NDAORALTABLET, CHEWABLE
Approved
Jun 2022
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
4/8 — Partial
DROSPIRENONE (drospirenone) by Xeltis is ovulation. First approved in 2022.
Drug data last refreshed 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Drospirenone is an oral contraceptive tablet approved in June 2022 by Xeltis for prevention of ovulation. It is a small-molecule progestin formulated as a chewable tablet, offering a novel delivery format in the contraceptive market. The drug works by suppressing ovulation through hormonal mechanisms.
Peak4.8 years to LOE
Product is in peak commercial phase with moderate-to-high competitive pressure (score: 8/10), suggesting active commercialization efforts and potential team expansion needs.
Mechanism of Action
ovulation.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Randomized Feasibility Trial Comparing Drospirenone and Norethindrone for Postpartum Hypertension Management in Preeclampsia
Started Jul 2026
50 enrolled
HypertensionPreeclampsia
Drospirenone (3 mg) + Ethinyl Estradiol (0.03 mg) Tablets Relative to Yasmin®
Started Mar 2024
32 enrolled
Healthy Subjects
Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) Tablets Relative to Yaz®
Started Feb 2024
32 enrolled
Healthy Subjects
A Study to Investigate the Effects of BMS-986278 on Drospirenone and Ethinyl Estradiol Drug Levels in Healthy Female Participants
Started Aug 2023
37 enrolled
Healthy Volunteers
Drospirenone-only Pill as Emergency Contraception
Started Feb 2023
35 enrolled
Contraception
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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.