deoxycholic acid

Trade name: kybella

Small moleculeapproved

Approved

Apr 29, 2015

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. As a bile acid, deoxycholic acid emulsifies fat in the gut. Synthetically derived deoxycholic acid, when injected, stimulates a targeted breakdown of adipose cells by disrupting the cell membrane and causing adipocytolysis. This results in an inflammatory reaction and clearing of the adipose tissue remnants by macrophages. Deoxycholic acid's actions are reduced by albumin and tissue-associated proteins, therefore its effect is limited to protein-poor subcutaneous fat tissue. Protein-rich tissues like muscle and skin are unaffected by deoxycholic acid, contributing to its safety profile. Deoxycholic acid is a cytolytic agent. The physiologic effect of deoxycholic acid is by means of decreased cell membrane integrity. Deoxycholic acid inhibits miR-21 expression in primary rat hepatocytes in a dose-dependent manner, and increases miR-21 pro-apoptotic target programmed cell death 4 (PDCD4) and apoptosis. Deoxycholic acid decreases NF-κB activity, shown to represent an upstream mechanism leading to modulation of the miR-21/PDCD4 pathway. — NCATS

Clinical trial activity

55 trials · 56 clinical orgs · 5 marketing orgs

Phase 1
18
Phase 2
27
Phase 3
16
Phase 4
9

Earliest trial started Jan 1, 1996 (NCT00002742)

Timeline

1990s

  1. Jan 1, 1996

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2007

    Kythera — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2007

    Kythera — Earliest Phase 2 Sponsor(trial)

2010s

  1. Apr 29, 2015

    Kythera — Earliest FDA Approval

  2. Apr 29, 2015

    Kythera — NDA Secondary Org

  3. Apr 29, 2015

    Kythera — NDA Organization

  4. Apr 29, 2015

    Allergan PLC (2015) — NDA Secondary Org

  5. Apr 29, 2015

    AbbVie — Marketing Organization

2020s

  1. Apr 2, 2021

    Slayback Pharma Llc — Marketing Organization

  2. Apr 2, 2021

    Wilshire Pharmaceuticals — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedApr 29, 2015

Chemistry & pharmacology

Loading structure…

SMILES

C[C@H](CCC(O)=O)[C@H]1CC[C@H]2[C@@H]3CC[C@@H]4C[C@H](O)CC[C@]4(C)[C@H]3C[C@H](O)[C@]12C
Mol. weight
392.572 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 3alpha,12alpha-dihydroxy-5beta-cholanic acid
  • 3alpha,12alpha-dihydroxy-5beta-cholanic acid
  • (3α,5β,12α)-3,12-dihydroxycholan-24-oic acid
  • (3α,5β,12α)-3,12-dihydroxycholan-24-oic acid
  • 7α-deoxycholic acid
  • 7α-deoxycholic acid
  • amphotericin b deoxycholate
  • amphotericin b deoxycholate
  • amphotericin b deoxycholate
  • amphotericin b - deoxycholate
  • amphotericin b-deoxycholate
  • amphotericin b, deoxycholate drug combination
  • atx-101
  • atx-101
  • atx-101
  • atx-101
  • atx-101
  • d-amb cpd
  • deoxycholate
  • deoxycholate
  • deoxycholate
  • deoxycholate
  • deoxycholate
  • deoxycholate
  • deoxycholic acid
  • deoxycholic acid
  • deoxycholic acid
  • deoxycholic acid
  • deoxycholic acid
  • deoxycholic acid
  • deoxycholic acid
  • deoxycholic acid
  • deoxycholic acid
  • desoxycholic acid
  • desoxycholic acid
  • desoxycholic acid
  • desoxycholsäure
  • desoxycholsäure
  • dihydroxycholanoic acid
  • hamb-doc
  • kybella
  • kybella
  • kybella
  • sodium deoxycholate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07237425Phase 1Nov 14, 2025Cathay General Hospital, Glonova Pharma Co., Ltd
NCT06783621Phase 4Jan 16, 2025AbbVie
NCT06525389Phase 3Jan 6, 2025Bach Mai Hospital, Chiangmai University, Duke University, Gilead Sciences, Guangzhou Medical University, Maharat Nakhon Ratchasima Hospital, National Hospital for Tropical Diseases, Hanoi, Vietnam, National Institute of Allergy and Infectious Diseases (NIAID), Pham Ngoc Thach University of Medicine, Shenzhen Third People's Hospital, Tropical Diseases Hospital, Ho Chi Minh City, Viatris
NCT06756490Phase 1Dec 26, 2024Chinese Academy of Medical Sciences, Government of China, Jiao Tong University
NCT06300502Phase 1Jun 30, 2024Harvard University, Johns Hopkins University
NCT06132165Phase 1Dec 1, 2023Harvard University, Johns Hopkins University
NCT06120036Phase 1Dec 6, 2022Harvard University, Johns Hopkins University
NCT05260008Phase 2Jun 7, 2022Allay Therapeutics, Inc.
NCT05116683Phase 2Nov 30, 2021Columbia University
NCT04814875Phase 1/Phase 2 (Phase 2)Sep 1, 2021Novotech, Sir Charles Gairdner Hospital
NCT04841551Phase 4May 31, 2021Beer, Kenneth R., M.D., PA
NCT04730583Phase 1May 31, 2021Harvard University, Johns Hopkins University
NCT04089722Phase 4Jul 26, 2019Allergan, Juva Skin & Laser Center
NCT04054011Early Phase 1 (Phase 1)Jul 5, 2019University of California, San Diego
NCT03712449Phase 4Jan 22, 2019Allergan
NCT03510598Phase 4May 19, 2018Zeltiq Aesthetics
NCT03425253Phase 4Feb 2, 2018Allergan
NCT03361176Phase 4Dec 31, 2017Allergan, Goldman, Butterwick, Fitzpatrick and Groff, Maryland Laser Skin and Vein Institute
NCT03284034N/ANov 27, 2017Northwestern University
NCT02656797Phase 2Jul 1, 2017Ben Gurion University
Showing 20 of 55 trials
Page 1 / 3

Organizations

Research & Development (56)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
KytheraFor profit222232007
Sponsor GmbHAcademic/Hospital6032008
AllerganFor profit5212016
Drugs for Neglected Diseases InitiativeAcademic/Hospital4232007
Harvard UniversityAcademic/Hospital4412021
Johns Hopkins UniversityAcademic/Hospital4012021
Banaras Hindu UniversityAcademic/Hospital3322003
BayerFor profit2012010
Goldman, Butterwick, Fitzpatrick and GroffAcademic/Hospital2212016
AbbVieFor profit1112025
Allay Therapeutics, Inc.For profit1112022
Aronex PharmaceuticalsFor profit1111996
AstellasFor profit1112013
Bach Mai HospitalAcademic/Hospital1012025
Beer, Kenneth R., M.D., PAAcademic/Hospital1112021
Ben Gurion UniversityAcademic/Hospital1112017
BodyAesthetic Research CenterAcademic/Hospital1112008
Cathay General HospitalAcademic/Hospital1012025
Chiangmai UniversityAcademic/Hospital1012025
Chinese Academy of Medical SciencesAcademic/Hospital1012024
56 organizations
Page 1 / 3

Marketing (6)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGApr 29, 2015
Allergan PLC (2015)For profitNDA2Apr 29, 2015
KytheraFor profitNDA2Apr 29, 2015
KytheraFor profitNDAApr 29, 2015
Slayback Pharma LlcFor profitMKTGApr 2, 2021
Wilshire PharmaceuticalsFor profitMKTGApr 2, 2021