Daxxify (daxibotulinumtoxinA-lanm) / Fosun Pharma, Crown Labs - LARVOL DELTA

Safety and Effectiveness of DaxibotulinumtoxinA in Cervical Dystonia: A Systematic Review and Meta-Analysis of Different Doses (MDS Congress 2026) - No abstract available

Retrospective data • Review • CNS Disorders • Dystonia • Movement Disorders

Postmarket Safety Profile of Daxxify: A Review of the FDA Adverse Event Reporting System Database (AAO-HNSF 2026) - "Daxxify demonstrates an early post-marketing safety profile dominated by expected, localized adverse events, with frequent reports of ineffectiveness and procedural complications. Comparative studies with Botox are needed to further define its real-world safety profile."

Adverse events • Clinical • P4 data • Review

BLEXI: DaxibotulinumtoxinA for Blepharospasm (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: University of Pennsylvania | Initiation date: Jul 2026 ➔ Oct 2026

Trial initiation date • CNS Disorders

Reply to Ståhl et al. Comment on "Honndorf et al. Comparative Analytics and Pharmacodynamics of the Complex Protein-Free Botulinum Toxin Type A Formulations DaxibotulinumtoxinA, IncobotulinumtoxinA and RelabotulinumtoxinA. Toxins 2026, 18, 142". (PubMed, Toxins (Basel)) - "We appreciate the comment [...]."

Journal • PK/PD data

Comment on Honndorf et al. Comparative Analytics and Pharmacodynamics of the Complex Protein-Free Botulinum Toxin Type A Formulations DaxibotulinumtoxinA, IncobotulinumtoxinA and RelabotulinumtoxinA. Toxins 2026, 18, 142. (PubMed, Toxins (Basel)) - "In their recent paper comparing three complexing protein-free botulinum toxin A products available on the market [...]."

Journal • PK/PD data

Therapeutic botulinum toxin preparations: an update. (PubMed, J Neural Transm (Vienna)) - "In IncobotulinumtoxinA (INCO), the complexing proteins have been removed. More recently, two products have been approved containing the complex-free neurotoxin: DaxibotulinumtoxinA (DAXI) and RelabotulinumtoxinA (RELA)...More recently, ready-to-use liquid preparations have been introduced: AbobotulinumtoxinA as Alluscience® and RELA...BoNT type E is currently being developed as a drug with rapid onset and short duration of action for aesthetic indications. Recombinant and hybrid BoNT/A/B are currently also being developed."

Journal • Review • RELA

RTP004 Peptide Binds to Botulinum Neurotoxin, Increases Cell Surface Binding, and Enhances Cellular SNAP-25 Cleavage. (PubMed, Toxins (Basel)) - "RTP004 also increased binding of BoNT to the synaptosomal cell membrane and enhanced cleavage of SNAP-25 in a dose-dependent manner. These findings demonstrate that RTP004, not the excipient HSA common in other BoNT/A1 drug products, enhances binding of BoNT to the cell surface, facilitates internalization of BoNT into the cell, and increases SNAP-25 cleavage."

Journal

Comparative Analytics and Pharmacodynamics of the Complex Protein-Free Botulinum Toxin Type A Formulations DaxibotulinumtoxinA, IncobotulinumtoxinA and RelabotulinumtoxinA. (PubMed, Toxins (Basel)) - "The in vivo spread of DAXI in the mouse gastrocnemius muscle was indistinguishable from that after INCO, and the spread of RELA ex vivo in porcine muscle was larger than INCO but equal to 0.9% NaCl. These results show the differences between 150 kDa botulinum type A toxin products beyond the published claims."

Clinical • Journal • PK/PD data • CNS Disorders • Dystonia • Movement Disorders • RELA

BLEXI: DaxibotulinumtoxinA for Blepharospasm (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: University of Pennsylvania

New P2 trial • CNS Disorders

Challenging Interchangeability: Dynamic Dose-Response Modelling of Botulinum Toxin A Products. (PubMed, Aesthetic Plast Surg) - "Static dose conversion ratios fail to represent the dynamic pharmacodynamic behaviour of BoNT-A formulations. This simulation-based, data-driven approach reproduces clinical outcomes with high fidelity and provides a robust framework for effect-based dose equivalence, improving precision in product substitution and individualized treatment planning."

Journal

DaxibotulinumtoxinA for Injection in Adults with Cervical Dystonia: Clinical Insights from a Real-World Early Experience Program. (PubMed, Mov Disord Clin Pract) - "In this real-world setting, DAXI demonstrated extended clinical benefit and a favorable safety profile."

Journal • Real-world evidence • CNS Disorders • Dystonia • Gastrointestinal Disorder • Movement Disorders • Pain

DaxibotulinumtoxinA efficacy, safety & effect duration in migraine prevention (EHF-EHC 2025) - "Background: OnabotulinumtoxinA CM effect duration is 8-12 wks. Daxibot appears safe & effective in CM prevention w/2 injection protocols. Prolonged benefit duration noted; placebo-controlled studies indicated. Injecting daxibot q12 wks may prevent wearing off seen w/other migraine botulinum toxins, & could result in better standard of care."

Clinical • CNS Disorders • Dystonia • Migraine • Movement Disorders • Pain

Comparing DaxibotulinumtoxinA to OnabotulinumtoxinA for Adductor Laryngeal Dystonia: A Pilot Study. (PubMed, Laryngoscope) - "This study represents the first implementation of Daxi for AdLD. Daxi was notably safe and effective. Although no overall significant difference was noted for the entire study cohort, 40% of patients reported substantially longer duration of voice benefit with Daxi than with BtxA, with 43.9% longer duration than their previous BtxA treatments."

Journal • CNS Disorders • Dysphonia • Dystonia • Movement Disorders

Repeat Administration and Dose Escalation of DaxibotulinumtoxinA in Adductor Type Laryngeal Dystonia. (PubMed, Laryngoscope) - "Our results were variable but showed reproducible results with Daxi, with overall longer DVB with Daxi in 42.8% of total injections, with an average of 33.5% longer DVB than BtxA in a cohort of known Daxi-responsive patients. Daxi dose escalation did not result in significant dysphagia or adverse events. Further studies are needed to determine the clinical utility of Daxi in the treatment of AdLD."

Journal • CNS Disorders • Dysphonia • Dystonia • Gastrointestinal Disorder • Movement Disorders

Computational Model-Informed Comparative Evaluation of Botulinum Toxin A Formulations: A 20-Year Simulation of Onset, Diffusion, Duration, and Immunogenicity. (PubMed, Toxicon) - "LetibotulinumtoxinA and PrabotulinumtoxinA predicted the most balanced profiles, combining high efficacy (mean peak strain reduction 72% and 68%, respectively), rapid onset (2.7-3.1 days), and minimal predicted neutralizing antibody incidence over 20 years (0.4-0.6%). DaxibotulinumtoxinA showed the longest modelled duration of effect (median 142 days), whereas AbobotulinumtoxinA and Relatox exhibited broader diffusion and higher immunogenicity risk...These simulations align closely with available empirical data and suggest that formulation-specific differences in protein structure, diffusion behaviour, and antigenicity may contribute to observed clinical variability. Model-informed comparative analysis can complement real-world and prospective studies to optimize product selection and dosing strategies in aesthetic and therapeutic applications."

Clinical • Journal

Successful Treatment of Hemifacial Spasm with Daxibotulinum Toxin A (MDS Congress 2025) - "DaxibotulinumtoxinA provided sustained improvement in hemifacial spasm symptoms. Patients who received OnabotulinumtoxinA before switching to DaxibotulinumtoxinA showed a return of symptoms before starting DaxibotulinumtoxinA (Patients 1, 3, 4, 5). In comparison, week 12 survey after DaxibotulinumtoxinA revealed sustained efficacy, suggesting a longer duration interval."

CNS Disorders • Movement Disorders

A novel peptide excipient stabilizes DaxibotulinumtoxinA. (PubMed, Int J Pharm) - "In combination with polysorbate 20 (PS20), RTP004 efficiently and completely prevents surface adsorption of the 150 kDa core neurotoxin and stabilizes the biologic drug substance during manufacturing processes, even at concentrations 10- to 100-fold less than those used for HSA in commercial BoNTA products. Thus, the combination of RTP004 and PS20 forms the basis for a novel and effective BoNTA formulation, removing the need for HSA and thereby avoiding its theoretical safety risks and documented limitations."

Journal

Efficacy and safety of DaxibotulinumtoxinA for injection in adults with cervical dystonia: Pooled global analysis of ASPEN-1 and ASPEN-1-CN randomized trials. (PubMed, Parkinsonism Relat Disord) - "This pooled analysis of two phase 3 trials demonstrates that DAXI is an effective, safe, and long-acting treatment for CD. Key adverse events occurred at rates lower than prior pivotal trials of BoNTs for CD."

Clinical • Journal • CNS Disorders • Dystonia • Gastrointestinal Disorder • Movement Disorders

Drugs linked to blepharitis, meibomian gland dysfunction, and chalazion: a real-world, population-based pharmacovigilance analysis. (PubMed, Eye (Lond)) - "This pharmacovigilance study identified associations between several systemic medications with reports of blepharitis, MGD, and chalazion. MGD and chalazion were overreported for finasteride and bortezomib, respectively, whereas all three conditions were overreported for dupilumab. These findings highlight systemic medications as often overlooked contributors to localised eyelid inflammation. Nonetheless, these drugs are known to reduce morbidity and mortality across many diseases. Therefore, while risks may not necessarily outweigh benefits to warrant changes in prescribing practices, clinicians should remain vigilant for such side effects, particularly in patients at higher risk, and to consider prophylactic measures when appropriate, such as educating patients about eyelid hygiene and counselling them to promptly report symptoms."

Adverse events • Journal • Real-world evidence • Dry Eye Disease • Inflammation • Ocular Inflammation • Ophthalmology

In Silico Multiscale Computational Modelling of Botulinum toxin A Diffusion for Glabellar Wrinkle Treatment: Optimizing Injection Volumes across formulations. (PubMed, Toxicon) - "Simulations encompassed five formulations- AbobotulinumtoxinA (ABO), DaxibotulinumtoxinA (DAXI), IncobotulinumtoxinA (INCO), OnabotulinumtoxinA (ONA), and PrabotulinumtoxinA (PRABO)-across injection volumes from 0.025 to 0.1 mL, at fixed toxin unit dosing, within anatomically realistic glabellar meshes (n=10,000 synthetic patient variants)...This study provides the first in-silico quantitative, multiscale evidence that reducing BoNT/A reconstitution volume to ≤0.045 mL/site significantly enhances target localization while minimizing off-target effects. Contrary to prevailing clinical heuristics, dilution amplifies mechanical spread and immune clearance risk."

Journal

Reply to letter re: "A randomized, double-blind, placebo-controlled trial of daxibotulinumtoxinA for injection for the treatment of upper limb spasticity in adults after stroke or traumatic brain injury". (PubMed, PM R) - No abstract available

Clinical • Journal • Cardiovascular • CNS Disorders • Movement Disorders • Vascular Neurology

The Role of Toxins and Fillers in Optimizing Perioral Rejuvenation. (PubMed, Facial Plast Surg) - "Changes in the perioral region are significant contributors to the visible signs of aging.Ideal candidates for perioral rejuvenation with toxin and filler are individuals experiencing age-related rhytids or volume loss who are interested in minimally invasive, nonsurgical interventions.Neurotoxins like Botox, Xeomin, Dysport, Jeuveau, and Daxxify are used to relax muscles that contribute to rhytids...Dermal fillers such as hyaluronic acid, calcium hydroxyapatite, and poly-L-lactic acid restore volume in areas like the nasolabial folds, lips, marionette lines, chin, prejowl sulcus, and perioral rhytids.Neurotoxins and dermal fillers offer effective, minimally invasive solutions for perioral rejuvenation. With an understanding of underlying anatomy, proper patient selection, and precise injection techniques, facial plastic surgeons can achieve natural, youthful results with minimal downtime."

Journal • Aesthetic Medicine

Long-Term Safety and Efficacy of Repeat Treatments with DaxibotulinumtoxinA in Cervical Dystonia: Results from the ASPEN-Open-Label Study. (PubMed, Mov Disord Clin Pract) - P3 | "DAXI was safe and efficacious over repeated treatments in adults with CD. Adverse event rates were similar to or potentially lower compared with conventional BoNTs."

Journal • CNS Disorders • Dystonia • Gastrointestinal Disorder • Movement Disorders • Pain

Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Following Distal Pancreatectomy (clinicaltrials.gov) - P2 | N=4 | Terminated | Sponsor: OHSU Knight Cancer Institute | N=63 ➔ 4 | Trial completion date: May 2025 ➔ Jul 2024 | Recruiting ➔ Terminated | Trial primary completion date: May 2025 ➔ Jul 2024; low enrollment

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Oncology • Solid Tumor

Exploring Nonresponse to Botulinum Toxin in Aesthetics: Narrative Review of Key Trigger Factors and Effective Management Strategies. (PubMed, JMIR Dermatol) - "Neutralizing antibodies developed with first-generation formulations, such as onabotulinumtoxinA and abobotulinumtoxinA that contain clostridial proteins, but not with second-generation BoNT-As, such as incobotulinumtoxinA and daxibotulinumtoxinA, which lack these proteins...Considering the potential for immunogenicity is essential when selecting a BoNT-A formulation. Preventing SNR is crucial, given the lack of solid data on effective treatments."

Journal • Review • Aesthetic Medicine • Infectious Disease