Relfydess (relabotulinumtoxinA) / Galderma - LARVOL DELTA

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

The influence of age on relabotulinumtoxinA outcomes in moderate-to-severe glabellar and lateral canthal lines: post-hoc analysis of three Phase 3 double-blind, placebo-controlled trials (AAD 2026) - "Background: RelabotulinumtoxinA (relaBoNT-A) is a novel, high-potency and high-purity ready-to-use liquid botulinum toxin A. A post-hoc analysis examined whether subject age influenced relaBoNT-A treatment outcomes in glabellar lines (GL) and lateral canthal lines (LCL), treated alone or in combination. In all age groups, subjects treated with relaBoNT-A achieved high rates of ≥1-grade improvement in GLs and LCLs and reported satisfaction with treatment and appearance through 6 months. The treatment was well tolerated in all age groups."

Clinical • P3 data • Retrospective data

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

A Global, Prospective, Non-Interventional Study to Collect Patient and Physician Satisfaction in Routine Clinical Practice During Long Term Treatment of Glabellar Lines and/or Lateral Canthal Lines with Relfydess® (GLORY) (ANZCTR) - P=N/A | N=180 | Recruiting | Sponsor: Galderma SA

New trial

Objective Assessment of the Onset of RelabotulinumtoxinA in the Elevation of the Eyebrow and Its Clinical Implications. (PubMed, J Cosmet Dermatol) - "In the real-world setting, RelabotulinumtoxinA showed efficacy in treating GLs and LCLs. In the post-intervention phases (follow-up and potential touch-ups), the fast onset of the ready-to-use product can save time. The palpebral area measurement technique, which was selected to assess objectively the response, may allow for a higher level of precision than measuring distances in the periocular range and can be helpful in this type of study."

Journal

A study of the effect of relabotulinumtoxinA on moderate to severe forehead wrinkles in adults aged 18 to 65 years. (ANZCTR) - P4 | N=60 | Not yet recruiting | Sponsor: The Dermatology Institute of Victoria

New P4 trial

A study of the effect of relabotulinumtoxinA on enlarged jaw muscles (masseter hypertrophy) and facial shape in adults aged 18 to 40 years. (ANZCTR) - P4 | N=20 | Not yet recruiting | Sponsor: Aesthetic Maxillofacial Clinic

New P4 trial • Dental Disorders

RelabotulinumtoxinA, a Ready-to-Use Formulation Neuromodulator Manufactured with PEARL™ Technology to Maintain High Biological and Specific Activity. (PubMed, Toxins (Basel)) - "In vitro, relabotulinumtoxinA demonstrated higher biological activity and earlier onset of SNAP-25-cleavage than onabotulinumtoxinA. PEARLTM Technology thus produces high-quality BoNT-A1 with high specific enzyme and biological activities, which may explain the clinical performance of relabotulinumtoxinA in Phase 3 clinical trials examining treatment of GLs and/or LCLs."

Journal

Galderma Delivers Record First Half 2025 Net Sales of 2.448 Billion USD and 12.2% Year-on-Year Growth at Constant Currency, Raises Full-Year Top-Line Guidance (Businesswire) - "Significant progress on the launch of new innovation, including Nemluvio (nemolizumab) which continues to outperform, delivering 131 million USD in sales, the ongoing positive uptake of Relfydess, now launched in 17 markets, and geographic expansion in Fillers & Biostimulators...Therapeutic Dermatology net sales for the first half of 2025 were 489 million USD, with year-on-year growth of 26.9% at constant currency. This accelerated performance was driven by an impressive ramp-up in Nemluvio sales, notably in the second quarter...Nemluvio delivered 131 million USD in net sales, performing ahead of expectations. Sales were primarily driven by the U.S., the majority still from prurigo nodularis, with the contribution from atopic dermatitis quickly increasing."

Commercial • Sales • Atopic Dermatitis • Musculoskeletal Diseases • Prurigo Nodularis

Subject-Reported Outcomes for Glabellar Line Improvement and Satisfaction With the Relabotulinumtoxina Ready-to-Use Liquid Formulation: Data From the Phase 3 READY-1 Trial. (PubMed, Aesthet Surg J) - "Adults with moderate-to-severe glabellar lines receiving a single relaBoNT-A treatment reported significant improvements in glabellar line severity throughout the 6-month study period. RelaBoNT-A provided natural looking results, high satisfaction and psychological well-being improvements."

Clinical • Journal • P3 data

RelaBoNT-A treatment of glabellar lines and lateral canthal lines of different baseline severity: subgroup analyses of pooled Phase III study data (AAD 2025) - P3 | "INTRODUCTION RelabotulinumtoxinA (RelaBoNT-A) is a novel, complexing-protein-free, ready-to-use, liquid botulinum toxin type-A1 investigational drug product, studied in glabellar lines (GLs) and lateral canthal lines (LCLs). Most treatment-emergent adverse events across both subgroups were mild or moderate. CONCLUSIONS Posthoc analysis demonstrated that a ≥1-grade tended to be more consistent between groups, however, regardless of baseline severity (moderate/severe) subjects achieved high rates of GL and LCL ≥1-grade improvement, along with reported improved well-being, and a long median duration of wrinkle severity improvement (>24 weeks)."

P3 data

Aesthetic Improvement with Liquid Relabotulinum-A Treatment in a 12-Month Randomized Controlled Trial Among Subjects with Moderate-to-Severe Glabellar Lines (AAD 2025) - P3 | "Introduction: RelabotulinumtoxinA (RelaBoNT-A) is a novel, complex-free, type-A1, investigational botulinum toxin formulated as a ready-to-use liquid for aesthetic use... Subject-assessed aesthetic improvement and investigator-assessed GL severity improvement lasted through Months 9-12. Injectors were highly satisfied with product usability and subjects remained satisfied through Month 12."

Clinical

READY-4: Long-term safety with repeated injections using RelabotulinumtoxinA, a novel liquid formulation botulinum toxin, in the treatment of glabellar and lateral canthal lines (AAD 2025) - P3 | "Background: RelabotulinumtoxinA (relaBoNT-A) is a novel, investigational, highly active, complexing protein free, ready-to-use, liquid botulinum toxin type-A1. Long-term safety of repeated relaBoNT-A injections for GLs/LCLs was demonstrated, consistent with the safety profile from previous trials (READY-1-3) and other marketed BoNT-A products. Efficacy and subject satisfaction were maintained across multiple treatments."

Clinical • Pain

Efficacy and Safety of RelabotulinumtoxinA Liquid Botulinum Toxin in the Treatment of Lateral Canthal Lines: Results From the Phase 3 READY-2 Study. (PubMed, Dermatol Surg) - "RelaBoNT-A (60 U) treatment provided statistically significant improvement of moderate-to-severe LCL. One-third of subjects reported onset within 1 day and improvements were maintained through Month 6. Treatment satisfaction was high. RelaBoNT-A was well tolerated."

Journal • P3 data

Efficacy and safety of a new formulation of liquid botulinum toxin, relabotulinumtoxinA, used for the combined treatment of glabellar lines and lateral canthal lines (JDP 2024) - No abstract available

Clinical

Efficacy and Safety of RelabotulinumtoxinA, a New Ready-to-Use Liquid Formulation Botulinum Toxin: Results From the READY-1 Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial in Glabellar Lines. (PubMed, Aesthet Surg J) - "A single RelaBoNT-A treatment was effective and demonstrated a favorable safety profile. RelaBoNT-A provided significant improvements in glabellar line severity, high satisfaction, rapid onset, and enduring effectiveness throughout the 6-month study period."

Journal • P3 data

Assess Aesthetic Improvement and Onset of QM1114-DP in Subjects With Moderate to Severe Glabellar Lines (clinicaltrials.gov) - P3 | N=132 | Completed | Sponsor: Galderma R&D | Active, not recruiting ➔ Completed | Phase classification: P3b ➔ P3 | Trial completion date: Dec 2023 ➔ Sep 2023

Phase classification • Trial completion • Trial completion date

Efficacy and safety of a novel formulation liquid botulinum toxin, RelabotulinumtoxinA, when used for combination treatment of glabellar and lateral canthal lines (AAD 2024) - P3 | "RelaBoNT-A demonstrated significant efficacy vs placebo, high subject satisfaction, and a favorable safety profile during treatment of GLs or LCLs alone, or GLs+LCLs in combination. Median return to baseline severity was ~6 months."

Clinical • Pain

Efficacy and Safety of a Novel Formulation Liquid Botulinum Toxin, RelabotulinumtoxinA, When used for Combination Treatment of Glabellar and Lateral Canthal Lines (TOXINS 2024) - P3 | "Conclusions RelaBoNT-A demonstrated significant efficacy versus placebo, high patient satisfaction, and a positive safety profile during treatment of GLs or LCLs alone, or GLs+LCLs in combination. Median return to baseline severity was ~6 months."

Clinical • Infectious Disease • Novel Coronavirus Disease • Pain

Treatment of Moderate-to-Severe Glabellar Lines With RelabotulinumtoxinA, an Investigational Liquid Botulinum Toxin: Clinical Efficacy and Safety Results From the READY-1 Phase 3 Trial (TOXINS 2024) - P3 | "Primary endpoint was met; RelaBoNT-A Month-1 composite 2-grade response was significantly higher than placebo. Effects remained for 6 months in a population with largely severe GLs at baseline."

Clinical • P3 data • Pain

Treatment of Lateral Canthal Lines With RelabotulinumtoxinA, an Investigational Liquid Botulinum Toxin: Clinical Efficacy and Safety Results From the READY-2 Phase 3 Trial (TOXINS 2024) - P3 | "Month-1 composite 2-grade response was statistically significantly higher versus placebo, meeting the primary endpoint. Onset of effect was rapid and 36% of patients sustained a statistically significant ≥1-grade improvement for a duration of 6 months."

Clinical • P3 data • Aesthetic Medicine

A Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Glabellar Lines (clinicaltrials.gov) - P3 | N=605 | Completed | Sponsor: Galderma R&D | Active, not recruiting ➔ Completed

Trial completion

Assess Aesthetic Improvement With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines (clinicaltrials.gov) - P3 | N=25 | Completed | Sponsor: Galderma R&D | Recruiting ➔ Completed

Trial completion