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Vaginal estrogen tablet
Vaginal estrogen tablet is a Small molecule drug developed by NYU Langone Health. It is currently in Phase 1 development.
Vaginal estrogen tablets contain the small molecule estradiol, a type of estrogen. They are used to treat conditions such as menopause, overactive bladder, and nonalcoholic steatohepatitis (NASH) in postmenopausal women, among other conditions.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Vaginal estrogen tablet |
|---|---|
| Sponsor | NYU Langone Health |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy (NA)
- Preventing Recurrent UTI With Vaginal Estrogen (PHASE4)
- A Real-World Study Comparing the Efficacy of Different Treatment Regimens for Early Missed Abortion (NA)
- Effect of Vaginal Estrogen on Alterations in the Urine Microbiome of Menopausal Women With Overactive Bladder (PHASE4)
- REVIVE: Replens Versus Intra-Vaginal Estrogen for the Treatment of Vaginal Dryness on Aromatase Inhibitor Therapy (PHASE2)
- Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections (PHASE4)
- Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen (NA)
- The Effectiveness of Combined Pelvic Floor Muscle Training and Vaginal Oestrogen Therapy in Postmenopausal Women With Stress Urinary Incontinence (NA)
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:
- Vaginal estrogen tablet CI brief — competitive landscape report
- Vaginal estrogen tablet updates RSS · CI watch RSS
- NYU Langone Health portfolio CI
Frequently asked questions about Vaginal estrogen tablet
What is Vaginal estrogen tablet?
Who makes Vaginal estrogen tablet?
What development phase is Vaginal estrogen tablet in?
Related
- Manufacturer: NYU Langone Health — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing