Interferon gamma-1b
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | ACTIMMUNE | — | 2000-02-10 – 2004-03-18 | fda.gov ↗ |
| Approved | US (FDA) | ACTIMMUNE | — | 1999-02-25 | fda.gov ↗ |
Trials 43
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT04628338 | Mar 2021 → Oct 2023 | acute myeloid leukemia, disease related to hematopoietic stem cell transplant, myelodysplastic syndrome | Sawa Ito, MD | Completed | No outcome recorded |
| Phase 0 | NCT01317017 | Jul 2010 → May 2011 | psoriasis | Rockefeller University | Terminated | No outcome recorded |
| Phase 19 trials · 1 met primary | ||||||
| Phase 1 | NCT02948426 | Feb 2017 → Sep 2020 | fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02609932 | Jul 2016 → Aug 2018 | chronic granulomatous disease | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 1 | NCT01929382 | Jul → Sep 2013 | interferon antiviral depressor | Vidara Therapeutics Research Ltd | Unknown | Met primary |
| Phase 1 | NCT00943982 | Jul 2009 → Jun 2010 | uveitis | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 1 | NCT00563212 | Jan 2007 → Jun 2010 | idiopathic pulmonary fibrosis | NYU Langone Health | Completed | No outcome recorded |
| Phase 1 | NCT00428272 | Dec 2006 → Apr 2011 | Ewing sarcoma, neuroblastoma, osteosarcoma, rhabdomyosarcoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT00111397 | May 2005 → Aug 2010 | Mycobacterium avium complex disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00001112 | ? → Apr 1993 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00000761 | ? → Oct 1997 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT02338973 | Jan 2015 → Jun 2018 | hereditary neuro-ophthalmological disease, inherited retinal dystrophy | National Eye Institute (NEI) | Terminated | No outcome recorded |
| Phase 1/2 | NCT01468337 | Oct 2011 → Nov 2013 | macular degeneration | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 1/2 | NCT01376362 | Jun 2011 → Feb 2012 | anterior uveitis | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 1/2 | NCT00057447 | Mar 2003 → Jun 2004 | non-Hodgkin lymphoma | InterMune | Terminated | No outcome recorded |
| Phase 1/2 | NCT00043342 | Apr 2002 → Mar 2003 | cystic fibrosis | InterMune | Completed | No outcome recorded |
| Phase 1/2 | NCT00043316 | Feb 2001 → Oct 2002 | cystic fibrosis | InterMune | Completed | No outcome recorded |
| Phase 218 trials · 1 missed | ||||||
| Phase 2 | NCT06381661 | May 2026 → Jun 2028 expected | infectious disease with sepsis | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06529731 | Sep 2024 → Oct 2027 expected | acute myeloid leukemia, myelodysplastic syndrome | Sawa Ito, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT05653193 | May 2024 → Nov 2026 expected | aspergillosis | Manchester University NHS Foundation Trust | Recruiting | No outcome recorded |
| Phase 2 | NCT04793568 | Mar → Nov 2021 | — | Nantes University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03063632 | Dec 2017 → Apr 2021 | mycosis fungoides and variants, myxoid liposarcoma, round cell liposarcoma, synovial sarcoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT02666768 | Feb 2016 → Mar 2019 | osteopetrosis | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02584608 | Jan 2016 → Nov 2019 | autosomal dominant osteopetrosis 2 | Indiana University | Completed | Missed primary |
| Phase 2 | NCT01965327 | Aug 2013 → Mar 2014 | Friedreich ataxia | Children's Hospital of Philadelphia | Completed | No outcome recorded |
| Phase 2 | NCT02035020 | May 2013 → Jul 2014 | Friedreich ataxia | Azienda Policlinico Umberto I | Completed | No outcome recorded |
| Phase 2 | NCT01639261 | Jul 2012 → Dec 2013 | transplant-related bronchiolitis obliterans | University Hospital Regensburg | Unknown | No outcome recorded |
| Phase 2 | NCT00201123 | Apr 2005 → Jan 2007 | AIDS related complex, tuberculosis | NYU Langone Health | Completed | No outcome recorded |
| Phase 2 | NCT00084279 | Apr 2004 → Apr 2006 | chronic hepatitis C virus infection | InterMune | Completed | No outcome recorded |
| Phase 2 | NCT00052052 | Sep 2002 → Sep 2004 | idiopathic pulmonary fibrosis | InterMune | Completed | No outcome recorded |
| Phase 2 | NCT00047658 | Nov 2001 → May 2003 | idiopathic pulmonary fibrosis | InterMune | Completed | No outcome recorded |
| Phase 2 | NCT00043303 | Sep 2001 → Nov 2003 | cirrhosis of liver, fibrotic liver disease | InterMune | Completed | No outcome recorded |
| Phase 2 | NCT00043355 | Dec 2000 → Feb 2003 | respiratory tract infectious disorder | InterMune | Terminated | No outcome recorded |
| Phase 2 | NCT00012467 | Jan 2000 → Jul 2001 | Cryptococcal meningitis, HIV infectious disease | InterMune | Completed | No outcome recorded |
| Phase 2 | NCT00001004 | ? → Feb 1990 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06694740 | Feb 2026 → Mar 2029 expected | acquired immunodeficiency | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 36 trials · 1 missed | ||||||
| Phase 3 | NCT06774235 | Jul 2025 → Oct 2028 expected | immunodeficiency disease | University Hospital, Limoges | Recruiting | No outcome recorded |
| Phase 3 | NCT00075998 | Dec 2003 → May 2007 | idiopathic pulmonary fibrosis, pulmonary fibrosis | InterMune | Terminated | Missed primary |
| Phase 3 | NCT00076635 | Nov 2003 → Apr 2007 | idiopathic pulmonary fibrosis, pulmonary fibrosis | InterMune | Terminated | No outcome recorded |
| Phase 3 | NCT00052039 | Apr → Jun 2002 | pulmonary fibrosis | InterMune | Terminated | No outcome recorded |
| Phase 3 | NCT00047632 | Oct 2001 → Feb 2006 | ovarian carcinoma, peritoneal carcinoma | InterMune | Terminated | No outcome recorded |
| Phase 3 | NCT00047645 | Apr 2000 → Dec 2002 | idiopathic pulmonary fibrosis | InterMune | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00002433 | — | HIV infectious disease | Amgen | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1/2 | NCT03747484 Background | Jul 2019 → Jan 2024 | — | Fred Hutchinson Cancer Center | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04979052 Comparator | Mar 2022 → Mar 2026 | candidemia | Radboud University Medical Center | Completed | No outcome recorded |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 45 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Interferon gamma-1b | “The purpose of this research study is to test the safety and effectiveness of Interferon gamma-1b (IFN-g 1b) injected subcutaneously (under the skin) for the treatment of...” NCT00043303 ↗45“Interferon gamma 1b (Actimmune) and GM-CSF (Leukine) are two cytokine therapies that have been approved in the treatment of chronic granulomatous disease and...” NCT00111397 ↗ “Injections of Interferon gamma-1b are sub-cutaneous and preferably in the deltoid region left or right or on the anterior part of the thigh.” NCT06774235 ↗ “A Study of the Safety and Clinical Effects of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)” NCT00047658 ↗ “Immune adjuvant therapy with recombinant interferon-gamma1b (rIFN-gammab) may reduce pulmonary inflammation” PMID 19753300 ↗ Sep 2009 “Consensus Interferon-Alpha (CIFN) Plus Interferon Gamma-1b (IFN-γ 1b) With or Without Ribavirin (RBV)” NCT00084279 ↗ “aerosol interferon-gamma-1b 100mcg given via nebulizer three times weekly for one year” NCT00563212 ↗ “Interferon gamma-1b (Actimmune(Registered Trademark)) is a bioengineered protein” NCT00943982 ↗ “Recombinant human interferon gamma-1b 2 X 106 IU, injectable solution.” NCT06694740 ↗ “Actimmune(R) (Interferon gamma-1b)” NCT02948426 ↗ |
| Known as | Actimmune | “Interferon gamma 1b (Actimmune) and GM-CSF (Leukine) are two cytokine therapies that have been approved in the treatment of chronic granulomatous disease and...” NCT00111397 ↗6“The investigators will treat 12 ADO2 subjects (children or adults age 3-65) with Actimmune® via a dose escalation protocol to a dose of 50 µg/m2 subcutaneously three times per...” NCT02584608 ↗ “A Multicenter Study of the Safety and Anti-Fibrotic Efficacy of Interferon-Gamma 1b (Actimmune) in Patients With Severe Lever Fibrosis or Compensated Cirrhosis Due to Hepatitis C.” NCT00043303 ↗ “Interferon gamma-1b ("Actimmune")” NCT00075998 ↗ |
| Known as | Actimmune(Registered Trademark) | “Interferon gamma-1b (Actimmune(Registered Trademark)) is a bioengineered protein” NCT00943982 ↗ |
| Known as | human interferon gamma | “(recombinant) human interferon gamma (IFN-G)” NCT00001112 ↗ |
| Known as | IFN-G | “I. To assess the overall response rate (ORR) of MK-3475 (pembrolizumab) and interferon gamma-1b (IFN-G) (Actimmune) combination immunotherapy in subjects with previously...” NCT03063632 ↗2“0.25ml of IFN-g (Actimmune TM 100 micrograms/0.5ml)” NCT01317017 ↗ “(recombinant) human interferon gamma (IFN-G)” NCT00001112 ↗ |
| Known as | IFN-g 1b | “The purpose of this research study is to test the safety and effectiveness of Interferon gamma-1b (IFN-g 1b) injected subcutaneously (under the skin) for the treatment of...” NCT00043303 ↗3“Interferon gamma-1b (IFN-g 1b) on lung function when given to patients with cystic fibrosis by inhalation” NCT00043316 ↗ “subcutaneous interferon gamma-1b (IFN g-1b) administered 3 times per week” NCT00057447 ↗ “inhaled Interferon gamma-1b (IFN-g 1b)” NCT00043355 ↗ |
| Known as | IFN-gamma | “aerosolized recombinant interferon gamma (IFN-gamma)” NCT00002433 ↗ |
| Known as | IFN-gamma 1b | “The purpose of this research study is to evaluate the safety, tolerability, and efficacy of Interferon gamma-1b (IFN-gamma 1b) when administered by subcutaneous injection over...” NCT00043342 ↗1“IFN gamma 1b (Immukin ®) will be administered by subcutaneous route at day 0, 14 and 28 at a dose of 100, 150 and 200 ug respectively.” NCT02035020 ↗ |
| Known as | IFN-γ 1b | “Consensus Interferon-Alpha (CIFN) Plus Interferon Gamma-1b (IFN-γ 1b) With or Without Ribavirin (RBV)” NCT00084279 ↗ |
| Known as | Imukin | “Recombinant Interferon gamma 1b (IMUKIN®, from Clinigen®)” NCT04793568 ↗ |
| Known as | Recombinant Human Interferon-gamma | “Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children” NCT00000761 ↗ |
| Known as | recombinant interferon gamma-1b | “PRIMARY: To determine the safety and toxicity of recombinant interferon gamma-1b ( rIFN-gamma ) in HIV-infected children receiving ongoing zidovudine ( AZT ) or didanosine (...” NCT00000761 ↗2“Immune adjuvant therapy with recombinant interferon-gamma1b (rIFN-gammab) may reduce pulmonary inflammation” PMID 19753300 ↗ Sep 2009 “Subcutaneous Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b)” NCT00012467 ↗ |
| Known as | rHuIFN-γ | “human recombinant Interferon gamma 1b (rHuIFN-γ, Imukin) treatment can restore immunity in critically ill patients” NCT04793568 ↗ |
| Known as | rIFN-gamma | “PRIMARY: To determine the safety and toxicity of recombinant interferon gamma-1b ( rIFN-gamma ) in HIV-infected children receiving ongoing zidovudine ( AZT ) or didanosine (...” NCT00000761 ↗ |
| Known as | rIFN-gamma1b | “We performed a randomized, controlled clinical trial of directly observed therapy (DOTS) versus DOTS supplemented with nebulized or subcutaneously administered rIFN-gamma1b...” PMID 19753300 ↗ Sep 2009 |
| Action | Inhibit | “TNF and IFN-G, in combination, can not only inhibit HIV infection of previously uninfected cells” NCT00001004 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant Human Interferon-gamma” NCT00000761 ↗ |
| Route | Subcutaneous | “Patients are treated with subcutaneous rIFN-gamma 3 times a week for 24 weeks” NCT00000761 ↗ |