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Estradiol (E2)
Estradiol (E2) is a Estrogen receptor agonist Small molecule drug developed by Martin Blomberg Jensen. It is currently in Phase 3 development for Menopausal vasomotor symptoms, Hormone replacement therapy, Hypogonadism. Also known as: Estreva, E2, Estrofem, Vaginal Estradiol.
Estradiol binds to estrogen receptors (ERα and ERβ) in target tissues to modulate gene expression and produce estrogenic effects.
Estradiol binds to estrogen receptors (ERα and ERβ) in target tissues to modulate gene expression and produce estrogenic effects. Used for Menopausal vasomotor symptoms, Hormone replacement therapy, Hypogonadism.
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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 | Estradiol (E2) |
|---|---|
| Also known as | Estreva, E2, Estrofem, Vaginal Estradiol |
| Sponsor | Martin Blomberg Jensen |
| Drug class | Estrogen receptor agonist |
| Target | Estrogen receptor alpha (ERα), Estrogen receptor beta (ERβ) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | Phase 3 |
Mechanism of action
Estradiol is the primary endogenous estrogen hormone that acts as a ligand for nuclear estrogen receptors, triggering downstream signaling cascades that regulate reproductive, cardiovascular, bone, and metabolic functions. It is used therapeutically in hormone replacement therapy and other endocrine conditions to restore or supplement estrogen levels.
Approved indications
- Menopausal vasomotor symptoms
- Hormone replacement therapy
- Hypogonadism
- Transgender hormone therapy
Common side effects
- Breast tenderness
- Nausea
- Headache
- Vaginal bleeding/spotting
- Fluid retention
- Thromboembolic events
Key clinical trials
- Impact Of FET Preparation Protocol On Endometrial Peristalsis: A Prospective Cohort Study
- COMPASS - COpenhagen MenoPAuSe Study (PHASE2)
- Assessing the Convenience of Natural Proliferative Phase Frozen Embryo Transfer
- Vaginal Estradiol and Oral Guaifenesin in Clomiphene Ovulation Induction (NA)
- The Role of Estrogen and Testosterone in Determining Brain Blood Flow and Metabolic Regulation in Humans (NA)
- Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy (PHASE3)
- A Dose-finding Study to Evaluate the Effect of a Contraceptive Vaginal Ring, Releasing Nestorone® and Estradiol, on Cycle Control, Ovulation Inhibition, and Pharmacokinetics in Normal Cycling Women (PHASE2)
- Understanding Cycles to Improve Women's Health
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:
- Estradiol (E2) CI brief — competitive landscape report
- Estradiol (E2) updates RSS · CI watch RSS
- Martin Blomberg Jensen portfolio CI
Frequently asked questions about Estradiol (E2)
What is Estradiol (E2)?
How does Estradiol (E2) work?
What is Estradiol (E2) used for?
Who makes Estradiol (E2)?
Is Estradiol (E2) also known as anything else?
What drug class is Estradiol (E2) in?
What development phase is Estradiol (E2) in?
What are the side effects of Estradiol (E2)?
What does Estradiol (E2) target?
Related
- Drug class: All Estrogen receptor agonist drugs
- Target: All drugs targeting Estrogen receptor alpha (ERα), Estrogen receptor beta (ERβ)
- Manufacturer: Martin Blomberg Jensen — full pipeline
- Therapeutic area: All drugs in Endocrinology
- Indication: Drugs for Menopausal vasomotor symptoms
- Indication: Drugs for Hormone replacement therapy
- Indication: Drugs for Hypogonadism
- Also known as: Estreva, E2, Estrofem, Vaginal Estradiol
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing