ELZONRIS

(Tagraxofusp)

Phase 2Small molecule

SStemline Therapeutics, Inc.

ELZONRIS is one of 131 small molecule programs targeting Myelofibrosis. It is currently in Phase 2.

Indications

Total Trials

Active Trials

130

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

MyelofibrosisActive, not recruiting

Blastic Plasmacytoid Dendritic Cell NeoplasmActive, not recruiting

Chronic Myelomonocytic LeukemiaActive, not recruiting

Acute Myeloid LeukemiaRecruiting

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)Recruiting

MyelofibrosisPhase 1

Active, not recruiting

Blastic Plasmacytoid Dendritic Cell NeoplasmPhase 1/Phase 2

Active, not recruiting

Chronic Myelomonocytic LeukemiaPhase 1/Phase 2

Active, not recruiting

Acute Myeloid LeukemiaPhase 2

Recruiting

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)Phase 2

Recruiting

Competition

Competitive Landscape

804 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Zarnestra

KKura Oncology, Inc.

Phase 3

9 2

Alkeran

AApotex Inc.

Phase 3

7 3

Decadron

AAspen Global Incorporated

Phase 3

5 4

Bicnu

MMelissa K Accordino

Phase 3

1 5

Experimental

Biogen

Phase 3

1 6

Valspodar

EEastern Cooperative Oncology Group

Phase 3

3 7

ELZONRIS

SStemline Therapeutics, Inc.

Phase 2

4 8

Grafalon

FFundación Canaria de Investigación Sanitaria

Phase 3

1 9

Iomab-B

AActinium Pharmaceuticals

Phase 3

1 10

Leukine

Sanofi

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

CMML

NCT05233618

Phase 1Not yet recruiting

Myelofibrosis

NCT06414681

Q4 2027

Phase 1Recruiting

Hematologic Malignancies

NCT05476770

Q4 2028

Phase 1/2Recruiting

Relapsed or Refractory

NCT06561152

Q1 2030

Phase 2Recruiting

Acute Myeloid Leukemia

NCT06456463

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia4 trials

A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy

Recruiting·SStemline Therapeutics, Inc.·Phase 2·NCT06456463·83 enrolled

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

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

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

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

Myelofibrosis1 trial

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

CMML1 trial

Study of Tagraxofusp for Post-Transplant Maintenance for Patients With CD 123+ AML, MDS, MF and CMML (HSCT 002)

Recruiting·—·Phase 1·NCT05233618·44 enrolled

3 more indications

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

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

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)1 trial

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

Regulatory

FDA Approval Timeline[4]

Dec 21, 2018

ELZONRIS

BLA BLA761116

Sources

References

[1]
ClinicalTrials.gov — 11 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.

ELZONRIS

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q4 2028

Q1 2030

Trials by Indication[1]

Acute Myeloid Leukemia4 trials

Blastic Plasmacytoid Dendritic Cell Neoplasm1 trial

Hematologic Malignancies1 trial

Myelofibrosis1 trial

CMML1 trial

Relapsed or Refractory1 trial

Chronic Myelomonocytic Leukemia1 trial

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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