Drug intelligence / Profile preview

estradiol vaginal cream

Development stage
Unknown
Lead developer
Prasco
Modality
Small Molecules
Administration
Vaginal
01

Overview

Estradiol vaginal cream is a topical hormonal preparation containing 17β-estradiol, a naturally occurring human estrogen. Developed by Prasco LLC as a generic equivalent to Estrace®, this formulation is specifically indicated for the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women. The drug works by binding to and activating estrogen receptors (ERα and ERβ) in the vaginal tissues, which reverses the thinning and drying of the vaginal lining caused by declining estrogen levels during menopause. By restoring the vaginal epithelium and maintaining a healthy acidic pH, the cream alleviates symptoms such as vaginal dryness, itching, and dyspareunia (painful intercourse). Prasco conducted Phase 3 clinical trials to demonstrate the therapeutic equivalence of their 0.01% estradiol cream to the reference brand, ensuring comparable efficacy and safety profiles.

Brand names
Estradiol Vaginal Cream USP, 0.01%
Other names
17-beta estradiolestradiol vaginal cream 0.01%
02

Targets

ESR2 (ERβ)GPER1 (G protein-coupled estrogen receptor 1)ESR1 (ERα)

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