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.
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 | Active, not 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
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/27/2019 |
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. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| XEOMIN, incobotulinumtoxinA, 50 units; purified neurotoxin, free from complexing proteins, Powder for solution for injection Vial | 205507 | Medicine | A | 3/21/2014 | |
| XEOMIN, incobotulinumtoxinA, 100 units; purified neurotoxin, free from complexing proteins, Powder for solution for injection Vial | 205508 | Medicine | A | 3/21/2014 |
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