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MetabolicApproved drug

Lemon Bottle

Published research and evidence base

Injectable lipolysis has been studied mainly as deoxycholic acid (ATX-101), a synthetic bile salt approved for submental fat reduction on the basis of two phase 3 randomised trials (REFINE-1 and REFINE-2), and as compounded phosphatidylcholine/sodium deoxycholate formulations, which were never approved for this use. Preclinical work indicated that the deoxycholate component, acting as a detergent that disrupts cell membranes, was the principal adipocytolytic agent rather than phosphatidylcholine. The reported adverse-event profile includes injection-site swelling and induration, marginal mandibular nerve paresis, skin ulceration and necrosis, fibrosis, and post-procedural infection, with animal data documenting demyelinating nerve injury after intrafascicular exposure. The branded product marketed as 'Lemon Bottle' was not identified in any peer-reviewed clinical or mechanistic study, so the evidence described here relates to deoxycholic acid and phosphatidylcholine/deoxycholate rather than to that specific formulation.

Studies cited
17
Published 2023+
10
Newest paper
2026
Last reviewed
Aug 2026

Recurring themes in the literature

  • Deoxycholic acid (ATX-101) as an approved injectable for submental fat, supported by two phase 3 randomised placebo-controlled trials
  • Sodium deoxycholate as a non-selective detergent causing adipocyte membrane lysis
  • Marginal mandibular nerve paresis, dysphagia, skin ulceration and necrosis as recurring serious adverse events
  • Compounded phosphatidylcholine/deoxycholate lipolysis and its association with fibrosis, granuloma, heterotopic ossification and atypical infection
  • Non-submental and off-label body applications supported mostly by small, non-randomised studies
  • Absence of the 'Lemon Bottle' branded lipolytic from the indexed peer-reviewed literature
The evidence

17 published studies.

Ordered by strength of study design, then by recency. Every entry links to its source record so the finding can be checked against the paper rather than taken on our word.

  1. 01Systematic review2025

    A Systematic Review of Injectable Lipolytic agents for Non-Submental Fat Reduction

    Carrion K, Salingaros S, Bernal C, Barger BT, Lipman KJ, et al. · Plastic and Reconstructive Surgery · systematic review of 25 studies, 3178 patients, deoxycholic acid and phosphatidylcholine at non-submental sites

    Reductions in localised adiposity were reported in 93.75% of the included studies, with adverse events described as generally mild and transient and satisfaction ranging from 57.1% to 86%. The authors noted heterogeneous protocols and called for further controlled trials to standardise treatment.

  2. 02Systematic review2024

    Management of Serious Adverse Events Following Deoxycholic Acid Injection for Submental and Jowl Fat Reduction: A Systematic Review and Management Recommendations

    Shridharani SM, Kennedy ML · Aesthetic Surgery Journal Open Forum · systematic review of reported serious adverse events after deoxycholic acid injection

    The review catalogued serious adverse events reported after ATX-101 treatment of the submental region and jowls and set out management approaches for each. Contributing factors identified included intradermal rather than subcutaneous placement and inadequate assessment of fat pad thickness.

  3. 03Human clinical2026

    Injection lipolysis-induced abdominal fibrosis mimicking desmoid fibromatosis

    Gkogkolou P, Arns B, Ziaja ZF, Drusenheimer J, Jasker P · Journal der Deutschen Dermatologischen Gesellschaft · single case report with histopathology after abdominal injection lipolysis

    Abdominal fibrosis developing after injection lipolysis was reported to clinically and radiologically resemble desmoid fibromatosis. Histopathological examination was required to establish the reactive nature of the lesion.

  4. 04Human clinical2026

    Heterotopic ossification of the masseter muscle following injection lipolysis: A case report and review

    Gaessler J, Partenheimer P, Gronewold M, Sabau R, Lentge F, et al. · Journal of Cranio-Maxillo-Facial Surgery · single case report, 35-year-old woman after jawline injection lipolysis

    Severe trismus and pain developed after jawline injection lipolysis, with imaging showing a solid mass in the right masseter muscle and histopathology confirming heterotopic ossification. Surgical excision was required.

  5. 05Human clinical2026

    Nocardia farcinica infection after facial lipolysis injection in an immunocompetent patient

    Xu W, Su F, Ji Y, Chen M, Hong X, Zhuo B, Ge Y · Journal of Infection in Developing Countries · single case report, immunocompetent adult after facial lipolytic injection

    Nocardia farcinica infection was documented following a facial lipolysis injection in a patient without immunodeficiency. The infection resolved with amoxicillin-clavulanate therapy.

  6. 06Human clinical2024

    Deoxycholic Acid for Submental Convexity: A MAUDE Database Analysis

    Gibson AC, Kompelli A, Saadi C, Patel VA, Saadi RA, Shokri T · Craniomaxillofacial Trauma & Reconstruction · retrospective analysis of FDA MAUDE adverse-event reports for deoxycholic acid injection

    Among the adverse event reports analysed, excessive swelling accounted for 24%, marginal mandibular nerve weakness 19% and skin necrosis 14%. Two patients required hospitalisation for management of necrosis, both with underlying systemic disease.

  7. 07Human clinical2021

    Improvements in Submental Contour 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 · Aesthetic Surgery Journal · long-term follow-up of REFINE-1/REFINE-2 responders, 224 enrolled (113 ATX-101, 111 placebo), up to 3 years

    Maintenance of response at year 3 was reported in 82.4% of the ATX-101 group versus 65.0% of the placebo group. No new treatment-related adverse events were reported over the follow-up period.

  8. 08Human clinical2016

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

    Jones DH, Carruthers J, Joseph JH, Callender VD, Walker P, et al. · Dermatologic Surgery · phase 3 randomised double-blind placebo-controlled trial, 256 ATX-101 versus 250 placebo adults with submental fat

    A one-grade or greater improvement in submental fat rating was recorded in 70.0% of ATX-101 recipients versus 18.6% of placebo recipients. Marginal mandibular nerve paresis was reported in 4.3% of treated subjects and was described as mostly mild, transient and resolving without sequelae.

  9. 09Human clinical2016

    ATX-101 for reduction of submental fat: A phase III randomized controlled trial

    Humphrey S, Sykes J, Kantor J, Bertucci V, Walker P, et al. · Journal of the American Academy of Dermatology · REFINE-2 phase 3 randomised placebo-controlled trial, approximately 258 participants per arm

    A one-grade or greater composite improvement was recorded in 66.5% of ATX-101 recipients versus 22.2% of placebo recipients. Of reported adverse events, 85.7% were localised to injection sites and were characterised as mild or moderate.

  10. 10Human clinical2014

    Efficacy, patient-reported outcomes and safety profile of ATX-101 (deoxycholic acid), an injectable drug for the reduction of unwanted submental fat: results from a phase III, randomized, placebo-controlled study

    Ascher B, Hoffmann K, Walker P, Lippert S, Wollina U, Havlickova B · Journal of the European Academy of Dermatology and Venereology · phase 3 randomised placebo-controlled trial, 360 adults with submental fat, two ATX-101 dose levels

    Both ATX-101 dose groups showed greater clinician-rated improvement in submental fat than placebo (58.3-62.3% versus 34.5%). Patient-reported satisfaction measures also improved, and reported adverse events were predominantly mild to moderate and localised to the injection area.

  11. 11Human clinical2009

    Randomized double-blind clinical trial of subcutaneously injected deoxycholate versus a phosphatidylcholine-deoxycholate combination for the reduction of submental fat

    Rotunda AM, Weiss SR, Rivkin LS · Dermatologic Surgery · randomised double-blind trial, 32 evaluable adults with submental fat, deoxycholate alone versus phosphatidylcholine-deoxycholate

    Both formulations produced only minimal aesthetic change, with a median improvement score of 0.5 on the scale used. No significant difference in efficacy or adverse events was detected between deoxycholate alone and the phosphatidylcholine-deoxycholate combination.

  12. 12Animal in vivo2025

    Peripheral Nerve Injury After Deoxycholic Acid (ATX-101) Injection in an Experimental Rat Model

    Chi D, Pinni S, Maloy S, Llaneras N, Hunter DA, et al. · Aesthetic Surgery Journal · rat sciatic nerve model comparing intrafascicular ATX-101 injection with saline control

    Intrafascicular ATX-101 injection produced 75% (SD 15%) nerve fibre damage compared with 7% in saline controls. Histology indicated a demyelinating pattern of injury with Wallerian degeneration evident at two weeks.

  13. 13In vitro2026

    Extracellular phosphatidylcholine functions as a noncanonical TLR4 activator to drive adipocyte lipolysis and apoptosis

    Lim DS, Bae KL, Pyo MK, Ko JH, Choi JK, et al. · Frontiers in Pharmacology · 3T3-L1 adipocytes exposed to phosphatidylcholine at 0-25 mg/mL

    Phosphatidylcholine reduced adipocyte viability in a concentration-dependent manner and induced lipolysis and apoptosis. TLR4 inhibition attenuated these effects, implicating a TLR4-NF-kappaB-TNF-alpha signalling axis.

  14. 14In vitro2004

    Detergent effects of sodium deoxycholate are a major feature of an injectable phosphatidylcholine formulation used for localized fat dissolution

    Rotunda AM, Suzuki H, Moy RL, Kolodney MS · Dermatologic Surgery · in vitro cell lysis assays and porcine/human tissue exposure to phosphatidylcholine-deoxycholate formulation components

    Cell lysis produced by the injectable phosphatidylcholine formulation was attributed principally to its sodium deoxycholate excipient, which behaved comparably to standard laboratory detergents. The authors described the effect as non-specific membrane disruption rather than a phosphatidylcholine-mediated metabolic action.

  15. 15Review2026

    Injection lipolysis in aesthetic medicine: mechanisms, clinical safety, and clinical applications

    Ao Y, Zhou Y · Frontiers in Medicine · narrative review of injection lipolysis mechanisms, safety and indications

    The review described deoxycholic acid as preferentially disrupting adipocytes with relative tissue selectivity and identified the submental fat pad as the best-documented indication. Skin necrosis and nerve injury were reported as consequences of improper injection technique.

  16. 16Review2024

    Lipolytic agents for submental fat reduction: Review

    Park SY, Kim SB, Wan J, Felice F, Yi KH · Skin Research and Technology · narrative review of lipolytic agents used in the submental region

    The review compared aminophylline, phosphatidylcholine and deoxycholic acid, noting that the mechanisms of several agents remain incompletely characterised. The authors emphasised submental anatomy as central to avoiding neurovascular injury.

  17. 17Review2022

    Injection lipolysis with phosphatidylcholine and sodium deoxycholate-Is it really worth the risk?

    Fratczak A, Polak K, Szczepanek M, Waliczek M, Bergler-Czop B · Dermatologic Therapy · commentary/letter reviewing safety of compounded phosphatidylcholine-sodium deoxycholate lipolysis

    The authors questioned the risk-benefit balance of phosphatidylcholine and sodium deoxycholate injection lipolysis. Concerns raised centred on the adverse-event burden relative to the strength of supporting efficacy data.

Limitations

What this evidence does not establish.

No peer-reviewed clinical trial, case report or mechanistic study of the branded 'Lemon Bottle' formulation was identified in Europe PMC or PubMed, so its composition, potency and safety profile are not independently characterised in the scientific literature. Controlled evidence for compounded phosphatidylcholine-deoxycholate products, for non-submental body sites and for long-term outcomes beyond three years remains limited, and comparative trials against surgical or device-based fat reduction are largely absent.

Common questions about the research.

What is Lemon Bottle?

Lemon Bottle is a ready-mixed 10 ml research solution in the lipolytic-solution category, marketed as combining riboflavin, bromelain, and lecithin-derived phosphatidylcholine. It is supplied strictly for laboratory research into the constituent compounds' biochemistry.

What does the research literature say about phosphatidylcholine solutions?

The cited review traces the history of phosphatidylcholine injection research, and a randomised controlled study examined phosphatidylcholine–deoxycholate preparations at the adipocyte level. Notably, that literature attributes much of the observed in-vitro activity to the deoxycholate detergent co-solvent rather than to phosphatidylcholine itself.

Has Lemon Bottle itself been studied in controlled trials?

No. The specific formulation has not been the subject of published controlled trials, and its composition is not standardised in the peer-reviewed literature. Only constituent-level research is cited on this page, and no conclusions about the mixture should be drawn from it.

What roles do riboflavin and bromelain play in the cited research?

Riboflavin is the precursor of the flavin coenzymes FAD and FMN, which participate in mitochondrial oxidation reactions. Bromelain is a pineapple-derived proteolytic enzyme complex characterised for fibrinolytic and anti-edematous enzymology. Both literatures describe general biochemistry, not effects of this product.

Available from our catalog

For research purposes only. Not for human consumption, diagnosis, treatment, or prevention of any condition. Nothing on this page is medical advice, and no study summarised here should be read as a recommendation.