interferon gamma-1b
Trade name: actimmune
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
Earliest trial started Apr 1, 1991 (NCT00002475)
Timeline
1980s
- Sep 30, 1988
Orphan Drug Designation
1990s
- Jan 1, 1991
Earliest Phase 2 Sponsor(trial)
- Jan 1, 1992
Earliest Phase 3 Sponsor(trial)
- Jan 1, 1995
Earliest Phase 1 Sponsor(trial)
- Feb 25, 1999
Horizon Therapeutics, LLC — Earliest FDA Approval
- Feb 25, 1999
Vidara Therapeutics — Marketing Organization
- Feb 25, 1999
Horizon Therapeutics, LLC — Marketing Organization
- Feb 25, 1999
Horizon Therapeutics, LLC — NDA Secondary Org
- Feb 25, 1999
Horizon Therapeutics, LLC — NDA Organization
Indications
Studied for
- Adenocarcinoma · Phase 1/Phase 2
- AIDS-Related Complex · Phase 2
- Arthritis, Reactive · Phase 2
- Aspergillosis · Phase 2
- Breast Neoplasms · Phase 3
- Breast Neoplasms, Male · Phase 1/Phase 2
- Bronchiolitis · Phase 2
- Candidemia · Phase 3
- Cholecalciferol · Phase 2/Phase 3
- Colonic Neoplasms · Phase 1/Phase 2
- Colorectal Neoplasms · Phase 2
- Critical Illness · Phase 2
- Cystic Fibrosis · Phase 1/Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 1
- Endoscopy · Phase 2/Phase 3
- Fallopian Tube Neoplasms · Phase 2
- Fibrosis · Phase 2
- Friedreich Ataxia · Phase 3
- Genotype · Phase 2/Phase 3
- Glioblastoma · Phase 1
- Graft vs Host Disease · Phase 3
- Granuloma · Phase 4
- Granulomatous Disease, Chronic · Phase 4
- Hamartoma · Phase 3
- Healthy Volunteers · Phase 2
- Hematopoietic Stem Cell Transplantation · Early Phase 1
- Hepatitis C · Phase 2/Phase 3
- Hepatitis C, Chronic · Phase 2
- HIV · Phase 1/Phase 2
- HIV Infections · Phase 2
- Idiopathic Pulmonary Fibrosis · Phase 3
- Infections · Phase 2
- Influenza, Human · Phase 4
- Interferon-gamma · Phase 4
- Kidney Neoplasms · Phase 2
- Lentivirus Infections · Phase 1/Phase 2
- Leukemia · Phase 1/Phase 2
- Leukemia, Myeloid · Early Phase 1
- Leukemia, Myeloid, Acute · Phase 2
- Leukocyte-Adhesion Deficiency Syndrome · Phase 2
- Liposarcoma · Phase 2
- Liver Cirrhosis · Phase 2
- Lung Diseases · Phase 3
- Lung Neoplasms · Phase 2
- Lymphoma · Phase 3
- Lymphoma, Non-Hodgkin · Phase 1/Phase 2
- Macrophage Activation Syndrome · Phase 2
- Macula Lutea · Phase 1/Phase 2
- Melanoma · Phase 3
- Meningitis, Cryptococcal · Phase 2
- Mesothelioma, Malignant · Phase 2
- Multiple Myeloma · Phase 2
- Mutation · Phase 4
- Mycobacterium avium-intracellulare Infection · Phase 2
- Mycobacterium bovis · Phase 2/Phase 3
- Mycobacterium Infections, Nontuberculous · Phase 2
- Myelodysplastic Syndromes · Phase 2
- Neoplasms · Phase 2
- Neuroblastoma · Phase 1
- Ophthalmology · Phase 1/Phase 2
- Osteopetrosis · Phase 3
- Osteosarcoma · Phase 1
- Ovarian Neoplasms · Phase 3
- Pancreatic Neoplasms · Phase 2
- Papillomavirus Infections · Phase 3
- Pleural Effusion, Malignant · Phase 1
- Pneumonia · Phase 2
- Pneumonia, Ventilator-Associated · Phase 3
- Preventive Medicine · Phase 4
- Primary Immunodeficiency Diseases · Phase 4
- Prostatic Neoplasms · Phase 1/Phase 2
- Prostatitis · Phase 3
- Pulmonary Fibrosis · Phase 3
- Respiratory Tract Infections · Phase 4
- Retinal Diseases · Phase 1/Phase 2
- Rhabdomyosarcoma · Phase 1
- RNA Virus Infections · Phase 1/Phase 2
- Sarcoma · Phase 1
- Sarcoma, Ewing · Phase 1
- Sarcoma, Synovial · Phase 2
- Sepsis · Phase 3
- Sezary Syndrome · Phase 2
- Shock, Septic · Phase 3
- Tuberculosis · Phase 2
- Tuberculosis, Pulmonary · Phase 2
- Uveitis · Phase 1/Phase 2
- Uveitis, Anterior · Phase 1/Phase 2
- Warts · Phase 3
Mechanism of action
- Interferon gammaSupplementation
IFNG supplementation
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
- WikipediaInterferon gamma ↗
- NCATS21K6M2I7AG ↗
- ChEMBLCHEMBL1201564 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06529731 | Phase 2 | Aug 22, 2024 | Amgen, Food and Drug Administration, University of Pittsburgh |
| NCT05843786 | Phase 3 | Jun 30, 2023 | University of Lyon |
| NCT05653193 | Phase 2 | Jan 31, 2023 | University of Manchester |
| NCT05268172 | Phase 1 | Dec 20, 2022 | Central South University, China Medical University, Jiangnan University, Sichuan University, Wuxi People's Hospital, Zhejiang University |
| NCT04979052 | Phase 2 | Dec 31, 2021 | European Commission, Radboud University |
| NCT04793568 | Phase 2 | Mar 29, 2021 | University of Nantes |
| NCT05054114 | N/A | Dec 21, 2020 | City Clinical Hospital named after M.E. Zhadkevich |
| NCT04628338 | Early Phase 1 (Phase 1) | Nov 30, 2020 | Horizon Pharma, University of Pittsburgh |
| NCT03984890 | Phase 2/Phase 3 (Phase 3) | Aug 1, 2019 | Fudan University |
| NCT03707912 | Phase 4 | Oct 9, 2018 | Materia Medica Holding |
| NCT03332225 | Phase 2 | Dec 15, 2017 | Hellenic Institute for the Study of Sepsis, University of Athens |
| NCT03063632 | Phase 2 | Oct 20, 2017 | Cancer Immunotherapy Trials Network, National Cancer Institute (NCI) |
| NCT03301155 | Phase 4 | Oct 3, 2017 | Materia Medica Holding |
| NCT05395702 | N/A | May 12, 2017 | — |
| NCT03112590 | Phase 1/Phase 2 (Phase 2) | Apr 28, 2017 | Horizon Pharma, University of South Florida |
| NCT03056599 | Phase 1 | Dec 15, 2016 | Presage Biosciences, University of Washington |
| NCT02609932 | Phase 1 | Jul 1, 2016 | University of Colorado, Denver |
| NCT03888664 | Phase 2 | Jun 26, 2016 | IRCCS Eugenio Medea |
| NCT02797080 | Phase 3 | Jun 1, 2016 | Friedreich's Ataxia Research Alliance (FARA), Horizon Pharma |
| NCT02666768 | Phase 2 | Feb 1, 2016 | Horizon Pharma, Los Angeles Biomedical Research Institute, University of California, Los Angeles, University of Minnesota |
Organizations
Research & Development (78)
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Horizon Therapeutics, LLC | For profit | MKTG | Feb 25, 1999 |
| Horizon Therapeutics, LLC | For profit | NDA2 | Feb 25, 1999 |
| Horizon Therapeutics, LLC | For profit | NDA | Feb 25, 1999 |
| Vidara Therapeutics | For profit | MKTG | Feb 25, 1999 |