liquid botulinum toxin (CKDB-501B) / Chong Kun Dang - LARVOL DELTA

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

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

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

Safety and Efficacy of CKDB-501B in Subjects With Moderate-to-severe Glabellar Lines (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: CKD Bio Corporation | Recruiting ➔ Completed

Trial completion

Safety and Efficacy of CKDB-501B in Subjects With Moderate-to-severe Glabellar Lines (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: CKD Bio Corporation

New P1 trial