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Interferon Gamma 1-b
Interferon Gamma 1-b is a Cytokine / Immunomodulator Small molecule drug developed by Assistance Publique - Hôpitaux de Paris. It is currently in Phase 3 development for Chronic granulomatous disease, Severe malignant osteopetrosis, Atypical mycobacterial infections in immunocompromised patients.
Interferon Gamma 1-b is a recombinant cytokine that activates macrophages and enhances immune cell function to boost the body's antimicrobial and antitumor responses.
Interferon Gamma 1-b is a recombinant cytokine that activates macrophages and enhances immune cell function to boost the body's antimicrobial and antitumor responses. Used for Chronic granulomatous disease, Severe malignant osteopetrosis, Atypical mycobacterial infections in immunocompromised patients.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Interferon Gamma 1-b |
|---|---|
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Drug class | Cytokine / Immunomodulator |
| Target | Interferon gamma receptor (IFNGR) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Interferon gamma (IFN-γ) is a Type II interferon produced by T cells and natural killer cells that acts as a key immunomodulatory cytokine. It binds to interferon gamma receptors on immune cells and tissue macrophages, enhancing their microbicidal and tumoricidal activity, increasing antigen presentation, and promoting Th1-mediated immune responses. The recombinant 1-b formulation is used to augment immune function in immunocompromised states or chronic granulomatous disease.
Approved indications
- Chronic granulomatous disease
- Severe malignant osteopetrosis
- Atypical mycobacterial infections in immunocompromised patients
Common side effects
- Fever
- Headache
- Fatigue
- Myalgia
- Nausea
- Diarrhea
- Injection site erythema
Key clinical trials
- Training Protocol on the Natural History of Tuberculosis
- Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB (PHASE2, PHASE3)
- Allogeneic Hematopoietic Stem Cell Transplantation for Chronic Granulomatous Disease (CGD) With an Alemtuzumab, Busulfan and TBI-based Conditioning Regimen Combined With Cytokine (IL-6, +/- IFN-gamma) Antagonists (PHASE1, PHASE2)
- PREVAIL VIIIa: Evaluation of Latent Tuberculosis Infection Screening Methods in People Living With Retroviral Infection in Liberia
- Mycobacterial and Opportunistic Infections in HIV-Negative Thai and Taiwanese Patients Associated With Autoantibodies to Interferon-gamma
- Evaluating the Safety and Immunogenicity of MTBVAC (PHASE2)
- Combining Epigenetic And Immune Therapy to Beat Cancer. (PHASE2)
- Interferon γ-Primed Mesenchymal Stromal Cells as Prophylaxis for Acute Graft v Host Disease (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Interferon Gamma 1-b CI brief — competitive landscape report
- Interferon Gamma 1-b updates RSS · CI watch RSS
- Assistance Publique - Hôpitaux de Paris portfolio CI
Frequently asked questions about Interferon Gamma 1-b
What is Interferon Gamma 1-b?
How does Interferon Gamma 1-b work?
What is Interferon Gamma 1-b used for?
Who makes Interferon Gamma 1-b?
What drug class is Interferon Gamma 1-b in?
What development phase is Interferon Gamma 1-b in?
What are the side effects of Interferon Gamma 1-b?
What does Interferon Gamma 1-b target?
Related
- Drug class: All Cytokine / Immunomodulator drugs
- Target: All drugs targeting Interferon gamma receptor (IFNGR)
- Manufacturer: Assistance Publique - Hôpitaux de Paris — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Chronic granulomatous disease
- Indication: Drugs for Severe malignant osteopetrosis
- Indication: Drugs for Atypical mycobacterial infections in immunocompromised patients
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing