Drugs / Tagraxofusp
Tagraxofusp
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ELZONRIS | — | 2022-10-27 | fda.gov ↗ |
| Approved | EU (EMA) | Elzonris | — | 2021-01-07 | europa.eu ↗ |
| Approved | US (FDA) | ELZONRIS | — | 2018-12-21 | fda.gov ↗ |
Trials 21 · a red edge is where a trial was stopped
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tagraxofusp | “Tagraxofusp (TAG), recombinant interleukin-3 fused to a truncated diphtheria toxin payload, is a first-in-class drug targeting CD123 approved for treatment of blastic...” PMID 38052038 ↗ Feb 202413“single-agent tagraxofusp-erzs (tagraxofusp).” NCT05032183 ↗ |
| Known as | SL-401 | “Patients received tagraxofusp-erzs (SL-401) by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in both stages.” NCT02270463 ↗ |
| Known as | TAG | “Tagraxofusp Patients will receive 12 micrograms/kg of Tagraxofusp (TAG) by IV infusion once daily for 3 consecutive days.” NCT06414681 ↗ |
| Known as | tagraxofusp-erzs | “Evaluate the safety and feasibility of tagraxofusp-erzs (tagraxofusp) with a fixed dose of azacitidine and determine the recommended phase 2 dose (RP2D)” NCT06498973 ↗8“SL-401 (tagraxofusp-erzs)” NCT02661022 ↗ |
| Action | Deplete | “delivers DT to kill them” NCT04216524 ↗ |
| Modality | Protein / enzyme biologic | “Tagraxofusp (SL-401) is a CD123-directed cytotoxin consisting of human interleukin-3 fused to truncated diphtheria toxin.” PMID 31018069 ↗ Apr 2019 |
| Route | Intravenous | “receive an intravenous infusion of tagraxofusp” PMID 31018069 ↗ Apr 2019 |