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Kybella (DEOXYCHOLIC ACID)
Kybella (generic name: DEOXYCHOLIC ACID) is a Cytolytic Agent [EPC] Small molecule drug developed by AbbVie. It is currently FDA-approved (first approved 2015) for Excess subcutaneous fat.
Kybella works by targeting and destroying excess fat cells through a process that involves disrupting the cell membrane.
Kybella, also known as deoxycholic acid, is a cytolytic agent originally developed by Kythera Biopharmaceuticals and currently owned by Abbvie. It targets the G-protein coupled bile acid receptor 1 to treat excess subcutaneous fat. Kybella is a small molecule modality that was FDA approved in 2015 for its approved indications. The commercial status of Kybella is patented, with only one generic manufacturer available. Key safety considerations include the potential for injection site reactions and nerve damage.
At a glance
| Generic name | DEOXYCHOLIC ACID |
|---|---|
| Sponsor | AbbVie |
| Drug class | Cytolytic Agent [EPC] |
| Target | G-protein coupled bile acid receptor 1 |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2015 |
Mechanism of action
KYBELLA injection is cytolytic drug, which when injected into tissue physically destroys the cell membrane causing lysis.
Approved indications
- Excess subcutaneous fat
Common side effects
- Injection site edema/swelling
- Injection site reactions
- Injection site numbness
- Injection site pain
- Injection site induration
- Hematoma/bruising
- Erythema
- Paresthesia
- Nodule
- Pruritus
- Site warmth
- Nerve injury
Key clinical trials
- A Study to Evaluate Patient Satisfaction With the Overall Face and Neck Appearance After Combined Treatment of OnabotulinumtoxinA, JUVÉDERM® Products, KYBELLA, CoolSculpting Elite and SkinMedica Products (PHASE4)
- Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia (PHASE4)
- The Role of Secondary Bile Acids in Intestinal Inflammation (PHASE2,PHASE3)
- A Phase I Study of HY-2003 in the Subjects With Excessive Submental Fat Accumulation (PHASE1)
- Comparing UDCA and Corticosteroids in Immunotherapy Induced Cholestatic Hepatitis (PHASE2)
- Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) for the Treatment of Flank Fat (NA)
- Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis (PHASE3)
- Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Kybella CI brief — competitive landscape report
- Kybella updates RSS · CI watch RSS
- AbbVie portfolio CI
Frequently asked questions about Kybella
What is Kybella?
How does Kybella work?
What is Kybella used for?
Who makes Kybella?
What is the generic name of Kybella?
What drug class is Kybella in?
When was Kybella approved?
What development phase is Kybella in?
What are the side effects of Kybella?
What does Kybella target?
Related
- Drug class: All Cytolytic Agent [EPC] drugs
- Target: All drugs targeting G-protein coupled bile acid receptor 1
- Manufacturer: AbbVie — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Excess subcutaneous fat
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing