Botox

ApprovedSmall molecule

AbbVie

Botox is one of 219 small molecule programs targeting Plantar Fasciitis. It is currently in Approved.

Indications

123

Total Trials

Active Trials

218

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Plantar FasciitisActive, not recruiting

Cervical DystoniaCompleted

Autonomic DysreflexiaCompleted

Brain InjuryActive, not recruiting

NecrosisActive, not recruiting

Sexual DysfunctionNot yet recruiting

BruxismActive, not recruiting

Hallux ValgusActive, not recruiting

Compartment SyndromeTerminated

Interstitial CystitisCompleted

Plantar FasciitisPreclinical

Active, not recruiting

Cervical DystoniaApproved

Completed

Autonomic DysreflexiaApproved

Completed

Brain InjuryApproved

Active, not recruiting

NecrosisApproved

Active, not recruiting

Sexual DysfunctionPhase 3

Not yet recruiting

BruxismPreclinical

Active, not recruiting

Hallux ValgusApproved

Active, not recruiting

Compartment SyndromeApproved

Terminated

Interstitial CystitisApproved

Completed

Showing 10 of 16 indications

Competition

Competitive Landscape

141 competitors in Osteoarthritis

#DrugCompanyPhaseTrials

Botox

AbbVie

Approved

1 2

Toradol

Roche

Preclinical

1 3

Cataflam

Bayer Aspirin

Enbrel

2 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

1 7

Chirocaine

PPurdue Pharma LP

Preclinical

1 8

Lunesta

Akero Therapeutics

Preclinical

1 9

Glucophage

EMD Serono

Preclinical

1 10

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2/3Not yet recruiting

Sexual Dysfunction

NCT06755099

Q1 2027

Phase 1/2Active, not recruiting

Urgency Incontinence

NCT05512039

Phase 1Active, not recruiting

Glabellar Lines

NCT07756580

Q1 2028

Phase 3Not yet recruiting

Buerger Disease

NCT05698979

Clinical

Trials by Indication[1]

Moderate to Severe Glabellar Lines10 trials

Treatment of Moderate to Severe Glabellar Lines (BMI2006)

Completed·BBMI Korea·Phase 3·NCT05531968·278 enrolled

Safety and Efficacy Study of ATGC-100 for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects

Completed·EEuBiologics Co.,Ltd·Phase 1/2·NCT03970876·60 enrolled

Clinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox With Moderate to Severe Glabellar Lines

Completed·MMedy-Tox·Phase 3·NCT03216408·504 enrolled

Show 7 more trials

Evaluate the Safety and Explore the Efficacy of DWP712 With Moderate to Severe Glabellar Lines

Completed· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 1·NCT06212960·20 enrolled

The Safety and Efficacy Study of PROTOXIN in Subjects With Moderate to Severe Glabellar Lines

Completed·PProtox Inc.·Phase 1/2·NCT04996810·60 enrolled

A Phase I/II, Randomized, Double-blind, Placebo, and Active Controlled Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, and Preliminary Efficacy of JHM03 in Subjects With Moderate to Severe Glabellar Lines

Completed·JJHM BioPharma (Tonghua) Co. , Ltd.·Phase 1/2·NCT06199336·190 enrolled

DWP450 for Treating Moderate to Severe Glabellar Lines

Completed· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 3·NCT06354127·473 enrolled

The Efficacy and Safety Study of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines

Completed·PProtox Inc.·Phase 3·NCT05364580·269 enrolled

The Efficacy and Safety of CUNOX® in Patients With Moderate to Severe Glabellar Lines

Completed·MMedy-Tox·Phase 3·NCT03837561·136 enrolled

Evaluate the Efficacy and Safety of DWP712 With Moderate to Severe Glabellar Lines

Not yet recruiting· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 3·NCT07013279·324 enrolled

Botulinum Toxin9 trials

The Movement of Botulinum Toxin Through the Lateral Gastrocnemius Muscle in Humans: An Expanded Examination

Terminated·WWeill Medical College of Cornell University·Phase 4·NCT03367429·4 enrolled

Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia

Completed·NNantes University Hospital·Phase 2·NCT01331356·18 enrolled

A Study to Assess the Effectiveness of BOTOX (Botulinum Toxin Type A) Injections for the Change of Masseter Muscle Prominence in Adult Participants

Completed· AbbVie logo

AbbVie·Phase 3·NCT06068855·249 enrolled

Show 6 more trials

A Double-Blind, Randomized Control Trial Comparing Botulinum Toxin Type A (Botox) and Placebo in the Treatment of Idiopathic Clubfoot

Completed·UUniversity of British Columbia·N/A·NCT00152347·36 enrolled

Botulinum Toxin Injection With Prostate Brachytherapy

Withdrawn·EEmory University·Phase 2·NCT00681148

Onabotulinum Toxin A in Direct Brow Lift

Unknown status·NNova Scotia Health Authority·N/A·NCT04383912·16 enrolled

Botulinum Toxin for the Management of Chronic Orchialgia

Completed·WWake Forest University Health Sciences·Phase 2·NCT02058836·8 enrolled

To Study the Peripheral Effect of Botulinum Toxin-A (Botox-A) on Experimentally Induced Cutaneous Pain in Healthy Subjects

Completed·—·N/A·NCT00435682

Botulinum Toxin for Stomach Cancer Treatment

Completed·SSt. Olavs Hospital·Phase 2·NCT01822210·7 enrolled

Botox9 trials

Itch Relieving Effect of Botox: a Study in Healthy Subjects

Completed·TTemple University·Phase 1/2·NCT02639052·35 enrolled

Pharmacodynamic and Safety of MT10107(Botulinum Type A Neurotoxin) in Comparison to BOTOX®

Completed·MMedy-Tox·Phase 1·NCT03796351·25 enrolled

Change in Biting Force After Botox Injection

Completed·—·N/A·NCT04940104·20 enrolled

Show 6 more trials

Botox vs Occlusal Splint for Masseter Pain

Completed·FFederal University of Pelotas·Phase 4·NCT03456154·60 enrolled

Sling vs Botox for Mixed Incontinence

Completed·NNICHD Pelvic Floor Disorders Network·Phase 3·NCT04171531·150 enrolled

Use of Botox to Treat Scrotal Pain

Completed·MMount Sinai Hospital, Canada·Phase 1·NCT01832194·20 enrolled

Randomization of Botox for Stent Pain and Irritative Voiding Symptoms

Terminated·UUniversity of California, Irvine·Phase 3·NCT02078895·15 enrolled

Injection of Botox in the Perineal Muscles in Resistant Cases of Vaginal Spasm

Completed·AAbdel-Maguid Ramzy·N/A·NCT01859507·32 enrolled

Botox Cosmetic and the Young Patient With Glabellar Furrows

Completed·OOregon Health and Science University·Phase 4·NCT00856999·50 enrolled

Spasticity8 trials

Safety and Efficacy of CKDB-501A in Subjects With Post-stroke Upper Limb Spasticity

Completed·CCKD Bio Corporation·Phase 1·NCT05382767·24 enrolled

CORETOX® in Treatment of Post Stroke Upper Limb Spasticity (Phase3)

Completed·MMedy-Tox·Phase 3·NCT03289702·220 enrolled

Study of a New Generation Botulinum Toxin A2NTX to Treat Spasticity After Stroke

Unknown status·UUniversity of Tokushima·Phase 2/3·NCT01910363·30 enrolled

Show 5 more trials

Comparative Efficacy of Three Preparations of Botox-A in Treating Spasticity

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT00178646·33 enrolled

The Effect of Oral Baclofen and Botulinum Toxin Treatments in Hemiplegic Spasticity on the Nociceptive Flexor Reflex

Completed·MMustafa Kemal University·Phase 4·NCT03860662·29 enrolled

A Clinical Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults

Recruiting·CChongqing Claruvis Pharmaceutical Co., Ltd.·Phase 2/3·NCT06783114·254 enrolled

CORETOX® in Treatment of Post Stroke Upper Limb Spasticity (Phase1)

Completed·MMedy-Tox·Phase 1·NCT05164003·30 enrolled

Study of Intramuscular Injections of ABBV-950 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Spasticity

Terminated· AbbVie logo

AbbVie·Phase 1·NCT05956509·1 enrolled

Efficacy and Safety6 trials

Efficacy and Safety of a New Botulinum Toxin Type A for Treatment of Facial Expression Lines

Completed·AAzidus Brasil·Phase 3·NCT01180348·192 enrolled

Efficacy and Safety of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines in Phase 3 Trial

Completed·CCKD Bio Corporation·Phase 3·NCT05804656·300 enrolled

Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Glabellar Lines

Completed·MMedytox Korea·Phase 3·NCT05059587·318 enrolled

Show 3 more trials

Clinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox With Essential Blepharospasm

Completed·MMedy-Tox·Phase 3·NCT03216473·140 enrolled

Efficacy and Safety Study of MT10107 in the Treatment of Glabella Line

Completed·MMedy-Tox·Phase 3·NCT03908008·136 enrolled

Efficacy and Safety of DWP450 Compared With Botox in Moderate to Severe Glabellar Line

Completed· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 3·NCT01629875·268 enrolled

58 more indications

Cerebral Palsy5 trials

Does Botulinum Toxin A Make Walking Easier in Children With Cerebral Palsy?

Completed·SSt. Olavs Hospital·Phase 4·NCT02546999·61 enrolled

The Effect of Botox Injection on Postural Stability of Cerebral Palsy (CP) Children

Terminated·SSoroka University Medical Center··NCT00651339·20 enrolled

Treatment With Xeomin Versus Botox in Children With Spastic Equine and Equinovarus Foot Deformation in Pediatric Cerebral Palsy

Completed·MMerz Pharmaceuticals GmbH·Phase 2·NCT02188277·64 enrolled

Show 2 more trials

Effect of Botox and Vibration on Bone in Children With Cerebral Palsy

Completed·UUniversity of Delaware·N/A·NCT01803464·29 enrolled

Evaluation of the Efficacy of the Injection of Botulinum Toxin A vs Scopolamine Patches in the Treatment of Drooling in Children With Cerebral Palsy

Terminated·HHospices Civils de Lyon·Phase 3·NCT03616067·23 enrolled

Overactive Bladder3 trials

Botox for the Treatment of Overactive Bladder Secondary to Benign Prostatic Obstruction

Completed·WWeill Medical College of Cornell University·Phase 3·NCT01220726·30 enrolled

Treatment of MEDITOXIN® in Female Patients With Idiopathic Overactive Bladder

Completed·MMedy-Tox·Phase 1·NCT03371342·30 enrolled

Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment (ROSETTA)

Completed·NNICHD Pelvic Floor Disorders Network·Phase 3·NCT01502956·386 enrolled

Urinary incontinence3 trials

A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence

Completed· AbbVie logo

AbbVie·Phase 3·NCT01767519·356 enrolled

A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence

Completed·UUniversity of Rochester·N/A·NCT00345332·31 enrolled

OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients (12 to 17)

Terminated· AbbVie logo

AbbVie·Phase 3·NCT02097121·56 enrolled

Cervical Dystonia3 trials

Efficacy and Safety of MEDITOXIN® in Cervical Dystonia

Completed·MMedy-Tox·Phase 3·NCT03905304·152 enrolled

Study for Determine the Safety and Efficacy of Clostridium Botulinum Toxin Type A in Subjects With Cervical Dystonia

Completed·MMedy-Tox·Phase 2·NCT01588574·60 enrolled

A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia

Completed·SSeoul National University Hospital·Phase 4·NCT00950664·103 enrolled

Treatment3 trials

Botox Injection for Treatment of Vaginismus

Completed·PPlastic Surgery Professional Association·Phase 1·NCT01352546·31 enrolled

Evaluation of Three Types of Injection for the Treatment of Lateral Epicondylalgia

Terminated·—·N/A·NCT02325063·13 enrolled

Evaluating Lip Repositioning for the Treatment of Excess Gingival Display With and Without Pretreatment With Botox

Unknown status·—·Phase 1·NCT04030767·22 enrolled

Masseter Muscle Prominence3 trials

BOTOX® (onabotulinumtoxinA) for the Reduction of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

Completed· AbbVie logo

AbbVie·Phase 3·NCT06387394·202 enrolled

BOTOX® (onabotulinumtoxinA) for the Reduction of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

Completed· AbbVie logo

AbbVie·Phase 3·NCT06399718·207 enrolled

BOTOX VISTA® (onabotulinumtoxinA) for Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

Completed· AbbVie logo

AbbVie·Phase 3·NCT06137287·259 enrolled

Benign Prostatic Hyperplasia2 trials

BOTOX in Men With Prostate Cancer With Lower Urinary Tract Symptoms(LUTS)/Benign Prostatic Hyperplasia (BPH)

Withdrawn·TThe University of Texas Health Science Center, Houston·Phase 1·NCT01520441

Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy

Completed·—·Phase 2/3·NCT01566292·33 enrolled

Interstitial Cystitis2 trials

Study of BOTOX Injections to Assess Change in Disease Activity and Adverse Events in Adult Female Participants With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Completed· AbbVie logo

AbbVie·Phase 2·NCT05141006·83 enrolled

Botox as a Treatment for Interstitial Cystitis in Women

Completed·UUniversity of Washington·Phase 4·NCT00194610·20 enrolled

Double-blind2 trials

This is a Prospective, Randomized, Double-Blind Study Comparing Intravesical Injection of Botox® to Placebo.

Unknown status·UUrological Sciences Research Foundation·Phase 2/3·NCT00479596·40 enrolled

Double-blind Comparative Randomized Multicenter

Completed·IInnopharm LLC·Phase 3·NCT06840158·80 enrolled

Bruxism2 trials

The Use of Low-Dose Botulinum Toxin Injection Into the Masseter Muscle to Treat Sleep Bruxism

Completed·—·N/A·NCT05620316·22 enrolled

Which is More Effective in Management of Bruxism: Botox or Occlusal Splints

Completed·OOctober University for Modern Sciences and Arts·N/A·NCT04366869·42 enrolled

Satisfaction2 trials

Study to Evaluate Subject Satisfaction With Facial Appearance and Impact of Combined Facial Treatment

Completed· AbbVie logo

AbbVie·Phase 4·NCT04609020·64 enrolled

A Study to Evaluate Participant Satisfaction and Natural Outcomes Following Administration of BOTOX Cosmetic Injections in Adult Participants for Treatment of Upper Facial Lines

Completed· AbbVie logo

AbbVie·Phase 4·NCT06218251·100 enrolled

Glabellar Lines2 trials

A Phase 1 Study to Evaluate the Safety and Efficacy of Sequential Administration of AGN-151586 and BOTOX® in Subjects for Treatment of Glabellar Lines (GL)

Active, not recruiting· AbbVie logo

AbbVie·Phase 1·NCT07756580·143 enrolled

A Phase 1 Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) in Subjects for Treatment of Glabellar Lines

Completed· AbbVie logo

AbbVie·Phase 1·NCT05496335·90 enrolled

Tics1 trial

JCP Study of Investigation of Patient Background Characteristics

Completed· GSK logo

GSK··NCT01332474·326 enrolled

Hallux valgus1 trial

Effect of Botulinum Toxin to Hallux Valgus in Addition to Total Contact Insole

Completed·—·Phase 4·NCT01501500·25 enrolled

Necrosis1 trial

Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis

Unknown status·SSheba Medical Center·Phase 4·NCT01500668·20 enrolled

Clinical Trial1 trial

Botox Clinical Trial

Withdrawn·SSheffield Children's NHS Foundation Trust·Phase 4·NCT00624299

Headache1 trial

Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches

Completed·YYale University·Phase 2/3·NCT00660192·25 enrolled

Headache Disorder1 trial

Safety and Efficacy Study of Botox in the Treatment of Forward Head Posture With Associated Episodic Headache Disorder

Completed·—·Phase 2/3·NCT01350375·30 enrolled

Neuropathic Pain1 trial

Early Administration of Botox® in Neuropathic Pain Due to Thoracoscopy or Thoracotomy

Withdrawn·UUniversity Hospital, Limoges·Phase 3·NCT01325090

Plantar Fasciitis1 trial

Treatment of Gastrocnemius Tightness and Subsequent Chronic Plantar Fasciitis with Botulinum Toxin a

Recruiting·OOslo University Hospital··NCT05218785·40 enrolled

Brain Injury1 trial

BOTOX® Versus Zanaflex® for the Treatment of Post-Stroke or Traumatic Brain Injury Upper Limb Spasticity

Completed·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT00430196·135 enrolled

Adverse Events1 trial

A Study to Assess the Adverse Events and Effectiveness of BOTOX Injections for the Treatment of Moderate to Severe Forehead Lines in Chinese Adult Participants

Completed· AbbVie logo

AbbVie·Phase 3·NCT06174688·140 enrolled

Compartment Syndrome1 trial

Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome

Terminated·UUniversity of Wisconsin, Madison·Phase 4·NCT05006417·1 enrolled

Depression1 trial

Efficacy Study of Botox for Depression

Unknown status·CCapital Clinical Research Associates, LLC·Phase 4·NCT01556971·60 enrolled

Hernia1 trial

This Randomized Controlled Study Aims to Investigate the Effect of Botox Injection in Abdominal Wall Muscle Post Major Abdominal Surgery in Terms of Postoperative Pain, Incidence of Incisional Hernia.

Unknown status·MMansoura University·N/A·NCT04422197·30 enrolled

Randomized1 trial

Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain

Completed·MMount Sinai Hospital, Canada·Phase 2·NCT02249234·64 enrolled

Spasmodic Dysphonia1 trial

BOTOX® Drug Use Investigation (Spasmodic Dysphonia)

Unknown status· GSK logo

GSK··NCT03543150·400 enrolled

Essential Tremor1 trial

Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor

Completed· AbbVie logo

AbbVie·Phase 2·NCT05216250·174 enrolled

Stellate Ganglion Block1 trial

Ultrasound-Guided Stellate Ganglion Block With Botulinum

Completed·—·N/A·NCT05099835·60 enrolled

Bladder Pain Syndrome1 trial

Comparison of the Treatment of Refractory Bladder Pain Syndrome With DMSO and DMSO With Botulinum Toxin A

Completed·UUniversity of Pennsylvania·Phase 1·NCT03103594·2 enrolled

Back pain1 trial

Are Paraspinous Intramuscular Injections of Botulinum Toxin A (BoNT-A) Efficient in the Treatment of Chronic Low-back Pain (LBP)?

Completed·UUniversity Hospital, Bordeaux·Phase 3·NCT03181802·19 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines

Completed·CCKD Bio Corporation·Phase 1·NCT05292638·30 enrolled

Chronic Prostatitis1 trial

Botox for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Terminated·QQueen's University·Phase 1·NCT00529386·7 enrolled

Atrophy1 trial

Myobloc Atrophy Study

Completed·GGeorgetown University·Phase 4·NCT02052024·10 enrolled

Torticollis1 trial

Comparative Trial of Botox in the Management of Children With Congenital Muscular Torticollis

Withdrawn·UUniversity of British Columbia·Phase 1·NCT00175604

Urgency Incontinence1 trial

Reduced-dose Botox for Urgency Incontinence Among Elder Females

Active, not recruiting·—·Phase 1/2·NCT05512039·376 enrolled

Premature Ejaculation1 trial

Safety and Efficacy of Botulinum Toxin-A Injection Into Ischiocavernosus Muscle for Premature Ejaculation

Active, not recruiting·AAbdallah Mohamed Abdallah Mohamed Elgendy·Phase 2/3·NCT06851598·45 enrolled

Steroid Injection1 trial

Comparison Between Type A Botulinum Toxin Injection and Corticosteroid Injection in the Treatment of Tennis Elbow

Unknown status·—·N/A·NCT00395616·40 enrolled

Osteoarthritis1 trial

Intra Articular Botox Injection in Treatment of Osteoarthritis

Completed·—·N/A·NCT03891680·60 enrolled

Physical Therapy1 trial

Neurotoxin and Physical Therapy

Completed·UUniversity of Florida·Phase 4·NCT02177617·16 enrolled

Myofascial Pain Dysfunction Syndrome1 trial

Acupuncture, Dry Needle and Botox Injection in Management of Patient With Myofascial Pain Dysfunction Syndrome

Unknown status·—·Phase 1·NCT06013644·39 enrolled

Systemic Sclerosis1 trial

Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic Sclerosis

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT03717961·91 enrolled

Hyperhidrosis1 trial

Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis

Unknown status·CCarl Swartling·Phase 2·NCT01930604·588 enrolled

Amyotrophic Lateral Sclerosis1 trial

Toxin Treatment for Amyotrophic Lateral Sclerosis (ALS) Related Sialorrhea

Completed·HHospices Civils de Lyon·Phase 2·NCT01551940·18 enrolled

Temporomandibular Disorders1 trial

Mandibular Splint vs Botox Injection in Lateral Pterygoid on Cervical Muscle Activity in Patients With Temporomandibular Disorders

Recruiting·—·N/A·NCT06553950·33 enrolled

Stroke1 trial

Central Effects of Botulinum Toxin: Neurophysiological Study in Stroke Patients With Spastic Lower Limb

Unknown status·AAssistance Publique Hopitaux De Marseille·Phase 3·NCT01829763·20 enrolled

Imaging Techniques1 trial

Exploring Advanced Imaging Techniques to Characterize Botulinum Toxin Diffusion in Human Muscle

Completed·NNew York Presbyterian Hospital·N/A·NCT01412008·5 enrolled

Hypertrophic Scars1 trial

Treatment of Hypertrophic Scars With Intradermal Botox

Unknown status·—·Phase 2·NCT03631368·20 enrolled

Surgery1 trial

Effect of Botox Injection in Anterior Belly of Digastric on Skeletal Relapse Following Mandibular Advancement Surgery

Unknown status·—·Phase 3·NCT05573581·10 enrolled

Fine Lines1 trial

Intradermal (ID) BOTOX in the Treatment of Facial Fine Lines

Completed· AbbVie logo

AbbVie·Phase 1·NCT04631588·172 enrolled

Efficacy1 trial

Efficacy of Botox in Patients With Idiopathic Clubfoot

Completed·UUniversity of British Columbia·N/A·NCT00152334·500 enrolled

Total Knee Arthroplasty1 trial

Botulinum Toxin A to Treat Flexion Contracture After Total Knee Arthroplasty

Unknown status·RRothman Institute Orthopaedics·N/A·NCT01829087·140 enrolled

Sexual Dysfunction1 trial

Female Sexual Dysfunction Assessment and Managment of Vaginismus

Not yet recruiting·—·Phase 2/3·NCT06755099·40 enrolled

Spinal Cord Injury1 trial

Botulinum-A Toxin Injection for Detrusor Hyperreflexia in Spinal Cord Injury: A Non-Surgical Approach.

Withdrawn·UUS Department of Veterans Affairs·Phase 2·NCT00262496

Autonomic Dysreflexia1 trial

Botox for Neurogenic Detrusor Overactivity and the Prevention of Autonomic Dysreflexia Following SCI

Completed·RRick Hansen Institute·Phase 4·NCT02298660·55 enrolled

Migraine1 trial

Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine

Terminated· AbbVie logo

AbbVie·Phase 3·NCT05028569·775 enrolled

Buerger Disease1 trial

Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease

Not yet recruiting·UUniversity Hospital, Toulouse·Phase 3·NCT05698979·8 enrolled

Unspecified4 trials

Brow Enhancement Study

Completed·SSkin Care and Laser Physicians of Beverly Hills·Phase 4·NCT01308593·30 enrolled

Anhidrotic Area and Safety of MEDITOXIN in Healthy Male Valunteers

Completed·MMedy-Tox·Phase 1·NCT03647982·13 enrolled

Pharmacodynamic and Safety of MEDITOXIN® in Healthy Male Volunteers

Completed·MMedy-Tox·Phase 1·NCT03317717·25 enrolled

Show 1 more trial

Pharmacodynamic and Safety of MBA-P01 in Healthy Male Volunteers

Completed·MMedy-Tox·Phase 1·NCT03547141·28 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 9, 1991

BOTOX COSMETIC, BOTOX

NDA BLA103000

Dec 21, 2000

BOTOX COSMETIC, BOTOX

NDA BLA103000

Apr 12, 2002

BOTOX COSMETIC, BOTOX

NDA BLA103000

Jul 19, 2004

BOTOX COSMETIC, BOTOX

NDA BLA103000

Jul 19, 2004

BOTOX COSMETIC, BOTOX

NDA BLA103000

Feb 1, 2005

BOTOX COSMETIC, BOTOX

NDA BLA103000

Mar 11, 2005

BOTOX COSMETIC, BOTOX

NDA BLA103000

Apr 14, 2005

BOTOX COSMETIC, BOTOX

NDA BLA103000

Nov 10, 2005

BOTOX COSMETIC, BOTOX

NDA BLA103000

Aug 17, 2006

BOTOX COSMETIC, BOTOX

NDA BLA103000

Sep 28, 2006

BOTOX COSMETIC, BOTOX

NDA BLA103000

Mar 1, 2007

BOTOX COSMETIC, BOTOX

NDA BLA103000

Apr 26, 2007

BOTOX COSMETIC, BOTOX

NDA BLA103000

Jun 18, 2007

BOTOX COSMETIC, BOTOX

NDA BLA103000

Aug 23, 2007

BOTOX COSMETIC, BOTOX

NDA BLA103000

Sep 6, 2007

BOTOX COSMETIC, BOTOX

NDA BLA103000

Mar 21, 2008

BOTOX COSMETIC, BOTOX

NDA BLA103000

Aug 6, 2008

BOTOX COSMETIC, BOTOX

NDA BLA103000

Jul 31, 2009

BOTOX COSMETIC, BOTOX

NDA BLA103000

Jul 31, 2009

BOTOX COSMETIC, BOTOX

NDA BLA103000

Aug 21, 2009

BOTOX COSMETIC, BOTOX

NDA BLA103000

Mar 9, 2010

BOTOX COSMETIC, BOTOX

NDA BLA103000

Mar 26, 2010

BOTOX COSMETIC, BOTOX

NDA BLA103000

Mar 26, 2010

BOTOX COSMETIC, BOTOX

NDA BLA103000

Jun 3, 2010

BOTOX COSMETIC, BOTOX

NDA BLA103000

Oct 15, 2010

BOTOX COSMETIC, BOTOX

NDA BLA103000

Jun 23, 2011

BOTOX COSMETIC, BOTOX

NDA BLA103000

Aug 24, 2011

BOTOX COSMETIC, BOTOX

NDA BLA103000

Jul 16, 2012

BOTOX COSMETIC, BOTOX

NDA BLA103000

Nov 9, 2012

BOTOX COSMETIC, BOTOX

NDA BLA103000

Jan 18, 2013

BOTOX COSMETIC, BOTOX

NDA BLA103000

Sep 11, 2013

BOTOX COSMETIC, BOTOX

NDA BLA103000

May 7, 2014

BOTOX COSMETIC, BOTOX

NDA BLA103000

Apr 17, 2015

BOTOX COSMETIC, BOTOX

NDA BLA103000

Aug 5, 2015

BOTOX COSMETIC, BOTOX

NDA BLA103000

Aug 11, 2015

BOTOX COSMETIC, BOTOX

NDA BLA103000

Jan 21, 2016

BOTOX COSMETIC, BOTOX

NDA BLA103000

Feb 4, 2016

BOTOX COSMETIC, BOTOX

NDA BLA103000

Apr 4, 2017

BOTOX COSMETIC, BOTOX

NDA BLA103000

Apr 4, 2017

BOTOX COSMETIC, BOTOX

NDA BLA103000

Apr 4, 2017

BOTOX COSMETIC, BOTOX

NDA BLA103000

Apr 20, 2017

BOTOX COSMETIC, BOTOX

NDA BLA103000

Oct 2, 2017

BOTOX COSMETIC, BOTOX

NDA BLA103000

May 15, 2018

BOTOX COSMETIC, BOTOX

NDA BLA103000

May 16, 2018

BOTOX COSMETIC, BOTOX

NDA BLA103000

Sep 12, 2018

BOTOX COSMETIC, BOTOX

NDA BLA103000

Jun 20, 2019

BOTOX COSMETIC, BOTOX

NDA BLA103000

Oct 18, 2019

BOTOX COSMETIC, BOTOX

NDA BLA103000

Jul 8, 2020

BOTOX COSMETIC, BOTOX

NDA BLA103000

Sep 13, 2020

BOTOX COSMETIC, BOTOX

NDA BLA103000

Feb 9, 2021

BOTOX COSMETIC, BOTOX

NDA BLA103000

Jul 28, 2021

BOTOX COSMETIC, BOTOX

NDA BLA103000

Aug 22, 2022

BOTOX COSMETIC, BOTOX

NDA BLA103000

Aug 10, 2023

BOTOX COSMETIC, BOTOX

NDA BLA103000

Aug 11, 2023

BOTOX COSMETIC, BOTOX

NDA BLA103000

Oct 18, 2024

BOTOX COSMETIC, BOTOX

NDA BLA103000

Oct 18, 2024

BOTOX COSMETIC, BOTOX

NDA BLA103000

Oct 18, 2024

BOTOX COSMETIC, BOTOX

NDA BLA103000

Oct 18, 2024

BOTOX COSMETIC, BOTOX

NDA BLA103000

Oct 18, 2024

BOTOX COSMETIC, BOTOX

NDA BLA103000

Sources

References

[1]
ClinicalTrials.gov — 123 trial records for Botox. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Botox compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Botox. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA BLA103000). U.S. Food & Drug Administration.
[5]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AbbVie

Botox

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q1 2028

Trials by Indication[1]

Moderate to Severe Glabellar Lines10 trials

Botulinum Toxin9 trials

Botox9 trials

Spasticity8 trials

Efficacy and Safety6 trials

Cerebral Palsy5 trials

Overactive Bladder3 trials

Urinary incontinence3 trials

Cervical Dystonia3 trials

Treatment3 trials

Masseter Muscle Prominence3 trials

Benign Prostatic Hyperplasia2 trials

Interstitial Cystitis2 trials

Double-blind2 trials

Bruxism2 trials

Satisfaction2 trials

Glabellar Lines2 trials

Tics1 trial

Hallux valgus1 trial

Necrosis1 trial

Clinical Trial1 trial

Headache1 trial

Headache Disorder1 trial

Neuropathic Pain1 trial

Plantar Fasciitis1 trial

Brain Injury1 trial

Adverse Events1 trial

Compartment Syndrome1 trial

Depression1 trial

Hernia1 trial

Randomized1 trial

Spasmodic Dysphonia1 trial

Essential Tremor1 trial

Stellate Ganglion Block1 trial

Bladder Pain Syndrome1 trial

Back pain1 trial

Safety and Efficacy1 trial

Chronic Prostatitis1 trial

Atrophy1 trial

Torticollis1 trial

Urgency Incontinence1 trial

Premature Ejaculation1 trial

Steroid Injection1 trial

Osteoarthritis1 trial

Physical Therapy1 trial

Myofascial Pain Dysfunction Syndrome1 trial

Systemic Sclerosis1 trial

Hyperhidrosis1 trial

Amyotrophic Lateral Sclerosis1 trial

Temporomandibular Disorders1 trial

Stroke1 trial

Imaging Techniques1 trial

Hypertrophic Scars1 trial

Surgery1 trial

Fine Lines1 trial

Efficacy1 trial

Total Knee Arthroplasty1 trial

Sexual Dysfunction1 trial

Spinal Cord Injury1 trial

Autonomic Dysreflexia1 trial

Migraine1 trial

Buerger Disease1 trial

Unspecified4 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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