Tagraxofusp

Summary

Tagraxofusp (CHEMBL4297573) is an approved protein (ATC L01XX67); indicated across 7 conditions including acute myeloid leukemia and neoplasm.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Protein
• ATC class: L01XX67
• Indications: 7 conditions
• Clinical trials: 21

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4297573
Name	Tagraxofusp
Type	Protein
Max phase	4
ATC	L01XX67

Also known as: DT-3881L3, DT388IL3, Elzonris, MOLECULE-129, Molecule 129, Sl-401, SL-401, Tagraxofusp, Tagraxofusp erzs, Tagraxofusp-erzs, TAGRAXOFUSP

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

7 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
acute myeloid leukemia	4	MONDO:0018874	EFO:0000222
neoplasm	4	MONDO:0005070	EFO:0000616
lymphoma	4	MONDO:0005062	EFO:0000574
CD4+/CD56+ hematodermic neoplasm	2	MONDO:0019467	EFO:0010580
myelodysplastic syndrome	1	MONDO:0018881	EFO:0000198
chronic myelomonocytic leukemia	1	MONDO:0020311	EFO:1001779
primary myelofibrosis	0	MONDO:0009692	MONDO:0044903

Clinical trials

Total trials: 21.

Phase distribution

Phase	Trials
PHASE1/PHASE2	9
PHASE2	6
PHASE1	5
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT04216524	PHASE2	RECRUITING	Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm
NCT05038592	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	Phase I/II Study of Tagraxofusp in Combination With Decitabine for Patients With Myelomonocytic/Myeloproliferative Neoplasm and High Risk Myelodysplastic Syndromes
NCT05442216	PHASE2	RECRUITING	Tagraxofusp and Azacitidine With Venetoclax in Newly Diagnosed Secondary AML After Hypomethylating Agents
NCT06456463	PHASE2	RECRUITING	A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
NCT06561152	PHASE1/PHASE2	RECRUITING	Tagraxofusp and Low-Intensity Chemotherapy for CD123-Positive Relapsed or Refractory AML
NCT07007052	PHASE2	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
NCT07148180	PHASE1/PHASE2	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
NCT00397579	PHASE1/PHASE2	COMPLETED	DT388IL3 Fusion Protein in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes
NCT02113982	PHASE1/PHASE2	COMPLETED	Tagraxofusp in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia
NCT02268253	PHASE1/PHASE2	COMPLETED	Tagraxofusp (SL-401) in Participants With Chronic Myelomonocytic Leukemia (CMML) and Myelofibrosis (MF)
NCT02270463	PHASE1/PHASE2	TERMINATED	SL-401 as Consolidation Therapy in Patients With Adverse Risk Acute Myeloid Leukemia in First Complete Remission
NCT02661022	PHASE1/PHASE2	TERMINATED	SL-401 in Combination With Pomalidomide and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma
NCT04317781	PHASE2	TERMINATED	Tagraxofusp in Treating Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm After Stem Cell Transplant
NCT04342962	PHASE2	TERMINATED	Tagraxofusp in Patients With CD123+ or With BPDCN-IPh-like Acute Myeloid Leukemia
NCT05032183	PHASE1/PHASE2	TERMINATED	Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
NCT03113643	PHASE1	RECRUITING	SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
NCT05233618	PHASE1	RECRUITING	Study of Tagraxofusp for Post-Transplant Maintenance for Patients With CD 123+ AML, MDS, MF and CMML (HSCT 002)
NCT05476770	PHASE1	RECRUITING	Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies
NCT06498973	PHASE1	RECRUITING	Tagraxofusp and Azacitidine for Maintenance Treatment in Patients With CD123 Positive AML and MDS Following Donor Hematopoietic Cell Transplant
NCT05720988	PHASE1	WITHDRAWN	Tagraxofusp to Eradicate Measurable Residual Disease in Patients With Acute Myeloid Leukemia
NCT06414681	EARLY_PHASE1	RECRUITING	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

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).