BOTOX (onabotulinumtoxina)
BOTOX (onabotulinumtoxinA) is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for various neurological, muscular, and autonomic conditions in adult and pediatric patients. It is used to treat bladder dysfunctions, including overactive bladder and neurogenic detrusor overactivity, in patients who have had an inadequate response to or are intolerant of anticholinergic medications. The drug is also approved for the prophylaxis of chronic migraine in adults and the treatment of spasticity, cervical dystonia, blepharospasm, and strabismus. Additionally, it is indicated for the management of severe axillary hyperhidrosis that is inadequately managed by topical agents.
How BOTOX Works
BOTOX blocks neuromuscular transmission by binding to acceptor sites on motor or autonomic nerve terminals and inhibiting the release of the neurotransmitter acetylcholine. This inhibition is achieved as the neurotoxin cleaves SNAP-25, a protein necessary for the successful docking and release of acetylcholine from vesicles within nerve endings. When injected into target tissues, the drug produces localized chemical denervation, resulting in a reduction of muscle activity or sweat gland production. In the bladder, the drug affects the efferent pathways of detrusor activity via this same inhibition of acetylcholine release.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1991-12-09
- Patent Cliff
- 2026
- Routes
- SINGLE-USE
- Dosage Forms
- VIAL
BOTOX Approval History
What BOTOX Treats
10 indicationsBOTOX is approved for 10 conditions since its original approval in 1991. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Overactive Bladder
- Urinary Incontinence
- Detrusor Overactivity
- Neurogenic Detrusor Overactivity
- Chronic Migraine
- Spasticity
- Cervical Dystonia
- Axillary Hyperhidrosis
BOTOX Boxed Warning
DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of BOTOX and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threat...
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of BOTOX and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to the se symptoms. In unapproved uses and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia an d spasticity and at lower doses [ see Warnings and Precautions ( 5.1 )] . WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning. The effects of BOTOX and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms. ( 5.1 )
BOTOX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to BOTOX
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
102 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06794866 | M24-697 | Ph 3 | completed | A Study to Assess Adverse Events and Effectiveness of OnabotulinumtoxinA Intramuscular Injections for the Change of Moderate to Severe Forehead Lines in Adult Participants |
| NCT05878951 | STU00218130 | Ph 2, Ph 3 | recruiting | Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms |
| NCT06902805 RHIBOTII | APHP230823 | Ph 2, Ph 3 | recruiting | Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis. |
| NCT06783621 US Harmony | M24-704 | Ph 4 | completed | A Study to Evaluate Patient Satisfaction With the Overall Face and Neck Appearance After Combined Treatment of OnabotulinumtoxinA, JUVÉDERM® Products, KYBELLA, CoolSculpting Elite and SkinMedica Products |
| NCT06583343 | GaziosmanpasaTREH-FTR-OB-01 | Ph 4 | completed | Effect of Botulinum Toxin on Selective Motor Control and Pain in Diplegic Cerebral Palsy |
| NCT05216250 | M21-471 2021-002191-39 | Ph 2 | completed | Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor |
| NCT06387394 MMP US P3 416 | M21-416 | Ph 3 | completed | A Study to Assess BOTOX Injections in Adult Participants for the Change of Masseter Muscle Prominence |
| NCT06068855 MMP EU P3 | M23-123 2022-500568-37-00 | Ph 3 | completed | A Study to Assess the Effectiveness of BOTOX (Botulinum Toxin Type A) Injections for the Change of Masseter Muscle Prominence in Adult Participants |
| NCT05028569 results posted | M21-307 2021-001979-16 | Ph 3 | terminated | Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine |
| NCT06218251 UFL BOND 974 results posted | M22-974 | Ph 4 | completed | A Study to Evaluate Participant Satisfaction and Natural Outcomes Following Administration of BOTOX Cosmetic Injections in Adult Participants for Treatment of Upper Facial Lines |
| NCT07220382 PRETOX | 25-824 | Ph 4 | recruiting | Preoperative BOTOX® Injection for Large Ventral Hernia Repair |
| NCT06834789 | M25-207 | Ph 1 | completed | A Study to Assess the Adverse Events of Intramuscular Injections of AGN-151586 and OnabotulinumtoxinA in Adult Participants for the Change of Glabellar Lines (GL) |
| NCT06399718 MMP US P3 417 | M21-417 | Ph 3 | completed | A Study to Assess BOTOX Injections for the Change of Masseter Muscle Prominence in Adult Participants |
| NCT06174688 | M22-043 | Ph 3 | completed | 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 |
| NCT06137287 MMP Japan 080 | M22-080 | Ph 3 | completed | A Study to Assess Adverse Events and Change of Masseter Muscle Prominence Using BOTOX Injections in Adult Participants |
| NCT04609020 results posted | CMO-MA-FAS-0580 | Ph 4 | completed | Study to Evaluate Subject Satisfaction With Facial Appearance and Impact of Combined Facial Treatment |
| NCT05141006 IC/BPS POC | M21-459 | Ph 2 | completed | 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) |
| NCT06755099 | Treatment trials in vaginismus | Ph 2, Ph 3 | not yet recruiting | Female Sexual Dysfunction Assessment and Managment of Vaginismus |
| NCT05134649 results posted | M21-323 | Ph 3 | completed | A Study To Assess the Safety of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence |
| NCT04949399 results posted | M21-309 | Ph 3 | completed | A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma Prominence |
| NCT05320393 results posted | EVOLUS-CLIN201 | Ph 2 | completed | Study to Demonstrate Safety and Duration of Effect of 40 Units of PrabotulinumtoxinA-xvfs to Treat Glabellar Lines |
| NCT04994535 results posted | M21-310 2021-000240-22 | Ph 3 | completed | A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence |
| NCT06530524 | PROTOX | Ph 2 | not yet recruiting | Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery |
| NCT06499688 | YY001-001-Ⅲ-REFINE CTR20233901 | Ph 3 | completed | A Phase III Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines |
| NCT05006417 results posted | 2020-1375 Protocol Version 8/4/2021, A536120 | Ph 4 | terminated | Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome |
| NCT06003049 | COPD 101 | Ph 2 | completed | A Study to Evaluate Safety and Efficacy of BOTOX in Adults With Moderate COPD |
| NCT05956509 | M23-499 | Ph 1 | terminated | Study of Intramuscular Injections of ABBV-950 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Spasticity |
| NCT03055767 results posted | 20163108 UCIANES09 | Ph 2 | completed | Effectiveness of Onabotulinumtoxin A (Botox) in Pediatric Patients Experiencing Migraines: A Study in the Pediatric Pain Population |
| NCT05463965 | 43QMCH1908 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Glabellar Lines |
| NCT05496335 | M23-365 | Ph 1 | completed | A Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) Injections in Adult Participants for Treatment of Glabellar Lines |
| NCT05743634 | YY001-001 CTR20221419 | Ph 1, Ph 2 | completed | A Phase I/II Study of Recombinant Botulinum Toxin Type A for the Treatment of Moderate to Severe Glabellar Lines |
| NCT05059587 | MT14-KR20GBL309 | Ph 3 | completed | Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Glabellar Lines |
| NCT02173405 BotoxMPP | UHCMC IRB 04-13-45 IIT #578 | Ph 1 | completed | Injection With OnabotulinumtoxinA (Botox) for the Treatment of Chronic Pelvic Pain |
| NCT02546999 WE | 2013/1195 2014-002539-32 | Ph 4 | completed | Does Botulinum Toxin A Make Walking Easier in Children With Cerebral Palsy? |
| NCT03367429 results posted | 1708018456 | Ph 4 | terminated | The Movement of Botulinum Toxin Through the Lateral Gastrocnemius Muscle in Humans: An Expanded Examination |
| NCT04631588 | 1940-102-008 | Ph 1 | completed | Intradermal (ID) BOTOX in the Treatment of Facial Fine Lines |
| NCT03860662 | MustafaKUPMR | Ph 4 | completed | The Effect of Oral Baclofen and Botulinum Toxin Treatments in Hemiplegic Spasticity on the Nociceptive Flexor Reflex |
| NCT03433859 SALUTOX | 2013RC09 2014-002068-34 | Ph 3 | completed | Topical Aluminium Chloride vs OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs) |
| NCT03861936 results posted | 1789-202-008 | Ph 2 | completed | BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence |
| NCT04578782 | FM-BOEM | Ph 2 | completed | Efficacy of OnabotulinumtoxinA in Migraine |
| NCT03796351 | MT_PRT_EDB01 | Ph 1 | completed | Pharmacodynamic and Safety of MT10107(Botulinum Type A Neurotoxin) in Comparison to BOTOX® |
| NCT01700387 results posted | 12-001AL 71403 | Ph 4 | completed | A Study to Evaluate the Tolerability of Botox and Topiramate or Botox and Placebo and Effect on Cognitive Efficiency |
| NCT03837561 | MT01-RU18GBL301 | Ph 3 | completed | The Efficacy and Safety of CUNOX® in Patients With Moderate to Severe Glabellar Lines |
| NCT03373162 results posted | 2017-3377 | Ph 4 | completed | Functional Effects of Botox on the Brain Using MRS and fMRI |
| NCT01852058 results posted | 191622-121 2012-004898-30 | Ph 3 | completed | A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity |
| NCT02298660 | H12-02215 | Ph 4 | completed | Botox for Neurogenic Detrusor Overactivity and the Prevention of Autonomic Dysreflexia Following SCI |
| NCT03052764 LO-BOT results posted | CMO-US-URO-0470 | Ph 4 | completed | Evaluation of an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence |
| NCT01852045 results posted | 191622-120 2012-004877-26 | Ph 3 | completed | Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients |
| NCT01350375 | BTX0805 | Ph 2, Ph 3 | completed | Safety and Efficacy Study of Botox in the Treatment of Forward Head Posture With Associated Episodic Headache Disorder |
| NCT03069911 | IRB00082708 | Ph 1 | terminated | Trial of OnabotulinumtoxinA for Depression in Parkinson Disease |
Showing 50 of 102 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BOTOX FDA Label Details
Indications & Usage
FDA Label (PDF)BOTOX is indicated for the treatment of Overactive Bladder; Urinary Incontinence; Detrusor Overactivity; Neurogenic Detrusor Overactivity; Chronic Migraine; Spasticity; Cervical Dystonia; Axillary Hyperhidrosis; Blepharospasm; Strabismus.
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of BOTOX and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptos...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment