GAMIFANT (emapalumab-lzsg)
GAMIFANT is indicated for the treatment of Hemophagocytic Lymphohistiocytosis; Macrophage Activation Syndrome; Still's Disease; Systemic Juvenile Idiopathic Arthritis.
How GAMIFANT Works
Emapalumab-lzsg functions as a monoclonal antibody that targets and neutralizes interferon gamma (IFNγ). This specific protein is hypersecreted in patients with hemophagocytic lymphohistiocytosis (HLH), contributing to the pathogenesis of the disease. By binding to IFNγ, the drug inhibits its biological activity to treat the condition.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-11-20
- Patent Cliff
- 2025
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
GAMIFANT Approval History
What GAMIFANT Treats
4 indicationsGAMIFANT is approved for 4 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hemophagocytic Lymphohistiocytosis
- Macrophage Activation Syndrome
- Still's Disease
- Systemic Juvenile Idiopathic Arthritis
GAMIFANT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to GAMIFANT
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06996119 | 23822 NCI-2025-03603, 23822 | Ph 1 | recruiting | Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versus-Host Disease After Donor Reduced-Intensity Hematopoietic Cell Transplant |
| NCT07567014 | 25-00098 | Ph 2 | not yet recruiting | Emapalumab Prophylaxis of Bispecific T-Cell Engagers (BiTEs) Associated CRS and ICANS |
| NCT06285825 | 2023-0864 NCI-2024-01736 | Ph 2 | recruiting | A Pilot Study of Emapalumab for the Treatment of CAR T-Cell Therapy-Associated Prolonged Cytopenia |
| NCT07538336 TIGER-Lung | 25-45438 | Ph 2 | not yet recruiting | Targeting Interferon Gamma With Emapalumab to Lung Transplant Recipients With Interferon Gamma-high Acute Lung Allograft Dysfunction |
| NCT07486869 | 20241227 | Ph 2 | not yet recruiting | Emapalumab MDA5 Rapidly Progressive Interstitial Lung Disease (RP-ILD) Study |
| NCT05001737 EMERALD results posted | NI-0501-14 2021-001577-24 | Ph 3 | completed | Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE |
| NCT06430788 | 23-278 FD-R-008175 | Ph 2 | recruiting | A Study of Emapalumab for Pediatric Aplastic Anemia |
| NCT07202598 | 10002480 002480-I | Ph 2 | recruiting | Randomized Stepped Wedge Study of Emapalumab in APECED Enteritis |
| NCT06550141 | 24-317 | Ph 2 | recruiting | Emapalumab Prevention of CAR-T Cell Associated Toxicities |
| NCT05787574 | 23-040 R01FD007829 | Ph 2 | recruiting | A Study of Treatment of Inflammation Before Stem Cell Transplant in People With a Primary Immune Regulatory Disorder (PIRD) and/or an Autoinflammatory Condition |
| NCT03312751 results posted | NI-0501-09 | Ph 3 | completed | Study to Assess the Efficacy and Safety of Emapalumab in Primary Haemophagocytic Lymphohistiocytosis |
| NCT04731298 results posted | NI-0501-12 | Ph 2 | terminated | Study to Investigate the Pharmacokinetics, Pharmacodynamics and Assess the Efficacy and Safety to Support Dose Selection of Emapalumab in Pre-empting Graft Failure in Patients at High Risk After HSCT. |
| NCT03985423 results posted | NI-0501-10 | Ph 2, Ph 3 | terminated | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Emapalumab in Adult Patients With HLH |
| NCT02069899 results posted | NI-0501-05 | Ph 2, Ph 3 | completed | A Study for Long-term Follow-up of Hemophagocytic Lymphohistiocytosis (HLH) Participants Who Received Treatment With Emapalumab (NI-0501), an Anti-interferon Gamma Monoclonal Antibody |
| NCT03311854 results posted | NI-0501-06 | Ph 2 | completed | A Study to Investigate the Safety and Efficacy of Emapalumab, an Anti-IFN-gamma mAb in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH) |
| NCT04324021 results posted | Sobi.IMMUNO-101 2020-001167-93 | Ph 2, Ph 3 | terminated | Efficacy and Safety of Emapalumab and Anakinra in Reducing Hyperinflammation and Respiratory Distress in Patients With COVID-19 Infection. |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GAMIFANT FDA Label Details
Indications & Usage
FDA Label (PDF)GAMIFANT is indicated for the treatment of Hemophagocytic Lymphohistiocytosis; Macrophage Activation Syndrome; Still's Disease; Systemic Juvenile Idiopathic Arthritis.
Track GAMIFANT with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment