MedPath

Deoxycholic acid

Generic Name
Deoxycholic acid
Brand Names
Belkyra, Kybella
Drug Type
Small Molecule
Chemical Formula
C24H40O4
CAS Number
83-44-3
Unique Ingredient Identifier
005990WHZZ

Overview

Deoxycholic acid is a a bile acid which emulsifies and solubilizes dietary fats in the intestine, and when injected subcutaneously, it disrupts cell membranes in adipocytes and destroys fat cells in that tissue. In April 2015, deoxycholic acid was approved by the FDA for the treatment submental fat to improve aesthetic appearance and reduce facial fullness or convexity. It is marketed under the brand name Kybella by Kythera Biopharma and is the first pharmacological agent available for submental fat reduction, allowing for a safer and less invasive alternative than surgical procedures.

Indication

For improvement in appearance of moderate to severe fullness associated with submental fat in adults.

Associated Conditions

No associated conditions information available.

Research Report

Published: Aug 25, 2025

Deoxycholic Acid: A Comprehensive Monograph on its Pharmacology, Clinical Utility, and Safety Profile

1.0 Introduction and Drug Identification

1.1 Overview of Deoxycholic Acid's Dual Nature

Deoxycholic acid is a molecule of dual identity, existing as both a fundamental component of human physiology and a targeted therapeutic agent in aesthetic medicine. Biologically, it is a secondary bile acid, a metabolic byproduct formed within the intestine through the action of gut microbiota on primary bile acids, such as cholic acid, which are synthesized in the liver from cholesterol.[1] Its principal physiological function is to act as a biological detergent, facilitating the emulsification, solubilization, and subsequent absorption of dietary fats and fat-soluble vitamins within the intestine.[1]

This inherent cytolytic (cell-disrupting) property has been harnessed for therapeutic purposes. A chemically synthesized, non-animal-derived formulation of deoxycholic acid has been developed as a first-in-class injectable drug for the localized reduction of subcutaneous adipose tissue.[3] Marketed under the brand names Kybella™ and Belkyra™, this formulation represents a paradigm shift in aesthetic medicine, offering a minimally invasive, non-surgical alternative to procedures like liposuction for contouring specific anatomical areas.[3] Its primary and regulatory-approved indication is for the improvement in the appearance of moderate to severe submental fullness, colloquially known as a "double chin".[1][ The development of injectable deoxycholic acid exemplifies the strategic application of a deep understanding of a natural biological process to achieve a targeted and predictable pharmacological outcome.]

1.2 Nomenclature and Chemical Identifiers

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/01/20
Phase 4
Recruiting
2024/07/29
Phase 3
Not yet recruiting
2024/06/07
Phase 3
Recruiting
Post Graduate Institute of Medical Education and Research, Chandigarh
2024/03/08
Phase 1
Not yet recruiting
2023/11/15
Phase 1
Recruiting
2023/11/07
Phase 1
Completed
2021/04/12
Phase 4
Completed
Beer, Kenneth R., M.D., PA
2021/01/29
Phase 1
Completed
2019/09/13
Phase 4
Completed
Juva Skin & Laser Center
2019/08/28
Early Phase 1
UNKNOWN
First Affiliated Hospital of Zhejiang University

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Kythera Biopharmaceuticals Inc.
61168-101
SUBCUTANEOUS
20 mg in 2 mL
3/11/2024

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
BELKYRA INJECTION 10 MG/ML
SIN15509P
INJECTION, SOLUTION
10.00 mg/mL
6/21/2018
ENZYPLEX TABLET
SIN06211P
ENTERIC COATED TABLET
30 mg
5/3/1991

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
BELKYRA deoxycholic acid 10 mg/mL injection glass vial
233201
Medicine
A
7/21/2016

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
BELKYRA
02443910
Solution - Subcutaneous
10 MG / ML
1/27/2016
MEDICHOL
medic laboratory ltée
00134759
Tablet - Oral
30 MG
12/31/1959
DUCHOL ECT
00391484
Tablet (Enteric-Coated) - Oral
30 MG
12/31/1977
ARTICHOKE COMPOUND TABLETS
pharmetics (2011) inc
02063980
Tablet - Oral
25 MG
12/31/1994
DEBILINE
lab nadeau ltée, division of technilab inc.
00145491
Tablet - Oral
100 MG
12/31/1951
DEBILINE H
lab nadeau ltée, division of technilab inc.
00145653
Tablet - Oral
100 MG
12/31/1951
REGUBIL
laboratoire riva inc.
00557110
Tablet - Oral
30 MG
12/31/1983

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.