Botulinum Neurotoxins in dermatology and interdisciplinary medicine: pharmacology, European regulation, clinical applications, and future directions

Abstract

Background: Botulinum neurotoxin (BoNT) has evolved from a cause of foodborne paralysis into a precisely dosed biologic used in aesthetic medicine and multiple therapeutic specialties. Objective: To review its pharmacology, European regulatory landscape, established clinical uses, emerging applications, immunogenicity, health-economic concepts, and contemporary procedural epidemiology. Methods: A structured narrative review was updated through 24 September 2026. The original manuscript was used as the conceptual starting point; scientific claims were checked against PubMed-indexed reviews and systematic reviews, regulatory claims against European Medicines Agency documents, and procedural statistics against the International Society of Aesthetic Plastic Surgery (ISAPS) Global Survey 2024. Results: BoNT inhibits neurotransmitter release through serotype-specific proteolysis of SNARE proteins. European products include both centrally and nationally authorised formulations, and their units are not interchangeable. Established uses include focal hyperhidrosis and several neurological and urological indications. Evidence for temporomandibular disorders, rosacea, scar modulation, chronic pruritus, and psychiatric applications is promising but heterogeneous and generally off-label or investigational. ISAPS reported 7,887,955 botulinum toxin procedures in 2024, 17.4% fewer than in 2023 but 26.9% more than in 2020. Conclusion: Future progress will depend on formulation innovation, comparative trials, standardized outcome measures, long-term pharmacovigilance, and precise separation of regulatory status from clinical evidence.

Keywords: botulinum neurotoxin; botulinum toxin A; botulinum toxin E; pharmacology; European regulation; hyperhidrosis; aesthetics