Kybella and Belkyra

Kybella and Belkyra are regional brand names for prescription deoxycholic-acid injections used to improve the appearance of moderate to severe submental fullness in adults. Kybella is the United States identity; Belkyra is the name used in Canada and some other markets. A shared active ingredient and corporate lineage do not make every regional carton, label, approval holder, or instruction interchangeable.

Quick reference

Field	Kybella — United States	Belkyra — Canada
Active ingredient	Deoxycholic acid 10 mg/mL	Deoxycholic acid 10 mg/mL
Presentation	Clear, colorless sterile solution; 2 mL single-patient-use vial	Solution; 2 mL single-use vial
Regulatory identifier	NDA 206333	DIN 02443910
Current regulatory status	FDA-approved prescription drug	Marketed prescription drug in Health Canada’s Drug Product Database
Approved objective	Improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults	Improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults
Current listed company role	AbbVie distributes the US product and the label says it is manufactured for AbbVie	AbbVie Corporation is the company listed in the Canadian record

Sources: current US prescribing information 🔗, FDA 2022 approval supplement 🔗, Health Canada product record 🔗, and Health Canada prescription-status notice 🔗.

One product lineage, regional identities

The names should be connected, but not collapsed into a single universal label.

• Kybella received its initial US approval in 2015 under NDA 206333. The original FDA action package names Kythera Biopharmaceuticals as the applicant (FDA original NDA action package 🔗).
• Belkyra is recorded by Health Canada as deoxycholic acid 10 mg/mL, DIN 02443910. The database lists an original market date of January 27, 2016, a current Marketed status, and AbbVie Corporation as the company (Health Canada product record 🔗).
• The current US label says Kybella is distributed by and manufactured for AbbVie Inc. It also identifies Kybella as a registered trademark of Allergan Sales, LLC, an AbbVie company (US prescribing information 🔗).

This history supports a connected product family. It does not establish that a Belkyra vial from one country has the same excipient list, packaging configuration, approved text, or local commercial company as Kybella in the United States.

US formulation and physical form

The October 2024 US prescribing information describes Kybella as a clear, colorless, sterile solution for subcutaneous use. Each 2 mL vial contains:

Component	Quantity per US vial
Synthetic deoxycholic acid	20 mg
Benzyl alcohol	18 mg
Dibasic sodium phosphate	2.84 mg
Sodium chloride	8.76 mg
Sodium hydroxide	2.86 mg
Water for injection	Vehicle

Hydrochloric acid and additional sodium hydroxide may be used to adjust the formulation to pH 8.3. These are Kybella US label facts. Do not automatically assign the full excipient list to Belkyra or another deoxycholic-acid product without its own current product monograph.

The formulation is not a phosphatidylcholine mixture and not a filler gel. The US label classifies deoxycholic acid as a cytolytic agent: in injected tissue it physically disrupts cell membranes and causes lysis. That mechanism should not be softened into the marketing phrase “melting fat,” and it should not be assumed to act selectively if deposited in the wrong tissue.

Approved anatomy is narrow

The US indication is improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. The label states that safe and effective use for subcutaneous fat outside the submental region has not been established and is not recommended (US prescribing information 🔗).

Health Canada’s prescription-status notice uses the same adult submental-fat objective and emphasizes that professionals administering the product must understand relevant submental anatomy, neuromuscular structures, and anatomy altered by prior surgical or aesthetic procedures (Health Canada notice 🔗).

Do not turn published use in the jowl, bra line, abdomen, thigh, or another body area into an approved Kybella or Belkyra indication. Deoxycholic acid injection is not itself a body-wide approval category.

Regional label and anatomy remain controlling

Kybella’s US label and Belkyra’s Canadian product monograph are separate documents. Use of a shared brand family does not transfer an indication, instruction, or company role between countries.

Evidence and treatment interpretation

The pivotal US evidence comprised two randomized, multicenter, double-blind, placebo-controlled trials in adults with clinician- and patient-rated moderate or severe submental fullness. The current label reports higher composite response rates with Kybella than placebo and an MRI substudy in which at least a 10% reduction in submental-fat volume occurred more often with Kybella (US prescribing information 🔗).

Those trials support the labeled product, anatomy, population, and assessment framework. They do not establish:

• equivalent outcomes for a compounded or online-market deoxycholate solution
• safety in anatomy outside the submental region
• interchangeability with a phosphatidylcholine/deoxycholate mixture
• a universal number of treatment sessions
• guaranteed permanence or absence of later contour change

This reference intentionally does not reproduce a point-by-point injection recipe. The current local prescribing information, patient anatomy, and professional training govern administration.

Company and regulatory roles

Role	Supported relationship
Original US NDA applicant	Kythera Biopharmaceuticals, Inc.
Current US distribution and manufactured for role	AbbVie Inc.
US trademark owner stated in current labeling	Allergan Sales, LLC, an AbbVie company
Canadian company in the Drug Product Database	AbbVie Corporation
Physical manufacturer	Not identified in the reviewed current US label or public Canadian database entry; verify from the controlling local supply-chain record

AbbVie, Allergan, and Kythera should not all be described simply as “the manufacturer.” Their documented roles differ by date and source.

Safety boundaries

The US label contraindicates treatment where infection is present at an injection site. Important warnings include marginal mandibular nerve injury, dysphagia, hematoma or bruising, injury near vulnerable anatomic structures, injection-site alopecia, and injection-site ulceration, necrosis, and infection. Inadvertent arterial or venous injection can cause vascular injury (US prescribing information 🔗).

Common reactions in the US trials included injection-site swelling, bruising, pain, numbness, redness, and induration. A familiar adverse-event profile does not make an unlabeled area or a different deoxycholic-acid product equivalent to Kybella.

Deoxycholic acid is not hyaluronic acid. There is no simple product-wide enzymatic reversal pathway analogous to hyaluronidase degradation of many HA gels.

Related reference

• Fat-Reduction Injectables places this approved regional product family within the wider formulation and regulatory map.