ASPARLAS

(Calaspargase Pegol)

Phase 3Protein / enzyme

SServier

ASPARLAS is one of 116 small molecule programs targeting B Acute Lymphoblastic Leukemia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

115

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

B Acute Lymphoblastic LeukemiaRecruiting

Hematologic MalignanciesRecruiting

Acute Lymphoblastic LeukemiaActive, not recruiting

Recurrent B Acute Lymphoblastic LeukemiaActive, not recruiting

T Lymphoblastic Leukemia/lymphomaNot yet recruiting

NK-Cell LymphomaRecruiting

Down SyndromeRecruiting

T-Cell Acute Lymphoblastic LeukemiaWithdrawn

Acute Leukemia of Ambiguous LineageActive, not recruiting

B Acute Lymphoblastic LeukemiaPhase 3

Recruiting

Hematologic MalignanciesPhase 1

Recruiting

Acute Lymphoblastic LeukemiaPhase 3

Active, not recruiting

Recurrent B Acute Lymphoblastic LeukemiaPhase 2

Active, not recruiting

T Lymphoblastic Leukemia/lymphomaPreclinical

Not yet recruiting

NK-Cell LymphomaPhase 1

Recruiting

Down SyndromePhase 2

Recruiting

T-Cell Acute Lymphoblastic LeukemiaPhase 2

Withdrawn

Acute Leukemia of Ambiguous LineagePhase 2

Active, not recruiting

Competition

Competitive Landscape

163 competitors in Acute Lymphoblastic Leukemia

#DrugCompanyPhaseTrials

Wellcovorin

EEastern Cooperative Oncology Group

Phase 3

40 2

Cerubidine

EEastern Cooperative Oncology Group

Phase 3

43 3

Fludara

Sanofi

Phase 3

15 4

Iclusig

Takeda

Phase 3

12 5

Medrol

Pfizer

Phase 3

12 6

Cellcept

Roche

Phase 3

11 7

Neoral

Novartis

Phase 3

10 8

Neupogen

EEastern Cooperative Oncology Group

Phase 3

25 9

Arranon

Novartis

Phase 3

7 10

Jakafi

Incyte

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 2Active, not recruiting

Recurrent B 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

Acute Leukemia of Ambiguous Lineage

NCT05761171

Clinical

Trials by Indication[1]

Acute Lymphoblastic Leukemia4 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

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

Show 1 more trial

International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones

Active, not recruiting·CChildren's Oncology Group·Phase 3·NCT03007147·352 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 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

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

T-cell acute lymphoblastic leukemia2 trials

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

SJALL23T: 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

Acute Leukemia of Ambiguous Lineage2 trials

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

A Phase 2 Study of SNDX-5613 in Combination With Chemotherapy for Patients With Relapsed or Refractory KMT2A-Rearranged Infant Leukemia

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

Hematologic Malignancies1 trial

Venetoclax Basket Trial for High Risk Hematologic Malignancies

Recruiting·—·Phase 1·NCT05292664·30 enrolled

5 more indications

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

Down syndrome1 trial

A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination With Nivolumab (NSC# 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/= 1 to < 31 Years Old With First Relapse

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

NK-Cell Lymphoma1 trial

Pilot Study Using Induction Chemo-immunotherapy Followed by Consolidation With Reduced Toxicity Conditioning and Allogenic Stem Cell Transplant in Advanced Stage Mature Non-anaplastic T-Cell or NK Lymphoma/Leukemia in Children, Adolescents and Young Adults; A NK/T-Cell Lymphoma/Leukemia Consortium Study

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

T lymphoblastic leukemia/lymphoma1 trial

A Phase 2/3 Randomized Trial Investigating Daratumumab on a Modified Augmented BFM (aBFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LL)

Not yet recruiting·CChildren's Oncology Group·Preclinical·NCT07072585·1,708 enrolled

Recurrent B Acute Lymphoblastic Leukemia1 trial

A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518) in Children and Young Adults With Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)

Active, not recruiting·CChildren's Oncology Group·Phase 2·NCT02981628·80 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 Leukemia4 trials

B Acute Lymphoblastic Leukemia3 trials

T-cell acute lymphoblastic leukemia2 trials

Acute Leukemia of Ambiguous Lineage2 trials

Hematologic Malignancies1 trial

Adult1 trial

Down syndrome1 trial

NK-Cell Lymphoma1 trial

T lymphoblastic leukemia/lymphoma1 trial

Recurrent B Acute Lymphoblastic Leukemia1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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