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Drug

Ospemifene

Approved · FDA / EMA
ClassEstrogen receptor modulatorEmerging researchLate-stage development
Also known as Deamino-hydroxytoremifene, Osphena, Ospemifeno, 2-(4-(4-Chloro-1,2-diphenyl-but-1-enyl)phenoxy)ethanol+1 more

Deamino-hydroxytoremifene, Osphena, Ospemifeno, 2-(4-(4-Chloro-1,2-diphenyl-but-1-enyl)phenoxy)ethanol, 2-(p-((Z)-4-Chloro-1,2-diphenyl-1-butenyl)phenoxy)ethanol.

RxNorm1370971ChEMBLCHEMBL2105395ATCG03XC05UNIIB0P231ILBK
2
Research papers
2
Protein targets
18
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: OSPEMIFENE (NDA203505)

Regulatory2025-02-07FDA

Hormonal Treatments and Vaginal Moisturizers for Genitourinary Syndrome of Menopause : A Systematic Review.

Research2024-09-10Annals of internal medicine

Label change: OSPEMIFENE (NDA203505)

Regulatory2024-02-15FDA

Effects of Ospemifene on Brain Activation Patterns in Women With Sexual Interest-arousal Disorders

Clinical trial2023-12-01Completed · ClinicalTrials.gov

A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Ospemifene in Patients With Moderate to Severe Vaginal Dryness, a Symptom of Vulvo-vaginal Atrophy (VVA) Due to Menopause

Clinical trial2019-04-02Results posted · ClinicalTrials.gov

Open-Label Pilot Prospective Vulvoscopy Photography Study of Visible Changes in the Vulva, Vestibule, Vagina Pre/Post 20 Weeks of Daily Administration 60 Mg Ospemifene in Post-Menopausal Women With Dyspareunia From Vulvar Vaginal Atrophy

Clinical trial2019-04-02Results posted · ClinicalTrials.gov

Indication expansion: OSPEMIFENE (NDA203505)

Regulatory2019-01-25FDA

Label change: OSPEMIFENE (NDA203505)

Regulatory2018-10-26FDA

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: A 40 Week Randomized, Double Blind, Placebo Controlled, Follow-Up to Protocol 15-50310.

Clinical trial2018-05-21Results posted · ClinicalTrials.gov

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: A 52-Week Open-Label Follow-Up to Protocol 15-50310

Clinical trial2018-05-21Results posted · ClinicalTrials.gov

Efficacy and Long-Term Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing 60 MG Oral Daily Dose of Ospemifene With Placebo

Clinical trial2018-05-18Results posted · ClinicalTrials.gov

Improvements to the Vulva, Vestibule, Urethral Meatus, and Vagina in Women Treated With Ospemifene for Moderate to Severe Dyspareunia: A Prospective Vulvoscopic Pilot Study.

Research2018-04-18Sexual medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ospemifene
Aliases & brands
Deamino-hydroxytoremifeneOsphenaOspemifeno2-(4-(4-Chloro-1,2-diphenyl-but-1-enyl)phenoxy)ethanol2-(p-((Z)-4-Chloro-1,2-diphenyl-1-butenyl)phenoxy)ethanol
RxNorm CUI
1370971
ChEMBL ID
CHEMBL2105395
ATC codes
G03XC05
UNII
B0P231ILBK
Primary mechanism
Estrogen receptor modulator
Regulatory jurisdictions
fdaema

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Estrogen receptor
ESR1 · P03372
MODULATOREstrogen receptor modulator
Estrogen receptor beta
ESR2 · Q92731
MODULATOREstrogen receptor modulator

Regulatory timeline

18 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2013-02-26 → 2015-01-14)
Earliest approval
2013-02-26
Latest approval
2019-01-25
Authorities
FDA · EMA
Total events
18
fdaU.S. Food and Drug Administration· 17 events
2025-02-07Label change
Label change: OSPEMIFENE (NDA203505)
Evidence ↗
2024-02-15Label change
Label change: OSPEMIFENE (NDA203505)
Evidence ↗
2019-01-25Indication expansion
Indication expansion: OSPEMIFENE (NDA203505)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2015-01-14ApprovalMulti-authority
Approval: Senshio (EMA)

Indication: Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

10 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
10
registered trials across all phases
LATEST COMPLETION 2023
9
Late-stage (III+)
9
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 10
Phase 21Phase 36Phase 43

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Effects of Ospemifene on Brain Activation Patterns in Women With Sexual Interest-arousal Disorders

CompletedPH IVHospital Clinic of Barcelonan=252023

Ospemifene Versus Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction

TerminatedPH IVEmory Universityn=12017

Open-Label Pilot Prospective Vulvoscopy Photography Study of Visible Changes in the Vulva, Vestibule, Vagina Pre/Post 20 Weeks of Daily Administration 60 Mg Ospemifene in Post-Menopausal Women With Dyspareunia From Vulvar Vaginal Atrophy

CompletedPH IVSue Goldsteinn=102017

A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Ospemifene in Patients With Moderate to Severe Vaginal Dryness, a Symptom of Vulvo-vaginal Atrophy (VVA) Due to Menopause

CompletedPH IIIShionogin=6312017

Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity, Symptoms of Vulvar and Vaginal Atrophy (VVA), Associated With Menopause: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 60 mg Dose With Placebo in Postmenopausal Women

CompletedPH IIIShionogin=9192009

Recent completions

Trials that read out recently, adding to the completed evidence base.

Effects of Ospemifene on Brain Activation Patterns in Women With Sexual Interest-arousal Disorders

CompletedPH IVHospital Clinic of Barcelonan=252023

A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Ospemifene in Patients With Moderate to Severe Vaginal Dryness, a Symptom of Vulvo-vaginal Atrophy (VVA) Due to Menopause

CompletedPH IIIShionogin=6312017

Open-Label Pilot Prospective Vulvoscopy Photography Study of Visible Changes in the Vulva, Vestibule, Vagina Pre/Post 20 Weeks of Daily Administration 60 Mg Ospemifene in Post-Menopausal Women With Dyspareunia From Vulvar Vaginal Atrophy

CompletedPH IVSue Goldsteinn=102017

Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity, Symptoms of Vulvar and Vaginal Atrophy (VVA), Associated With Menopause: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 60 mg Dose With Placebo in Postmenopausal Women

CompletedPH IIIShionogin=9192009

Efficacy and Long-Term Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing 60 MG Oral Daily Dose of Ospemifene With Placebo

CompletedPH IIIShionogin=4262009

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: A 52-Week Open-Label Follow-Up to Protocol 15-50310

CompletedPH IIIShionogin=3012008

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20182024
Major research themes3
Estrogens1Female Urogenital Diseases1Menopause1
Journals, researchers & institutions
Top journals
  • Annals of internal medicine1
  • Sexual medicine1
Leading researchers
  • Abdi HI1
  • Anthony M1
  • Butler M1
  • Dahm P1
  • Danan ER1
  • Diem S1
  • Ensrud K1
  • Fok C1
Leading institutions
free-text, unnormalised
  • Alvarado Hospital1
  • Center for Care Delivery & Outcomes Research1
  • School of Public Health1
  • University of Minnesota1
  • VA Center for the Study of Healthcare Innovation1

Related drugs

3 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Dehydroepiandrosterone

Studied across 3 of the same disease areas as Ospemifene in the shared literature.

3 shared diseases1 shared paper
Estrogens

Studied across 3 of the same disease areas as Ospemifene in the shared literature.

3 shared diseases1 shared paper
Tamoxifen

Studied across 3 of the same disease areas as Ospemifene in the shared literature.

3 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.