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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06414681 | Aug 2025 → Dec 2026 expected | myelofibrosis | University of Kansas Medical Center | Recruiting | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT06498973 | Jan 2025 → Apr 2027 expected | acute myeloid leukemia, myelodysplastic syndrome | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05720988 | Aug 2024 → Aug 2025 | acute myeloid leukemia | Jonsson Comprehensive Cancer Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT05716009 | Nov 2023 → May 2025 | acute myeloid leukemia | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT05476770 | Nov 2022 → Nov 2025 overdue | B-cell non-Hodgkin lymphoma, CD4+/CD56+ hematodermic neoplasm, Hodgkins lymphoma, acute undifferentiated leukemia +3 | Therapeutic Advances in Childhood Leukemia Consortium | Recruiting | No outcome recorded |
| Phase 1 | NCT05233618 | Jul 2022 → Oct 2026 expected | acute myeloid leukemia, chronic myelomonocytic leukemia, myelofibrosis | Karen Ballen, MD | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03113643 | Jun 2017 → Sep 2021 overdue | CD4+/CD56+ hematodermic neoplasm, acute myeloid leukemia, myelodysplastic syndrome | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 1/28 trials | ||||||
| Phase 1/2 | NCT07148180 | Feb 2026 → Dec 2028 expected | acute myeloid leukemia | Jacqueline Garcia, MD | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06561152 | Feb 2025 → Oct 2027 expected | acute myeloid leukemia | Stanford University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05038592 | Mar 2022 → Jan 2027 expected | chronic myelomonocytic leukemia | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05032183 | Feb 2022 → Jul 2024 | B-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic leukemia | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT02268253 | Feb 2016 → Mar 2023 | chronic myelomonocytic leukemia, myelofibrosis | Stemline Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT02661022 | Jan 2016 → Dec 2019 | plasma cell myeloma | Stemline Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT02270463 | Feb 2015 → Dec 2019 | acute myeloid leukemia | Stemline Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT02113982 | Sep 2014 → Feb 2020 | CD4+/CD56+ hematodermic neoplasm, acute myeloid leukemia | Stemline Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07007052 | Dec 2025 → Dec 2028 expected | CD4+/CD56+ hematodermic neoplasm | French Innovative Leukemia Organisation | Recruiting | No outcome recorded |
| Phase 2 | NCT06456463 | Jan 2025 → Feb 2028 expected | acute myeloid leukemia | Stemline Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT05442216 | May 2024 → Jul 2030 expected | acute myeloid leukemia | Joshua Zeidner | Recruiting | No outcome recorded |
| Phase 2 | NCT04342962 | Feb 2021 → Jan 2024 | acute myeloid leukemia | GIMEMA Foundation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04216524 | May 2020 → Dec 2026 expected | CD4+/CD56+ hematodermic neoplasm | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04317781 | Mar 2020 → Jul 2023 | CD4+/CD56+ hematodermic neoplasm | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
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 |