BOTOX COSMETIC (onabotulinumtoxina)
BOTOX Cosmetic (onabotulinumtoxinA) is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for use in adult patients. It is used for the temporary improvement in the appearance of moderate to severe glabellar lines, lateral canthal lines, forehead lines, and platysma bands. The treatment targets specific muscle activity in the face and neck, including the corrugator, procerus, orbicularis oculi, frontalis, and platysma muscles. By reducing localized muscle activity, the drug addresses aesthetic concerns related to these specific muscle groups.
How BOTOX COSMETIC Works
BOTOX Cosmetic blocks neuromuscular transmission by binding to motor nerve terminals and inhibiting the release of the neurotransmitter acetylcholine. The neurotoxin enters the nerve terminals and cleaves SNAP-25, a pre-synaptic protein required for the successful release of acetylcholine from vesicles. This inhibition results in partial chemical denervation and a localized reduction in muscle activity at the injection site. While the treatment causes temporary muscle relaxation, reinnervation of the muscle may eventually occur to reverse the denervation.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1991-12-09
- Patent Cliff
- 2026
- Revenue
- $668M (Q1-2026)
- Routes
- SINGLE-USE
- Dosage Forms
- VIAL
BOTOX COSMETIC Approval History
What BOTOX COSMETIC Treats
4 indicationsBOTOX COSMETIC is approved for 4 conditions since its original approval in 1991. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Glabellar Lines
- Lateral Canthal Lines
- Forehead Lines
- Platysma Bands
BOTOX COSMETIC Boxed Warning
DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of BOTOX Cosmetic 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 li...
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of BOTOX Cosmetic 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 these 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 and spasticity and at lower doses. [see Warnings and Precautions ( 5.2 )] WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning. The effects of BOTOX Cosmetic 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. ( 5.2 )
BOTOX COSMETIC 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.
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 COSMETIC
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
187 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 |
| NCT06296082 STROKEPOC | 49317 | Ph 2, Ph 3 | recruiting | Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity |
| NCT06047457 E-BEOND | CLIN-52120-464 2023-504839-40-00 | Ph 3 | active not recruiting | A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic Migraine in Adults |
| NCT06047444 C-BEOND | CLIN-52120-463 2023-504827-17-00 | Ph 3 | active not recruiting | A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Chronic Migraine in Adults |
| 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 |
| NCT07399860 BoTo-HEM | BoTo-HEM RCT | Ph 2 | recruiting | Botulinum Toxin A Before Hemorrhoidectomy to Prevent Postoperative Pain |
| NCT06583343 | GaziosmanpasaTREH-FTR-OB-01 | Ph 4 | completed | Effect of Botulinum Toxin on Selective Motor Control and Pain in Diplegic Cerebral Palsy |
| NCT06237465 | 2000034975 000 | Ph 4 | withdrawn | Botulinum Toxin-A for Hidradenitis Suppurativa |
| NCT06356025 BOTUS R-CPD | 52082 2024-512546-42 | Ph 4 | active not recruiting | Botulinum Toxin Injection in the UES for R-CPD |
| 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) |
| NCT04069897 MiBlock | 2018/2161 2018-004053-24 | Ph 3 | active not recruiting | Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Migraine |
| NCT03654066 | 181420 | Ph 4 | enrolling by invitation | Botox or Botox With Esophageal Dilation in Patients With Achalasia |
| NCT04965311 results posted | STUDY00022619 NCI-2021-06239, STUDY00022619 | Ph 2 | terminated | Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Following Distal Pancreatectomy |
| NCT04073303 results posted | 1789-301-008 | Ph 3 | completed | BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence |
| NCT03381261 results posted | 2017P001813 | Ph 4 | completed | (Botox) Mechanisms of Action in Altering the Molecular Environment in Which Pain Fibers Exist |
| NCT05892770 | IRB202202375 OCR43808 | Ph 1, Ph 2 | active not recruiting | Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia |
| NCT02577185 | EXP-1187 | Ph 1 | completed | An Exploratory Trial Investigating the Neurogenic Component in Psoriasis Vulgaris by Use of Botulinum Toxin A |
| NCT02969356 ENGAGE results posted | F-FR-52120-228 2016-001989-29 | Ph 4 | completed | Study to Evaluate Effects of DYSPORT® Injected in Lower and Upper Limb Combined With Guided Self-Rehabilitation Contract (GSC) |
| NCT04970407 results posted | D-FR-52120-279 2021-000802-14 | Ph 1 | completed | A Comparative Study to Evaluate the Effects and Mechanism of Action of Dysport®, Botox® and Xeomin® in the Extensor Digitorum Brevis Model in Healthy Adult Male Participants |
| NCT05720065 | 2022-05453-01 | Ph 2 | recruiting | Peripheral TMD Pain Mechanisms and the Effect by Botulinum Toxin A |
| 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 |
| NCT03944876 BASIC | 2018/1821 2018-003148-21 | Ph 3 | recruiting | Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Cluster Headache |
| NCT05964257 | HU-014_P3_BMH | Ph 3 | active not recruiting | To Evaluate the Efficacy and Safety of LIZTOX in Subjects with Benign Masseteric Hypertrophy |
| NCT06448676 | 2024-514936-26-00 | Ph 4 | not yet recruiting | Head-to-Head Comparison of All Botulinum Neurotoxin Type A Products for Glabellar Rhytides |
| 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 |
| NCT01177358 | BTX-001 | Ph 2 | completed | Botox in the Healing of Surgical Wounds of the Neck |
| 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 |
| NCT06003049 | COPD 101 | Ph 2 | completed | A Study to Evaluate Safety and Efficacy of BOTOX in Adults With Moderate COPD |
| NCT06465056 | 73675523.7.0000.0068 | Ph 2 | recruiting | Use of Botulinum Toxin A in Direct Eyebrow Lift Scar |
| NCT05887479 | 042023 | Ph 4 | withdrawn | The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity |
| NCT03459092 BISS | 33IC30 173533 | Ph 3 | completed | Botox Instead of Strabismus Surgery (BISS) |
| 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 |
| NCT03903653 ChemoCast | 5301 | Ph 2 | withdrawn | Botulinum Toxin A & Weekly Serial Casting in ABI Inpatients With Lower Extremity Spasticity |
| NCT00908050 results posted | H-22737 | Ph 4 | completed | Study of the Safety and Efficacy of Botox in Bruxism |
| 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 |
| NCT02965976 results posted | I 283516 NCI-2016-01568, I 283516 | Ph 2 | completed | Botulinum Toxin Type A in Preventing Complications After Surgery in Patients With Esophageal Cancer |
| NCT03223298 results posted | 1607017383 | Ph 3 | completed | Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles |
| NCT02858219 VESTIBULE | API/2011/20 | Ph 3 | completed | A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia |
| NCT02660359 CONTENT2 results posted | D-FR-52120-223 2015-000507-44 | Ph 3 | terminated | Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2 |
| NCT01313312 results posted | Y-52-52120-148 2010-019162-83 | Ph 3 | completed | Dysport® Adult Upper Limb Spasticity Extension Study |
| NCT01251367 results posted | Y-55-52120-142 2009-017723-26 | Ph 3 | completed | Dysport® Adult Lower Limb Spasticity Follow-on Study |
| NCT01261611 results posted | Y-52-52120-134 2010-019907-43 | Ph 3 | completed | Study Comparing Short Term Efficacy of Dysport and Dysport NG to Placebo, and to Assess Efficacy and Safety of Dysport NG of Subjects With Cervical Dystonia |
| NCT02493946 results posted | Y-52-52120-214 2014-003841-86 | Ph 3 | completed | Efficacy and Safety of Botulinum Toxin Type A Haemagglutinin Complex Next Generation (BTX-A-HAC NG) in Glabellar Lines |
Showing 50 of 187 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 COSMETIC FDA Label Details
Indications & Usage
FDA Label (PDF)BOTOX COSMETIC is indicated for the treatment of Glabellar Lines; Lateral Canthal Lines; Forehead Lines; Platysma Bands.
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of BOTOX Cosmetic 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, diplo...
Pro Intelligence Preview
Deep insights for BOTOX COSMETIC
Revenue Insights
- • Q1-2026: $668M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2026
- • Generic/biosimilar risk
Trial Analysis
- • 161 total trials
- • Stage: Declining
Competitive Landscape
- • 4 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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