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rimabotulinumtoxinB

Trade name: Myobloc

BiologicalapprovedOrphan Drug FDA

Approved

Dec 8, 2000

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

552 trials · 313 clinical orgs · 3 marketing orgs

Phase 1
57
Phase 2
305
Phase 3
165
Phase 4
123

Earliest trial started Jan 1, 1997 (NCT00004416)

Timeline

1990s

  1. Jan 16, 1992

    Orphan Drug Designation

  2. Jan 1, 1997

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Earliest Phase 3 Sponsor(trial)

  2. Dec 8, 2000

    Solstice Neurosciences — Earliest FDA Approval

  3. Dec 8, 2000

    Elan Pharmaceuticals — Marketing Organization

  4. Dec 8, 2000

    Solstice Neurosciences — NDA Secondary Org

  5. Dec 8, 2000

    Solstice Neurosciences — NDA Organization

  6. Jan 1, 2002

    Earliest Phase 1 Sponsor(trial)

  7. Apr 29, 2009

    Ipsen — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 8, 2000

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

  • azzalure
  • azzalure
  • bont/a
  • bontoxilysin a
  • botulinum b toxin
  • botulinum b toxin
  • botulinum neurotoxin b
  • botulinum neurotoxin type a precursor
  • botulinum neurotoxin type b precursor
  • botulinum toxin
  • botulinum toxin
  • botulinum toxin b
  • botulinum toxin type b
  • botulinum toxin type b
  • botulinum toxin type b
  • botulinum toxin type b
  • botulinum toxin type b
  • bta-20-ab
  • btx-b
  • btx-b
  • btx-b
  • btxb cpd
  • clostridium botulinum b toxin
  • elan brand of botulinum toxin type b
  • incobotulinumtoxina
  • myobloc
  • myobloc
  • myobloc
  • myobloc
  • neurobloc
  • neurobloc
  • rimabotulinumtoxinb
  • rimabotulinumtoxinb
  • rimabotulinumtoxinb
  • rimabotulinumtoxinb
  • rimabotulinum toxin b
  • rimabotulinumtoxin b
  • vistabel

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05097079Phase 3Nov 30, 2021Solstice Neurosciences, Supernus Pharmaceuticals
NCT04815967Phase 2/Phase 3 (Phase 3)Jul 30, 2021Supernus Pharmaceuticals
NCT04099667Phase 2/Phase 3 (Phase 3)Oct 31, 2019US WorldMeds
NCT03284047N/ASep 27, 2018Northwestern University
NCT03459092Phase 3Jun 30, 2018University of Bern
NCT03367429Phase 4Jun 15, 2018Allergan, Cornell University
NCT03569098Phase 2Jun 13, 2018Ipsen
NCT03543254Phase 2Jun 1, 2018Mayo Clinic, Norwegian University of Science and Technology
NCT03462290Phase 2May 1, 2018Norwegian University of Science and Technology
NCT03472261Phase 3Mar 26, 2018Kocaeli University
NCT03456154Phase 4Mar 15, 2018Federal University of Pelotas
NCT03193359Phase 3Jan 15, 2018Allergan
NCT03369990Phase 2Dec 31, 2017Daewoong Pharmaceutical Co. LTD.
NCT03371342Phase 1Dec 31, 2017Medy-Tox
NCT03331913Phase 3Nov 7, 2017Capital Medical University, Zhengzhou University
NCT03373162Phase 4Sep 30, 2017Allergan, University of California, Irvine
NCT03186001Phase 4Jul 1, 2017St Joseph University of Beirut
NCT03187626Phase 2/Phase 3 (Phase 3)Jul 1, 2017University of Paris
NCT03103074N/AMay 24, 2017Government of Norway, Hidrosis Clinic, Stockholm, Sweden, University Hospital of North Norway
NCT03136341Phase 4May 1, 2017Icahn School of Medicine at Mount Sinai, Ipsen
Showing 20 of 552 trials
Page 1 / 28

Organizations

Research & Development (313)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AllerganFor profit1296852002
IpsenFor profit453742003
Revance Therapeutics, Inc.For profit181822008
MerzFor profit151042006
Norwegian University of Science and TechnologyAcademic/Hospital131322005
National Institutes of Health (NIH)Government10241997
University of British ColumbiaAcademic/Hospital101042003
Mayo ClinicAcademic/Hospital9832005
Medy-ToxFor profit9742009
Moscow State UniversityAcademic/Hospital9932012
Department of Veteran AffairsGovernment8642003
Chang Gung UniversityAcademic/Hospital7722000
Tzu Chi UniversityAcademic/Hospital7712012
Icahn School of Medicine at Mount SinaiAcademic/Hospital6531999
Northwestern UniversityAcademic/Hospital6622003
Pontifical Catholic University of Rio Grande do SulAcademic/Hospital6612005
University of TorontoAcademic/Hospital6542006
Daewoong Pharmaceutical Co. LTD.For profit5522012
Emory UniversityAcademic/Hospital5542007
Q-Med ABFor profit5532014
313 organizations
Page 1 / 16

Marketing (4)

OrganizationOrg typeRelationshipDate
Elan PharmaceuticalsFor profitMKTGDec 8, 2000
IpsenFor profitMKTGApr 29, 2009
Solstice NeurosciencesFor profitNDA2Dec 8, 2000
Solstice NeurosciencesFor profitNDADec 8, 2000