ELSPAR (asparaginase)
Rylaze is an asparagine-specific enzyme indicated for use as a component of a multi-agent chemotherapeutic regimen. It is approved for the treatment of adult and pediatric patients, aged one month and older, with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL). This medication serves as a therapeutic option for patients who have developed hypersensitivity to E. coli-derived asparaginase.
How ELSPAR Works
This drug is a recombinant enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. This action results in 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 their own asparagine and die when the exogenous supply is removed.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1978-01-10
- Routes
- N/A
- Dosage Forms
- VIAL
ELSPAR Approval History
What ELSPAR Treats
3 indicationsELSPAR is approved for 3 conditions since its original approval in 1978. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Lymphoblastic Leukemia
- Lymphoblastic Lymphoma
- Hypersensitivity
ELSPAR 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 ELSPAR's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ELSPAR treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ELSPAR
3 of 19FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02101853 results posted | NCI-2014-00631 NCI-2014-00631, s15-00970 | Ph 3 | active not recruiting | Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia |
| NCT01371981 results posted | NCI-2011-02670 NCI-2011-02670, CDR0000701850 | Ph 3 | active not recruiting | Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia |
| NCT02521493 results posted | AAML1531 NCI-2015-00324, AAML1531 | Ph 3 | active not recruiting | Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome |
| NCT03817320 results posted | T2017-002 | Ph 1, Ph 2 | active not recruiting | PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma |
| NCT00557193 results posted | AALL0631 NCI-2009-00313, CDR0000573996 | Ph 3 | completed | Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia |
| NCT03668392 ALL2518 | ALL2518 2018-003517-17 | Ph 2 | terminated | Asparaginase Activity Monitoring (AAM) in Adult Patients With Acute Lymphoblastic Leukemia (ALL) |
| NCT00720109 results posted | NCI-2009-00312 NCI-2009-00312, AALL0622 | Ph 2, Ph 3 | completed | Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia |
| NCT02538926 | 9459 NCI-2015-01402, CC9459 | Ph 2 | withdrawn | Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride With Asparaginase in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma |
| NCT00784017 | MC-ASP.5/ALL EudraCT number 2006-003180-31 | Ph 3 | completed | Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia |
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.
ELSPAR FDA Label Details
Indications & Usage
FDA Label (PDF)ELSPAR is indicated for the treatment of Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma; Hypersensitivity.
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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