CDEK
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anifrolumab

Trade name: Saphnelo

mAbapprovedFast Track FDA

Approved

Jul 30, 2021

Anifrolumab, sold under the brand name Saphnelo, is a monoclonal antibody used for the treatment of systemic lupus erythematosus. It binds to the type I interferon receptor, blocking the activity of type I interferons such as interferon-α and interferon-β. — Wikipedia

Clinical trial activity

28 trials · 18 clinical orgs · 1 marketing orgs

Phase 1
7
Phase 2
19
Phase 3
10
Phase 4
1

Earliest trial started Sep 1, 2009 (NCT00930683)

Timeline

2000s

  1. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2012

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2015

    AstraZeneca — Earliest Phase 3 Sponsor(trial)

2020s

  1. Jul 30, 2021

    AstraZeneca — Earliest FDA Approval

  2. Jul 30, 2021

    AstraZeneca — Marketing Organization

  3. Jul 30, 2021

    AstraZeneca — NDA Secondary Org

  4. Jul 30, 2021

    AstraZeneca — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedFast trackJul 30, 2021

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

  • anifrolumab
  • anifrolumab
  • anifrolumab
  • medi-546
  • medi-546

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06594068Phase 4Nov 29, 2024AstraZeneca, PPD
NCT06662123Phase 1Oct 21, 2024AstraZeneca
NCT06374212Phase 2Jun 21, 2024AstraZeneca, University of North Carolina at Chapel Hill
NCT06455449Phase 3Jun 20, 2024AstraZeneca
NCT05917561Phase 2Dec 15, 2023AstraZeneca, University of Bordeaux
NCT06015737Phase 3Oct 25, 2023AstraZeneca, Parexel
NCT05925803Phase 3Jul 13, 2023AstraZeneca
NCT05835310Phase 3Jun 21, 2023AstraZeneca
NCT05440422Phase 1Dec 29, 2022National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NCT05383677Phase 2Oct 1, 2022AstraZeneca, University of Groningen
NCT05339100Phase 1Mar 22, 2022AstraZeneca, Parexel
NCT05138133Phase 3Jan 31, 2022AstraZeneca
NCT04931563Phase 3Sep 13, 2021AstraZeneca
NCT05001698Phase 1Jul 27, 2021AstraZeneca
NCT04877691Phase 3Jun 8, 2021AstraZeneca, IQVIA
NCT04726553Early Phase 1 (Phase 1)Jan 20, 2021Columbia University, New York University, Oklahoma Medical Research Foundation, Piedmont Heart Institute, Yale University
NCT03435601Phase 2Apr 18, 2018Medical University of Vienna
NCT02962960Phase 2Feb 14, 2017AstraZeneca
NCT02794285Phase 3Jun 30, 2016AstraZeneca, Pharmaceutical Research Associates, Inc. (PRA), University of California, San Diego
NCT02547922Phase 2Nov 1, 2015AstraZeneca, Parexel
Showing 20 of 28 trials
Page 1 / 2

Organizations

Research & Development (18)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AstraZenecaFor profit221952012
MedImmuneFor profit4322009
ParexelFor profit4032015
Pharmaceutical Research Associates, Inc. (PRA)For profit3012015
Clinigen, Inc.For profit101—
Columbia UniversityAcademic/Hospital1012021
IQVIAFor profit1012021
Medical University of ViennaAcademic/Hospital1112018
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Government1112022
New York UniversityAcademic/Hospital1012021
Oklahoma Medical Research FoundationAcademic/Hospital1112021
Piedmont Heart InstituteAcademic/Hospital1012021
PPDFor profit1012024
University of BordeauxAcademic/Hospital1112023
University of California, San DiegoAcademic/Hospital1012016
University of GroningenAcademic/Hospital1112022
University of North Carolina at Chapel HillAcademic/Hospital1112024
Yale UniversityAcademic/Hospital1012021
18 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
AstraZenecaFor profitMKTGJul 30, 2021
AstraZenecaFor profitNDA2Jul 30, 2021
AstraZenecaFor profitNDAJul 30, 2021