Drugs / Emapalumab
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | GAMIFANT | — | 2025-06-27 | fda.gov ↗ |
| Refused (EMA) | EU (EMA) | Gamifant | — | 2021-01-07 | europa.eu ↗ |
| Approved | US (FDA) | GAMIFANT | — | 2018-11-20 | fda.gov ↗ |
Trials 20 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07244419 Comparator | Jan 2026 → Jun 2029 expected | disease related to hematopoietic stem cell transplant, transplant rejection | Children's Hospital Medical Center, Cincinnati | Recruiting | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT04765553 Comparator | Jan → Jun 2021 | — | Swedish Orphan Biovitrum | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04324021 Comparator | Apr → Nov 2020 | COVID-19 | Swedish Orphan Biovitrum | Terminated | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06504030 Background | Aug 2024 → Aug 2026 overdue | hemophagocytic syndrome | The First Affiliated Hospital of Soochow University | Not yet recruiting | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | emapalumab | “This is a randomized, placebo-controlled and double-blinded study to evaluate the PK, PD and safety of a single dose (1 mg/kg) of emapalumab in adult healthy Japanese subjects,...” NCT04765553 ↗20“Refractory/recurrent hemophagocytic lymphohistiocytosis patients will be treated with GTP regimen (Emapalumab+Teniposide+Methylprednisolone)” NCT06038422 ↗ “1. Emapalumab, a monoclonal antibody that blocks interferon-gamma, a key driver of the overactive immune response seen in HLH.” NCT06951971 ↗ “Emapalumab, if needed.” NCT06504030 ↗ |
| Known as | Emapalumab-Lzsg | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05744063 ↗ |
| Known as | NI-0501 | “The purpose of this study is to expand the knowledge on the efficacy and safety of emapalumab (previously known as NI-0501) as a treatment for primary haemophagocytic...” NCT03312751 ↗ |
| Action | Inhibit | “a drug called emapalumab can be used to block the action of interferon-gamma” PMID 38662147 ↗ Apr 2024 |
| Modality | Monoclonal antibody | “Anti-IFN Gamma Monoclonal Antibody” NCT01459562 ↗ |
| Route | Intravenous | “Single Intravenous Doses of NI-0501” NCT01459562 ↗ |
| Target | IFNG | “Emapalumab is a fully human monoclonal antibody that targets free and receptor-bound interferon-gamma (IFNγ)” PMID 38662147 ↗ Apr 2024 |