MedPath

Botulinum toxin type A

Generic Name
Botulinum toxin type A
Brand Names
Botox, Botox Cosmetic, Dysport, Jeuveau, Xeomin, Nuceiva
Drug Type
Biotech
CAS Number
93384-43-1
Unique Ingredient Identifier
0A6JH35GMQ

Overview

In 2002, botulinum toxin A, also known as onabotulinumtoxinA or Botox, was the first type A botulism toxin to be introduced into the market for cosmetic use. With a wide variety of applications and favourable safety profile, Botulinum toxin A injection is a minimally invasive and promising treatment for cosmetic imperfections, muscle spasms, and other conditions. A popular use for Botox is the treatment of facial wrinkles and lines, however, there are many uses for the botulinum toxin A in the treatment of dystonia, incontinence, migraine, blepharospasm, and hyperhidrosis.

Background

In 2002, botulinum toxin A, also known as onabotulinumtoxinA or Botox, was the first type A botulism toxin to be introduced into the market for cosmetic use. With a wide variety of applications and favourable safety profile, Botulinum toxin A injection is a minimally invasive and promising treatment for cosmetic imperfections, muscle spasms, and other conditions. A popular use for Botox is the treatment of facial wrinkles and lines, however, there are many uses for the botulinum toxin A in the treatment of dystonia, incontinence, migraine, blepharospasm, and hyperhidrosis.

Indication

Botulinum toxin A is indicated for a variety of conditions, depending on the preparations. Cosmetically, it is used for the treatment of facial fine lines and wrinkles, specifically for upper facial rhytides, including forehead, lateral canthus, and glabellar lines. In addition to the above indications, botulinum toxin A is used for the following conditions: treatment of adults with symptomatic overactive bladder with or without incontinence, treatment of incontinence in adult patients who are not candidates for anticholinergic therapy, treatment of Neurogenic Detrusor Overactivity (NDO) in patients over 5 years who cannot undergo anticholinergic therapy. Botulinum toxin A is indicated for the prevention of chronic migraines, for the treatment of muscle spasms, cervical dystonia, axillary hyperhidrosis, strabismus, and disorders of the 7th cranial nerve. Off-label, botulinum toxin A is used for a variety of conditions such as temporomandibular joint (TMJ) disorders and myofascial pain, neurogenic thoracic outlet syndrome, epicondylitis, post-stroke pain, post-herpetic neuralgia, diabetic neuropathy, trigeminal neuralgia, neuropathic pain, spinal cord injury, and bladder pain.

Associated Conditions

  • Bladder pain
  • Blepharospasm
  • Cervical Dystonia
  • Chronic Migraine
  • Diabetic Neuropathies
  • Epicondylitis
  • Equinus deformity of foot, acquired
  • Facial Skin Wrinkles
  • Glabellar Frown Lines (GL)
  • Lower Limb Spasticity
  • Myofascial Pain Syndrome
  • Neurogenic Detrusor Overactivity
  • Neurogenic Thoracic Outlet Syndrome
  • Overactive Bladder Syndrome (OABS)
  • Post Stroke Pain
  • Postherpetic Neuralgia
  • Sialorrhea
  • Spasticity
  • Spinal Cord Injuries
  • Strabismus
  • TMJ Disorders
  • Trigeminal Neuralgia (TN)
  • Upper Limb Spasticity
  • Urinary Incontinence (UI)
  • Hypertonicity disorders of the 7th nerve
  • Moderate Glabellar Frown Lines (GL)
  • Severe Glabellar Frown Lines (GL)
  • Severe axillary hyperhidrosis

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/05/16
Not Applicable
Recruiting
2025/03/30
Phase 2
Not yet recruiting
2025/03/28
Not Applicable
Completed
Bursa City Hospital
2025/03/20
Phase 4
Not yet recruiting
Western University, Canada
2025/03/17
Phase 4
Recruiting
2025/02/19
Phase 1
Recruiting
2025/02/07
Phase 2
Active, not recruiting
2025/01/27
Phase 3
Active, not recruiting
2025/01/20
Phase 4
Recruiting
2025/01/07
Not Applicable
Completed
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Merz Pharmaceuticals, LLC
0259-1620
INTRAMUSCULAR
200 [USP'U] in 1 1
9/14/2023
Merz North America, Inc.
46783-161
INTRAMUSCULAR
50 [USP'U] in 1 1
9/14/2023
Allergan, Inc.
0023-3921
INTRADERMAL, INTRAMUSCULAR
200 [USP'U] in 1 1
2/2/2024
Merz Pharmaceuticals, LLC
0259-1610
INTRAMUSCULAR
100 [USP'U] in 1 1
9/14/2023
Merz North America, Inc.
46783-165
INTRAMUSCULAR
50 [USP'U] in 1 1
9/14/2023
Allergan, Inc.
0023-3919
INTRAMUSCULAR
50 [USP'U] in 1 1
1/30/2024
Allergan, Inc.
0023-1145
INTRADERMAL, INTRAMUSCULAR
100 [USP'U] in 1 1
2/2/2024
Allergan, Inc.
0023-9232
INTRAMUSCULAR
100 [USP'U] in 1 1
1/30/2024
Ipsen Biopharmaceuticals, Inc.
15054-0530
INTRAMUSCULAR
300 U in 1 1
9/28/2023
Ipsen Biopharmaceuticals, Inc.
15054-0500
INTRAMUSCULAR
500 U in 1 1
9/28/2023

EMA Drug Approvals

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
BOTOX POWDER FOR SOLUTION FOR INJECTION 100 Units/Vial
SIN08205P
INJECTION, POWDER, FOR SOLUTION
100 units/vial
6/10/1995
Botox® Powder for Solution for Injection 50 Units/Vial
SIN14202P
INJECTION, POWDER, FOR SOLUTION
50 Units
7/27/2012
NABOTA POWDER FOR SOLUTION FOR INJECTION 100 UNITS/VIAL
SIN16680P
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
100 Units/vial
1/20/2023
Botox® Powder for Solution for Injection 200 Units/Vial
SIN14203P
INJECTION, POWDER, FOR SOLUTION
200 Units
7/27/2012

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Botulinum Toxin Type A for Injection
国药准字SJ20240041
生物制品
注射剂
9/3/2024
Botulinum Toxin Type A for Injection
国药准字SJ20200016
生物制品
注射剂
2/25/2025
Botulinum Toxin Type A for Injection
国药准字SJ20171004
生物制品
注射剂
6/14/2022
Botulinum Toxin Type A for Injection
S20200016
生物制品
注射剂
6/17/2020
Botulinum Toxin Type A for Injection
国药准字SJ20210004
生物制品
注射剂
2/10/2021
Botulinum Toxin Type A for Injection
国药准字SJ20240011
生物制品
注射剂
2/23/2024
Botulinum Toxin Type A for Injection
国药准字SJ20240010
生物制品
注射剂
2/23/2024
Botulinum Toxin Type A for Injection
国药准字SJ20171005
生物制品
注射剂
6/14/2022
Botulinum Toxin Type A for Injection
国药准字SJ20171003
生物制品
注射剂
6/14/2022
Botulinum Toxin Type A for Injection
国药准字SJ20200024
生物制品
注射剂
10/21/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.
© Copyright 2025. All Rights Reserved by MedPath