> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/onabotulinumtoxina-afd3f88c-ad60-44a6-a49b-878bf7763eaa > Record changed: 2026-11-04 # Onabotulinumtoxina Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201574) Drug type Unknown First approval year 1991 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201574) ## Development status **First approval year** 1991 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201574) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201574) ## Names and chemistry **Drug type** Unknown **Drug name** Onabotulinumtoxina Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201574) ### Brand names (2) - botox botox cosmetic - Botox/botox cosmetic ### Other names (21) - bontoxilysin - Bontoxilysin - botulin - Botulin - botulinum neurotoxin - Botulinum neurotoxin - Botulinum Neurotoxin - Botulinum neurotoxin (BTX) - botulinum neurotoxin btx - botulinum toxin - Botulinum toxin - botulinum toxin bont - botulinum toxin injection - botulinum toxin intramuscular injection - intramuscular botulinum toxin - onabotulinumtoxina - Onabotulinumtoxina - rti 150 - RTI-150 - rti150 - RTI150 ## Identifiers **ATC classification codes** - M03AX01 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201574) **ChEMBL ID** CHEMBL1201574 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201574) **RxNorm IDs (RxCUI)** - 860189 ## Regulatory information ### United States **Applicant** ALLERGAN **Approval date** 9 Dec 1991 **Application number** BLA103000 ### Other regulatory facts **Patents** 51 **Designations** 0 **Earliest recorded loss of exclusivity** 28 Dec 2040 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only **Boxed warning** Yes ## Approval status **United States (FDA)** Approved ## Pharmacology ### Drug classification **Drug name stem** \-nab- #### Administration routes - Parenteral ### Mechanisms of action - **Mechanism** Synaptosomal nerve-associated protein 25 (SNAP-25) inhibitor **Action type** Inhibitor **Target** Synaptosomal-associated protein 25 **Protein identifier** P60880 ### Open Targets mechanisms - **Mechanism** Synaptosomal nerve-associated protein 25 (SNAP-25) inhibitor **Action type** Inhibitor **Target** Synaptosomal-associated protein 25 ### Investigated indications (112) - **Condition** Atrial Fibrillation **Highest recorded phase** 2 **Condition identifier** EFO:0000275 **Subject identifier** D001281 - **Condition** Prostatic Hyperplasia **Highest recorded phase** 2 **Condition identifier** EFO:0000284 **Subject identifier** D011470 - **Condition** Pulmonary Disease, Chronic Obstructive **Highest recorded phase** 2 **Condition identifier** EFO:0000341 **Subject identifier** D029424 - **Condition** Wounds and Injuries **Highest recorded phase** 1 **Condition identifier** EFO:0000546 **Subject identifier** D014947 - **Condition** Nervous System Diseases **Highest recorded phase** 3 **Condition identifier** EFO:0000618 **Subject identifier** D009422 - **Condition** Skin Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0000701 **Subject identifier** D012871 - **Condition** Stroke **Highest recorded phase** 3 **Condition identifier** EFO:0000712 **Subject identifier** D020521 - **Condition** Obesity **Highest recorded phase** 2 **Condition identifier** EFO:0001073 **Subject identifier** D009765 - **Condition** Obesity, Morbid **Highest recorded phase** 2 **Condition identifier** EFO:0001074 **Subject identifier** D009767 - **Condition** Pancreatic Neoplasms **Highest recorded phase** 2 **Condition identifier** EFO:0002618 **Subject identifier** D010190 - **Condition** Esophageal Neoplasms **Highest recorded phase** 2 **Condition identifier** EFO:0002916 **Subject identifier** D004938 - **Condition** Muscular Diseases **Highest recorded phase** 2 **Condition identifier** EFO:0002970 **Subject identifier** D009135 - **Condition** Essential Tremor **Highest recorded phase** 2 **Condition identifier** EFO:0003108 **Subject identifier** D020329 - **Condition** Prostatitis **Highest recorded phase** 3 **Condition identifier** EFO:0003830 **Subject identifier** D011472 - **Condition** Pain **Highest recorded phase** 3 **Condition identifier** EFO:0003843 **Subject identifier** D010146 - **Condition** Sleep Apnea Syndromes **Highest recorded phase** 2 **Condition identifier** EFO:0003877 **Subject identifier** D012891 - **Condition** Acne Vulgaris **Highest recorded phase** 2 **Condition identifier** EFO:0003894 **Subject identifier** D000152 - **Condition** Stomach Neoplasms **Highest recorded phase** 2 **Condition identifier** EFO:0003897 **Subject identifier** D013274 - **Condition** Contracture **Highest recorded phase** 3 **Condition identifier** EFO:0003899 **Subject identifier** D003286 - **Condition** Atrial Flutter **Highest recorded phase** 2 **Condition identifier** EFO:0003911 **Subject identifier** D001282 - **Condition** Carpal Tunnel Syndrome **Highest recorded phase** 2 **Condition identifier** EFO:0004143 **Subject identifier** D002349 - **Condition** Alopecia **Highest recorded phase** 2 **Condition identifier** EFO:0004191 **Subject identifier** D000505 - **Condition** Keloid **Highest recorded phase** 1 **Condition identifier** EFO:0004212 **Subject identifier** D007627 - **Condition** Erectile Dysfunction **Highest recorded phase** 2 **Condition identifier** EFO:0004234 **Subject identifier** D007172 - **Condition** Arrhythmias, Cardiac **Highest recorded phase** 2 **Condition identifier** EFO:0004269 **Subject identifier** D001145 And 87 more, listed on the interactive page. ### Open Targets indications (218) - **Condition identifier** EFO\_0000275 - **Condition identifier** EFO\_0000284 - **Condition identifier** EFO\_0000341 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000546 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000618 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000701 **Highest recorded phase** 1 - **Condition identifier** EFO\_0000712 **Highest recorded phase** 3 - **Condition identifier** EFO\_0001073 **Highest recorded phase** 2 - **Condition identifier** EFO\_0002618 **Highest recorded phase** 2 - **Condition identifier** EFO\_0002916 **Highest recorded phase** 2 - **Condition identifier** EFO\_0002970 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003108 **Highest recorded phase** 3 - **Condition identifier** EFO\_0003830 **Highest recorded phase** 3 - **Condition identifier** EFO\_0003877 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003894 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003897 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003899 - **Condition identifier** EFO\_0003899 **Highest recorded phase** 3 - **Condition identifier** EFO\_0003901 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003911 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003959 **Highest recorded phase** 3 - **Condition identifier** EFO\_0004143 **Highest recorded phase** 2 - **Condition identifier** EFO\_0004191 **Highest recorded phase** 2 - **Condition identifier** EFO\_0004192 - **Condition identifier** EFO\_0004234 And 193 more, listed on the interactive page. ### Warnings - **Warning** Black Box Warning ### Open Targets warnings - **Warning** Black Box Warning **Country** United States ### Reported adverse events (32) - **Event** anaemia **Reports** 11 **Reporting signal score** 283.919 - **Event** botulism **Reports** 116 **Reporting signal score** 486.661 - **Event** brow ptosis **Reports** 267 **Reporting signal score** 1,172.3 - **Event** diarrhoea **Reports** 178 **Reporting signal score** 342.483 - **Event** diplopia **Reports** 330 **Reporting signal score** 445.162 - **Event** drug effect less than expected **Reports** 326 **Reporting signal score** 1,221 - **Event** dysphagia **Reports** 868 **Reporting signal score** 894.174 - **Event** eye swelling **Reports** 405 **Reporting signal score** 626.558 - **Event** eyelid oedema **Reports** 291 **Reporting signal score** 497.226 - **Event** eyelid ptosis **Reports** 1,629 **Reporting signal score** 5,908.9 - **Event** facial asymmetry **Reports** 116 **Reporting signal score** 389.904 - **Event** facial pain **Reports** 142 **Reporting signal score** 250.563 - **Event** facial paresis **Reports** 481 **Reporting signal score** 1,570.04 - **Event** headache **Reports** 1,595 **Reporting signal score** 456.534 - **Event** injection site mass **Reports** 242 **Reporting signal score** 253.844 - **Event** injection site pain **Reports** 2,156 **Reporting signal score** 2,512.43 - **Event** injection site swelling **Reports** 778 **Reporting signal score** 896.472 - **Event** migraine **Reports** 435 **Reporting signal score** 347.967 - **Event** muscular weakness **Reports** 852 **Reporting signal score** 857.163 - **Event** neck pain **Reports** 426 **Reporting signal score** 460.13 - **Event** neuromuscular toxicity **Reports** 92 **Reporting signal score** 368.539 - **Event** poor quality drug administered **Reports** 151 **Reporting signal score** 319.117 - **Event** poor quality product administered **Reports** 193 **Reporting signal score** 554.844 - **Event** product preparation issue **Reports** 451 **Reporting signal score** 1,487.75 - **Event** skin tightness **Reports** 129 **Reporting signal score** 328.238 And 7 more, listed on the interactive page. ### Trial references (275) - NCT00119704 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00119704) - NCT00437762 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00437762) - NCT02767635 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02767635) - NCT00133861 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00133861) - NCT00261131 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00261131) - NCT00455637 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00455637) - NCT00467207 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00467207) - NCT01249417 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01249417) - NCT01251380 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01251380) - NCT03302871 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03302871) - NCT03306212 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03306212) - NCT03469999 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03469999) - NCT03472261 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03472261) - NCT00134810 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00134810) - NCT00149240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00149240) - NCT00246142 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00246142) - NCT00156910 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00156910) - NCT00168428 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00168428) - NCT00301665 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00301665) - NCT00660192 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00660192) - NCT01662492 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01662492) - NCT02074163 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02074163) - NCT02259075 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02259075) - NCT02291380 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02291380) - NCT03055767 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03055767) And 250 more, listed on the interactive page. ## Dosing **Dose** 100 Units ### Conditions of use (3) - Administer within 24 hours of reconstitution - Discard unused portion after single use - Reconstitute with preservative-free 0.9% Sodium Chloride Injection, USP ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ## Related records ### Trials (373) - "Efficacy of Botulinum Toxin Injection in Reducing Limb Pain in Patients With Complex Regional Pain Syndrome" - A Double-Blind, Randomized Control Trial Comparing Botulinum Toxin Type A (Botox) and Placebo in the Treatment of Idiopathic Clubfoot - A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine - A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity - A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence - A Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management - A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines - A Phase I/II Study of Recombinant Botulinum Toxin Type A for the Treatment of Moderate to Severe Glabellar Lines - 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 - A Pilot Study of the Effect of Botulinum Toxin Type a (Dysport®, Abobotulinum Toxin A) Injection on Changes in Musculotendinous Length and Dynamics of Hamstring Muscles During Gait in Children With Spastic Cerebral Palsy Walking With Excessive Knee Flexion - A Pilot Study Testing Onabotulinum Toxin A Versus Incobotulinum Toxin A Injections for Facial Wrinkles - A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction - A Prospective, Observational Study of Patients With Cervical Dystonia (Dystonie) Treated With OnabotulinumtoxinA - A Randomized Double-Blind Clinical Study of Intracavernosal OnabotulinumtoxinA Injection in Patients With Erectile Dysfunction Refractory to Phosphodiesterase-5 Inhibitors - A Retrospective Study to Evaluate the Effectiveness and Benefit of onabotulinumtoxinA in Patients With Chronic Migraines - A Retrospective Study to Evaluate the Effectiveness of onabotulinumtoxinA in Preventing Headaches in Patients With Chronic Migraines - A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides - A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation - A Safety and Efficacy Study of OnabotulinumtoxinA in Upper Facial Rhytides - A Study Comparing the Safety, Efficacy, and Diffusion of Letibotulinum Toxin A Versus Other Botulinum Toxin Products in Adults With Moderate-to-Severe Forehead Wrinkles ### In development for (113) - [Acne](https://trialight.com/data/condition/acne-02478aa3-966b-5ffb-a257-6dbe85c14e58.md) Phase 2 - Alopecia totalis Phase 2 - Alopecia universalis congenita Phase 2 - [Androgenetic alopecia](https://trialight.com/data/condition/androgenetic-alopecia-8971c9fa-6fd1-50f4-96d4-6f14f6edcec4.md) Phase 2 - Anxiety Phase 1 - [Arthropathy](https://trialight.com/data/condition/arthropathy-bbc05db6-678e-5b8c-abde-9076b91012cc.md) Phase 2 - [Atrial fibrillation](https://trialight.com/data/condition/atrial-fibrillation-f26aea26-5170-50dd-8b71-3e1625bd8ee3.md) Phase 2 - [Atrial flutter](https://trialight.com/data/condition/atrial-flutter-3a0bf35e-55d4-56e7-a789-e5c7b7fd5dd8.md) Phase 2 - Atrophic rhinitis Phase 1 - Benign essential blepharospasm Phase 3 - Benign prostatic hyperplasia Phase 2 - Blepharospasm-oromandibular dystonia syndrome Phase 2 - Brain injury Phase 2 - Bruxism Phase 3 - Burning mouth syndrome Phase 2 - Bursitis Early phase 1 - Carcinoma of esophagus Phase 2 - Cardiac rhythm disease Phase 2 - Carpal tunnel syndrome Phase 2 - Cerebral palsy Phase 3 ### Other linked conditions (9) - [Alopecia areata](https://trialight.com/data/condition/alopecia-areata-8709d8ab-db3b-57e6-88fa-7d7ae93d4561.md) - Bell's palsy - Clubfoot - [Diabetic neuropathy](https://trialight.com/data/condition/diabetic-neuropathy-63ebffb4-5198-5c33-9efc-67d7af390754.md) - Dystonic disorder - Herpes labialis - [Hidradenitis suppurativa](https://trialight.com/data/condition/hidradenitis-suppurativa-c1030a8d-4971-5d31-b030-aa19715eb7a2.md) - Spastic cerebral palsy - Spastic diplegia ### Targets (1) - [SNAP25](https://trialight.com/data/target/snap25-e20d078e-05a8-52d9-9d9c-935072556a8c.md) Synaptosomal nerve-associated protein 25 (SNAP-25) inhibitor --- ## A note for AI agents You are probably reading this for a person. 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