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Ospemifene (Dose 1) — Competitive Intelligence Brief
phase 3
Selective estrogen receptor modulator (SERM)
Estrogen receptor (ER-α and ER-β)
Women's Health / Gynecology
Small molecule
Live · refreshed every 30 min
Target snapshot
Ospemifene (Dose 1) (Ospemifene (Dose 1)) — Shionogi. 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.
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| Ospemifene (Dose 1) TARGET | Ospemifene (Dose 1) | Shionogi | phase 3 | Selective estrogen receptor modulator (SERM) | Estrogen receptor (ER-α and ER-β) | |
| Toremifene; Anastrozole | Toremifene; Anastrozole | Peking Union Medical College Hospital | marketed | Selective estrogen receptor modulator (SERM) + aromatase inhibitor (AI) | Estrogen receptor (ER); aromatase (CYP19A1) | |
| Tamoxifen (open label) | Tamoxifen (open label) | Oregon Health and Science University | marketed | Selective estrogen receptor modulator (SERM) | Estrogen receptor alpha (ERα) | |
| Low Dose Clomiphencitrat | Low Dose Clomiphencitrat | University Hospital, Basel, Switzerland | marketed | Selective estrogen receptor modulator (SERM) | Estrogen receptor (ER-α and ER-β) | |
| E2Nomac | E2Nomac | Sydney Centre for Reproductive Health Research | marketed | Selective Estrogen Receptor Modulator (SERM) | Estrogen receptor (ER-α/ER-β) | |
| tamoxifen citrate (Tamoxifen) | tamoxifen citrate (Tamoxifen) | H. Lee Moffitt Cancer Center and Research Institute | marketed | Selective estrogen receptor modulator (SERM) | Estrogen receptor alpha (ERα) | |
| Metformin plus clomiphene citrate | Metformin plus clomiphene citrate | University Magna Graecia | marketed | Combination therapy: biguanide + selective estrogen receptor modulator (SERM) | Insulin signaling pathway (metformin); estrogen receptor (clomiphene citrate) |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (Selective estrogen receptor modulator (SERM) class)
- University Hospital, Basel, Switzerland · 2 drugs in this class
- AstraZeneca · 2 drugs in this class
- Estetra · 1 drug in this class
- Fundació Privada Eugin · 1 drug in this class
- H. Lee Moffitt Cancer Center and Research Institute · 1 drug in this class
- National Taiwan University Hospital · 1 drug in this class
- Oregon Health and Science University · 1 drug in this class
- Samsung Medical Center · 1 drug in this class
- Shandong Suncadia Medicine Co., Ltd. · 1 drug in this class
- Sheba Medical Center · 1 drug in this class
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- Ospemifene (Dose 1) CI watch — RSS
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- Ospemifene (Dose 1) alone — RSS
- Whole Selective estrogen receptor modulator (SERM) class — RSS
Cite this brief
Drug Landscape (2026). Ospemifene (Dose 1) — Competitive Intelligence Brief. https://druglandscape.com/ci/ospemifene-dose-1. Accessed 2026-06-10.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing