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

DaxibotulinumtoxinA efficacy, safety & effect duration in migraine prevention (EHF-EHC 2025) - "Background: OnabotulinumtoxinA CM effect duration is 8-12 wks. 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

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

A Prospective Clinical Trial Comparing Daxibotulinumtoxina-Ianm (DAXI) to Onabotulinumtoxina (BTXA) for Adductor Type Laryngeal Dystonia (ADLD) (COSM 2025) - "Daxi was found to be safe and effective, with 37% of patients reporting longer duration of voice benefit than with BtxA. Mean duration of voice benefit was 47% longer than previous BtxA treatments."

Clinical • CNS Disorders • Dystonia • Movement Disorders

Safety and Efficacy of Repeat Administration and Dose Escalation of DaxibotulinumtoxinA-lanm (Daxi) Versus OnabotulinumtoxinA (BtxA) for Adductor Type Laryngeal Dystonia (AdLD) (COSM 2025) - No abstract available

Clinical • CNS Disorders • Dystonia • Movement Disorders

Phase 2a Study of DaxibotulinumtoxinA-lanm for Injection in Dynamic Forehead Lines and Glabellar Lines (clinicaltrials.gov) - P2 | N=27 | Completed | Sponsor: Revance Therapeutics, Inc. | Recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Feb 2025 | Trial primary completion date: May 2025 ➔ Dec 2024

Trial completion • Trial completion date • Trial primary completion date

Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: Montefiore Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders

Efficacy Remaining at Time of Requested Re-Treatment for Cervical Dystonia: A Potential New Treatment Paradigm with DaxibotulinumtoxinA. (PubMed, Toxins (Basel)) - "A significant proportion of CD patients wished to be re-treated with efficacy still remaining from prior BoNT injections as early symptoms re-emerged. With the overall clinical profile of DAXI, physicians can safely provide individualized treatment regimens based on the treatment goals or symptomatic needs of their patients."

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

DaxibotulinimtoxinA for Treatment of Platysmal Neck Bands (clinicaltrials.gov) - P4 | N=20 | Completed | Sponsor: Main Line Center for Laser Surgery | Recruiting ➔ Completed | Trial completion date: Jan 2026 ➔ Jan 2025

Trial completion • Trial completion date

DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia (clinicaltrials.gov) - P1/2 | N=22 | Completed | Sponsor: University of California, San Francisco | Active, not recruiting ➔ Completed | Trial completion date: Jun 2025 ➔ Mar 2025 | Trial primary completion date: Jun 2025 ➔ Mar 2025

Trial completion • Trial completion date • Trial primary completion date • Dysphonia • Otorhinolaryngology

Successful Treatment of Sialorrhea with Daxibotulinum Toxin A (AAN 2025) - "Currently, IncobotulinumtoxinA (USA and Europe) and RimabotulinumtoxinB (USA) are approved for this indication. All surveys suggest DaxibotulinumtoxinA provided sustained improvement of sialorrhea and may provide a novel alternative option for those refractory to other treatments."

CNS Disorders • Movement Disorders • Parkinson's Disease

Insights from Clinical Experience with DaxibotulinumtoxinA for the Treatment of Cervical Dystonia (AAN 2025) - "Our cohort consisted of both toxin-naïve and toxin-experienced individuals allowing for a broad evaluation of dosing strategies and treatment outcomes.Patients received doses ranging between 60-570U, with toxin-experienced individuals transitioning from OnabotulinumtoxinA or IncobotulinumtoxinA using a conversion ratio ranging from 1:1 to 1:3. Daxxify is a good treatment option in patients with CD, particularly in patients unsatisfied with the outcomes of previous therapies. Further studies may be warranted to explore its broader applications in the treatment of other conditions and to optimize dosing strategies for individualized patient care."

Clinical • CNS Disorders • Dystonia • Gastrointestinal Disorder • Infectious Disease • Migraine • Movement Disorders • Pain • Parkinson's Disease

DaxibotulinumtoxinA Treatment for Laryngeal Respiratory Dystonia. (PubMed, J Voice) - "DAXI appears to provide ~80% better duration than the patient's average BtxA injection and a 57% improvement than his best BtxA injection. DAXI is a safe and realistic alternative to BtxA injection in patients with LRD."

Journal • CNS Disorders • Dystonia • Movement Disorders • Pulmonary Disease

Successful Treatment of Severe, Poorly Controlled Benign Essential Blepharospasm with DaxibotulinumtoxinA. (PubMed, Ophthalmic Plast Reconstr Surg) - "This case highlights a 57-year-old male with severe, poorly controlled benign essential blepharospasm despite high-dose injections of onabotulinumtoxinA and incobotulinumtoxinA...Notably, the patient experienced 50% to 75% efficacy retention at 3 months postinjection, significantly better than his response to other botulinum toxin type A products. This case suggests that daxibotulinumtoxinA may be an effective treatment for benign essential blepharospasm including patients experiencing poor symptom control with other botulinum toxin type A products."

Journal • CNS Disorders • Dystonia • Movement Disorders

Dysphagia and Muscle Weakness Secondary to Botulinum Toxin Type A Treatment of Cervical Dystonia: A Drug Class Analysis of Prescribing Information. (PubMed, Toxins (Basel)) - "Current clinical trials suggest that DAXI, a novel BoNTA formulation, provides a potentially wider safety margin compared with other approved BoNTAs for CD. The lower amount of core neurotoxin administered at approved doses compared with conventional BoNTAs may explain low on-target ADRs like muscle weakness, whereas reduced diffusion from the injection site is thought to be responsible for low off-target ADRs like dysphagia."

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

Do Lower Doses of Botulinum Neurotoxin Type-A Offer a Longer Duration of Effect and Superior Efficacy in Patients with Cervical Dystonia? (MDS Congress 2024) - "Background: Recently, a long-acting neurotoxin, daxibotulinumtoxinA, was approved for cervical dystonia (CD)...Patients with a history of essential tremor, who previously received rimabotulinumtoxinB, or received injections for multiple indications, were excluded from the study. The cutoff between low-dose and high-dose groups was 220 units for those who received either onabotulinumtoxinA or incobotulinumtoxinA and 500 units for those who received abobotulinumtoxinA... Our preliminary data showed that patients administered a lower dose of BoNT-A reported a longer duration of effect and superior efficacy compared to those who received a higher dose. While a potential explanation for our result is a greater disease burden in patients requiring higher doses, it is also possible that there is a ceiling effect, and we are unnecessarily overdosing patients."

Clinical • CNS Disorders • Dystonia • Essential Tremor