crizanlizumab

Trade name: Adakveo

mAbapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Nov 15, 2019

Crizanlizumab, sold under the brand name Adakveo among others, is a monoclonal antibody medication that binds to P-selectin. It is a medication used to reduce the frequency of vaso-occlusive crisis in people aged 16 years and older who have sickle cell anemia. It is given by injection into a vein. — Wikipedia

Clinical trial activity

16 trials · 9 clinical orgs · 1 marketing orgs

Phase 1
2
Phase 2
12
Phase 3
2
Phase 4
2

Earliest trial started Jul 1, 2013 (NCT01895361)

Timeline

2000s

  1. Jul 22, 2008

    Orphan Drug Designation

2010s

  1. Jan 1, 2013

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2019

    Novartis — Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2019

    Novartis — Earliest Phase 3 Sponsor(trial)

  4. Nov 15, 2019

    Novartis — Earliest FDA Approval

  5. Nov 15, 2019

    Novartis — Marketing Organization

  6. Nov 15, 2019

    Novartis — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewBreakthroughNov 15, 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

  • selg1

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06439082Phase 3Oct 1, 2024Novartis
NCT05909618Phase 2Jul 11, 2023Tel Aviv University
NCT05469828Phase 1/Phase 2 (Phase 2)Jul 1, 2023Children's Hospital Los Angeles, Novartis
NCT05334576N/AApr 11, 2022Novartis, Washington University in St. Louis
NCT04657822Phase 4Apr 28, 2021Novartis
NCT04662931Phase 4Jan 26, 2021Novartis
NCT04611880Phase 2Dec 1, 2020Washington University in St. Louis
NCT04435184Phase 2Jun 30, 2020Harvard University, Johns Hopkins University, Novartis, Socar Research SA
NCT04053764Phase 2Oct 1, 2019Novartis
NCT04097821Phase 1/Phase 2 (Phase 2)Sep 18, 2019Novartis
NCT03938454Phase 2Sep 2, 2019Novartis
NCT03814746Phase 3Jul 25, 2019Novartis
NCT03474965Phase 2Aug 30, 2018Novartis
NCT03264989Phase 2Dec 19, 2017Novartis
NCT01895361Phase 2Jul 1, 2013National Heart, Lung, and Blood Institute (NHLBI), Selexys Pharmaceuticals Corporation
NCT03720626N/ANovartis
Showing 16 of 16 trials
Page 1 / 1

Organizations

Research & Development (9)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NovartisFor profit131042017
Washington University in St. LouisAcademic/Hospital2222020
Children's Hospital Los AngelesAcademic/Hospital1112023
Harvard UniversityAcademic/Hospital1012020
Johns Hopkins UniversityAcademic/Hospital1112020
National Heart, Lung, and Blood Institute (NHLBI)Government1012013
Selexys Pharmaceuticals CorporationFor profit1112013
Socar Research SAFor profit1012020
Tel Aviv UniversityAcademic/Hospital1112023
9 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
NovartisFor profitMKTGNov 15, 2019
NovartisFor profitNDANov 15, 2019