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incobotulinumtoxinA

Trade name: Xeomin

Biologicalapproved

Approved

Jul 30, 2010

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

82 trials · 55 clinical orgs · 1 marketing orgs

Phase 1
5
Phase 2
59
Phase 3
34
Phase 4
13

Earliest trial started Jun 1, 2006 (NCT00432666)

Timeline

2000s

  1. Dec 1, 2005

    Merz — IND Organization

  2. Dec 1, 2005

    Merz — IND Organization

  3. Jan 1, 2006

    Merz — Earliest Phase 3 Sponsor(trial)

2010s

  1. Jul 30, 2010

    Merz — Earliest FDA Approval

  2. Jul 30, 2010

    Merz — Marketing Organization

  3. Jul 30, 2010

    Merz — NDA Organization

  4. Jan 1, 2011

    Earliest Phase 2 Sponsor(trial)

2020s

  1. Jan 1, 2022

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

  • Synaptosomal-associated protein 25INHIBITOR

    SNAP25 inhibitor

    BOTOX blocks neuromuscular transmission by binding to acceptor sites on motor or sympathetic nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine. This inhibition occurs as the neurotoxin cleaves SNAP-25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within nerve endings.

Approval history

  • approvedJul 30, 2010

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

  • bocouture
  • bont-a
  • incobotulinumtoxina
  • incobotulinumtoxina
  • incobotulinumtoxina
  • incobotulinumtoxina
  • nt201
  • nt 201
  • nt-201
  • xeomin
  • xeomin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07210463Phase 3Oct 1, 2025Merz
NCT07122193Phase 3Aug 27, 2025Merz
NCT07018713Phase 3Aug 21, 2025Merz
NCT07018700Phase 3Aug 21, 2025Merz
NCT06995287Phase 3Jun 1, 2025Government of France, Merz, University of Nantes
NCT06499324Phase 3Nov 4, 2024Assistance Publique - Hôpitaux de Paris, University of Paris
NCT06604832Phase 1Sep 3, 2024Evolus, Inc., K. Kay Durairaj, MD, FACS, A Medical Corporation
NCT06788158Phase 1Sep 1, 2024Instituto Mexicano del Seguro Social
NCT06205797Phase 3Jun 20, 2024Huons Biopharma
NCT06091020Phase 2Nov 22, 2023Merz
NCT05980559Phase 3Sep 15, 2023Alexandria University
NCT06034288Phase 2May 4, 2023United States Army
NCT05773053Phase 2Mar 22, 2023Merz
NCT05623111Phase 2Mar 1, 2023Government of Denmark, Merz, University of Copenhagen
NCT05650645Phase 2Jan 1, 2023University of Minnesota
NCT05598723Phase 3Nov 1, 2022United States Navy
NCT05784363Phase 1Oct 27, 2022Merz
NCT05585398Phase 1Oct 19, 2022Merz
NCT05536570Phase 4Oct 15, 2022Harvard University
NCT05623410Phase 3Oct 11, 2022ATGC Co., Ltd.
Showing 20 of 82 trials
Page 1 / 5

Organizations

Research & Development (55)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerzFor profit523642006
Assistance Publique - Hôpitaux de ParisAcademic/Hospital3322022
Harvard UniversityAcademic/Hospital3322012
Yale UniversityAcademic/Hospital3312012
Instituto Portugues da FaceAcademic/Hospital2222016
Thomas Jefferson UniversityAcademic/Hospital2222012
University of CopenhagenAcademic/Hospital2122020
Alexandria UniversityAcademic/Hospital1112023
Astrakhan State Medical UniversityAcademic/Hospital1012019
ATGC Co., Ltd.For profit1112022
DeNova ResearchFor profit1112012
Ente Ospedaliero CantonaleAcademic/Hospital1112018
Evolus, Inc.Academic/Hospital1012024
Fundació IMIM - Parc de Salut MarAcademic/Hospital1012015
Gottfried Wilhelm Leibniz Universität HannoverAcademic/Hospital1112016
Government of DenmarkGovernment1012023
Government of FranceGovernment1012025
Government of RussiaGovernment1112019
Hannover Clinical Trial Center GmbHFor profit1012016
Hôpital LariboisièreAcademic/Hospital1012022
55 organizations
Page 1 / 3

Marketing (3)

OrganizationOrg typeRelationshipDate
MerzFor profitINDDec 1, 2005
MerzFor profitMKTGJul 30, 2010
MerzFor profitNDAJul 30, 2010