Belkyra

Deoxycholic acid · AbbVie

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How it works

Injected into the fat under the chin, disrupting the fat cells’ membranes

Subcutaneous fatNeedleThe fat cells beside eachdeposit, their membranesdisrupted.

Deoxycholic acidThe fat cells’ membranes disrupted

Layers, top to bottom: epidermis, dermis, subcutaneous fat, platysma muscle.

EpidermisDermisSubcutaneous fatPlatysma muscleNeedleThe fat cells beside each deposit, theirmembranes disrupted.

Deoxycholic acidThe fat cells’ membranes disrupted

0.2 mL a site, 1 cm apart, up to 50 sites. Into the subcutaneous fat between the dermis and the platysma muscle, never the fat behind the muscle, at mid-depth, the needle perpendicular to the skin, on a 1 cm grid; a cytolytic drug that “physically disrupts the cell membrane”, the monograph states. Use anywhere but under the chin is not established. Illustrations are schematic.

What Belkyra is for, and who it isn't for

Which chins its label rules out, how many improved in the maker's trials, the swelling to expect, and the catch: an uneven smile in about four in a hundred.

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What it costs

Treating the fat under the chin costs $650 – $1,100 a vial on clinic pages

Under the chin, the one area the licence names

AreaA vial
two pages price the visit instead$650 – $1,100a vial
Per vial, not per visit or course. Four price the vial, $650 to $1,100; two price the visit, $850 to $1,200. A vial holds 2 mL, ten sites at 0.2 mL, and is discarded after the session; the trials’ first session averaged 6.4 mL, more than three vials, where the pages call two typical. Canadian dollars before tax, as the clinic pages state them.

Results & duration

Two in three improved in the maker’s trials

Two trials, the maker’s, pooled. Two in three improved a grade at 12 weeks, clinician and patient agreeing, in the maker’s two trials; one in five did on placebo. 1,022 adults with moderate or severe fullness under the chin, 514 on Belkyra and 508 on placebo, up to six treatments a month or more apart, rated 12 weeks after the last; the co-primary measure was a grade’s improvement reported by clinician and patient at once, as the monograph tabulates it.

Clinician and patient ratings together

Improved at least one grade at 12 weeks

68.2%Belkyra · of 514 people

20.5%Placebo · of 508 people

A grade down on both the clinician’s and the patient’s five-point scale of fullness under the chin, 12 weeks after the last of up to six treatments, the two trials pooled; two grades down in 16% against 1.5%. Response was lower in non-Caucasian subjects, the monograph states.

Belkyra product monograph §14, Table 5

Measured on MRI, a subset

Volume under the chin down a tenth or more

43.3%Belkyra

5.3%Placebo

At least a 10% reduction in submental volume from baseline to 12 weeks after the last treatment, in the 449 people scanned; the trials’ secondary endpoint.

Belkyra product monograph §14, Study Results

How long does Belkyra last?

Measured to 3 years. Among initial trial responders assessed at year 3, 82.4% of those treated with Belkyra maintained at least a one-grade improvement on the clinician’s scale, against 65% on placebo, with no further treatment. These rates describe the responders followed at that visit, not everyone originally treated. The trials themselves followed people 24 weeks after the last treatment; the monograph sets at least 1 month between treatments and up to 6, the number depending on the person.

Humphrey 2021, PMID 33617632 · Belkyra monograph §§ 4.2 and 14

Recovery & risks

Swelling and numbness are common

Two phase 3 trials, Belkyra · 513 people

  • Swelling87%
  • Bruise72%
  • Pain70%
  • Numbness66%
At the site
Redness in 27%, hardness in 23%, tingling in 14%, a nodule in 13%, itching in 12%; bruising was nearly as common on placebo, 70%. 1.6% left the trials over an adverse event, against 1% on placebo.
The smile
Injury to the marginal mandibular branch of the facial nerve, an asymmetric smile or facial weakness, in 4% of Belkyra-treated patients, lasting 1 to 298 days, a median 44; the monograph keeps every injection below a line 1 to 1.5 cm under the jaw to avoid it.
Swallowing
Difficulty swallowing in 2%, lasting 1 to 81 days, a median 3; not recommended for anyone with a history of it, the monograph states.
Next session
At least 1 month between treatments and up to 6, the monograph says; at most 10 mL, 50 sites, a session. Trial patients were rated 12 weeks after the last and followed 24.

Side effects in the product monograph

An asymmetric smile in 4%, difficulty swallowing in 2%, in the trials. Ulceration, necrosis, hair loss and injection-site infection have been reported after marketing, with no rate established. The monograph describes cellulitis and abscess, sometimes requiring intravenous antibiotics or surgical treatment, and advises prompt medical attention for signs of infection.

Marginal mandibular nerve injury: an asymmetric smile

Difficulty swallowing

Ulceration and necrosis, from too shallow an injection

Warnings and adverse reactions in Belkyra’s product monograph · Illustrations are schematic.

Read from the trials’ adverse-reaction table and the monograph’s warnings. Swelling in 87% and numbness in 66% in the trials; an asymmetric smile in 4%, lasting a median 44 days. The table lists reactions in at least 2% of the 513 Belkyra-treated people and more often than on placebo; swelling, bruising, pain and numbness led it. Nerve injury and difficulty swallowing lasted several months in some cases, the monograph states. Downtime was not measured. The harms on the cards are the monograph’s.

Frequently asked questions

Yes, as a prescription drug. Belkyra holds drug identification number 02443910, AbbVie Corporation, marketed since January 2016, Health Canada’s Drug Product Database records; the monograph states the use as “improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults”, and adds that use outside the submental region, or in mild or extreme submental fat, is not established and not recommended. A drug identification number records Health Canada’s review of the product for the use filed; it does not establish every benefit, area or duration a clinic advertises.Health Canada · DPD, DIN 02443910 · Belkyra monograph §1

GST or HST applies to taxable cosmetic treatments: 13% in Ontario, 5% where only GST is charged. The clinic prices here are before tax. A treatment for a medical or reconstructive purpose may be exempt when it meets the applicable health-care exemption’s conditions, including who supplies or performs the service; its purpose alone does not establish an exemption.Excise Tax Act · s. 165, Sch. V Pt. II ss. 1, 1.1, 1.2 and 5 to 7, Sch. VIII

A physician, a nurse practitioner, or a nurse working under one — and the drug itself is prescription-only, so someone with prescribing authority orders it for the person treated. The College of Nurses of Ontario’s guideline on aesthetic services (2026) names administering a substance by injection among the controlled acts, so an RN or RPN needs an order or directive from a nurse practitioner or physician, while nurse practitioners are autonomous. The monograph adds that Belkyra should only be used by health professionals specially trained in it who understand the anatomy under the chin. Other provinces set their own rules.CNO · Aesthetic services, practice guideline (2026) · RHPA s. 27(2), para 5 · Belkyra monograph §4.1

Not in the figures above. The monograph’s two trials are REFINE-1 and REFINE-2, run by Kythera Biopharmaceuticals, which developed the drug as ATX-101, and reported by Allergan and now AbbVie after their acquisitions; the three-year follow-up lists an Allergan Aesthetics employee among its authors. Both trials had placebo arms and blind raters, and the second’s first author is at the University of British Columbia, but the maker designed, funded and reported them. This page cites no trial run by anyone else.Belkyra monograph §14 · Jones 2016, PMID 26673433 · Humphrey 2016, PMID 27430612 · Humphrey 2021, PMID 33617632

The monograph contraindicates it for anyone allergic to deoxycholic acid, any other ingredient or the vial’s components, and where the treatment area is infected. People with excessive skin laxity, prominent platysmal bands (the neck muscle’s vertical cords) or another condition in which reducing the fat under the chin may give an aesthetically undesirable outcome should not be treated, it states, and it does not recommend Belkyra in pregnancy, while breastfeeding, with a history of difficulty swallowing, or for mild or extreme fullness; no use under 18 is authorized. It adds that patients should be screened for other causes of fullness, such as an enlarged thyroid or swollen lymph nodes. The trials enrolled people without excessive skin laxity, so their results do not describe people who have it.Belkyra monograph §§ 1, 2, 4.1, 7, 7.1 and 8.2

Yes. Both are deoxycholic acid injection, 10 mg/mL in 2 mL single-use vials, developed as ATX-101: Kybella is its name in the United States, where the FDA approved it in April 2015, and Belkyra its name in Canada, authorized in July 2015. The two labels report the same two trials, and their doses are the same, 0.2 mL a site on a 1 cm grid.FDA · Kybella prescribing information (2015) · Belkyra monograph §§ 4.2 and 14 · Health Canada · DPD

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