Botulinum toxin type A
Highest phase reached
Approved
Drug type
Protein
First approval year
2019
- First approval year
- 2019
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Botulinum toxin type A
- nuceiva
- Nuceiva
- 100 units botulinum toxin a
- 100 units Botulinum Toxin A
- 25 units botox
- 50 units Botox
- 75 units Botox
- abobotulinumtoxin a
- Abobotulinumtoxin A
- ABOBOTULINUMTOXIN A
- Abobotulinumtoxin A (Espad Pharmed Darou Co.)
- Abobotulinumtoxin A (Ipsen Co.)
- Abobotulinumtoxin-A
- abobotulinumtoxina
- ABOBOTULINUMTOXINA
- ABOBOTULINUMTOXINA [PURPLE BOOK CDER]
- ABOBOTULINUMTOXINA [USAN]
- ABOBOTULINUMTOXINA [VANDF]
- abobotulinumtoxina purple book cder
- abobotulinumtoxina usan
- abobotulinumtoxina vandf
- agn 151607
- Agn-151607
- ant 1207
- ant 1401
- ant 1403
- ANT-1207
And 220 more, listed on the interactive page.
- ATC classification codes
- M03AX01
- CAS registry numbers
- 93384-43-1
- ChEMBL ID
- CHEMBL4297862
- RxNorm IDs (RxCUI)
- 1712
- FDA ingredient codes (UNII)
- E211KPY694
- Applicant
- ALLERGAN
- Approval date
- 9 Dec 1991
- Application number
- BLA103000
- Status
- Authorised
- Status date
- 27 Sept 2019
- Authorisation date
- 27 Sept 2019
- Approved indications
- Temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age.
- Product number
- EMEA/H/C/004587
- Authorisation holder
- Evolus Pharma B.V.
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Skin Aging
European medicines record
- Patents
- 0
- Designations
- 2
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Boxed warning
- Yes
- Drug name stem
- -oxin
Mechanisms of action
- Mechanism
- Synaptosomal nerve-associated protein 25 (SNAP-25) hydrolytic enzyme
- Action type
- HYDROLYTIC_ENZYME
- Target
- Synaptosomal-associated protein 25
- Protein identifier
- P60880
Open Targets mechanisms
- Mechanism
- Synaptosomal nerve-associated protein 25 (SNAP-25) hydrolytic enzyme
- Action type
- HYDROLYTIC ENZYME
- Target
- Synaptosomal-associated protein 25
- Condition
- Skin Aging
- Highest recorded phase
- 4
- Condition identifier
- EFO:0005422
- Subject identifier
- D015595
- Condition
- Urinary Incontinence, Urge
- Highest recorded phase
- 4
- Condition identifier
- EFO:0006865
- Subject identifier
- D053202
- Condition
- Muscle Cramp
- Highest recorded phase
- 3
- Condition identifier
- EFO:0009846
- Subject identifier
- D009120
- Condition
- Urinary Bladder, Overactive
- Highest recorded phase
- 4
- Condition identifier
- EFO:1000781
- Subject identifier
- D053201
- Condition
- Joint Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000999
- Subject identifier
- D007592
- Condition
- Tinnitus
- Highest recorded phase
- 2
- Condition identifier
- HP:0000360
- Subject identifier
- D014012
- Condition
- Torticollis
- Highest recorded phase
- 3
- Condition identifier
- HP:0000473
- Subject identifier
- D014103
- Condition
- Hyperhidrosis
- Highest recorded phase
- 2
- Condition identifier
- HP:0000975
- Subject identifier
- D006945
- Condition
- Sialorrhea
- Highest recorded phase
- 2
- Condition identifier
- HP:0002307
- Subject identifier
- D012798
- Condition
- Migraine Disorders
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0005277
- Subject identifier
- D008881
- Condition
- Blepharospasm
- Highest recorded phase
- 3
- Condition identifier
- Orphanet:93955
- Subject identifier
- D001764
- Condition identifier
- EFO_0000556
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000712
- Condition identifier
- EFO_0003108
- Condition identifier
- EFO_0003899
- Condition identifier
- EFO_0003901
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003959
- Condition identifier
- EFO_0004192
- Condition identifier
- EFO_0005422
- Condition identifier
- EFO_0005422
- Highest recorded phase
- 4
- Condition identifier
- EFO_0005762
- Highest recorded phase
- 3
- Condition identifier
- EFO_0006865
- Condition identifier
- EFO_0006865
- Highest recorded phase
- 4
- Condition identifier
- EFO_0007383
- Condition identifier
- EFO_0008008
- Highest recorded phase
- 1
- Condition identifier
- EFO_0009510
- Condition identifier
- EFO_0009523
- Highest recorded phase
- 3
- Condition identifier
- EFO_0009846
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009846
- Highest recorded phase
- 3
- Condition identifier
- EFO_0009952
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000632
- Condition identifier
- EFO_1000781
- Condition identifier
- EFO_1000948
- Condition identifier
- EFO_1000999
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001145
- Condition identifier
- EFO_1001494
- Highest recorded phase
- 1
And 124 more, listed on the interactive page.
- Warning
- Black Box Warning
- Warning
- Black Box Warning
- Effect
- hepatotoxicity
- Warning
- Black Box Warning
- Country
- United States
- Warning
- Black Box Warning
- Effect
- hepatotoxicity
- Country
- United States
- Event
- anaemia
- Reports
- 11
- Reporting signal score
- 285.123
- Event
- botulism
- Reports
- 118
- Reporting signal score
- 496.531
- Event
- brow ptosis
- Reports
- 269
- Reporting signal score
- 1,181.87
- Event
- diarrhoea
- Reports
- 182
- Reporting signal score
- 342.662
- Event
- diplopia
- Reports
- 333
- Reporting signal score
- 450.752
- Event
- drug effect less than expected
- Reports
- 326
- Reporting signal score
- 1,219.52
- Event
- dysphagia
- Reports
- 890
- Reporting signal score
- 933.097
- Event
- eye swelling
- Reports
- 410
- Reporting signal score
- 637.462
- Event
- eyelid oedema
- Reports
- 289
- Reporting signal score
- 492.879
- Event
- eyelid ptosis
- Reports
- 1,661
- Reporting signal score
- 6,054.78
- Event
- facial asymmetry
- Reports
- 116
- Reporting signal score
- 389.384
- Event
- facial pain
- Reports
- 145
- Reporting signal score
- 256.596
- Event
- facial paresis
- Reports
- 481
- Reporting signal score
- 1,575.77
- Event
- headache
- Reports
- 1,640
- Reporting signal score
- 489.796
- Event
- injection site mass
- Reports
- 242
- Reporting signal score
- 252.908
- Event
- injection site pain
- Reports
- 2,152
- Reporting signal score
- 2,495.15
- Event
- injection site swelling
- Reports
- 783
- Reporting signal score
- 903.527
- Event
- migraine
- Reports
- 449
- Reporting signal score
- 369.631
- Event
- muscular weakness
- Reports
- 862
- Reporting signal score
- 872.509
- Event
- neck pain
- Reports
- 421
- Reporting signal score
- 449.437
- Event
- neuromuscular toxicity
- Reports
- 100
- Reporting signal score
- 408.437
- Event
- poor quality drug administered
- Reports
- 151
- Reporting signal score
- 318.463
- Event
- poor quality product administered
- Reports
- 192
- Reporting signal score
- 550.134
- Event
- product preparation issue
- Reports
- 451
- Reporting signal score
- 1,485.71
- Event
- skin tightness
- Reports
- 126
- Reporting signal score
- 317.166
And 7 more, listed on the interactive page.
- NCT01262339
- NCT01799824
- NCT01588574
- NCT03805152
- NCT01653132
- NCT03216473
- NCT03726788
- NCT04113941
- NCT04589364
- NCT05650645
- Dose
- 40 Units
- Route
- Intramuscular
- How often
- Every 3 months
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 0023-1145
- 0023-3919
- 0023-3921
- 0023-9232
- 0259-1605
- 0259-1610
- 0259-1620
- 0259-4110
- 0259-4150
- 0299-5962
- 46783-160
- 46783-161
- 46783-165
- 72301-595
- 72960-112
- 85766-155
- 15054-0500
- 15054-0530
Related records
Trials (776)
- " Treating MS Patients With Lower Extremity Spasticity Using Dysport"
- "Efficacy of Botulinum Toxin Injection in Reducing Limb Pain in Patients With Complex Regional Pain Syndrome"
- (Botox) Mechanisms of Action in Altering the Molecular Environment in Which Pain Fibers Exist
- A Clinical Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults
- A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults
- A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine
- A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine
- A Comparative Study of Botulinum Neurotoxin Type A in Treatment of Moderate to Severe Glabellar Frown Lines
- A Comparative Study on the Impact of Trigger Points Injection of Platelet Rich Plasma Versus Botulinum Toxin on the Relief of Jaw Muscles Myofascial Pain
- 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
- A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity
- A Dosage-dependent Manner of Botulinum Toxin Type A on the Prevention of Postoperative Scars of Various Anatomic Regions of the Body
- A Double-Blind, Randomized Control Trial Comparing Botulinum Toxin Type A (Botox) and Placebo in the Treatment of Idiopathic Clubfoot
- A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis
- A Long-Term Safety Study of Repeat Treatment With PurTox® for Frown Lines Between the Eyebrows
- A Multi-Center Study Of CD07743 for the Improvement of Lateral Canthal Lines (CROW'S FEET)
- A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Upper Limb Spasticity
- A Multicenter, Open-label, Single Dose Study of the Safety and Efficacy of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Focal Upper Limb Spasticity
- A Multicentre, Randomised, Single-blind, Controlled Protocol to Evaluate the Efficacy of Early Administration of Botulinum Toxin for Primary Midline Closure in Patients With Open Abdomen.
Approved for (2)
- Migraine disorder
- Overactive bladder
In development for (4)
- Arthropathy Phase 2
- Benign essential blepharospasm Phase 3
- Inherited torticollis Phase 3
- Tinnitus Phase 2
Other linked conditions (16)
- Alopecia areata
- Cerebral palsy
- Cervical dystonia
- Complex regional pain syndrome
- Dystonic disorder
- Essential tremor
- Facial paralysis
- Focal dystonia
- Gastroparesis
- Keratoconus
- Major depressive disorder
- Mumps infectious disease
- Raynaud disease
- Spastic diplegia
- Stroke disorder
- Wilson disease
Targets (1)
- SNAP25 Synaptosomal nerve-associated protein 25 (SNAP-25) hydrolytic enzyme