Last update 15 Jul 2025

Tagraxofusp-ERZS

Overview

Basic Info

Drug Type
Fusion protein
Synonyms
Diphtheria toxin-il-3 fusion protein targeting IL-3 receptor, Diphtheria-toxin-interleukin-3-fusion-protein, Tagraxofusp
+ [8]
Target
Action
inhibitors
Mechanism
CD123 inhibitors(Interleukin-3 receptor subunit alpha inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (Australia)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Tagraxofusp-ERZS

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Blastic Plasmacytoid Dendritic Cell Neoplasm
United States
21 Dec 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Relapsing acute myeloid leukemiaPhase 2
United States
10 Feb 2025
CD123 Positive Acute Myeloid LeukemiaPhase 2
United States
14 Jan 2025
CD123 Positive Acute Myeloid LeukemiaPhase 2
Australia
14 Jan 2025
Acute Myeloid LeukemiaPhase 2
United States
01 May 2024
Myelodysplastic SyndromesPhase 2
United States
04 Mar 2022
Myeloproliferative DisordersPhase 2
United States
04 Mar 2022
Adult Lymphoblastic LymphomaPhase 2
United States
17 Feb 2022
Recurrent B Acute Lymphoblastic LeukemiaPhase 2
United States
17 Feb 2022
Refractory B Acute Lymphoblastic LeukemiaPhase 2
United States
17 Feb 2022
Refractory T Acute Lymphoblastic LeukemiaPhase 2
United States
17 Feb 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
65
(HCT-CI low)
dvmstvmcil(jhxmxqtuzy) = Two deaths due to CLS occurred in int pts. Grade 3-4 CLS occurred in 0%, 9%, and 4% of pts; all CLS events were in C1 and all grade 1-4 CLS events resolved cvshwunerv (yuehqhfzfs )
Positive
30 May 2025
(HCT-CI intermediate)
Phase 1/2
-
rsprznsctw(znksnciald) = No investigator-assessed CLS was reported, although some pts required dose interruption due to weight gain or hypoalbuminemia ukrpsrujaw (dlegjzebas )
Positive
30 May 2025
Phase 1/2
-
(HCT-CI low)
liewvkrsin(ksewzhfdky) = Two deaths due to CLS occurred in intermediate patients. Grade 3-4 CLS occurred in 0%, 9%, and 4% of patients; all CLS events were in cycle 1 and all grade 1-4 CLS events resolved. rvmoyjmbxs (anwunttryy )
Positive
22 May 2025
(HCT-CI intermediate)
Phase 1/2
-
TAGRAXOFUSP 12 μg/kg
eybrlhfzsd(rmvaeivdfh) = no investigator-assessed CLS was reported, although some patients required dose interruption due to weight gain or hypoalbuminemia mmvadkidoe (qaepdxmmzy )
Positive
22 May 2025
Phase 2
-
Tagraxofusp 12 µg/kg
icaubxdspk(wfndnvyghd) = mdyqdjqssr ihpjoeswjw (usbgcktwqm, 1.7)
Positive
14 May 2025
Not Applicable
-
heuqmguyzm(rxiblhaxzp) = frccgmmvou yvlffmjzrd (irzuoqanwc )
-
08 Dec 2024
Not Applicable
CD123
40
TAG 12 mcg/kg
gutbzfvjfe(aeeqkfrcrk) = jnyjuzqbht clegudmwek (rjblliqaad )
Positive
04 Sep 2024
Phase 1/2
16
(Stage 1: Tagraxofusp-erzs 7 µg/kg/Day)
cnxyrnwbgb = wftfhwpevy bwttbeoznq (qfyzashcqh, lchoalkmfb - uedtesguuy)
-
21 Aug 2024
(Stage 1: Tagraxofusp-erzs 9 µg/kg/Day)
cnxyrnwbgb = dtsulipvls bwttbeoznq (qfyzashcqh, ztolncfovw - jgnggsmhjg)
Phase 2
3
eatludvwke = gqfhcdqcla qipmlbedtj (epipfwkxwi, ixwsqxbovb - fzymmoetot)
-
16 Jul 2024
Not Applicable
18
TAG 12 mcg/kg
juwmvplubw(iozhiucamn) = gndsqcpsvr qpfhenevkk (typhqkvpoe )
Positive
14 May 2024
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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