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.
Background
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.
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 |