Onabotulinumtoxina
- First approval year
- 1991
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Unknown
- Drug name
- Onabotulinumtoxina
- botox botox cosmetic
- Botox/botox cosmetic
- 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
- ATC classification codes
- M03AX01
Sources for recorded values
- ChEMBL ID
- CHEMBL1201574
- RxNorm IDs (RxCUI)
- 860189
- Applicant
- ALLERGAN
- Approval date
- 9 Dec 1991
- Application number
- BLA103000
- 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
- United States (FDA)
- Approved
- 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
- 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.
- 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
- 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.
- NCT00119704
- NCT00437762
- NCT02767635
- NCT00133861
- NCT00261131
- NCT00455637
- NCT00467207
- NCT01249417
- NCT01251380
- NCT03302871
- NCT03306212
- NCT03469999
- NCT03472261
- NCT00134810
- NCT00149240
- NCT00246142
- NCT00156910
- NCT00168428
- NCT00301665
- NCT00660192
- NCT01662492
- NCT02074163
- NCT02259075
- NCT02291380
- NCT03055767
And 250 more, listed on the interactive page.
- Dose
- 100 Units
- Administer within 24 hours of reconstitution
- Discard unused portion after single use
- Reconstitute with preservative-free 0.9% Sodium Chloride Injection, USP
- 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 Phase 2
- Alopecia totalis Phase 2
- Alopecia universalis congenita Phase 2
- Androgenetic alopecia Phase 2
- Anxiety Phase 1
- Arthropathy Phase 2
- Atrial fibrillation Phase 2
- Atrial flutter 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
- Bell's palsy
- Clubfoot
- Diabetic neuropathy
- Dystonic disorder
- Herpes labialis
- Hidradenitis suppurativa
- Spastic cerebral palsy
- Spastic diplegia
Targets (1)
- SNAP25 Synaptosomal nerve-associated protein 25 (SNAP-25) inhibitor