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 2h ago · AI intelligence enriched 2h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IMVEXXY is a vaginal insert formulation of estradiol, a small-molecule estrogen receptor agonist approved by the FDA in 2018. It is indicated for moderate-to-severe dyspareunia (vaginal pain during intercourse) due to menopause-related vaginal atrophy. The drug works by delivering estradiol directly to vaginal tissue to restore hormonal balance and improve symptoms.
$13MPart D
Peak7.5 years to LOEThe product is in peak commercial phase with stable Part D spending of $13M annually; team size likely stable but not expanding significantly.
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
15 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.