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
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
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. |
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