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Gamifant (EMAPALUMAB)
Gamifant works by blocking the action of interferon gamma, a protein that helps coordinate the immune response.
Gamifant (emapalumab) is a small molecule interferon gamma blocker developed by Novimmune S.A. It targets interferon gamma, a cytokine involved in immune responses, to treat primary hemophagocytic lymphohistiocytosis. Gamifant was FDA-approved in 2018 and has a half-life of 22 days. As a patented product, it is not yet available as a generic. Key safety considerations include its potential to increase the risk of infections due to its immunosuppressive effects.
At a glance
| Generic name | EMAPALUMAB |
|---|---|
| Sponsor | Novimmune S.A. |
| Drug class | Interferon gamma Blocker [EPC] |
| Target | Interferon gamma |
| Modality | Monoclonal antibody |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2018 |
Mechanism of action
Emapalumab-lzsg is monoclonal antibody that binds to and neutralizes interferon gamma (IFN). Nonclinical data suggest that IFN plays pivotal role in the pathogenesis of HLH by being hypersecreted.
Approved indications
- Primary hemophagocytic lymphohistiocytosis
Common side effects
- Infections
- Hypertension
- Infusion-related reactions
- Pyrexia
- Hypokalemia
- Constipation
- Rash
- Abdominal pain
- Cytomegalovirus infection
- Diarrhea
- Lymphocytosis
- Cough
Key clinical trials
- 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)
- Emapalumab MDA5 Rapidly Progressive Interstitial Lung Disease (RP-ILD) Study (PHASE2)
- A Post-authorization Study to Describe the Safety and Efficacy of Emapalumab for the Treatment of pHLH in Treatment Experienced Chinese Patients (PHASE4)
- First-in-human Study of Interferon-y PET Imaging to Assess Response to Immunotherapy (PHASE1)
- Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE (PHASE3)
- A Pilot Study of Emapalumab for the Treatment of CAR T-Cell Therapy-Associated Prolonged Cytopenia (PHASE2)
- Prevention of Graft Rejection in Hematopoietic Stem Cell Transplant (HSCT) Recipients (EARLY_PHASE1)
- A Study of Emapalumab for Pediatric Aplastic Anemia (PHASE2)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Gamifant CI brief — competitive landscape report
- Gamifant updates RSS · CI watch RSS
- Novimmune S.A. portfolio CI