Tagraxofusp-Erzs

Treats blastic plasmacytoid dendritic cell neoplasm (BPDCN). Sold as Elzonris. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Tagraxofusp-Erzs (sold as Elzonris), first approved Dec 21, 2018, with 1 new use approved and 0 published complete response letters.

First approved: Dec 21, 2018
Applications: 1
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $6.8M
First approved in the EU: Jan 7, 2021
First approved in Japan: Dec 22, 2025

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Elzonris	Part B	$6.8M	-55%	13

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of blastic plasmacytoid dendritic cell neoplasmStemline Therapeutics, Inc. · designated Jun 6, 2013 · approved Dec 21, 2018

Approvals in the EU (EMA)

First approved in the EU 25 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Elzonris, new substanceStemline Therapeutics B.V. · Jan 7, 2021

Approvals in Japan (PMDA)

First approved in Japan 84 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Elzonris, new ingredientA drug with a new active ingredient indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm. · Nippon Shinyaku Co., Ltd. · Dec 22, 2025

Clinical Trials

4 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Tagraxofusp and Azacitidine for Maintenance Treatment in Patients With CD123 Positive AML and MDS Following Donor Hematopoietic Cell TransplantAcute Myeloid Leukemia, Myelodysplastic Syndrome · City of Hope Medical Center	Phase 1	Recruiting	Jul 12, 2024
Phase I/II Study of Tagraxofusp in Combination With Decitabine for Patients With Myelomonocytic/Myeloproliferative Neoplasm and High Risk Myelodysplastic SyndromesChronic Myelomonocytic Leukemia, Chronic Myelomonocytic Leukemia-1 · M.D. Anderson Cancer Center	Phase 1 / Phase 2	Active, not recruiting	Sep 9, 2021
Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell NeoplasmBlastic Plasmacytoid Dendritic Cell Neoplasm · M.D. Anderson Cancer Center	Phase 2	Recruiting	Jan 2, 2020
Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCNBlastic Plasmacytoid Dendritic Cell Neoplasm, Myeloproliferative Neoplasm · AbbVie	Phase 1 / Phase 2	Active, not recruiting	Dec 29, 2017

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Dec 21, 2018	ElzonrisBLA 761116 · New molecular entity	Stemline Therapeutics Inc	3	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA