interferon gamma-1b

Trade name: actimmune

Recombinant proteinapprovedOrphan Drug FDA

Approved

Feb 25, 1999

Interferon gamma is a dimerized soluble cytokine that is the only member of the type II class of interferons. The existence of this interferon, which early in its history was known as immune interferon, was described by E. F. Wheelock as a product of human leukocytes stimulated with phytohemagglutinin, and by others as a product of antigen-stimulated lymphocytes. It was also shown to be produced in human lymphocytes. or tuberculin-sensitized mouse peritoneal lymphocytes challenged with Mantoux test (PPD); the resulting supernatants were shown to inhibit growth of vesicular stomatitis virus. Those reports also contained the basic observation underlying the now widely employed interferon gamma release assay used to test for tuberculosis. In humans, the IFNG protein is encoded by the IFNG gene. — Wikipedia

Clinical trial activity

93 trials · 78 clinical orgs · 2 marketing orgs

Phase 1
28
Phase 2
64
Phase 3
21
Phase 4
5

Earliest trial started Apr 1, 1991 (NCT00002475)

Timeline

1980s

  1. Sep 30, 1988

    Orphan Drug Designation

1990s

  1. Jan 1, 1991

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1992

    Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 1995

    Earliest Phase 1 Sponsor(trial)

  4. Feb 25, 1999

    Horizon Therapeutics, LLC — Earliest FDA Approval

  5. Feb 25, 1999

    Vidara Therapeutics — Marketing Organization

  6. Feb 25, 1999

    Horizon Therapeutics, LLC — Marketing Organization

  7. Feb 25, 1999

    Horizon Therapeutics, LLC — NDA Secondary Org

  8. Feb 25, 1999

    Horizon Therapeutics, LLC — NDA Organization

Indications

Studied for

Mechanism of action

Approval history

  • approvedFeb 25, 1999

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

  • anaferon
  • gamma interferon
  • ifn-gamma-1b
  • interferon gama-1b
  • interferon gamma
  • interferon gamma
  • interferon-gamma
  • interferon gamma 1b
  • interferon gamma-1b
  • interferon gamma-1b
  • interferon gamma-1b
  • interferon gamma-1b
  • interferon gamma-1b
  • interferon gamma-1b
  • interferon-gamma 1-b
  • interferon gamma-1b, recombinant
  • interferon gamma-2a
  • interferon gamma-2a
  • interferon gamma-2a
  • interferon-y

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06529731Phase 2Aug 22, 2024Amgen, Food and Drug Administration, University of Pittsburgh
NCT05843786Phase 3Jun 30, 2023University of Lyon
NCT05653193Phase 2Jan 31, 2023University of Manchester
NCT05268172Phase 1Dec 20, 2022Central South University, China Medical University, Jiangnan University, Sichuan University, Wuxi People's Hospital, Zhejiang University
NCT04979052Phase 2Dec 31, 2021European Commission, Radboud University
NCT04793568Phase 2Mar 29, 2021University of Nantes
NCT05054114N/ADec 21, 2020City Clinical Hospital named after M.E. Zhadkevich
NCT04628338Early Phase 1 (Phase 1)Nov 30, 2020Horizon Pharma, University of Pittsburgh
NCT03984890Phase 2/Phase 3 (Phase 3)Aug 1, 2019Fudan University
NCT03707912Phase 4Oct 9, 2018Materia Medica Holding
NCT03332225Phase 2Dec 15, 2017Hellenic Institute for the Study of Sepsis, University of Athens
NCT03063632Phase 2Oct 20, 2017Cancer Immunotherapy Trials Network, National Cancer Institute (NCI)
NCT03301155Phase 4Oct 3, 2017Materia Medica Holding
NCT05395702N/AMay 12, 2017
NCT03112590Phase 1/Phase 2 (Phase 2)Apr 28, 2017Horizon Pharma, University of South Florida
NCT03056599Phase 1Dec 15, 2016Presage Biosciences, University of Washington
NCT02609932Phase 1Jul 1, 2016University of Colorado, Denver
NCT03888664Phase 2Jun 26, 2016IRCCS Eugenio Medea
NCT02797080Phase 3Jun 1, 2016Friedreich's Ataxia Research Alliance (FARA), Horizon Pharma
NCT02666768Phase 2Feb 1, 2016Horizon Pharma, Los Angeles Biomedical Research Institute, University of California, Los Angeles, University of Minnesota
Showing 20 of 93 trials
Page 1 / 5

Organizations

Research & Development (78)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
InterMuneFor profit171422000
National Cancer Institute (NCI)Government15841992
National Institute of Allergy and Infectious Diseases (NIAID)Government101031992
Horizon PharmaFor profit7332015
Friedreich's Ataxia Research Alliance (FARA)Academic/Hospital4022013
Materia Medica HoldingFor profit4422014
National Eye Institute (NEI)Government4422009
Radboud UniversityAcademic/Hospital4432011
City Clinical Hospital named after M.E. ZhadkevichAcademic/Hospital3332006
Herbert Irving Comprehensive Cancer CenterAcademic/Hospital3221996
New York UniversityAcademic/Hospital3232003
University of Texas at HoustonAcademic/Hospital3121997
AmgenFor profit2121999
Food and Drug AdministrationGovernment2121999
Johns Hopkins UniversityAcademic/Hospital2111997
University of PennsylvaniaAcademic/Hospital2122013
University of PittsburghAcademic/Hospital2222020
University of South FloridaAcademic/Hospital2122014
University of WashingtonAcademic/Hospital2122013
Vidara TherapeuticsFor profit2122013
78 organizations
Page 1 / 4

Marketing (4)

OrganizationOrg typeRelationshipDate
Horizon Therapeutics, LLCFor profitMKTGFeb 25, 1999
Horizon Therapeutics, LLCFor profitNDA2Feb 25, 1999
Horizon Therapeutics, LLCFor profitNDAFeb 25, 1999
Vidara TherapeuticsFor profitMKTGFeb 25, 1999