deoxycholic acid
Trade name: kybella
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
Earliest trial started Jan 1, 1996 (NCT00002742)
Timeline
1990s
- Jan 1, 1996
Earliest Phase 3 Sponsor(trial)
2000s
2010s
- Apr 29, 2015
Kythera — Earliest FDA Approval
- Apr 29, 2015
Kythera — NDA Secondary Org
- Apr 29, 2015
Kythera — NDA Organization
- Apr 29, 2015
Allergan PLC (2015) — NDA Secondary Org
- Apr 29, 2015
AbbVie — Marketing Organization
2020s
- Apr 2, 2021
Slayback Pharma Llc — Marketing Organization
- Apr 2, 2021
Wilshire Pharmaceuticals — Marketing Organization
Indications
Approved for
Studied for
- Adiposity · Phase 4
- Body Contouring · Phase 4
- Body Fat Distribution · Phase 4
- Candidiasis · Phase 3
- Candidiasis, Invasive · Phase 2
- Drug Evaluation · Phase 3
- Fallopian Tube Neoplasms · Phase 1/Phase 2
- Fat Body · Phase 4
- Hamartoma · Phase 1/Phase 2
- Healthy Volunteers · Phase 3
- Infections · Phase 3
- Leiomyosarcoma · Phase 2
- Leishmaniasis · Phase 2
- Leishmaniasis, Cutaneous · Phase 1/Phase 2
- Leishmaniasis, Visceral · Phase 4
- Leukemia · Phase 3
- Lipoma · Phase 2
- Liposarcoma · Phase 2
- Lung Diseases · Phase 3
- Lymphoma · Phase 3
- Multiple Myeloma · Phase 3
- Mycoses · Phase 3
- Myelodysplastic Syndromes · Phase 3
- Myeloproliferative Disorders · Phase 3
- Neurofibroma · Phase 1
- Neurofibromatosis 1 · Phase 1
- Ovarian Neoplasms · Phase 1/Phase 2
- Postoperative Pain · Phase 2
- Rhytidoplasty · Phase 4
- Safety · Phase 3
Mechanism of action
- Cell membraneDISRUPTING AGENT
Cell membrane disrupting agent
Approval history
- approvedApr 29, 2015
Chemistry & pharmacology
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
- WikipediaDeoxycholic acid ↗
- NCATS005990WHZZ ↗
- ChEMBLCHEMBL514674 ↗
- ChEMBLCHEMBL453873 ↗
- ChEMBLCHEMBL406393 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07237425 | Phase 1 | Nov 14, 2025 | Cathay General Hospital, Glonova Pharma Co., Ltd |
| NCT06783621 | Phase 4 | Jan 16, 2025 | AbbVie |
| NCT06525389 | Phase 3 | Jan 6, 2025 | Bach 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 |
| NCT06756490 | Phase 1 | Dec 26, 2024 | Chinese Academy of Medical Sciences, Government of China, Jiao Tong University |
| NCT06300502 | Phase 1 | Jun 30, 2024 | Harvard University, Johns Hopkins University |
| NCT06132165 | Phase 1 | Dec 1, 2023 | Harvard University, Johns Hopkins University |
| NCT06120036 | Phase 1 | Dec 6, 2022 | Harvard University, Johns Hopkins University |
| NCT05260008 | Phase 2 | Jun 7, 2022 | Allay Therapeutics, Inc. |
| NCT05116683 | Phase 2 | Nov 30, 2021 | Columbia University |
| NCT04814875 | Phase 1/Phase 2 (Phase 2) | Sep 1, 2021 | Novotech, Sir Charles Gairdner Hospital |
| NCT04841551 | Phase 4 | May 31, 2021 | Beer, Kenneth R., M.D., PA |
| NCT04730583 | Phase 1 | May 31, 2021 | Harvard University, Johns Hopkins University |
| NCT04089722 | Phase 4 | Jul 26, 2019 | Allergan, Juva Skin & Laser Center |
| NCT04054011 | Early Phase 1 (Phase 1) | Jul 5, 2019 | University of California, San Diego |
| NCT03712449 | Phase 4 | Jan 22, 2019 | Allergan |
| NCT03510598 | Phase 4 | May 19, 2018 | Zeltiq Aesthetics |
| NCT03425253 | Phase 4 | Feb 2, 2018 | Allergan |
| NCT03361176 | Phase 4 | Dec 31, 2017 | Allergan, Goldman, Butterwick, Fitzpatrick and Groff, Maryland Laser Skin and Vein Institute |
| NCT03284034 | N/A | Nov 27, 2017 | Northwestern University |
| NCT02656797 | Phase 2 | Jul 1, 2017 | Ben Gurion University |
Organizations
Research & Development (56)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Kythera | For profit | 22 | 22 | 3 | 2007 |
| Sponsor GmbH | Academic/Hospital | 6 | 0 | 3 | 2008 |
| Allergan | For profit | 5 | 2 | 1 | 2016 |
| Drugs for Neglected Diseases Initiative | Academic/Hospital | 4 | 2 | 3 | 2007 |
| Harvard University | Academic/Hospital | 4 | 4 | 1 | 2021 |
| Johns Hopkins University | Academic/Hospital | 4 | 0 | 1 | 2021 |
| Banaras Hindu University | Academic/Hospital | 3 | 3 | 2 | 2003 |
| Bayer | For profit | 2 | 0 | 1 | 2010 |
| Goldman, Butterwick, Fitzpatrick and Groff | Academic/Hospital | 2 | 2 | 1 | 2016 |
| AbbVie | For profit | 1 | 1 | 1 | 2025 |
| Allay Therapeutics, Inc. | For profit | 1 | 1 | 1 | 2022 |
| Aronex Pharmaceuticals | For profit | 1 | 1 | 1 | 1996 |
| Astellas | For profit | 1 | 1 | 1 | 2013 |
| Bach Mai Hospital | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Beer, Kenneth R., M.D., PA | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Ben Gurion University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| BodyAesthetic Research Center | Academic/Hospital | 1 | 1 | 1 | 2008 |
| Cathay General Hospital | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Chiangmai University | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 1 | 0 | 1 | 2024 |
Marketing (6)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AbbVie | For profit | MKTG | Apr 29, 2015 |
| Allergan PLC (2015) | For profit | NDA2 | Apr 29, 2015 |
| Kythera | For profit | NDA2 | Apr 29, 2015 |
| Kythera | For profit | NDA | Apr 29, 2015 |
| Slayback Pharma Llc | For profit | MKTG | Apr 2, 2021 |
| Wilshire Pharmaceuticals | For profit | MKTG | Apr 2, 2021 |