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BELKYRA ®

is an injectable lipolytic or fat dissolving injection that has been available in the UK since 2021. It is a only medicine which contains deoxycholic acid and is used to treatment submental fullness or double chins.

It is made by Allergan Aesthetics, the same manufacturers as the toxin brand, , and is marketed as BELKYRA® in the UK, Australia, Canada, and other countries. It has been approved in the USA since April 2015 where it is marketed under the brand name .

Prior to as a medicine in both the USA and the UK, it was known in clinical trials as ATX-101, thus many of the clinical papers about its safety and efficacy refer to it as ATX-101.

The active ingredient is 20 mg of acid in each 2ml vial of solution. There are 4 x 2ml vials in each per box of which should be enough to HRT What We Treat a single over the course of sessions.

Each vial also water for injection, sodium chloride, sodium hydroxide (for dissolution and pH adjustment), anhydrous, and acid (for pH adjustment). The pH of the is 8.3, making it slightly and on a level with sea water.

The manufacturers note that acid is a cytolytic drug. When it is injected into the subcutaneous layer where the fat sits, its of action is to the cell membrane of the fat cells or adipocytes. By the fat cell walls and making them leak out their liquid fat content, or lipids, this a wound response in the body, which sets about the debris the natural metabolism and ridding the body of the excess fat which has been targeted for removal. It also the production of new in the area as a reaction to the trauma with tightens and contours the area.

During treatment, your practitioner will inject 0.2 ml (2 mg) per site into the subcutaneous level below the skin where the fat resides, injection points are spaced 1 cm apart under your chin and will be marked out prior to treatment. You will usually need more than one treatment session for optimal results.

To ensure comfort, the procedure is usually performed using either topical cream or local anaesthetic injection to numb the area being . A cold compress may also be applied.

became widely available and licensed in the UK in 2021 following several years of trial amongst UK .

is licensed in the UK and indicated for “the treatment of moderate to severe convexity or fullness associated with submental fat in adults when the presence of submental fat has an important psychological impact for the patient“. 

The U.S. Food and Drug in the product in April 2015 under the brand name KYBELLA® for the “improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults“.

The is not for use in anyone under 18 years of age.

Appropriately and qualified members of the medical only. Currently only available on through GMC-registered .

is indicated for to severe fat, more known as a double chin.

The idea patient is either male or female and is bothered by the area under their chin, they feel it makes them look older or heavier in appearance, and despite eating well and exercising the double chin or submental fullness does not reduce.

Because treatment with BELKYRA® under the trial name AXT-101 and the brand name of KYBELLA® has been available for longer in the USA, the long-term results from treatment have been more thoroughly assessed. From the clinical trials, a subset of those treated have continued to be followed-up for further study and this has demonstrated the continued effects of treatment for up to 5 years.

Very reported side effects following treatment with BELKYRA include, redness, pain, swelling, itching, or at the sites. Other common side effects include headache, nausea, a feeling of or warmth to the skin in the area treated. Most common reactions including and within days.

More severe and rare include nerve injuries, which can take a few months to resolve.

You can take pain medication to ease after each treatment session.

Pregnant and breast-feeding women, or the under 18s.

Should not be used in anyone with a known sensitivity to acid or any of the other ingredients within the product. 

cannot take place if there is an active in the area to be .

Due to the of salt within the product, patients on a controlled sodium diet may not be suitable for treatment.

You will be recommended to have 2-4 treatment up to a maximum of 6. These will be spaced at least 4 weeks apart.

The cost of treatment depends on the size of the area being treated and the amount of treatment sessions required. Be for prices to be between £750-£1,000 per treatment .

The manufacturers have performed various randomised, double-blind, trials at across the USA, Canada, and Europe over the last decade to gather data for medicines approval in the various territories. The U.S. and Canadian Phase III trials were known as REFINE-1 and REFINE-2 (Randomised E of Fat Reduction IN ATX-101 TrEated Patients) and enrolled more than 1,000 who were treated with ATX-101 or placebo, in 70 centres. Similar trials were in Europe.

The various trials have demonstrated results which show that 68.2% of subjects with experienced a ≥1-grade with the use of the product to 20.5% of subjects; this was based upon validated physician and patient measurements. 16% of patients a ≥2- grade improvement, to 2% of patients who to placebo. Similarly, KYBELLA treatment resulted in high patient – 79% of patients reported satisfaction with their in association with their face and chin. also reported in the visual and impact of fat when asked how happy, bothered, self-conscious, embarrassed, old, and they felt following in to the amount of their submental fat.

in Up to 3 Years After ATX-101: Efficacy and Safety Follow-Up of the Phase 3 REFINE Trials.

Humphrey S, Cohen JL, Bhatia AC, Green LJ, Green JB, Bowen B.

Surg J. 2021 Feb 22:sjab100. 

Uncommon Adverse of Deoxycholic Acid Injection for Submental Fullness: Beyond the Clinical Trials.

KC, Crowley EL, D, MJ.

J Cutan Med Surg. 2020 Nov/Dec;24(6): . Epub 2020 Aug 5.

acid in the fat reduction: A review of properties, adverse effects, and .

Farina GA, Cherubini K, de Figueiredo MAZ, Salum FG.

J Cosmet . 2020 Oct;19(10): . Epub 2020 Jul 29.

and safety of ATX-101 as a for submental fullness: A analysis of two aesthetic practices.

Zarbafian M, M, Greene R, Fabi SG.

J Cosmet . 2020 Jun;19(6): . Epub 2019 Sep 25.

ATX-101 (Deoxycholic Acid Injection) Leads to Clinically Meaningful Improvement in Fat: Final Data From .

Behr K, Kavali CM, Munavalli G, Teller CF, Yoelin S, L, Sangha S.

Dermatol Surg. 2020 May;46(5): .  

Experience With 100 Consecutive Patients Undergoing Neck Contouring With ATX-101 (Deoxycholic Acid): An Updated Report With A 2-Year Analysis.

Shridharani SM.

Dermatol Surg. 2019 Oct;45(10): . 

ATX-101 ( Acid Injection) for Reduction of Fat: Results From a 12-Month Study.

Beer K, Weinkle SH, Cox SE, Rubin MG, A, Somogyif C.

J Drugs . 2019 Sep 1;18(9): .

The Use of Acid for the Clinical of Excess Submental Fat in Indian Patients.

Shome D, Khare S, Kapoor R.

J Drugs Dermatol. 2019 Mar 1;18(3): .

Efficacy and Safety of ATX-101 by Treatment Session: Pooled of Data From the Phase 3 REFINE Trials.

Dayan SH, Schlessinger J, Beer K, LM, Jones DH, Humphrey S, J, Lizzul PF, Gross TM, FC 3rd, C.

Aesthet Surg J. 2018 Aug 16;38(9): .

ATX-101 (Deoxycholic Acid Injection) in Men: Insights From Our .

Shridharani SM, Behr KL.

Dermatol Surg. 2017 Nov;43 Suppl 2:S225-S230. 

The development, evidence, and use of ATX-101 for the of fat.

Georgesen C, Lipner SR.

J Cosmet Dermatol. 2017 Jun;16(2): . Epub 2017 Apr 21.

Prevention and Management of Adverse in Facial Aesthetics: for ATX-101 (Deoxycholic Acid Injection) Treatment.

Fagien S, McChesney P, Subramanian M, Jones DH.

Dermatol Surg. 2016 Nov;42 Suppl 1:S300-S304. 

Management of Patient Experience With ATX-101 ( Acid Injection) for of Submental Fat.

Dover JS, Kenkel JM, A, Lizzul PF, Gross TM, M, Beddingfield FC 3rd.

Dermatol Surg. 2016 Nov;42 Suppl 1:S288-S299. 

Overview of ATX-101 ( Acid Injection): A Approach for Reduction of Submental Fat.Dayan SH, Humphrey S, Jones DH, Lizzul PF, Gross TM, K, Beddingfield FC 3rd.

Surg. 2016 Nov;42 Suppl 1:S263-S270. 

REFINE-1, a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial With ATX-101, an Drug for Submental Fat Reduction.

Jones DH, J, Joseph JH, Callender VD, Walker P, Lee DR, M, Lizzul PF, Gross TM, FC 3rd.

Dermatol Surg. 2016 Jan;42(1):38-49.

[The use of deoxycholic acid (ATX-101) in aesthetic medicine: A promising treatment].

B, Calmon A, JP.

Rev Stomatol Chir Maxillofac Chir Orale. 2015 Dec;116(6):350-2. doi: 10.1016/j.revsto.2015.09.003. Epub 2015 Dec 1.

Results from a pooled analysis of two European, randomized, placebo-controlled, phase 3 studies of ATX-101 for the pharmacologic of excess submental fat.

McDiarmid J, Ruiz JB, Lee D, S, Hartisch C, Havlickova B.

Aesthetic Plast Surg. 2014 Oct;38(5):849-60. Epub 2014 Jul 2.

Efficacy, patient-reported and safety profile of ATX-101 ( acid), an drug for the reduction of fat: results from a phase III, randomized, study.

Ascher B, K, Walker P, Lippert S, U, Havlickova B.

J Eur Acad Dermatol . 2014 Dec;28(12): . Epub 2014 Mar 8.

Reduction of fat with ATX-101 (deoxycholic acid), an treatment: results from a phase III, randomized, placebo-controlled study.

Rzany B, T, Walker P, Lippert S, J, Havlickova B.

Br J Dermatol. 2014 Feb;170(2):445-53.

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