Botox
(Botulinum toxin type A)ApprovedSmall molecule
Botulinum toxin type A is used to reduce the appearance of wrinkles by temporarily paralyzing facial muscles, and it's also used to treat medical conditions like chronic migraines, excessive sweating, and muscle spasms.[2] Botox is currently approved and in use across 42 indications[4].[1]
Botox is one of 451 small molecule programs targeting Wilson disease. It is currently in Approved.
42
Indications
323
Total Trials
8
Active Trials
450
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 42 indications
Competition
Competitive Landscape
350 competitors in Treatment
#DrugCompanyPhaseTrials
1Botox
RRevance Therapeutics, Inc.
Approved
Dexilant
TakedaPreclinical
Niclocide
BayerPreclinical
Alfenta
Jazz PharmaceuticalsPreclinical
Hivid
CConrado Roberto Hoffmann Filho
Preclinical
Valium
Akero TherapeuticsPreclinical
Clomid
FerringPreclinical
Barhemsys
Tibotec Pharmaceuticals, IrelandPreclinical
Norpramin
VValidus Pharmaceuticals
Preclinical
Lotemax
PPharmos
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Botulinum Toxin27 trials
Show 24 more trials
Botulinum Toxin Injection for the Management of BPH
Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT00451191·134 enrolled
Occlusal Splints or Botulinum Toxin?
Completed·—·N/A·NCT03891121·73 enrolled
The Effect of Botulinum Toxin A In Patients With Excessive Gingival Display With And Without Zinc Supplementation
Completed·—·Phase 3·NCT03717987·26 enrolled
Botulinum Toxin Injections by Ultrasounds Guidance and Stretching Exercise in Spastic Toe Clawing
Completed·—·Phase 3·NCT02586142·30 enrolled
A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia
Completed·—·Phase 3·NCT02858219·60 enrolled
Botulinum Toxin to Improve Results in Cleft Lip Repair
Unknown status·—·Phase 3·NCT01429402·120 enrolled
Spasticity16 trials
Dry Needling and Botulinum Toxin in the Management of Poststroke Spasticity
Completed·SSultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey·N/A·NCT03747900·30 enrolled
Show 13 more trials
CLINICAL EFFECT OF BOTULINUM TOXIN TYPE A IN TREATMENT OF SPASTICITY
Unknown status·—··NCT04673240·70 enrolled
Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Lower Extremities
Unknown status·—·Phase 3·NCT02469948·40 enrolled
Cervical Dystonia11 trials
Show 8 more trials
Cerebral Palsy9 trials
Show 6 more trials
Botulinum Toxin (BOTOX) for Cerebral Palsy
Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 2·NCT00060957·40 enrolled
Lateral Canthal Lines9 trials
Show 6 more trials
70 more indications
Lower limb spasticity9 trials
Show 6 more trials
Hyperhidrosis7 trials
Show 4 more trials
Headache7 trials
Urinary incontinence7 trials
Mixed Urinary Incontinence Symptoms Before and After Treatment With Botox and Bulkamid
Completed·—··NCT02815046·58 enrolled
Show 4 more trials
Overactive Bladder5 trials
Safety and Efficacy5 trials
Moderate to Severe Glabellar Lines4 trials
Hypertrophy4 trials
Treatment3 trials
Efficacy and Safety3 trials
Cluster headache3 trials
Erectile Dysfunction3 trials
Intracavernosal Injection of Botulinum Toxin Type A (50 and 100 Unit) in the Treatment of Erectile Dysfunction
Completed·—·Phase 2·NCT03355963·200 enrolled
Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Vascular Erectile Dysfunction
Completed·—·Phase 1·NCT02584686·24 enrolled
Botulinum Toxin for Erectile Dysfunction
Completed·—·Phase 2/3·NCT03102762·70 enrolled
Migraine3 trials
Osteoarthritis2 trials
Keloid2 trials
Neuropathic Pain2 trials
Botulinum Toxin Type A for Neuropathic Pain in Patients With Diabetic Peripheral Polyneuropathy
Terminated·—·Phase 1·NCT02460107·9 enrolled
Multiple Sclerosis2 trials
Thoracic Outlet Syndrome2 trials
Myofascial Pain Syndrome2 trials
Patient Satisfaction2 trials
Trigeminal Neuralgia1 trial
Botulinum Toxin for Trigeminal Neuralgia
Unknown status·TThe First Affiliated Hospital of Zhengzhou University·Phase 3·NCT03331913·150 enrolled
Intra Articular Injection1 trial
Anal fissure1 trial
Stroke1 trial
Effects of EMG-driven Robot-assisted Therapy for the Distal Upper Limb Motor Function in the Chronic Stroke Patients With Botox Injections
Completed·—·Phase 2·NCT04502264·24 enrolled
Epiphora1 trial
Determination of the Optimum Delivery Route for Botulinum Toxin A in Patients With Epiphora
Completed·—·Phase 2·NCT01282541·26 enrolled
Back pain1 trial
Atrial Flutter1 trial
Radiofrequency Ablation Plus Botulinum Toxin Injection Versus Radiofrequency Ablation Only in Patients With Atrial Flutter
Unknown status·MMeshalkin Research Institute of Pathology of Circulation·Phase 2·NCT02002962·60 enrolled
Hypertrophic Scars1 trial
Lateral Epicondylitis1 trial
Botulinum Toxin Versus Active Strength Training in the Treatment of Lateral Epicondylitis
Completed·—·N/A·NCT00930709·103 enrolled
Parkinson's Disease1 trial
Effectiveness of Botulinum Toxin in Freezing of Gate in Parkinson's Disease Walking in Parkinson's Disease.
Unknown status·—·N/A·NCT06094309·20 enrolled
Leiomyoma1 trial
Esophageal Cancer1 trial
Chronic Pelvic Pain Syndrome1 trial
Postherpetic Neuralgia1 trial
Spastic Cerebral Palsy1 trial
Concentration1 trial
Premature Ejaculation1 trial
Hyaluronic Acid vs Botulinum Toxin Injection in Treatment of Lifelong Drug-Resistant Premature Ejaculation: Randomized Study
Not yet recruiting·—·N/A·NCT07236632·80 enrolled
Glabellar Frown Lines1 trial
Scoliosis1 trial
Sleep Disorder1 trial
Botulinum Toxin Relieves Anxiety, Depression and Sleep Disorderes in Patients With Blepharospasm
Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 1·NCT04939909·50 enrolled
Botox1 trial
Pancreatectomy1 trial
Amputation1 trial
Shoulder pain1 trial
Ultrasound Guided Botulinum Toxin Type A Injection of Subacromial-Subdeltoid Bursa in Hemiplegic Shoulder Pain
Unknown status·—·Phase 1·NCT04467450·36 enrolled
Hemorrhoid1 trial
Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain
Recruiting·LLomonosov Moscow State University Medical Research and Educational Center·Phase 2·NCT07399860·292 enrolled
Benign Prostatic Hyperplasia1 trial
Effectiveness1 trial
Regulatory
FDA Approval Timeline[5]
Apr 29, 2009
DYSPORT
BLA BLA125274
Sep 7, 2022
DAXXIFY
BLA BLA761127
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Botox drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Botulinum toxin type A. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Synaptosomal Nerve-Associated Protein 25 (SNAP-25) Hydrolytic Enzyme[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- RRevance Therapeutics, Inc.