |
| Target | Estrogen receptor (ER-α and ER-β) |
| Modality | Small molecule |
| Therapeutic area | Women's Health / Gynecology |
| Phase | Phase 3 |
Mechanism of action
Ospemifene selectively binds to estrogen receptors in the vaginal epithelium, promoting tissue proliferation and improving vaginal maturation and lubrication. This mechanism addresses the vaginal atrophy and dryness characteristic of genitourinary syndrome of menopause (GSM), thereby reducing pain during intercourse without systemic hormonal effects typical of hormone replacement therapy.
Approved indications
- Moderate to severe dyspareunia due to genitourinary syndrome of menopause (GSM)
Common side effects
- Hot flashes
- Vaginal discharge
- Vaginal bleeding or spotting
- Headache
- Muscle spasms
Key clinical trials
- Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus (PHASE3)
- Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus (PHASE3)
- Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity (PHASE3)
- A Clinical Study to Evaluate the Safety of Ospemifene (PHASE3)
- A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women (PHASE2)
- A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ospemifene (Dose 1) CI brief — competitive landscape report
- Ospemifene (Dose 1) updates RSS · CI watch RSS
- Shionogi portfolio CI
Frequently asked questions about Ospemifene (Dose 1)
What is Ospemifene (Dose 1)?
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What is Ospemifene (Dose 1) used for?
Who makes Ospemifene (Dose 1)?
What drug class is Ospemifene (Dose 1) in?
What development phase is Ospemifene (Dose 1) in?
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What does Ospemifene (Dose 1) target?
Related
- Drug class: All Selective estrogen receptor modulator (SERM) drugs
- Target: All drugs targeting Estrogen receptor (ER-α and ER-β)
- Manufacturer: Shionogi — full pipeline
- Therapeutic area: All drugs in Women's Health / Gynecology
- Indication: Drugs for Moderate to severe dyspareunia due to genitourinary syndrome of menopause (GSM)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing