KYBELLA (deoxycholic acid)
Kybella (deoxycholic acid) is a cytolytic agent indicated for the improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. Its use is specifically limited to the submental region; safety and efficacy for the treatment of subcutaneous fat outside this area have not been established and are not recommended.
How KYBELLA Works
Kybella is a cytolytic drug that physically destroys the cell membrane of adipocytes (fat cells) upon injection into tissue. This disruption leads to cell lysis, resulting in the permanent destruction of the targeted fat cells in the submental area.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-04-29
- Patent Cliff
- 2032
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
KYBELLA Approval History
What KYBELLA Treats
1 indicationsKYBELLA is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Submental Fat
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Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06300502 | 2023P003620 | Ph 1 | enrolling by invitation | Assessing the Efficacy of Repeat, Monthly Treatments of Deoxycholate for NF1 Associated Cutaneous Neurofibromas (cNFs) |
| NCT06783621 US Harmony | M24-704 | Ph 4 | completed | A Study to Evaluate Patient Satisfaction With the Overall Face and Neck Appearance After Combined Treatment of OnabotulinumtoxinA, JUVÉDERM® Products, KYBELLA, CoolSculpting Elite and SkinMedica Products |
| NCT07237425 | SDC003 | Ph 1 | recruiting | Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma |
| NCT06132165 | 2023P002152 | Ph 1 | completed | Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas |
| NCT06120036 | 2022P001946 | Ph 1 | completed | Dosing and Tolerability of Deoxycholic Acid vs. Polidocanol in the Treatment of Neurofibromatosis Type 1 Cutaneous Neurofibromas |
| NCT04730583 | 2020P004137 | Ph 1 | completed | Tolerability of Device Based Therapies for Neurofibromatosis Type 1 Cutaneous Neurofibromas |
| NCT04089722 | 60E56 | Ph 4 | completed | Efficacy and Safety of Deoxycholic Acid Injections for Removal of Adipose Tissue in the "Bra Strap Fat" Region |
| NCT02035267 results posted | ATX-101-13-27 | Ph 3 | completed | Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat |
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.
KYBELLA FDA Label Details
Indications & Usage
FDA Label (PDF)KYBELLA is indicated for the treatment of Submental Fat.
KYBELLA Patents & Exclusivity
Patents (14 active)
Pro Intelligence Preview
Deep insights for KYBELLA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 14 active patents
Trial Analysis
- • 5 total trials
- • Stage: Stable
Competitive Landscape
- • 1 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