Deoxycholic acid

(Kybella®)

Kybella®

Drug updated on 10/31/2024

Dosage FormInjection (subcutaneous; 10 mg/mL)
Drug ClassCytolytic drugs
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.

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Summary
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  • This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
  • Submental Fat Reduction: Phase 3 randomized control trials and a systematic review demonstrated that deoxycholic acid significantly reduced submental fat compared to placebo, with no differences in efficacy between doses of 1 mg/cm² and 2 mg/cm².
  • General Safety Profile: Common mild to moderate adverse effects associated with deoxycholic acid included injection site reactions, such as pain, erythema, numbness, swelling, and pruritus, most of which were transient and resolved within the treatment interval. Rare but severe adverse events, including severe pain, dysphagia, and gastrointestinal upset, were noted, particularly in cases involving higher injection volumes.
  • Procedure-Related Serious Adverse Events (SAEs): Serious adverse events, primarily due to procedural factors, were reported in real-world settings, highlighting the need for careful administration to mitigate avoidable risks.
  • There is no population types or subgroups information available in the reviewed studies.