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ELZONRIS

(Tagraxofusp)

Phase 2Small molecule

SStemline Therapeutics, Inc.

ELZONRIS is one of 144 small molecule programs targeting Myelofibrosis. It is currently in Phase 2.

5

Indications

12

Total Trials

9

Active Trials

143

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

MyelofibrosisNot yet recruiting

Acute Myeloid LeukemiaRecruiting

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)Recruiting

Hematologic MalignanciesRecruiting

Relapsed or RefractoryRecruiting

MyelofibrosisPhase 1

Not yet recruiting

Acute Myeloid LeukemiaPhase 2

Recruiting

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)Phase 2

Recruiting

Hematologic MalignanciesPhase 1

Recruiting

Relapsed or RefractoryPhase 2

Recruiting

Competition

Competitive Landscape

255 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Idamycin

Novantrone

Xospata

Cerubidine

EEastern Cooperative Oncology Group

Mylotarg

WWyeth-Lederle Vaccines

Vepesid

Vanflyta

Neupogen

EEastern Cooperative Oncology Group

Cerubidine

HHikma Pharmaceuticals LLC

Nexavar

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Not yet recruiting

Myelofibrosis

NCT06414681

Phase 1Active, not recruiting

Myelofibrosis

NCT05233618

Q4 2027

Phase 1Recruiting

Hematologic Malignancies

NCT05476770

Q4 2028

Phase 1/2Recruiting

Relapsed or Refractory

NCT06561152

Q1 2030

Phase 2Active, not recruiting

Acute Myeloid Leukemia

NCT06456463

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia4 trials

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

Recruiting·JJacqueline Garcia, MD·Phase 1/2·NCT07148180·31 enrolled

Tagraxofusp in Patients With CD123+ or With BPDCN-IPh-like Acute Myeloid Leukemia

Terminated·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT04342962·25 enrolled

A Phase II Multicenter Open-label Trial of Tagraxofusp (Tag) in Combination With Venetoclax and Azacitidine (Ven/Aza) in Adults With Previously Untreated CD123+ Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy

Active, not recruiting·SStemline Therapeutics, Inc.·Phase 2·NCT06456463·85 enrolled

Show 1 more trial

Phase II Study of TAGraxofusp and Azacitidine With Venetoclax in Newly Diagnosed Secondary AML After Previous Exposure to HypOmethylatiNG Agents

Recruiting·JJoshua Zeidner·Phase 2·NCT05442216·53 enrolled

Myelofibrosis2 trials

Combination of Tagraxofusp with Pacritinib in Patients with Intermediate-1 or Higher Myelofibrosis, Who Have Had Prior Therapy with the Approved JAK Inhibitors or in Which Therapy with the Approved JAK Inhibitors is Not Appropriate, Contraindicated or Declined

Not yet recruiting·UUniversity of Kansas Medical Center·Phase 1·NCT06414681·20 enrolled

Phase I Study of Tagraxofusp for Post-Transplant Maintenance for Patients With CD 123+ Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myelofibrosis and Chronic Myelomonocytic Leukemia

Active, not recruiting·KKaren Ballen, MD·Phase 1·NCT05233618·44 enrolled

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)2 trials

Post-Authorisation Registry of ELZONRIS (Tagraxofusp) in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Recruiting·SStemline Therapeutics, Inc.··NCT07785154·80 enrolled

Open Label Phase II Study Evaluating the Efficacy and Safety of the Combination of Tagraxofusp and Venetoclax in Treatment-naive Blastic Plasmacytoid Dendritic Cell Neoplasm Patients

Recruiting·FFrench Innovative Leukemia Organisation·Phase 2·NCT07007052·33 enrolled

Blastic Plasmacytoid Dendritic Cell Neoplasm1 trial

Tagraxofusp in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia

Completed·SStemline Therapeutics, Inc.·Phase 1/2·NCT02113982·138 enrolled

Relapsed or Refractory1 trial

Tagraxofusp and Low-Intensity Chemotherapy for CD123-Positive Relapsed or Refractory AML

Recruiting·SStanford University·Phase 1/2·NCT06561152·20 enrolled

2 more indications

Hematologic Malignancies1 trial

Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies

Recruiting·TTherapeutic Advances in Childhood Leukemia Consortium·Phase 1·NCT05476770·54 enrolled

Chronic Myelomonocytic Leukemia1 trial

Tagraxofusp (SL-401) in Participants With Chronic Myelomonocytic Leukemia (CMML) and Myelofibrosis (MF)

Completed·SStemline Therapeutics, Inc.·Phase 1/2·NCT02268253·82 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 21, 2018

ELZONRIS

BLA BLA761116

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for Tagraxofusp. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tagraxofusp compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tagraxofusp. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761116). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Stemline Therapeutics, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: SStemline Therapeutics, Inc.

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