ELZONRIS (tagraxofusp-erzs)
ELZONRIS is indicated for the treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm.
How ELZONRIS Works
Tagraxofusp-erzs is a fusion protein composed of recombinant human interleukin-3 (IL-3) and a truncated diphtheria toxin. The IL-3 component of the drug specifically targets and binds to the CD123 receptor on the surface of cells. Once the drug is internalized, it inhibits protein synthesis, which leads to cell death in CD123-expressing cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-12-21
- Patent Cliff
- 2025
- Routes
- INJECTION
- Dosage Forms
- SOLUTION
ELZONRIS Approval History
What ELZONRIS Treats
1 indicationsELZONRIS is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Blastic Plasmacytoid Dendritic Cell Neoplasm
ELZONRIS Boxed Warning
CAPILLARY LEAK SYNDROME Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended [see Warnings and Precautions ( 5.1 )] . WARNING: CAPILLARY LEAK SYNDROME See full prescribing information for complete boxed warning. Capillary Leak Syndrome (CLS), which may be life-threatening or fatal if not properly managed, can occur in patients receiving ELZONRIS. ( 5.1 )...
WARNING: CAPILLARY LEAK SYNDROME Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended [see Warnings and Precautions ( 5.1 )] . WARNING: CAPILLARY LEAK SYNDROME See full prescribing information for complete boxed warning. Capillary Leak Syndrome (CLS), which may be life-threatening or fatal if not properly managed, can occur in patients receiving ELZONRIS. ( 5.1 )
What's emerging in ELZONRIS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ELZONRIS treats. First-in-class if their pivotal trials read out positive.
Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05038592 | 2020-0895 NCI-2021-04293, 2020-0895 | Ph 1, Ph 2 | active not recruiting | Phase I/II Study of Tagraxofusp in Combination With Decitabine for Patients With Myelomonocytic/Myeloproliferative Neoplasm and High Risk Myelodysplastic Syndromes |
| NCT06561152 | IRB-76512 NCI-2025-01963 | Ph 1, Ph 2 | recruiting | Tagraxofusp and Low-Intensity Chemotherapy for CD123-Positive Relapsed or Refractory AML |
| NCT04216524 | 2019-0587 NCI-2019-08358, 2019-0587 | Ph 2 | recruiting | Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm |
| NCT05442216 TAGALONG | HCRN AML20-472 | Ph 2 | recruiting | Tagraxofusp and Azacitidine With Venetoclax in Newly Diagnosed Secondary AML After Hypomethylating Agents |
| NCT06456463 TRILLIUM | STML-401-0423 U1111-1290-9087, 2024-514660-48 | Ph 2 | recruiting | A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy |
| NCT06498973 | 23400 NCI-2024-05359, 23400 | Ph 1 | recruiting | Tagraxofusp and Azacitidine for Maintenance Treatment in Patients With CD123 Positive AML and MDS Following Donor Hematopoietic Cell Transplant |
| NCT07148180 | 25-330 | Ph 1, Ph 2 | recruiting | A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: A Phase 1/2 Study of Tagraxofusp, Azacitidine, and Venetoclax |
| NCT07007052 TAGVEN | TAGVEN | Ph 2 | not yet recruiting | Phase II Study Evaluating the Efficacy and Safety of the Combination of Tagraxofusp and Venetoclax in Treatment-naive Blastic Plasmacytoid Dendritic Cell Neoplasm Patients |
| NCT05032183 results posted | 2021-0545 NCI-2021-08859, 2021-0545 | Ph 1, Ph 2 | terminated | Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma |
| NCT05233618 | HSR210434 | Ph 1 | recruiting | Study of Tagraxofusp for Post-Transplant Maintenance for Patients With CD 123+ AML, MDS, MF and CMML (HSCT 002) |
| NCT04342962 | AML2020 | Ph 2 | terminated | Tagraxofusp in Patients With CD123+ or With BPDCN-IPh-like Acute Myeloid Leukemia |
| NCT05476770 | T2020-006 | Ph 1 | recruiting | Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies |
| NCT02270463 results posted | STML-401-0214 | Ph 1, Ph 2 | terminated | SL-401 as Consolidation Therapy in Patients With Adverse Risk Acute Myeloid Leukemia in First Complete Remission |
| NCT02113982 results posted | STML-401-0114 | Ph 1, Ph 2 | completed | Tagraxofusp in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia |
| NCT04317781 results posted | 2018-0646 NCI-2019-03832, 2018-0646 | Ph 2 | terminated | Tagraxofusp in Treating Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm After Stem Cell Transplant |
| NCT05720988 | 21-001115 NCI-2021-12912 | Ph 1 | withdrawn | Tagraxofusp to Eradicate Measurable Residual Disease in Patients With Acute Myeloid Leukemia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ELZONRIS FDA Label Details
Indications & Usage
FDA Label (PDF)ELZONRIS is indicated for the treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm.
WARNING: CAPILLARY LEAK SYNDROME Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended [see Warnings and Precautions ( 5.1 )] . WARNING: CAPILLARY LEAK SYNDROME See full pr...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment