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caplacizumab

Trade name: cablivi

mAbapprovedOrphan Drug FDAFast Track FDA

Approved

Feb 6, 2019

Caplacizumab is a bivalent single-domain antibody (VHH) designed for the treatment of thrombotic thrombocytopenic purpura (TTP) and thrombosis. — Wikipedia

Clinical trial activity

9 trials · 3 clinical orgs · 2 marketing orgs

Phase 1
2
Phase 2
6
Phase 3
4
Phase 4
0

Earliest trial started Sep 1, 2009 (NCT01020383)

Timeline

2000s

  1. Jan 1, 2009

    Ablynx — Earliest Phase 2 Sponsor(trial)

  2. Apr 14, 2009

    Orphan Drug Designation

2010s

  1. Jan 1, 2014

    Ablynx — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2015

    Ablynx — Earliest Phase 3 Sponsor(trial)

  3. Feb 6, 2019

    Ablynx — Earliest FDA Approval

  4. Feb 6, 2019

    Ablynx — Marketing Organization

  5. Feb 6, 2019

    Ablynx — NDA Organization

  6. Feb 6, 2019

    Sanofi-Aventis — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

  • von Willebrand factorINHIBITOR

    VWF inhibitor

    Inhibits the interaction between ultralarge von Willebrand factor (ULvWF) multimers and platelets by targeting the A1 domain of vWF and thus has the potential to immediately block the ULvWF mediated platelet interactions and the formation of the string-like clots in the blood of patients with acquired thrombotic thrombocytopenic purpura (TTP).

    A1 domain of vWF.

Approval history

  • approvedPriority reviewFast trackFeb 6, 2019

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

First in class

Sources

Also known as

  • alx-0081
  • alx-0081
  • alx-0081
  • anti-vwf nanobody
  • caplacizumab
  • caplacizumab
  • caplacizumab
  • caplacizumab-yhdp

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05468320Phase 3Nov 21, 2022Sanofi
NCT04720261Phase 2May 1, 2021Rouen Normandy University
NCT04074187Phase 2/Phase 3 (Phase 3)Sep 18, 2019Sanofi
NCT03172208Phase 1Jun 1, 2017Ablynx
NCT02878603Phase 3Aug 1, 2016Ablynx
NCT02553317Phase 3Sep 1, 2015Ablynx
NCT02189733Phase 1Jul 1, 2014Ablynx
NCT01151423Phase 2Sep 1, 2010Ablynx
NCT01020383Phase 2Sep 1, 2009Ablynx
Showing 9 of 9 trials
Page 1 / 1

Organizations

Research & Development (3)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AblynxFor profit6632009
SanofiFor profit2212019
Rouen Normandy UniversityAcademic/Hospital1112021
3 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
AblynxFor profitMKTGFeb 6, 2019
AblynxFor profitNDAFeb 6, 2019
Sanofi-AventisFor profitNDA2Feb 6, 2019