ASPARLAS

(Calaspargase Pegol)

Phase 3Protein / enzyme

ASPARLAS is one of 173 small molecule programs targeting T-cell acute lymphoblastic leukemia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

172

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

T-Cell Acute Lymphoblastic LeukemiaActive, not recruiting

Lymphoblastic LymphomaActive, not recruiting

LeukemiaActive, not recruiting

Acute Lymphoblastic LeukemiaActive, not recruiting

B Acute Lymphoblastic LeukemiaRecruiting

B-Cell Acute Lymphoblastic LeukemiaActive, not recruiting

Acute Leukemia of Ambiguous LineageRecruiting

Acute LeukemiaActive, not recruiting

T-Cell Acute Lymphoblastic LeukemiaPhase 2

Active, not recruiting

Lymphoblastic LymphomaPhase 2/Phase 3

Active, not recruiting

LeukemiaPhase 2

Active, not recruiting

Acute Lymphoblastic LeukemiaPhase 1/Phase 2

Active, not recruiting

B Acute Lymphoblastic LeukemiaPhase 3

Recruiting

B-Cell Acute Lymphoblastic LeukemiaPhase 3

Active, not recruiting

Acute Leukemia of Ambiguous LineagePhase 2

Recruiting

Acute LeukemiaPhase 3

Active, not recruiting

Competition

Competitive Landscape

508 competitors in Leukemia

#DrugCompanyPhaseTrials

Cytosar

Teva

Phase 3

51 2

Trexall

Alnylam Pharmaceuticals

Phase 3

31 3

Fludara

Sanofi

Phase 3

22 4

Cytoxan

BBaxter Healthcare Corporation

Phase 3

58 5

Rituxan

Roche

Phase 3

16 6

Vepesid

AAvyxa

Phase 3

25 7

Oncovin

Eli Lilly

Phase 3

9 8

Decadron

AAspen Global Incorporated

Phase 3

24 9

Leukine

Sanofi

Phase 3

7 10

Cellcept

Roche

Phase 3

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

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Acute Lymphoblastic Leukemia

NCT05581030

Phase 2Recruiting

Acute Lymphoblastic Leukemia

NCT02981628

Q1 2027

Phase 1/2Active, not recruiting

Acute Lymphoblastic Leukemia

NCT05192889

Q3 2027

Phase 3Active, not recruiting

Acute Lymphoblastic Leukemia

NCT03007147

Q4 2027

Phase 2Active, not recruiting

Leukemia

NCT05761171

Clinical

Trials by Indication[1]

Acute Lymphoblastic Leukemia5 trials

Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 1/2·NCT05192889·35 enrolled

Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Active, not recruiting·CChildren's Oncology Group·Phase 3·NCT03007147·475 enrolled

Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia

Recruiting·CChildren's Oncology Group·Phase 2·NCT02981628·80 enrolled

Show 2 more trials

CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT05581030·7 enrolled

Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 2/3·NCT03117751·790 enrolled

B Acute Lymphoblastic Leukemia3 trials

An International Phase 2 Study of Chemotherapy and Tyrosine Kinase Inhibitors With Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-Class Philadelphia Chromosome-Like B-Cell Acute Lymphoblastic Leukemia

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06124157·222 enrolled

A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy

Active, not recruiting·CChildren's Oncology Group·Phase 3·NCT05602194·440 enrolled

A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Recruiting·CChildren's Oncology Group·Phase 3·NCT03959085·5,951 enrolled

Leukemia2 trials

A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia

Active, not recruiting·CChildren's Oncology Group·Phase 2·NCT05761171·78 enrolled

Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma

Recruiting·NNew York Medical College·Phase 1·NCT03719105·40 enrolled

T-cell acute lymphoblastic leukemia2 trials

Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)

Recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT06390319·100 enrolled

Adding Targeted Drugs to Usual Chemotherapy for Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LBL)

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT06210750

Adult1 trial

SPARK-ALL: Calaspargase Pegol in Adults With ALL

Terminated· Institut de Recherches Internationales Servier logo

Institut de Recherches Internationales Servier·Phase 2/3·NCT04817761·42 enrolled

4 more indications

Lymphoblastic Lymphoma1 trial

Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL)

Not yet recruiting·CChildren's Oncology Group·Phase 2/3·NCT07072585·1,708 enrolled

B-cell acute lymphoblastic leukemia1 trial

A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04546399·461 enrolled

Hematologic Malignancies1 trial

Venetoclax Basket Trial for High Risk Hematologic Malignancies

Recruiting·—·Phase 1·NCT05292664·30 enrolled

Acute Leukemia of Ambiguous Lineage1 trial

A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06317662·153 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 20, 2018

ASPARLAS

BLA BLA761102

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Calaspargase Pegol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Calaspargase Pegol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Calaspargase Pegol. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761102). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Servier company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Protein / enzyme[2]
Highest Phase: Phase 3[1]
Company: SServier

ASPARLAS

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Acute Lymphoblastic Leukemia5 trials

B Acute Lymphoblastic Leukemia3 trials

Leukemia2 trials

T-cell acute lymphoblastic leukemia2 trials

Adult1 trial

Lymphoblastic Lymphoma1 trial

B-cell acute lymphoblastic leukemia1 trial

Hematologic Malignancies1 trial

Acute Leukemia of Ambiguous Lineage1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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