DEOXYCHOLIC ACID
Kybella helps adult patients improve the appearance of moderate to severe fullness or convexity under the chin caused by submental fat. It is used specifically for this area, as its use for fat in other parts of the body has not been established. This medication provides a way to reduce fat deposits located directly beneath the chin.
How DEOXYCHOLIC ACID Works
This drug works by physically destroying the cell membrane when it is injected into tissue. This action causes lysis, which results in the breakdown of the targeted cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-04-02
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
DEOXYCHOLIC ACID Approval History
What DEOXYCHOLIC ACID Treats
1 indicationsDEOXYCHOLIC ACID is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Submental Fat
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Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06132165 | 2023P002152 | Ph 1 | completed | Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of 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.
DEOXYCHOLIC ACID FDA Label Details
Indications & Usage
DEOXYCHOLIC ACID is indicated for the treatment of Submental Fat.
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KYBELLA
Full clinical data, patents, trials, and competitive landscape for deoxycholic acid.
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