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Drug

Deoxycholic Acid

Established medicine
ResearchOngoing clinical research
Also known as 3alpha,12alpha-Dihydroxy-5beta-cholanic acid, DCA - Deoxycholic acid, DESOXYCHOLIC ACID, Desoxycholsäure+2 more

3alpha,12alpha-Dihydroxy-5beta-cholanic acid, DCA - Deoxycholic acid, DESOXYCHOLIC ACID, Desoxycholsäure, Kybella, 3 alpha,12 alpha, dihydroxycholanic acid.

RxNorm3194ChEMBLCHEMBL406393ATCD11AX24UNII005990WHZZ
1
Research papers
7
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

FDA Approves Additional Information in Labeling for Kybella (Deoxycholic Acid) Injection Warning of Adverse Reactions Associated with Unapproved Use

Regulatory2026-09-15Regulatory news · FDA Drug Approvals

Label change: DEOXYCHOLIC ACID (NDA206333)

Regulatory2026-09-11FDA

Label change: DEOXYCHOLIC ACID (NDA206333)

Regulatory2026-09-11FDA

Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas

Clinical trial2025-07-31Completed · ClinicalTrials.gov

Production of deoxycholic acid by low-abundant microbial species is associated with impaired glucose metabolism.

Research2024-05-20Nature communications

Label change: DEOXYCHOLIC ACID (NDA206333)

Regulatory2022-10-05FDA

Safety and Efficacy of Deoxycholic Acid Injection for Reduction of Upper Inner Thigh Fat

Clinical trial2021-01-20Results posted · ClinicalTrials.gov

Efficacy and Safety of Deoxycholic Acid Injections for Removal of Adipose Tissue in the Anterior and Posterior Aspect of the Axilla "Bra Strap Fat"

Clinical trial2020-10-22Completed · ClinicalTrials.gov

Label change: DEOXYCHOLIC ACID (NDA206333)

Regulatory2020-05-20FDA

Label change: DEOXYCHOLIC ACID (NDA206333)

Regulatory2020-05-20FDA

A Multicenter, Double-blind, Placebo-controlled Safety Study of ATX-101 (Deoxycholic Acid) Injection for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects With Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Grade 1 or CR-SMFRS Grade 4

Clinical trial2020-02-17Results posted · ClinicalTrials.gov

Label change: DEOXYCHOLIC ACID (NDA206333)

Regulatory2018-01-18FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Deoxycholic Acid
Aliases & brands
3alpha,12alpha-Dihydroxy-5beta-cholanic acidDCA - Deoxycholic acidDESOXYCHOLIC ACIDDesoxycholsäureKybella3 alpha,12 alpha, dihydroxycholanic acid
RxNorm CUI
3194
ChEMBL ID
CHEMBL406393
ATC codes
D11AX24
UNII
005990WHZZ
Regulatory jurisdictions
fda

Regulatory timeline

7 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2015-04-29
Latest approval
2015-04-29
Authorities
FDA
Total events
7
fdaU.S. Food and Drug Administration· 7 events
2026-09-11Label change
Label change: DEOXYCHOLIC ACID (NDA206333)
Evidence ↗
2026-09-11Label change
Label change: DEOXYCHOLIC ACID (NDA206333)
Evidence ↗
2022-10-05Label change
Label change: DEOXYCHOLIC ACID (NDA206333)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

15 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
15
registered trials across all phases
LATEST COMPLETION 2025
8
Late-stage (III+)
15
Completed
PHASE DISTRIBUTIONn = 15
Early Phase 11Phase 12Phase 1 / 21Phase 23Phase 37Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Efficacy and Safety of Deoxycholic Acid Injections for Removal of Adipose Tissue in the Anterior and Posterior Aspect of the Axilla "Bra Strap Fat"

CompletedPH IVJuva Skin & Laser Centern=222020

A Multicenter, Double-blind, Placebo-controlled Safety Study of ATX-101 (Deoxycholic Acid) Injection for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects With Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Grade 1 or CR-SMFRS Grade 4

CompletedPH IIIKythera Biopharmaceuticalsn=932015

A Single Center, Double-blind, Parallel-group, Two Factor Patient-Experience Management Study of ATX-101 (Deoxycholic Acid Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area

CompletedPH IIIKythera Biopharmaceuticalsn=842014

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

CompletedPH IIIKythera Biopharmaceuticalsn=5162013

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

CompletedPH IIIKythera Biopharmaceuticalsn=5062013

Recent completions

Trials that read out recently, adding to the completed evidence base.

Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas

CompletedPH IMassachusetts General Hospitaln=132025

Efficacy and Safety of Deoxycholic Acid Injections for Removal of Adipose Tissue in the Anterior and Posterior Aspect of the Axilla "Bra Strap Fat"

CompletedPH IVJuva Skin & Laser Centern=222020

Safety and Efficacy of Deoxycholic Acid Injection for Reduction of Upper Inner Thigh Fat

CompletedPH IUniversity of California, San Diegon=152020

A Multicenter, Double-blind, Placebo-controlled Safety Study of ATX-101 (Deoxycholic Acid) Injection for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects With Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Grade 1 or CR-SMFRS Grade 4

CompletedPH IIIKythera Biopharmaceuticalsn=932015

A Single Center, Double-blind, Parallel-group, Two Factor Patient-Experience Management Study of ATX-101 (Deoxycholic Acid Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area

CompletedPH IIIKythera Biopharmaceuticalsn=842014

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

CompletedPH IIIKythera Biopharmaceuticalsn=5162013

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes4
Deoxycholic Acid1Diabetes Mellitus, Type 21Gastrointestinal Microbiome1Glucose1
Journals, researchers & institutions
Top journals
  • Nature communications1
Leading researchers
  • Bäckhed F1
  • Bergström G1
  • Brumbaugh A1
  • Fischbach MA1
  • Hazen SL1
  • Henricsson M1
  • Lundqvist A1
  • Makki K1
Leading institutions
free-text, unnormalised
  • Center for Microbiome and Human Health1
  • ChEM-H Institute1
  • Lerner Research Institute1
  • Novo Nordisk Foundation Center for Basic Metabolic Research1
  • Sahlgrenska University Hospital1
  • Stanford University1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Cholic Acid

Studied across the same disease area as Deoxycholic Acid in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.