SKYLA (levonorgestrel)
Skyla is a progestin-containing intrauterine system used for the prevention of pregnancy for up to three years. This device helps patients who are looking for long-term contraception by providing continuous hormone release within the uterus. If a patient wants to continue preventing pregnancy after the initial three-year period, the system is replaced with a new one.
How SKYLA Works
The exact local mechanism by which Skyla prevents pregnancy has not been conclusively demonstrated. However, studies suggest several contributing actions: thickening of the cervical mucus to prevent sperm passage, inhibition of sperm capacitation and survival, and alteration of the endometrium (uterine lining).
Details
- Status
- Prescription
- First Approved
- 2013-01-09
- Patent Cliff
- 2029
- Routes
- INTRAUTERINE
- Dosage Forms
- SYSTEM
SKYLA Approval History
What SKYLA Treats
1 indicationsSKYLA is approved for 1 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pregnancy prevention
SKYLA 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 SKYLA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
15 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03537768 | CCN013C | Ph 4 | terminated | Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg |
| 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 |
| 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 |
| 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.
SKYLA FDA Label Details
Indications & Usage
FDA Label (PDF)SKYLA is indicated for the treatment of Pregnancy prevention.
Pro Intelligence Preview
Deep insights for SKYLA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 3 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 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.