CDEK
← All drugs Report issue

retifanlimab

Trade name: Zynyz

mAbapprovedOrphan Drug FDAFast Track FDA

Approved

Mar 22, 2023

Clinical trial activity

39 trials · 30 clinical orgs · 1 marketing orgs

Phase 1
19
Phase 2
26
Phase 3
3
Phase 4
0

Earliest trial started Nov 1, 2016 (NCT03059823)

Timeline

2010s

  1. Jan 1, 2016

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2018

    Incyte — Earliest Phase 2 Sponsor(trial)

2020s

  1. Jan 1, 2020

    Incyte — Earliest Phase 3 Sponsor(trial)

  2. Mar 24, 2020

    Orphan Drug Designation

  3. Mar 22, 2023

    Incyte — Earliest FDA Approval

  4. Mar 22, 2023

    Incyte — Marketing Organization

  5. Mar 22, 2023

    Incyte — NDA Secondary Org

  6. Mar 22, 2023

    Incyte — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedFast trackMar 22, 2023

Chemistry & pharmacology

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

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • mga012

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07219576Phase 1/Phase 2 (Phase 2)Dec 31, 2025Incyte, University of California, San Diego
NCT06896188Phase 1Sep 22, 2025Actuate Therapeutics Inc., Incyte, University of Pittsburgh
NCT06959537Phase 1Aug 13, 2025University of Texas at Houston
NCT06939036Phase 1/Phase 2 (Phase 2)Jul 1, 2025Ariceum Therapeutics GmbH
NCT06873789Phase 1/Phase 2 (Phase 2)Jun 30, 2025Incyte
NCT06290622Phase 1Aug 30, 2024University of Alabama, Birmingham
NCT06389799Phase 2Jun 20, 2024Lund University
NCT06320405Phase 1/Phase 2 (Phase 2)May 31, 2024Incyte, OHSU Knight Cancer Institute, Oregon Health and Science University
NCT06160206Phase 2Apr 30, 2024Academic and Community Cancer Research United, National Cancer Institute (NCI)
NCT06149481Phase 1/Phase 2 (Phase 2)Jan 3, 2024National Cancer Institute (NCI)
NCT06179160Phase 1Dec 30, 2023Incyte
NCT06056895Phase 2Nov 8, 2023Incyte, University of Washington
NCT05743595Phase 1Oct 27, 2023Incyte, Washington University in St. Louis
NCT06072612Phase 3Oct 20, 2023BriaCell Therapeutics Corporation
NCT05359692Phase 2Jan 13, 2023Incyte
NCT05455697Phase 1/Phase 2 (Phase 2)Jan 7, 2023University of Washington
NCT05440942Phase 1Dec 31, 2022Incyte, Novartis, University of Miami
NCT05594290Phase 2Nov 30, 2022Gruppo Oncologico del Nord-Ovest, University of Milan
NCT05345002Phase 2Nov 16, 2022Incyte, University of Pennsylvania
NCT05287113Phase 2Nov 14, 2022Incyte
Showing 20 of 39 trials
Page 1 / 2

Organizations

Research & Development (30)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
IncyteFor profit231142018
MacroGenicsFor profit6632016
National Cancer Institute (NCI)Government3112020
Actuate Therapeutics Inc.For profit2022022
Johns Hopkins UniversityAcademic/Hospital2212021
University of Texas at HoustonAcademic/Hospital2222021
University of WashingtonAcademic/Hospital2212023
Academic and Community Cancer Research UnitedAcademic/Hospital1112024
Ariceum Therapeutics GmbHFor profit1112025
BriaCell Therapeutics CorporationFor profit1112023
European Network for Gynaecological Oncological TrialAcademic/Hospital1012020
Free University of AmsterdamAcademic/Hospital1012021
GOG Foundation, Inc.Academic/Hospital1012020
Gruppo Oncologico del Nord-OvestAcademic/Hospital1112022
Gynecologic Oncology GroupAcademic/Hospital1012020
Lund UniversityAcademic/Hospital1112024
NovartisFor profit1012022
OHSU Knight Cancer InstituteAcademic/Hospital1112024
Oncolytics BiotechFor profit1012020
Oregon Health and Science UniversityAcademic/Hospital1012024
30 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
IncyteFor profitMKTGMar 22, 2023
IncyteFor profitNDA2Mar 22, 2023
IncyteFor profitNDAMar 22, 2023