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onabotulinumtoxinA

Trade name: Botox

BiologicalapprovedOrphan Drug FDA

Approved

Dec 29, 1989

Botulinum toxin, or botulinum neurotoxin, is a neurotoxic protein produced by the bacterium Clostridium botulinum and related species. It prevents the release of the neurotransmitter acetylcholine from axon endings at the neuromuscular junction, thus causing flaccid paralysis. The toxin causes the disease botulism. The toxin is also used commercially for medical and cosmetic purposes. Botulinum toxin is an acetylcholine release inhibitor and a neuromuscular blocking agent. — Wikipedia

Clinical trial activity

384 trials · 281 clinical orgs · 2 marketing orgs

Phase 1
64
Phase 2
169
Phase 3
113
Phase 4
72

Earliest trial started Dec 31, 2005 (NCT00723866)

Timeline

1980s

  1. Mar 22, 1984

    Orphan Drug Designation

  2. Dec 29, 1989

    Earliest FDA Approval

1990s

  1. Dec 9, 1991

    SmithKline Beecham — First NDA Organization

  2. Dec 9, 1991

    Allergan — Marketing Organization

  3. Dec 9, 1991

    SmithKline Beecham — NDA Secondary Org

  4. Dec 9, 1991

    SmithKline Beecham — NDA Organization

2010s

  1. Jan 1, 2011

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2012

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2012

    Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 29, 1989

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • abobotulinumtoxina
  • abobotulinumtoxina
  • abobotulinumtoxina
  • abobotulinumtoxina
  • abobotulinumtoxina
  • abobotulinum toxin a
  • abobotulinum toxin a
  • abobotulinumtoxin a
  • ant-1207
  • botox
  • botox
  • botox
  • botox
  • botox cosmetic
  • botulin toxin a
  • botulinum toxin
  • botulinum toxin
  • botulinum toxin a
  • botulinum toxin type a
  • botulinum toxin type a
  • botulinum toxin type a purified neurotoxin complex
  • botulinum tox type a
  • btx-a
  • btx-a
  • mt10109
  • onabotulinumtoxina
  • onabotulinumtoxina
  • onabotulinumtoxina
  • onabotulinumtoxina
  • onabotulinumtoxina
  • onabotulinum toxin a
  • onabotulinum toxin a
  • onabotulinumtoxin a
  • onabotulinum toxin type a
  • onaclostox

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07226791Phase 2Feb 28, 2026AbbVie
NCT07295288Phase 4Feb 1, 2026Free University of Amsterdam, Vanderbilt University
NCT07242300Phase 3Jan 31, 2026Government of China
NCT07236632N/ADec 15, 2025Benha University
NCT07270042N/ADec 1, 2025Tishreen University
NCT07220382Phase 4Nov 3, 2025The Cleveland Clinic
NCT07160699N/AOct 1, 2025Technical University of Bern
NCT07180394N/ASep 30, 2025Foundation University Islamabad
NCT07082972Phase 4Sep 1, 2025Istanbul University
NCT06928246Phase 1Jul 17, 2025Almirall, University of Pittsburgh
NCT07013279Phase 3Jul 15, 2025Daewoong Pharmaceutical Co. LTD.
NCT07025642N/AJul 1, 2025Mackay Medical College
NCT07057050N/AJun 30, 2025Cairo University
NCT07040813Phase 3Jun 6, 2025Norwegian University of Science and Technology, Sorlandet Hospital HF, South-Eastern Norway Regional Health Authority, Sykehuset Innlandet HF, Telemark Hospital Trust, University of Oslo
NCT06902805Phase 2/Phase 3 (Phase 3)May 31, 2025Assistance Publique - Hôpitaux de Paris
NCT06974617N/AMay 15, 2025Cairo University
NCT06941636Phase 3May 1, 2025County of Stockholm
NCT06937944Phase 3Apr 30, 2025Government of China
NCT07184307N/AApr 15, 2025Benha University
NCT06886750Phase 4Mar 30, 2025University of Western Ontario
Showing 20 of 384 trials
Page 1 / 20

Organizations

Research & Development (281)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AllerganFor profit372642017
Medy-ToxFor profit242442011
AbbVieFor profit181642020
Cairo UniversityAcademic/Hospital10932018
IpsenFor profit10842012
Government of ChinaGovernment9922022
HugelFor profit9842015
Mansoura UniversityAcademic/Hospital8822006
Assiut UniversityAcademic/Hospital6652019
Peking UniversityAcademic/Hospital6222019
Q-Med ABFor profit6612020
Alexandria UniversityAcademic/Hospital5522021
Benha UniversityAcademic/Hospital5532019
Chung-Ang UniversityAcademic/Hospital5032020
Daewoong Pharmaceutical Co. LTD.For profit5432016
Eirion TherapeuticsFor profit5512017
Assistance Publique - Hôpitaux de ParisAcademic/Hospital4412018
Huons Co.,Ltd.For profit4422017
Norwegian University of Science and TechnologyAcademic/Hospital4212019
United States ArmyGovernment4422019
281 organizations
Page 1 / 15

Marketing (3)

OrganizationOrg typeRelationshipDate
AllerganFor profitMKTGDec 9, 1991
SmithKline BeechamFor profitNDA2Dec 9, 1991
SmithKline BeechamFor profitNDADec 9, 1991