emapalumab-lzsg
Trade name: gamifant
mAbapprovedCOVID-19Orphan Drug FDABreakthrough Therapy FDA
Approved
Nov 20, 2018
Emapalumab, sold under the brand name Gamifant, is an anti-interferon-gamma (IFNγ) antibody medication used for the treatment of hemophagocytic lymphohistiocytosis (HLH), which has no cure. — Wikipedia
Clinical trial activity
22 trials · 27 clinical orgs · 2 marketing orgs
Phase 1
6
Phase 2
12
Phase 3
6
Phase 4
1
Earliest trial started Sep 1, 2011 (NCT01459562)
Timeline
2010s
- Mar 26, 2010
Orphan Drug Designation
- Jan 1, 2011
NovImmune SA — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2013
NovImmune SA — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2018
NovImmune SA — Earliest Phase 3 Sponsor(trial)
- Nov 20, 2018
NovImmune SA — Earliest FDA Approval
- Nov 20, 2018
NovImmune SA — Marketing Organization
- Nov 20, 2018
NovImmune SA — NDA Organization
- Nov 20, 2018
Swedish Orphan Biovitrum — NDA Secondary Org
Indications
Studied for
- Allografts · Phase 2
- Anemia, Aplastic · Phase 2
- Arthritis, Juvenile · Phase 3
- Autoimmune Diseases · Phase 2
- Bone Marrow · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 1
- Graft vs Host Disease · Phase 1
- Granulomatous Disease, Chronic · Phase 1/Phase 2
- Healthy Volunteers · Phase 1
- Hematopoietic Stem Cell Transplantation · Early Phase 1
- Immune System Diseases · Phase 2
- Leukemia, Myeloid, Acute · Phase 1
- Lupus Erythematosus, Systemic · Phase 3
- Lymphohistiocytosis, Hemophagocytic · Phase 4
- Lymphoma, B-Cell · Phase 2
- Lymphoma, Follicular · Phase 2
- Lymphoma, Large B-Cell, Diffuse · Phase 2
- Lymphoma, Large-Cell, Immunoblastic · Phase 2
- Lymphoma, Non-Hodgkin · Phase 2
- Macrophage Activation Syndrome · Phase 3
- Myelodysplastic Syndromes · Phase 1
- Rare Diseases · Phase 1
- Recurrence · Phase 3
- SARS-CoV-2 · Phase 2/Phase 3
- Sepsis · Phase 2
- Still's Disease, Adult-Onset · Phase 3
- Thrombocytopenia · Phase 2
Mechanism of action
- Tumor antigensANTAGONIST
Tumor antigens antagonist
- Interferon gammaINHIBITOR
Interferon gamma inhibitor
IFNgamma is neutralised by emapalumab reducing the concentration of CXCL9 chemokine (induced by IFNgamma).
Approval history
- approvedPriority reviewBreakthroughNov 20, 2018
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- WikipediaEmapalumab ↗
- NCATS3S252O2Z4X ↗
- ChEMBLCHEMBL3989977 ↗
Also known as
- emapalumab-lzsg
- ni-0501
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06996119 | Phase 1 | May 25, 2026 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT07244419 | Early Phase 1 (Phase 1) | Dec 31, 2025 | Swedish Orphan Biovitrum, University of Cincinnati |
| NCT07202598 | Phase 2 | Nov 12, 2025 | National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT06439914 | Phase 1 | Jan 31, 2025 | Wayne State University |
| NCT06694701 | Phase 2 | Nov 30, 2024 | Hellenic Institute for the Study of Sepsis |
| NCT06550141 | Phase 2 | Aug 31, 2024 | Harvard University, Swedish Orphan Biovitrum |
| NCT06285825 | Phase 2 | Jul 5, 2024 | Swedish Orphan Biovitrum, University of Texas at Houston |
| NCT06430788 | Phase 2 | May 21, 2024 | Memorial Sloan-Kettering Cancer Center |
| NCT06038422 | Phase 3 | Sep 15, 2023 | Capital Medical University |
| NCT05787574 | Phase 2 | Mar 15, 2023 | Memorial Sloan-Kettering Cancer Center, Swedish Orphan Biovitrum |
| NCT05744063 | Phase 4 | Feb 3, 2023 | Capital Medical University, Swedish Orphan Biovitrum |
| NCT05463133 | Phase 1/Phase 2 (Phase 2) | Jul 8, 2022 | National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT05001737 | Phase 3 | Nov 15, 2021 | Swedish Orphan Biovitrum |
| NCT04731298 | Phase 2 | Apr 15, 2021 | ABF Pharmaceutical Services GmbH, BioMérieux, Cromsource, Cytel Inc., GxP Consulting, Hebrew University, Peter MacCallum Cancer Centre, Pharmaceutical Research Associates, Inc. (PRA), Proteinsimple, Q2 solutions, Rambam Health Care Campus, St. Justine's Hospital, Swedish Orphan Biovitrum, Sydney Children's Hospitals Network |
| NCT04765553 | Phase 1 | Jan 14, 2021 | P-One Clinic, Swedish Orphan Biovitrum |
| NCT04324021 | Phase 2/Phase 3 (Phase 3) | Apr 2, 2020 | Swedish Orphan Biovitrum |
| NCT03985423 | Phase 2/Phase 3 (Phase 3) | Sep 30, 2019 | NovImmune SA |
| NCT03311854 | Phase 2 | Mar 2, 2018 | NovImmune SA |
| NCT03312751 | Phase 3 | Jan 31, 2018 | NovImmune SA |
| NCT02069899 | N/A | Jun 1, 2013 | NovImmune SA |
Showing 20 of 22 trials
Page 1 / 2
Organizations
Research & Development (27)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Swedish Orphan Biovitrum | For profit | 9 | 5 | 4 | 2020 |
| NovImmune SA | For profit | 6 | 6 | 4 | 2011 |
| Capital Medical University | Academic/Hospital | 2 | 1 | 2 | 2023 |
| Memorial Sloan-Kettering Cancer Center | Academic/Hospital | 2 | 2 | 1 | 2023 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 2 | 2 | 1 | 2022 |
| ABF Pharmaceutical Services GmbH | For profit | 1 | 0 | 1 | 2021 |
| BioMérieux | For profit | 1 | 0 | 1 | 2021 |
| City of Hope National Medical Center | Academic/Hospital | 1 | 1 | 1 | 2026 |
| Cromsource | For profit | 1 | 0 | 1 | 2021 |
| Cytel Inc. | For profit | 1 | 0 | 1 | 2021 |
| GxP Consulting | For profit | 1 | 0 | 1 | 2021 |
| Harvard University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Hebrew University | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Hellenic Institute for the Study of Sepsis | Academic/Hospital | 1 | 1 | 1 | 2024 |
| ICON | For profit | 1 | 0 | 1 | 2011 |
| National Cancer Institute (NCI) | Government | 1 | 0 | 1 | 2026 |
| Peter MacCallum Cancer Centre | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Pharmaceutical Research Associates, Inc. (PRA) | For profit | 1 | 0 | 1 | 2021 |
| P-One Clinic | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Proteinsimple | For profit | 1 | 0 | 1 | 2021 |
27 organizations
Page 1 / 2
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| NovImmune SA | For profit | MKTG | Nov 20, 2018 |
| NovImmune SA | For profit | NDA | Nov 20, 2018 |
| Swedish Orphan Biovitrum | For profit | NDA2 | Nov 20, 2018 |