ASPARLAS (calaspargase pegol-mknl)
ASPARLAS is indicated for the treatment of Acute Lymphoblastic Leukemia.
How ASPARLAS Works
This drug is an L-asparaginase enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. Its therapeutic effect is derived from the depletion of plasma asparagine, which leukemic cells require for survival. Because these malignant cells have low expression of asparagine synthetase, they lack the ability to synthesize the amino acid internally. Depleting the exogenous source of asparagine leads to the death of the leukemic cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-12-20
- Patent Cliff
- 2001
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
ASPARLAS Approval History
What ASPARLAS Treats
1 indicationsASPARLAS is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Lymphoblastic Leukemia
ASPARLAS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ASPARLAS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ASPARLAS treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ASPARLAS
3 of 19FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06561074 | 2022-0416 NCI-2024-06907 | Ph 2 | recruiting | A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy) |
| NCT05034627 | STUDY00022141 NCI-2021-09061, STUDY00022141 | Ph 1 | active not recruiting | Calaspargase Pegol-Mnkl and Cobimetinib for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer |
| NCT04953780 | 2502110131 | Ph 1 | active not recruiting | 2157GCCC:Phase 1 of Calaspargase Pegol-mknl W/ Cytarabine and Idarubicin in Newly Dx AML |
| NCT00671034 results posted | AALL07P4 NCI-2009-00317, CDR0000594340 | Ph 3 | completed | Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ASPARLAS FDA Label Details
Indications & Usage
FDA Label (PDF)ASPARLAS is indicated for the treatment of Acute Lymphoblastic Leukemia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment