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Generic Estradiol Vaginal Cream USP, 0.01%
Generic Estradiol Vaginal Cream USP, 0.01% is a Estrogen receptor agonist Small molecule drug developed by Actavis Inc.. It is currently in Phase 3 development for Atrophic vaginitis / Genitourinary syndrome of menopause (GSM), Vaginal atrophy associated with menopause.
Estradiol binds to estrogen receptors in vaginal tissue to restore local estrogen levels and alleviate symptoms of vaginal atrophy and urogenital dysfunction.
Estradiol binds to estrogen receptors in vaginal tissue to restore local estrogen levels and alleviate symptoms of vaginal atrophy and urogenital dysfunction. Used for Atrophic vaginitis / Genitourinary syndrome of menopause (GSM), Vaginal atrophy associated with menopause.
At a glance
| Generic name | Generic Estradiol Vaginal Cream USP, 0.01% |
|---|---|
| Sponsor | Actavis Inc. |
| Drug class | Estrogen receptor agonist |
| Target | Estrogen receptor alpha (ERα), Estrogen receptor beta (ERβ) |
| Modality | Small molecule |
| Therapeutic area | Gynecology / Menopause |
| Phase | Phase 3 |
Mechanism of action
Estradiol is a naturally occurring estrogen that acts as an agonist at estrogen receptors (ERα and ERβ) in the vaginal epithelium and urogenital tissues. Local vaginal application delivers high concentrations of estradiol directly to affected tissues while minimizing systemic absorption, restoring vaginal maturation, elasticity, and moisture to relieve symptoms of genitourinary syndrome of menopause (GSM).
Approved indications
- Atrophic vaginitis / Genitourinary syndrome of menopause (GSM)
- Vaginal atrophy associated with menopause
Common side effects
- Vaginal irritation or burning
- Headache
- Breast tenderness
- Vaginal discharge
Key clinical trials
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:
- Generic Estradiol Vaginal Cream USP, 0.01% CI brief — competitive landscape report
- Generic Estradiol Vaginal Cream USP, 0.01% updates RSS · CI watch RSS
- Actavis Inc. portfolio CI
Frequently asked questions about Generic Estradiol Vaginal Cream USP, 0.01%
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Related
- Drug class: All Estrogen receptor agonist drugs
- Target: All drugs targeting Estrogen receptor alpha (ERα), Estrogen receptor beta (ERβ)
- Manufacturer: Actavis Inc. — full pipeline
- Therapeutic area: All drugs in Gynecology / Menopause
- Indication: Drugs for Atrophic vaginitis / Genitourinary syndrome of menopause (GSM)
- Indication: Drugs for Vaginal atrophy associated with menopause
- Compare: Generic Estradiol Vaginal Cream USP, 0.01% vs similar drugs
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