Ozmosi | Onabotulinumtoxina Drug Profile
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Onabotulinumtoxina

Alternative Names: onabotulinumtoxina, botox, botulinum toxin type a, Botox - Therapeutic, meditoxin, botulinum toxin a, botulinum toxin, botugeltm, botugel, Azzalure, Botulinumtoxin A, Botulinic toxin, botulin toxin, Botulinum A toxin, Botulinum Neurotoxin Type A, nt 101, nt 201, botox cosmetic
Clinical Status: Inactive
Latest Update: 2026-03-10
Latest Update Note: Clinical Trial Update

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

Map of Global Clinical Trials for Onabotulinumtoxina

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