Interferon gamma-1b
Protein / enzyme biologic targets FXN via activation
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 57 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03747484 Background | Jul 2019 → Jan 2024 | — | Fred Hutchinson Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT00002796 Background | May 1997 → Dec 2004 | colon mucinous adenocarcinoma, colon signet ring cell adenocarcinoma, rectal signet ring cell adenocarcinoma, rectum mucinous adenocarcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04979052 Comparator | Mar 2022 → Mar 2026 | candidemia | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00002475 Background | Apr 1991 → Dec 2007 | breast cancer, colorectal cancer, kidney cancer, lung cancer +2 | St. Vincent Medical Center - Los Angeles | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01147042 Comparator | May 2010 → Nov 2014 | chronic granulomatous disease, immunodeficiency disease | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
Evidence & citations 28 cited values
Every value below carries the sentence it was read from. 64 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 ↗46“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 ↗ “Open label study of Interferon gamma 1b (IFN-γ) in Friedreich ataxia.” NCT03888664 ↗ “Actimmune(R) (Interferon gamma-1b)” NCT02948426 ↗ |
| Known as | Actimmune | “Since γIFN is also a drug available on the market as a recombinant protein (γIFN - 1b, TD Imukin® and Actimmune®), and already approved for two pediatric indications (malignant...” NCT03888664 ↗7“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 ↗ “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 | gamma interferon | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03888664 ↗ |
| Known as | Gamma-Interferon-1b | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00786643 ↗ |
| 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 | “combined cyclosporine A (CsA) at 1.25 mg/kg intravenously daily from day 0 to +28 and interferon gamma (IFN-gamma) 0.025 mg/m(2) SQ every 2 days from day +7 to +28” PMID 17563739 ↗ Jun 2007 |
| 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 | “We previously demonstrated that both MHC expression and T-cell infiltration can be increased using systemic interferon gamma (IFN-γ), which could improve the efficacy of ACT for SS.” PMID 32269142 ↗ Apr 20202“Open label study of Interferon gamma 1b (IFN-γ) in Friedreich ataxia.” NCT03888664 ↗ “Gamma-Interferon-1b (IFN-γ)” NCT00786643 ↗ |
| 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 | interferon gamma | “It has recently been shown that interferon gamma (γIFN), a natural regulator of the immune response and iron metabolism, stimulates frataxin gene transcription and promotes...” NCT03888664 ↗1“combined cyclosporine A (CsA) at 1.25 mg/kg intravenously daily from day 0 to +28 and interferon gamma (IFN-gamma) 0.025 mg/m(2) SQ every 2 days from day +7 to +28” PMID 17563739 ↗ Jun 2007 |
| Known as | Interferon γ-1b | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02593773 ↗ |
| 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 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00003414 ↗ |
| Known as | recombinant interferon-gamma1b | “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 |
| Known as | TD Imukin | “Since γIFN is also a drug available on the market as a recombinant protein (γIFN - 1b, TD Imukin® and Actimmune®), and already approved for two pediatric indications (malignant...” NCT03888664 ↗ |
| Known as | γIFN | “The investigator proposes an open label pilot study to investigate the safety and efficacy of gamma interferon (γIFN) in patients with Friedreich's Ataxia (FRDA).” NCT03888664 ↗ |
| Known as | γIFN - 1b | “Since γIFN is also a drug available on the market as a recombinant protein (γIFN - 1b, TD Imukin® and Actimmune®), and already approved for two pediatric indications (malignant...” NCT03888664 ↗ |
| 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 ↗ |
| Target | FXN | “interferon gamma (γIFN), a natural regulator of the immune response and iron metabolism, stimulates frataxin gene transcription” NCT03888664 ↗ |