NDAVAGINALINSERT
Approved
May 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
IMVEXXY (estradiol) by Pfizer is estrogen receptor agonists [moa]. First approved in 2018.
Drug data last refreshed 28m ago · AI intelligence enriched 3h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IMVEXXY is a vaginal estradiol insert approved by the FDA in 2018 for the treatment of moderate-to-severe dyspareunia associated with menopausal atrophy. It works as an estrogen receptor agonist to restore vaginal tissue health and function. The product represents a localized hormone therapy approach with minimal systemic absorption.
$13MPart D
PeakStable
7.6 years to LOEProduct is at peak commercial maturity with $13M in Medicare Part D spending; the small patient base and stable trend suggest a focused, specialized commercial team rather than broad-based field expansion.
Mechanism of Action
Estrogen Receptor Agonists
Pharmacologic Class:
Estrogen
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel)
Started Jun 2026
24 enrolled
Healthy Participants
A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together
Started Mar 2026
48 enrolled
Healthy Volunteers
A Phase 1 Study to Assess the Effect of ABBV-722 on Ethinyl Estradiol and Levonorgestrel Drug Levels in Healthy Adult Female Participants
Started Mar 2026
16 enrolled
Healthy Volunteer
Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain
Started Dec 2025
130 enrolled
EndometriosisPelvic Pain
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Ethinyl Estradiol/Levonorgestrel (EE/LNG)
Started Dec 2025
24 enrolled
Healthy Volunteer Study
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.