Atrophic Vaginitis

6
Pipeline Programs
3
Companies
3
Clinical Trials
3
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
0
0
2
3
Early DiscoveryClinical DevelopmentMarket

On Market (3)

Approved therapies currently available

U
ESCLIMApproved
estradiol
Unknown Company
transdermal1998
U
GYNODIOLApproved
estradiol
Unknown Company
oral1997
U
IMVEXXYApproved
estradiol
Unknown Company
Estrogen [EPC]vaginal2018

Competitive Landscape

3 companies ranked by most advanced pipeline stage

Alvogen
AlvogenNJ - Morristown
1 program
1
EstradiolPhase 31 trial
Active Trials
NCT02995694Completed535Est. Dec 2016
Teva
TevaIsrael - Petach Tikva
1 program
1
Generic Estradiol Vaginal Cream USP, 0.01%Phase 31 trial
Active Trials
NCT03294538Completed663Est. Feb 2017
Pfizer
PfizerNEW YORK, NY
1 program
1
Premarin® Vaginal CreamPhase 11 trial
Active Trials
NCT00167921Completed24

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
TevaGeneric Estradiol Vaginal Cream USP, 0.01%
AlvogenEstradiol
PfizerPremarin® Vaginal Cream

Clinical Trials (3)

Total enrollment: 1,222 patients across 3 trials

NCT03294538TevaGeneric Estradiol Vaginal Cream USP, 0.01%

Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis

Start: May 2016Est. completion: Feb 2017663 patients
Phase 3Completed

A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis

Start: Mar 2016Est. completion: Dec 2016535 patients
Phase 3Completed
NCT00167921PfizerPremarin® Vaginal Cream

Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis

Start: Oct 200524 patients
Phase 1Completed

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
3 companies competing in this space