Product Description
OnabotulinumtoxinA (Botox®; a formulation of botulinum toxin type A (BoNT/A)] is indicated for the prevention of headaches in adults with chronic migraine (CM) in numerous countries, including those of Europe. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/33314008/)
Mechanisms of Action: SNAP-25 Inhibitor
Novel Mechanism: No
Modality: Peptide/Protein
Route of Administration: Intramuscular
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: AbbVie
Company Location: Eastern America
Company Founding Year: 2013
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Austria, Belgium, Bulgaria, Canada, China, Czech Republic, France, Georgia, Germany, Hungary, Italy, Japan, Korea, Latvia, Netherlands, Poland, Russia, Slovakia, Spain, Switzerland, Taiwan, Ukraine, United Kingdom, United States
Active Clinical Trial Count: 65
Recent & Upcoming Milestones
- Clinical Outcomes Reported - AbbVie presented P2 Tremor results on 2025-10-06 for Onabotulinumtoxina
Highest Development Phases
Phase 3: Atrial Fibrillation|Cerebral Palsy|Chronic Pain|Dyspareunia|Glabellar Reflex|Hyperhidrosis|Migraine Disorders|Multiple Sclerosis|Other|Overactive Bladder|Pelvic Pain|Sialorrhea|Spinal Cord Injuries|Stroke|Traumatic Brain Injury
Phase 2: Chronic Obstructive Pulmonary Disease|Cystitis, Interstitial|Essential Tremor|Muscle Spasticity|Neuralgia|Neuralgia, Postherpetic|Neuropathic Pain|Pancreatic Fistula|Paraplegia|Paresis|Peripheral Nerve Injuries|Trigeminal Neuralgia|Urinary Incontinence, Urge
Phase 1: Blepharospasm|Healthy Volunteers|Urinary Incontinence, Stress
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2017-000642-22 |
2017-000642-22 | P3 |
Active, not recruiting |
Pelvic Pain|Chronic Pain |
2029-07-12 |
2022-03-13 |
Treatments |
|
NCT04984317 |
NCT04984317 | P1 |
Suspended |
Urinary Incontinence, Stress |
2026-12-01 |
4% |
2026-01-27 |
|
NCT05512039 |
RELIEF | P2 |
Active, not recruiting |
Overactive Bladder|Urinary Incontinence, Urge |
2026-09-01 |
2026-02-04 |
||
NCT06410859 |
HengLi009-Ⅱ | P2 |
Enrolling by invitation |
Trigeminal Neuralgia |
2026-06-30 |
12% |
2024-05-14 |
Primary Endpoints|Treatments |
NCT06047444 |
C-BEOND | P3 |
Active, not recruiting |
Migraine Disorders |
2026-06-05 |
43% |
2026-01-28 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date |
NCT06794866 |
M24-697 | P3 |
Active, not recruiting |
Other |
2026-04-01 |
56% |
2025-08-15 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2023-505810-12-00 |
M602011014 | P3 |
Recruiting |
Stroke|Traumatic Brain Injury |
2026-03-02 |
2025-05-02 |
Treatments |
|
NCT07321834 |
AI-09-GL-201 | P2 |
Active, not recruiting |
Glabellar Reflex |
2026-02-01 |
12% |
2026-01-08 |
Primary Endpoints|Treatments |
NCT04075981 |
BOTAF | P3 |
Recruiting |
Atrial Fibrillation |
2025-10-30 |
20% |
2025-05-17 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT03848143 |
IIT-10247 | P2 |
Completed |
Neuropathic Pain|Neuralgia |
2025-06-30 |
2% |
2025-08-05 |
Primary Endpoints|Study Completion Date |
CTR20243420 |
CTR20243420 | P2 |
Completed |
Muscle Spasticity |
2025-06-09 |
2025-07-15 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
NCT06091020 |
PaiNT | P2 |
Completed |
Chronic Pain|Neuralgia, Postherpetic|Neuropathic Pain|Peripheral Nerve Injuries |
2025-05-07 |
12% |
2025-07-25 |
Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2023-503420-19-00 |
M602011072 | P3 |
Completed |
Cerebral Palsy |
2025-03-04 |
2025-05-02 |
Treatments |
|
NCT05216250 |
M21-471 | P2 |
Completed |
Essential Tremor |
2025-02-03 |
12% |
2025-03-06 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT05141006 |
IC/BPS POC | P2 |
Completed |
Cystitis, Interstitial |
2024-07-05 |
50% |
2025-01-08 |
Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT06003049 |
COPD 101 | P2 |
Completed |
Chronic Obstructive Pulmonary Disease |
2024-04-24 |
32% |
2024-07-23 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
jRCT2051210082 |
jRCT2051210082 | P3 |
Active, not recruiting |
Sialorrhea |
2024-03-31 |
|||
2019-002461-35 |
2019-002461-35 | P2 |
Active, not recruiting |
Pancreatic Fistula |
2021-07-07 |
2022-03-13 |
Treatments |
|
2018-003231-30 |
BOTULINUM TOXIN IN PATIENTS WITH SPASTIC PARAPARESIA ASSOCIATED WITH ESCLEROSIS MULTIPLE | P3 |
Active, not recruiting |
Multiple Sclerosis |
2021-04-15 |
2022-03-13 |
Treatments |
|
2016-000375-25 |
BotA-KKDS2016 | P3 |
Active, not recruiting |
Dyspareunia |
2020-04-19 |
2022-03-13 |
Treatments |
|
2016-005049-21 |
2016-005049-21 | P2 |
Active, not recruiting |
Paresis|Cerebral Palsy|Paraplegia |
2016-10-20 |
2025-06-28 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
2021-000240-22 |
2021-000240-22 | P3 |
Active, not recruiting |
Unknown |
2034-05-24 |
|||
NCT07210463 |
PLATINUM EU | P3 |
Recruiting |
Other |
2027-01-01 |
18% |
2025-10-10 |
Primary Endpoints|Treatments|Trial Status |
jRCT2061240117 |
jRCT2061240117 | P3 |
Recruiting |
Unknown |
2026-11-30 |
|||
NCT07122193 |
PLATINUM US | P3 |
Recruiting |
Other |
2026-10-01 |
52% |
2025-08-30 |
Primary Endpoints|Start Date |
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