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Botulinum toxin type A

Generic Name
Botulinum toxin type A
Brand Names
Botox, Botox Cosmetic, Dysport, Jeuveau, Xeomin, Nuceiva
Drug Type
Biotech
CAS Number
93384-43-1
Unique Ingredient Identifier
0A6JH35GMQ
Background

In 2002, botulinum toxin A, also known as onabotulinumtoxinA or Botox, was the first type A botulism toxin to be introduced into the market for cosmetic use. With a wide variety of applications and favourable safety profile, Botulinum toxin A injection is a minimally invasive and promising treatment for cosmetic imperfections, muscle spasms, and other conditions. A popular use for Botox is the treatment of facial wrinkles and lines, however, there are many uses for the botulinum toxin A in the treatment of dystonia, incontinence, migraine, blepharospasm, and hyperhidrosis.

Indication

Botulinum toxin A is indicated for a variety of conditions, depending on the preparations. Cosmetically, it is used for the treatment of facial fine lines and wrinkles, specifically for upper facial rhytides, including forehead, lateral canthus, and glabellar lines.

In addition to the above indications, botulinum toxin A is used for the following conditions: treatment of adults with symptomatic overactive bladder with or without incontinence, treatment of incontinence in adult patients who are not candidates for anticholinergic therapy, treatment of Neurogenic Detrusor Overactivity (NDO) in patients over 5 years who cannot undergo anticholinergic therapy. Botulinum toxin A is indicated for the prevention of chronic migraines, for the treatment of muscle spasms, cervical dystonia, axillary hyperhidrosis, strabismus, and disorders of the 7th cranial nerve.

Off-label, botulinum toxin A is used for a variety of conditions such as temporomandibular joint (TMJ) disorders and myofascial pain, neurogenic thoracic outlet syndrome, epicondylitis, post-stroke pain, post-herpetic neuralgia, diabetic neuropathy, trigeminal neuralgia, neuropathic pain, spinal cord injury, and bladder pain.

Associated Conditions
Bladder pain, Blepharospasm, Cervical Dystonia, Chronic Migraine, Diabetic Neuropathies, Epicondylitis, Equinus deformity of foot, acquired, Facial Skin Wrinkles, Glabellar Frown Lines (GL), Lower Limb Spasticity, Myofascial Pain Syndrome, Neurogenic Detrusor Overactivity, Neurogenic Thoracic Outlet Syndrome, Overactive Bladder Syndrome (OABS), Post Stroke Pain, Postherpetic Neuralgia, Sialorrhea, Spasticity, Spinal Cord Injuries, Strabismus, TMJ Disorders, Trigeminal Neuralgia (TN), Upper Limb Spasticity, Urinary Incontinence (UI), Hypertonicity disorders of the 7th nerve, Moderate Glabellar Frown Lines (GL), Severe Glabellar Frown Lines (GL), Severe axillary hyperhidrosis
Clinical Trials
Related News

REPOSE Study Confirms Real-World Efficacy of Higher-Dose OnabotulinumtoxinA for Chronic Migraine

• The two-year REPOSE study demonstrated that 156-195 U onabotulinumtoxinA significantly reduced monthly headache days in adults with chronic migraine, with reductions ranging from 8.7 to 14.2 days. • Treatment with higher-dose onabotulinumtoxinA (156-195 U) showed comparable safety to the standard 155 U dose, with eyelid ptosis, neck pain, and musculoskeletal stiffness being the most commonly reported adverse reactions. • Quality of life measurements improved consistently across treatment visits for patients receiving both standard and higher doses, supporting the clinical benefit of onabotulinumtoxinA in real-world settings.

AbbVie Seeks FDA Approval for Novel Serotype E Botulinum Neurotoxin for Glabellar Lines

• AbbVie has submitted a Biologics License Application to the FDA for TrenibotE (trenibotulinumtoxinE), a first-in-class serotype E botulinum neurotoxin for treating moderate to severe glabellar lines. • TrenibotE demonstrates a differentiated clinical profile with rapid onset of action within 8 hours and shorter duration of 2-3 weeks, potentially addressing patient concerns about "looking unnatural" with traditional neurotoxins. • The submission is supported by data from over 2,100 patients across two pivotal Phase 3 trials and a long-term safety study, all of which met primary and secondary endpoints with a safety profile comparable to placebo.

AEON Biopharma Appoints Rob Bancroft as New CEO to Lead ABP-450 Therapeutic Development

• AEON Biopharma has appointed industry veteran Rob Bancroft as Chief Executive Officer to lead the company's development of ABP-450 for therapeutic applications. • ABP-450 (prabotulinumtoxinA) is the same botulinum toxin complex marketed for cosmetic use as Jeuveau, with AEON focusing on its potential for debilitating medical conditions in neurosciences. • The company is pursuing a 351(k) biosimilar pathway with the FDA, aiming to position ABP-450 as a biosimilar to BOTOX for both current and future therapeutic indications.

EG 427 Secures €27M Series B to Advance Novel Gene Therapy for Spinal Cord Injury-Related Bladder Dysfunction

• French biotech EG 427 has raised €27M in Series B funding led by Andera Partners and Bpifrance to advance its lead candidate EG110A into Phase Ib/IIa trials for neurogenic detrusor overactivity. • EG110A, utilizing a non-replicating HSV-1 vector, demonstrated promising preclinical results comparable to botulinum toxin A, without the common side effect of increased post-void residual urine volume. • The first-in-human trial will evaluate EG110A in spinal cord injury patients with NDO across four US sites, with an initial 12-month follow-up period and potential 5-year extension for responders.

Allergan Aesthetics Launches AA Signature Program to Transform Personalized Aesthetic Treatments

• Allergan Aesthetics has unveiled its new AA Signature Program at IMCAS 2025, offering healthcare professionals an innovative approach to personalized, multimodal aesthetic treatment planning. • Research shows 8 in 10 patients proceed with treatment following holistic consultations, and clinics using multi-area treatment plans experience 68% higher patient retention rates compared to single-area approaches. • The program addresses three key patient needs: lift (structure and firmness), definition (enhanced facial angles), and skin quality (smoother, more hydrated skin), utilizing Allergan's comprehensive product portfolio.

Eirion Therapeutics' ET-02 Shows Promise in Phase 1 Trial for Androgenic Alopecia

• Eirion Therapeutics announced positive results from its first-in-man clinical trial of topical ET-02 for androgenic alopecia. • The Phase 1 trial demonstrated that ET-02 was safe and well-tolerated among participants. • Early results indicated that improvements were observed as early as 5 weeks into the treatment. • The 5% dosage of ET-02 showed a significant increase in non-vellus hair count, marking a potential breakthrough in hair loss treatment.

Atogepant Shows Rapid Migraine Relief in Clinical Trials

• Atogepant, a CGRP receptor antagonist, demonstrates rapid reduction in migraine symptoms, potentially starting from the first dose. • Clinical trials (ADVANCE, ELEVATE, PROGRESS) show atogepant outperforms placebo in reducing migraine days within the first four weeks of treatment. • Patients on atogepant reported improvements in daily activities and overall quality of life compared to those on placebo. • The drug's quick onset may encourage treatment adherence, offering hope for those who have discontinued other migraine medications.

Medytox's Hyaluronic Acid Filler Atiere Receives Approval in Thailand

• Medytox has received approval from Thailand's Food and Drug Administration for its hyaluronic acid (HA) filler, Atiere. • Atiere includes two formulations: Atiere Volume for significant volume deficiency and Atiere Intensive for moderately deep wrinkles. • This marks Atiere's second international approval, following its debut in Indonesia in June, with plans for further expansion. • The approval is expected to boost Medytox's global filler market strategy, creating synergy with its botulinum toxin, Meditoxin.

Xenon Pharmaceuticals Advances Azetukalner Program for Epilepsy and MDD

• Xenon Pharmaceuticals is progressing its Phase 3 epilepsy program with azetukalner, anticipating topline data from the X-TOLE2 study in the second half of 2025. • The company plans to initiate the X-NOVA2 Phase 3 trial for azetukalner in major depressive disorder (MDD) by the end of the year, expanding its therapeutic focus. • Xenon is expanding its ion channel portfolio, with multiple candidates advancing towards IND filings in 2025, targeting Kv7, Nav1.7, and Nav1.1. • Long-term data from the X-TOLE open-label extension study of azetukalner in focal onset seizures will be presented at the American Epilepsy Society (AES) annual meeting.

Botox Cosmetic Receives FDA Approval for Platysma Bands, Expanding Aesthetic Applications

• Botox Cosmetic gains FDA approval for treating moderate to severe platysma bands, marking its fourth approved aesthetic indication. • Clinical trials demonstrated statistically significant improvements in platysma band appearance with Botox Cosmetic compared to placebo (p < 0.0001). • The approval enables direct-to-consumer marketing, potentially increasing patient awareness and inquiries for this non-surgical treatment option. • Standardized training for aesthetic providers will promote safe and optimal outcomes in platysma band treatment using Botox Cosmetic.

FDA Accepts Satsuma and SNBL's NDA Resubmission for STS101 Migraine Treatment

• The FDA has accepted for review Satsuma Pharmaceuticals and SNBL's resubmitted NDA for STS101, a dihydroergotamine nasal powder, for acute migraine treatment. • The PDUFA date is set for April 30, 2025, offering hope for the nearly 40 million Americans suffering from migraine, especially women in their 20s to 40s. • STS101 is designed for quick self-administration, leveraging a proprietary nasal delivery device for rapid DHE absorption and sustained plasma concentrations. • The resubmission addresses FDA's previous concerns related to formulation, with no additional clinical trials requested, marking a significant step toward potential approval.

Vensica Medical Raises $11M to Advance Needle-Free Overactive Bladder Treatment

• Vensica Medical secured $11 million in funding to support Phase 2 clinical trials of its needle-free botulinum toxin A (Xeomin®) delivery system for overactive bladder (OAB). • The funding round was led by Israel Biotech Fund (IBF), with participation from Merz and Laborie, to advance a minimally invasive OAB treatment option. • Vensica's technology delivers Xeomin® directly to the bladder wall, potentially offering a more comfortable alternative to traditional injections for OAB patients. • The strategic partnership with Merz grants Vensica exclusive rights to use Xeomin® in needle-free applications for urologic indications, enhancing its clinical development.

Vensica Medical Raises $11M to Advance Needle-Free OAB Treatment

• Vensica Medical secured $11 million in funding to support Phase 2 clinical trials of its needle-free botulinum toxin A (Xeomin®) delivery system for overactive bladder (OAB). • The funding round was led by Israel Biotech Fund (IBF), with participation from strategic partners Merz and Laborie, to advance minimally invasive OAB treatment. • Vensica's technology delivers Xeomin® directly to the bladder wall, offering a potentially more comfortable alternative to traditional injections for OAB patients. • The collaboration with Merz grants Vensica exclusive rights to use Xeomin® in needle-free applications for urologic indications, enhancing its next-generation urology treatments.

Vensica Medical Raises $11M to Advance Needle-Free Overactive Bladder Treatment

• Vensica Medical secured $11 million in funding to support Phase 2 clinical trials of its needle-free botulinum toxin A (Xeomin®) delivery system for overactive bladder (OAB). • The funding round was led by Israel Biotech Fund (IBF), with participation from Merz and Laborie, to advance minimally invasive OAB treatment. • Vensica's technology delivers Xeomin® directly to the bladder wall, offering a potentially more comfortable alternative to traditional injections. • The strategic partnership with Merz grants Vensica exclusive rights to Xeomin® for needle-less urologic applications, enhancing next-generation urology treatments.

RelabotulinumtoxinA Shows Long-Term Safety and Efficacy in Phase III Trial for Facial Lines

• Galderma's RelabotulinumtoxinA (Relfydess™) demonstrates sustained safety and efficacy in treating frown lines and crow's feet with repeated injections over 12 months. • The Phase III READY-4 trial met its primary and secondary endpoints, showing high patient satisfaction and a low incidence of mild to moderate adverse events. • Data supports RelabotulinumtoxinA as a durable treatment option, with many patients maintaining improvements and satisfaction throughout multiple treatment cycles. • RelabotulinumtoxinA is the first ready-to-use liquid neuromodulator using PEARL™ Technology, optimized for ease of use and consistent dosing.

BOTOX® Cosmetic Receives FDA Approval for Platysma Bands

• BOTOX® Cosmetic (onabotulinumtoxinA) gains FDA approval for temporarily improving the appearance of moderate to severe platysma bands in adults. • This approval expands BOTOX® Cosmetic's indications, making it the first and only product approved for forehead lines, frown lines, crow's feet, and platysma bands. • Phase III trials showed statistically significant improvement in platysma band appearance with BOTOX® Cosmetic compared to placebo (p<0.0001), based on investigator and subject assessments. • The treatment involves injecting BOTOX® Cosmetic along the jawline and vertical bands of the neck, reducing muscle activity and improving jawline definition.

FDA Approves Botox Cosmetic for Platysma Bands, Expanding Aesthetic Applications

• Botox Cosmetic receives FDA approval for improving the appearance of moderate to severe platysma bands in adults, marking its fourth aesthetic indication. • Clinical trials demonstrated statistically significant improvements in platysma band appearance with Botox Cosmetic compared to placebo (p<0.0001). • The approval provides a non-surgical, injectable option for patients bothered by vertical bands connecting the jaw and neck, enhancing jawline definition. • This approval expands Allergan Aesthetics' offerings, providing aesthetic specialists with a new tool to meet patient aesthetic goals.

DemRisk Model Predicts Dementia Risk in Primary Care; S100β Levels Indicate Stroke Prognosis; DaxibotulinumtoxinA Improves Spasticity

• A new dementia risk prediction model, DemRisk, uses routinely collected primary care data to identify high-risk individuals aged 60-79, incorporating factors like age, stroke history, and medication use. • Elevated S100β levels 24 hours post-intravenous thrombolysis (IVT) in stroke patients are independently associated with hemorrhagic transformation, infarct volume, and unfavorable outcomes, including mortality. • DaxibotulinumtoxinA-lanm 500U significantly reduces muscle tone in adults with upper limb spasticity post-stroke or traumatic brain injury, demonstrating a greater therapeutic effect compared to placebo.

ION464 Shows Promise in MSA, OnabotulinumtoxinA Explored for Essential Tremor, Dietary Challenges in Parkinson's

• ION464 (BIIB101), an antisense medicine targeting alpha-synuclein, demonstrates safety and tolerability in a Phase 1/2 trial for multiple system atrophy (MSA) patients. • A Phase 2b trial (ELATE) is underway to evaluate the safety and efficacy of onabotulinumtoxinA for upper limb essential tremor (ULET), potentially offering a better risk-benefit profile than oral therapies. • A crossover study reveals that while Parkinson's disease (PD) patients embrace Mediterranean diets, combining them with ketogenic interventions faces challenges due to restrictiveness and gastrointestinal side effects.

AEON Biopharma Achieves Positive Outcome in FDA Biosimilar Advisory Meeting for ABP-450

• AEON Biopharma is aligned with the FDA on the 351(k) regulatory pathway for ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX® (onabotulinumtoxinA). • Comparative analytical studies are scheduled to begin in Q4 2024 to demonstrate biosimilarity between ABP-450 and BOTOX®. • A Biosimilar Biological Product Development (BPD) Type 2 meeting with the FDA is planned for 2025 to review study results. • AEON aims for a single approval to market prabotulinumtoxinA for all of BOTOX's approved and future therapeutic indications in the U.S.
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