NDAINTRAUTERINESYSTEM1 Generic Approved
Approved
Sep 2016
Lifecycle
Peak
Competitive Pressure
23/100
Clinical Trials
20
Data completeness
6/8 — Strong
KYLEENA (levonorgestrel) by Bayer. Approved for progestin [epc]. First approved in 2016.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KYLEENA is a levonorgestrel-releasing intrauterine system (IUS) approved in 2016 for contraception and treatment of menorrhagia. It works through multiple mechanisms including thickening cervical mucus to inhibit sperm passage, reducing sperm mobility, and altering the endometrium. The product is indicated for contraception, menorrhagia, dysmenorrhea, and several off-label uses including adenomyosis and endometrial hyperplasia.
$49KPart D
Peak3.4 years to LOEKYLEENA is at peak lifecycle with low Part D penetration, suggesting significant untapped commercial opportunity and sustained team investment.
Mechanism of Action
Pharmacologic Class:
Progestin
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 May 2026
24 enrolled
Healthy Participants
A Study to Evaluate the Efficacy and Safety of Subcutaneous Levonorgestrel Butanoate for Female Contraception
Started Apr 2026
165 enrolled
Healthy WomenFemale Contraception
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
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Ethinyl Estradiol/Levonorgestrel (EE/LNG)
Started Dec 2025
24 enrolled
Healthy Volunteer Study
A Study to Investigate the Effect of AZD6234, AZD9550, and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity
Started Jun 2025
50 enrolled
Healthy Participants
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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.