Botulinum toxin A

Phase 3Small molecule

GSK

Botulinum toxin A is one of 202 small molecule programs targeting Botulinum Toxin. It is currently in Phase 3.

Indications

Total Trials

Active Trials

201

Competitors

Pipeline

Status by Indication[3][1]

Indication

Botulinum ToxinNot yet recruiting

GastroparesisActive, not recruiting

StrokeActive, not recruiting

Brain InjuryActive, not recruiting

Compartment SyndromeActive, not recruiting

Temporomandibular Joint DisordersNot yet recruiting

Fecal IncontinenceNot yet recruiting

StrabismusNot yet recruiting

KeloidActive, not recruiting

Facial FlushingActive, not recruiting

Botulinum ToxinPhase 3

Not yet recruiting

GastroparesisPreclinical

Active, not recruiting

StrokePreclinical

Active, not recruiting

Brain InjuryPreclinical

Active, not recruiting

Compartment SyndromePreclinical

Active, not recruiting

Temporomandibular Joint DisordersPreclinical

Not yet recruiting

Fecal IncontinencePhase 1

Not yet recruiting

StrabismusPhase 3

Not yet recruiting

KeloidPhase 2

Active, not recruiting

Facial FlushingPhase 3

Active, not recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

150 competitors in Stroke

#DrugCompanyPhaseTrials

Botulinum toxin A

GSK

Phase 3

1 2

Standard-Dose Rtpa

TThe George Institute

Phase 3

1 3

Savella

AbbVie

Preclinical

1 4

Zometa

Pfizer

Preclinical

1 5

Proamatine

Repatha

Haldol

1 8

Periactin

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 9

Zantac 150

CChattem

Preclinical

1 10

Alka-Seltzer

AAbbott

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalNot yet recruiting

Psoriasis Vulgaris

NCT06203470

Post-ApprovalNot yet recruiting

Botulinum Toxin

NCT06556030

N/ARecruiting

Plantar Fasciitis

NCT02196155

Q2 2027

N/ANot yet recruiting

Botulinum Toxin

NCT06470581

PreclinicalNot yet recruiting

Temporomandibular Joint Disorders

NCT07736521

Q4 2027

ApprovedActive, not recruiting

Facial Flushing

NCT02216838

Clinical

Trials by Indication[1]

Botulinum Toxin15 trials

Botulinum Toxin A for Idiopathic Toe-walking

Completed·KKarolinska Institutet·N/A·NCT01590693·52 enrolled

A Multicentre, Randomised, Single-blind, Controlled Protocol to Evaluate the Efficacy of Early Administration of Botulinum Toxin for Primary Midline Closure in Patients With Open Abdomen.

Not yet recruiting·IInstituto de Investigación Hospital Universitario La Paz·Phase 4·NCT06556030·50 enrolled

Thoracic Sympathetic Ganglion Block With Botulinum Toxin Type A

Not yet recruiting·SSeoul National University·N/A·NCT06470581·78 enrolled

Show 12 more trials

Glabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression

Withdrawn·HHelse Stavanger HF·Phase 1·NCT03833063

Hyperhydrosis Treatment Using Botulinum Toxin

Completed·SSt Joseph University, Beirut, Lebanon·Phase 4·NCT03816046·15 enrolled

Botulinum Toxins Intralesional Injection for Scar Pain

Unknown status·KKaohsiung Medical University·Phase 4·NCT03982862·20 enrolled

Botulinum Toxin in the Treatment of Raynaud's

Completed·EEmory University·N/A·NCT01233999·10 enrolled

Effect of Blood Flow by Botulinum Toxin Injection for Severe Peripheral Artery Occlusive Disease

Recruiting·YYonsei University·Phase 4·NCT06878482·15 enrolled

Botulinum Toxin A as a Treatment for Provoked Vestibulodynia

Completed·KKarolinska Institutet·Phase 3·NCT04057755·90 enrolled

Botulinum Toxin Injection for Treatment of Vaginismus

Unknown status·TTehran University of Medical Sciences·Phase 3·NCT00638066·40 enrolled

The Effect of Subcutaneous Injection of Botulinum Toxin A on Chronic Wound Pain in Lower Extremities

Completed·—·Phase 4·NCT05426161·10 enrolled

Efficiency of Botulinum Toxin type-a in the Management of the Myofascial Pain

Completed·HHacettepe University·N/A·NCT06840730·25 enrolled

Clinical Trial to Assess Efficacy, Safety and Tolerability of Botulinum Toxin A (Xeomin®) in Treatment of Expression Wrinkles in the Upper Third of the Face

Completed·BBiolab Sanus Farmaceutica·Phase 3·NCT00986570·121 enrolled

Botulinum Toxin Urethral Sphincter Injection for Dysfunctional Voiding

Completed·—·Phase 2·NCT01733290·70 enrolled

Subcutaneous Botulinum Toxin for Cutaneous Allodynia

Completed·SStanford University·N/A·NCT00725322·84 enrolled

Cerebral Palsy4 trials

Intensive Strength Training in Children With Cerebral Palsy - Effect on Hand Function

Completed·SSt. Olavs Hospital·Phase 2·NCT00467207·10 enrolled

The Effect of Botox on Children With Cerebral Palsy

Completed·SShriners Hospitals for Children··NCT00503620·11 enrolled

Efficacy and Functional Outcomes of Botulinum Toxin A Injections to Hamstrings in Flexed Knee Gait in Cerebral Palsy

Completed·SShriners Hospitals for Children·Phase 3·NCT00261131·250 enrolled

Show 1 more trial

Repetitive Transcranial Magnetic Stimulation Versus Botulinum Injection on Spasticity on Children With Diplegic Cerebral Palsy

Completed·MMTI University·N/A·NCT06218316·75 enrolled

Botox3 trials

Effects of Botox in Obstructed Defecation Syndrome

Terminated·MMassachusetts General Hospital·Phase 2·NCT02160288·1 enrolled

Trigonal vs Non Trigonal Botox Injection in OAB.

Completed·MMansoura University·N/A·NCT03533062·80 enrolled

Anticholinergic vs. Botox Comparison Study

Completed·NNICHD Pelvic Floor Disorders Network·Phase 3·NCT01166438·249 enrolled

Cervical Dystonia3 trials

Effects of Botulinum Toxin in Cervical Dystonia

Completed·HHenry Ford Health System··NCT01056861·7 enrolled

Botox for Cervical Dystonia Following EMG Mapping

Completed·UUniversity of California, San Francisco·Phase 4·NCT00773253·10 enrolled

Motor and Non-motor Symptoms in Cervical Dystonia

Unknown status·UUniversity of Roma La Sapienza··NCT04560101·43 enrolled

Efficacy and Safety3 trials

Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study II

Completed·CCroma-Pharma GmbH·Phase 3·NCT02677805·251 enrolled

Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study III (BLESSIII)

Completed·CCroma-Pharma GmbH·Phase 3·NCT03985982·410 enrolled

Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study I

Completed·CCroma-Pharma GmbH·Phase 3·NCT02677298·784 enrolled

44 more indications

Migraine3 trials

Efficacy of Nerve Block Versus Botox in Chronic Migraine Management

Recruiting·ZZagazig University·N/A·NCT06684249·64 enrolled

Migraine Medication Effects on Urinary Symptoms

Enrolling by invitation·TThe Cleveland Clinic··NCT06212661·200 enrolled

Chronic Migraine Treatment With Botulinum Toxin-A: an Investigation of Functional Magnetic Resonance Imaging Changes.

Completed·UUniversity of Manitoba·Phase 4·NCT02436499·12 enrolled

Osteoarthritis3 trials

Trial Comparing Botulin Toxin Versus Hyaluronic Acid by Intra-articular Injection for the Treatment of Painful Knee Osteoarthritis

Unknown status·UUniversity Hospital, Strasbourg, France·Phase 2·NCT02832713·50 enrolled

Effects of Intraarticular Botulinum Toxin A in Ankle Osteoarthritis

Completed·KKaohsiung Veterans General Hospital.·N/A·NCT01760577·70 enrolled

Efficacy of an Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2/3·NCT03187626·60 enrolled

Neurogenic Detrusor Overactivity2 trials

Intravesical Injection of Botulinum Toxin A Versus Saline for Neurogenic Detrusor Overactivity

Completed·SSunnybrook Health Sciences Centre·Phase 3·NCT01091727·57 enrolled

A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity

Completed·CCentro de Reabilitação e Readaptação Dr. Henrique Santillo·N/A·NCT01477736·68 enrolled

Overactive Bladder2 trials

Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder

Terminated·UUniversity of Alabama at Birmingham·N/A·NCT02995967·3 enrolled

Efficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder.

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT00231491·160 enrolled

Spasticity2 trials

Comparing the Radial Extracorporeal Shock Waves and Botulinum Toxin Injection for Spasticity

Completed·MMackay Memorial Hospital·N/A·NCT03131791·42 enrolled

A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity

Completed· GSK logo

GSK·Phase 3·NCT03261167·124 enrolled

Detrusor Overactivity2 trials

Injections of Botulinum Toxin A in Treatment of Patients With Detrusor Overactivity and Impaired Contractility

Completed·—·Phase 2·NCT02135341·60 enrolled

Effect of Botulinum Toxin A on Detrusor Overactivity and Renal Function in Chronic Spinal Cord Injured Patients

Completed·—·Phase 2·NCT01682603·34 enrolled

Plantar Fasciitis2 trials

The Efficacy of Botulinum Toxin vs. Corticosteroid for the Treatment of Refractory Plantar Fasciitis

Completed·WWestern Institute for Veterans Research·Phase 2/3·NCT05367271·62 enrolled

Botulinum Toxin A Versus Steroids for the Treatment of Chronic Plantar Fasciitis

Recruiting·IInsel Gruppe AG, University Hospital Bern·N/A·NCT02196155·54 enrolled

Spinal Cord Injury2 trials

Investigating Botulinum Toxin A to Treat Acute Neck/Upper Shoulder Pain Following a New Spinal Cord Injury.

Completed·—·Phase 4·NCT00320281·19 enrolled

Injecting Botulinum Toxin A Underneath the Skin to Treat Spinal Cord Pain in Patients With Spinal Cord Injury

Terminated·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT02736890·8 enrolled

Stroke1 trial

SURGERY VS BOTULINUM TOXIN ON QUALITY OF LIFE IN STROKE PATIENTS: RANDOMIZED TRIAL

Recruiting·FFundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental·N/A·NCT06392633·44 enrolled

Shoulder pain1 trial

Botulinum Toxin A for Shoulder Pain After Stroke

Unknown status·SSir Run Run Shaw Hospital·Phase 4·NCT02618603·50 enrolled

Compartment Syndrome1 trial

Treatment of Lower Leg Anterolateral Chronic Exertional Compartment Syndrome With Intra-muscular Botulinum Injections.

Unknown status·UUniversity of Calgary·N/A·NCT05765071·50 enrolled

Lateral Epicondylitis1 trial

Dysport® Injection in the Treatment of Chronic Lateral Epicondylitis

Completed·TTehran University of Medical Sciences·Phase 3·NCT00497913·52 enrolled

Hyperhidrosis1 trial

Longevity of Microwave Thermolysis and Botulinum Toxin A for Treatment of Axillary Hyperhidrosis

Completed·MMerete Haedersdal·Phase 4·NCT05057117·30 enrolled

Peripheral Neuropathy1 trial

Botulinum Toxin Type A in Diabetic Peripheral Neuropathy

Completed·—·Phase 4·NCT05296759·30 enrolled

Alopecia Totalis1 trial

The Randomized Double-blind Placebo-controlled Trial of Intralesional Botulinum Toxin A Injection for Recalcitrant Alopecia Totalis and Alopecia Universalis

Completed·SSiriraj Hospital·Phase 2/3·NCT00997815·20 enrolled

Restless Legs Syndrome1 trial

Botulinum Toxin to Treat Restless Legs Syndrome

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 1/2·NCT00479154·6 enrolled

Keloid1 trial

The Effectiveness of Intralesional Botulinum Toxin A and Triamcinolone Acetonide Injections in Keloid Treatment

Active, not recruiting·UUniversitas Padjadjaran·Phase 2·NCT06814288·20 enrolled

Gastroparesis1 trial

Placebo Controlled Trial of Botulinum Toxin for Gastroparesis

Completed·TTemple University·N/A·NCT00372970·32 enrolled

Contracture1 trial

Effect of Type-A Botulinum Toxin in the Post-radiosurgical Neck Contractures

Completed·HHopital Foch·Phase 2·NCT02986880·14 enrolled

Psoriasis Vulgaris1 trial

Botox Versus Tacrolimus in Psoriasis Vulgaris

Not yet recruiting·—·Phase 4·NCT06203470·60 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Botulinum Toxin A Injection in Patients With Painful Artificial Knee Arthroplasty (TKA)

Completed·MMinneapolis Veterans Affairs Medical Center·Phase 2·NCT00403273·54 enrolled

Treatment1 trial

Biofeedback Therapy Versus Botox Injection in Treatment of Dyssynergic Defecation.

Completed·MMansoura University·Phase 4·NCT06724250·78 enrolled

Blepharospasm1 trial

Wumeiwan Jiawei Fang Use in Patients With Blepharospasm

Unknown status·CChina Academy of Chinese Medical Sciences·Phase 2/3·NCT05618470·80 enrolled

Breast Reconstruction1 trial

The Use of Botulinum Toxin A in Two-Stage Tissue Expander/ Implant Breast Reconstruction

Unknown status·UUniversity of British Columbia·Phase 4·NCT01427400·128 enrolled

Vitiligo1 trial

Botulinum Toxin Treatment for Localized Vitiligo

Completed·KKing Saud University·Phase 4·NCT01051687·10 enrolled

Erythema1 trial

Intradermal BoNT-A Treatment in Erythematotelangiectatic Rosacea

Completed·IIstanbul Training and Research Hospital·Phase 4·NCT06331533·30 enrolled

Peyronie's Disease1 trial

H-22411: BOTOX® for Peyronie's Disease

Completed·MMohit Khera·Phase 2·NCT00812838·12 enrolled

Effectiveness1 trial

Effectiveness of Methods for Pyloric Drainage in esophagecTomY: Botox vs. Pyloromyotomy

Recruiting·TThe Cleveland Clinic·Phase 2/3·NCT06721520·170 enrolled

Fecal Incontinence1 trial

Intra-rectal Botulinum Toxin Injection for Intractable Non-retentive Fecal Incontinence in Children - an Open Label Pilot Study

Not yet recruiting·SShaare Zedek Medical Center·Phase 1·NCT06785844·14 enrolled

Brain Injury1 trial

Efficacy of Botulinum Toxin Injections in the Rectus Femoris to Treat Stiff Knee Gait Following Acquired Brain Injury

Terminated·MMary Free Bed Rehabilitation Hospital·N/A·NCT00900666·19 enrolled

Pelvic Pain1 trial

Botox as a Treatment for Chronic Male Pelvic Pain Syndrome

Terminated·UUniversity of Washington·Phase 4·NCT00194623·30 enrolled

Interstitial Cystitis1 trial

Intravesical Botulinum Toxin A Injections in Treatment of Interstitial Cystitis Refractory to Conventional Treatment

Completed·—·Phase 2·NCT01969773·60 enrolled

HIV Posterior Cheek Enlargement1 trial

HIV Posterior Cheek Enlargement

Completed·UUniversity of British Columbia·N/A·NCT01635504·5 enrolled

Trigeminal Neuralgia1 trial

Safety and Efficacy of Botulinum Toxin A in Patients With Trigeminal Neuralgia

Recruiting·HHenrik Schytz·Phase 3·NCT06315790·80 enrolled

Low back pain1 trial

Pilot Study to Assess the Efficacy of Botulinum Toxin A Treatments on Pain and Disability in Sub-Acute Low Back Pain

Terminated·UUnited States Department of Defense·Phase 4·NCT00384371

Erectile Dysfunction1 trial

Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction

Recruiting·—·Phase 2/3·NCT06583590·32 enrolled

Strabismus1 trial

Botulinum Toxin A vs Strabismus Surgery for Esotropia

Not yet recruiting·JJaeb Center for Health Research·Phase 3·NCT07470164·244 enrolled

Neuropathic Pain1 trial

Efficacy Study of Botox to Treat Neuropathic Pain

Completed·HHospital Ambroise Paré Paris·Phase 4·NCT00527202·29 enrolled

Efficacy1 trial

Efficacy of Intermittent Serial Casting on Spastic Wrist Flexion Deformity

Completed·KKocaeli University·Phase 3·NCT03306212·34 enrolled

Social Anxiety Disorder1 trial

A Study of the Efficacy of Botox in the Treatment of Social Anxiety Disorder

Terminated·DDaniel Lieberman·Phase 4·NCT03078270·4 enrolled

Hidradenitis Suppurativa (HS)1 trial

Botulinum Toxin Blockade of Neuronal Signals to Immune Cells as a Novel Treatment for Hidradenitis Suppurativa

Not yet recruiting·UUniversity of Massachusetts, Worcester·Phase 2·NCT07756346·40 enrolled

Hemifacial Spasm1 trial

A 50-Week Prospective, Double-Blinded, Randomized, Cross-over Design in Multicenter Study of100 Unit of Abobotulinum Toxin Type A (Dysport®) Versus 33.33 Unit of Neubotulinum Toxin Type A (Neuronox®) Injection for Hemifacial Spasm in Thai Patients

Completed·DDepartment of Medical Services Ministry of Public Health of Thailand·Phase 3·NCT04589364·107 enrolled

Temporomandibular Joint Disorders1 trial

Arthrocentesis Versus Botulinum Toxin Injection in Patients With Temporomandibular Joint Disorders: A Randomized Controlled Trial

Not yet recruiting·MMudher MB Alsunbuli·Preclinical·NCT07736521·66 enrolled

Facial Flushing1 trial

Treatment of Facial Flushing With Botulinum Toxin A Injections: A Split-Face, Double-blinded, Randomized Control Trial

Active, not recruiting·NNorthwestern University·Approved·NCT02216838·16 enrolled

Sources

References

[1]
ClinicalTrials.gov — 82 trial records for Botulinum toxin A. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Botulinum toxin A compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Botulinum toxin A. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — GSK company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: GSK

Botulinum toxin A

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q4 2027

Trials by Indication[1]

Botulinum Toxin15 trials

Cerebral Palsy4 trials

Botox3 trials

Cervical Dystonia3 trials

Efficacy and Safety3 trials

Migraine3 trials

Osteoarthritis3 trials

Neurogenic Detrusor Overactivity2 trials

Overactive Bladder2 trials

Spasticity2 trials

Detrusor Overactivity2 trials

Plantar Fasciitis2 trials

Spinal Cord Injury2 trials

Stroke1 trial

Shoulder pain1 trial

Compartment Syndrome1 trial

Lateral Epicondylitis1 trial

Hyperhidrosis1 trial

Peripheral Neuropathy1 trial

Alopecia Totalis1 trial

Restless Legs Syndrome1 trial

Keloid1 trial

Gastroparesis1 trial

Contracture1 trial

Psoriasis Vulgaris1 trial

Safety and Efficacy1 trial

Treatment1 trial

Blepharospasm1 trial

Breast Reconstruction1 trial

Vitiligo1 trial

Erythema1 trial

Peyronie's Disease1 trial

Effectiveness1 trial

Fecal Incontinence1 trial

Brain Injury1 trial

Pelvic Pain1 trial

Interstitial Cystitis1 trial

HIV Posterior Cheek Enlargement1 trial

Trigeminal Neuralgia1 trial

Low back pain1 trial

Erectile Dysfunction1 trial

Strabismus1 trial

Neuropathic Pain1 trial

Efficacy1 trial

Social Anxiety Disorder1 trial

Hidradenitis Suppurativa (HS)1 trial

Hemifacial Spasm1 trial

Temporomandibular Joint Disorders1 trial

Facial Flushing1 trial

References

Drug Info

Quick Facts

Related News