MIRENA (levonorgestrel)
Mirena is a progestin-containing intrauterine system used for long-term pregnancy prevention for up to eight years. It also helps patients with heavy menstrual bleeding for up to five years if they choose an intrauterine device as their contraceptive method. This system provides a continuous release of hormones directly within the uterus to manage these reproductive health needs.
How MIRENA Works
This system works by continuously releasing levonorgestrel locally to prevent pregnancy through several actions. It thickens cervical mucus to block sperm from entering the uterus, inhibits sperm survival, and alters the uterine lining.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2000-12-06
- Patent Cliff
- 2029
- Routes
- INTRAUTERINE
- Dosage Forms
- SYSTEM
MIRENA Approval History
What MIRENA Treats
1 indicationsMIRENA is approved for 1 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Heavy Menstrual Bleeding
MIRENA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MIRENA
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03537768 | CCN013C | Ph 4 | terminated | Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg |
| NCT06073184 WE-FiERCE | 25-5042 | Ph 2 | not yet recruiting | Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Low-grade Cancer of the Endometrium |
| NCT06727734 | UW 24-054 | Ph 3 | recruiting | Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception |
| NCT02722421 | 0234-16-FB 1R01HD085887-01A1 | Ph 2 | completed | Pharmacologic Strategies to Use the Levonorgestrel Implant in HIV-infected Women |
| NCT01686126 feMMe | feMMe | Ph 2 | active not recruiting | Improving the Treatment for Women With Early Stage Cancer of the Uterus |
| NCT00995150 results posted | M360-L102 | Ph 3 | terminated | A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception |
| NCT06492889 | 8007 | Ph 2, Ph 3 | not yet recruiting | Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens |
| NCT02203331 results posted | 15832 2013-005090-53 | Ph 2 | completed | Bay98-7196, Dose Finding / POC Study |
| NCT01789879 | 0022-14-EP 1R21HD074462-01 | Ph 2 | completed | A Pharmacokinetic Evaluation of Levonorgestrel Implant and Antiretroviral Therapy |
| NCT00445887 results posted | GOG-0214 NCI-2009-00588, 10-01367 | Ph 2 | completed | Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer |
| NCT02490774 | 15731 2013-003980-74 | Ph 2 | terminated | To Investigate the Pharmacological Effects, Drug Blood Levels and Safety of an Intrauterine System Releasing the Study Drug BAY1007626 in Comparison to Mirena and Jaydess in Healthy Young Women Treated for 90 Days to Determine the Drug Dose for Further Development |
| NCT01623466 ATI-CL21 results posted | ATI-CL21 | Ph 1, Ph 2 | completed | Study to Evaluate Pharmacokinetics Profile, Wearability, and Safety of 2 Progestin-Only Patches |
| NCT02480647 | 44827415200005404 | Ph 4 | completed | Clinical Trial the Use of Levonorgestrel-releasing Intrauterine System Versus Etonogestrel Implant in Endometriosis |
| NCT02599077 | FSantafeBogota | Ph 2, Ph 3 | suspended | Impact vs. Dienogest: A Combined Oral Contraceptive in the Size of Endometriomas |
| NCT01570244 results posted | 1220.56 2011-006061-17 | Ph 1 | completed | Drug-drug Interaction of BI 201335 and Microgynon |
| NCT02159131 | 117011 | Ph 1 | completed | Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel and Ethinyl Estradiol When Co-administered With GSK1265744 in Healthy Adult Female Subjects |
| NCT01328184 results posted | 1245.41 2010-023432-16 | Ph 1 | completed | Drug-drug Interaction of Empagliflozin (BI 10773) and Microgynon |
| NCT00922233 results posted | 10139 | Ph 3 | completed | Pericoital Oral Contraception With Levonorgestrel |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MIRENA FDA Label Details
Indications & Usage
FDA Label (PDF)MIRENA is indicated for the treatment of Heavy Menstrual Bleeding.
MIRENA Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for MIRENA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 2 active patents
Trial Analysis
- • 22 total trials
- • Stage: Declining
Competitive Landscape
- • 4 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment