Kybella

(Deoxycholic Acid)

Phase 1Small molecule

AbbVie

Kybella is one of 35 small molecule programs targeting Neurofibromatosis Type 1. It is currently in Phase 1.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Neurofibromatosis Type 1Active, not recruiting

LipomaActive, not recruiting

Neurofibromatosis Type 1Phase 1

Active, not recruiting

LipomaPhase 1

Active, not recruiting

Competition

Competitive Landscape

41 competitors in Neurofibromatosis Type 1

#DrugCompanyPhaseTrials

Ritalin

Novartis

Approved

1 2

Verzenio

Afinitor

Temodar

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

—5

Acetadote

AArbor Pharmaceuticals, Inc.

Approved

—6

Lamictal

GGlaxo Dba Glaxosmithkline

Approved

—7

Levulan

BBiomed Industries, Inc.

Approved

—8

Celebrex

PPhiladelphia Eye Associates

Koselugo

4 10

Cysteine Hydrochloride

Novartis

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Safety and Efficacy3 trials

Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat

Completed·KKythera Biopharmaceuticals·Phase 3·NCT01294644·360 enrolled

Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat

Completed·KKythera Biopharmaceuticals·Phase 3·NCT01305577·363 enrolled

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

Completed·UUniversity of California, San Diego·Phase 1·NCT04054011·15 enrolled

Subcutaneous Fat3 trials

Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

Completed·KKythera Biopharmaceuticals·Phase 3·NCT01542034·506 enrolled

Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

Completed·KKythera Biopharmaceuticals·Phase 3·NCT01546142·516 enrolled

Open-Label Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area

Completed·KKythera Biopharmaceuticals·Phase 3·NCT01426373·165 enrolled

Lipoma2 trials

Phase 2 Study for the Treatment of Superficial Lipomas

Completed·KKythera Biopharmaceuticals·Phase 2·NCT00608842·62 enrolled

Deoxycholic Acid Injection for the Treatment of Superficial Lipomas

Completed·KKythera Biopharmaceuticals·Phase 1·NCT00422188·16 enrolled

ESS1 trial

Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat

Completed·KKythera Biopharmaceuticals·Phase 3·NCT02035267·93 enrolled

Treatment Outcome1 trial

Condition of Submental Fullness and Treatment Outcomes Registry

Completed·KKythera Biopharmaceuticals··NCT02438813·1,029 enrolled

7 more indications

Phase 11 trial

Phase 1-2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat

Completed·KKythera Biopharmaceuticals·Phase 1/2·NCT00618722·85 enrolled

Magnetic Resonance Imaging (MRI)1 trial

Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study

Completed·KKythera Biopharmaceuticals·Phase 2·NCT01032889·129 enrolled

Efficacy1 trial

Long-term 24-month Follow-up Study on Safety and Maintenance of Efficacy of ATX-101 (Sodium Deoxycholate Injection)

Completed· AbbVie logo

AbbVie··NCT03682471·201 enrolled

Phase 21 trial

Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat

Completed·KKythera Biopharmaceuticals·Phase 2·NCT00618618·73 enrolled

Neurofibromatosis Type 11 trial

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

Completed·MMassachusetts General Hospital·Phase 1·NCT06132165·13 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Deoxycholic Acid Injections for Removal of Adipose Tissue in the "Bra Strap Fat" Region

Completed·JJuva Skin & Laser Center·Phase 4·NCT04089722·22 enrolled

Unspecified1 trial

Patient Experience Study of Deoxycholic Acid Injection

Completed·KKythera Biopharmaceuticals·Phase 3·NCT02007434·84 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 29, 2015

KYBELLA

NDA NDA206333

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Deoxycholic Acid. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Deoxycholic Acid compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Deoxycholic Acid. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA206333). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Kybella. U.S. Food & Drug Administration.
[6]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 1[1]
Company: AbbVie

Patent Landscape[5]

Patent Cliff

Dec 10, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7754230Dec 10, 2027

7622130Dec 10, 2027

9636349Feb 21, 2028

9522155Feb 21, 2028

8546367Feb 21, 2028

9 more patents

8461140Feb 21, 2028

9949986Feb 21, 2028

8883770Feb 21, 2028

8242294May 16, 2028

8653058Mar 2, 2030

8367649Mar 2, 2030

8101593Mar 2, 2030

10500214Mar 2, 2030

12161653Feb 17, 2032

Kybella

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Safety and Efficacy3 trials

Subcutaneous Fat3 trials

Lipoma2 trials

ESS1 trial

Treatment Outcome1 trial

Phase 11 trial

Magnetic Resonance Imaging (MRI)1 trial

Efficacy1 trial

Phase 21 trial

Neurofibromatosis Type 11 trial

Efficacy and Safety1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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