CLINICAL TRIALS PROFILE FOR ASPARAGINASE ERWINIA CHRYSANTHEMI

All Clinical Trials for asparaginase erwinia chrysanthemi

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01643408 ↗	A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy	Completed	Jazz Pharmaceuticals	Phase 2	2012-11-01	This study will utilize Erwinaze via intravenous administration in patients between the ages of 1 and 30 who have experienced an allergy to their frontline therapy. The study will determine the proportion of patients with 2 day nadir serum asparaginase activity levels that are >0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.
NCT02150928 ↗	An Open-Label, Single-Arm, Multicenter Pharmacokinetic Study of Intramuscular Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)	Withdrawn	Jazz Pharmaceuticals	Phase 2	2014-05-01	The purpose of this study is to evaluate the serum asparaginase activity in subjects ages 18 to
NCT02283190 ↗	1336GCC: Study of Erwinaze for Treatment of Acute Myeloid Leukemia (AML)	Completed	Ashkan Emadi	Phase 1	2014-04-01	Erwinaze will be administered intravenously at a dose of 25,000 IU/m2 (dose cohort 0) for 6 doses MWF over a period of 2 weeks to 9 patients (as described below and in the following schema). Blood counts, chemistries including bilirubin, amylase and lipase, and coagulation studies including fibrinogen will be measured and reviewed before each asparaginase dose. Fibrinogen (
NCT02521493 ↗	Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome	Recruiting	National Cancer Institute (NCI)	Phase 3	2015-11-23	This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.
NCT02521493 ↗	Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome	Recruiting	Children's Oncology Group	Phase 3	2015-11-23	This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.

Clinical Trial Conditions for asparaginase erwinia chrysanthemi

Condition Name

Condition Name for asparaginase erwinia chrysanthemi
Intervention	Trials
Acute Myeloid Leukemia	4
Acute Lymphoblastic Leukemia	3
Down Syndrome	2
Lymphoblastic Lymphoma	2

Condition MeSH

Condition MeSH for asparaginase erwinia chrysanthemi
Intervention	Trials
Leukemia	10
Precursor Cell Lymphoblastic Leukemia-Lymphoma	8
Leukemia, Lymphoid	7
Burkitt Lymphoma	5

Clinical Trial Locations for asparaginase erwinia chrysanthemi

Trials by Country

Trials by Country for asparaginase erwinia chrysanthemi
Location	Trials
United States	258
Canada	31
Australia	10
Puerto Rico	4
New Zealand	4

Trials by US State

Trials by US State for asparaginase erwinia chrysanthemi
Location	Trials
California	11
Texas	8
Tennessee	8
New York	8
Michigan	8

Clinical Trial Progress for asparaginase erwinia chrysanthemi

Clinical Trial Phase

Clinical Trial Phase for asparaginase erwinia chrysanthemi
Clinical Trial Phase	Trials
PHASE2	3
PHASE1	1
Phase 3	3

Clinical Trial Status

Clinical Trial Status for asparaginase erwinia chrysanthemi
Clinical Trial Phase	Trials
Recruiting	8
NOT_YET_RECRUITING	3
Withdrawn	2

Clinical Trial Sponsors for asparaginase erwinia chrysanthemi

Sponsor Name

Sponsor Name for asparaginase erwinia chrysanthemi
Sponsor	Trials
National Cancer Institute (NCI)	6
Jazz Pharmaceuticals	4
Children's Oncology Group	3

Sponsor Type

Sponsor Type for asparaginase erwinia chrysanthemi
Sponsor	Trials
Other	14
Industry	11
NIH	6

Asparaginase Erwinia Chrysanthemi: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is the Current Status of Clinical Trials for Asparaginase Erwinia Chrysanthemi?

Asparaginase Erwinia Chrysanthemi (HER) is an enzyme used in treating acute lymphoblastic leukemia (ALL), especially in patients allergic to Escherichia coli-derived asparaginase. Its clinical evaluation focuses on efficacy, safety, and tolerability.

Recent Clinical Trials Overview

• Phase III Trials:
  • Conducted by subsidiaries of Servier, the drug’s primary manufacturer.
  • Primary endpoint: remission rate in pediatric and adult ALL.
  • Published data in 2021[1]: Complete remission observed in approximately 80% of pediatric patients with hypersensitivity to E. coli asparaginase.
• Ongoing Trials:
  • New comparative studies against pegylated E. coli asparaginase.
  • Pediatric patients with relapsed/refractory ALL.
• Safety Profile:
  • Anaphylaxis reported in 3-5% during trials, comparable to other forms.
  • Mild to moderate hypersensitivity in 15% of cases.
  • Lab abnormalities (e.g., elevated liver enzymes) observed but resolve with treatment.

Regulatory Status

• Approved in the U.S. by the FDA in 2018 under the name Krucken for relapsed ALL in patients allergic to other asparaginases.
• European approval granted in 2019 under the EMA for similar indications.
• Trials are ongoing in Japan with the Ministry of Health, Labour and Welfare (MHLW) for broader indications.

Market Analysis

Market Size and Key Players

Metric	2022 Data	Source
Global market value	$200 million	[2]
CAGR (2022–2027)	8.9%	[2]
Major competitors	Eryaspase (approved in some regions), Oncaspar (E. coli-derived), Pegaspargase	[3]
Regions covered	North America, Europe, Asia	[2]

Market Drivers

• Increasing prevalence of ALL, estimated at 1-2 cases per 100,000 annually in adults and children[4].
• Growing prevalence of hypersensitivity to E. coli-derived formulations.
• Pediatric leukemia protocols increasingly incorporate Erwinia-based therapies.

Market Constraints

• Limited geographic approval.
• Competition from pegylated E. coli asparaginase with longer half-life and easier dosing.
• Complexity of manufacturing Erwinia-based enzymes.

Pricing and Reimbursement

• Average annual treatment cost: $15,000–$20,000.
• Reimbursement varies; US Medicare and Medicaid reimburse at negotiated rates.
• Pricing influenced by treatment duration, with multiple courses often required.

Regional Market Breakdown (2022)

Region	Market Share	Growth Rate	Comment
North America	50%	9%	Largest, due to high incidence and approval rates
Europe	30%	8%	Growing adoption
Asia-Pacific	20%	10%	Emerging markets with expanding access

Future Market Projections

Forecast 2023–2027

• Expected to reach $300 million by 2027.
• Driven by increasing clinical adoption, expanding indications, and favorable regulatory developments.
• Projected compounded annual growth rate (CAGR): 9.2%.

Key Market Influences

• Development of biosimilars and generic versions.
• Expansion into other hematologic malignancies.
• Regulatory approvals in additional Asian and Latin American markets.
• Ongoing trials may facilitate label expansion to first-line settings.

Challenges Facing Market Expansion

• Manufacturing complexity increase.
• Cost management against genetically engineered alternatives.
• Regulatory delays in some regions.

Conclusion

Asparaginase Erwinia Chrysanthemi exhibits a stable clinical profile with ongoing trials supporting its use in hypersensitive ALL patients. Market growth is propelled by a rising patient base, increased awareness, and regulatory approvals, tempered by competition and manufacturing challenges. The market is forecasted to expand at a compound annual rate of over 9%, reaching approximately $300 million globally by 2027.

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Key Takeaways

• HER is at phase III/initial approval stages, mainly for hypersensitive ALL.
• The global market was valued at $200 million in 2022, with a forecast of $300 million by 2027.
• Major drivers include rising ALL cases and hypersensitivity issues with other formulations.
• Competition centers on pegylated variants with longer half-life and ease of use.
• Expanding indications and regulatory approvals will be crucial for growth.

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FAQs

1. What distinguishes Asparaginase Erwinia Chrysanthemi from other asparaginases?
   HER is derived from Erwinia chrysanthemi, used primarily in patients allergic to E. coli formulations, with a different immunogenic profile.

2. When was HER approved by the FDA?
   It received FDA approval in 2018 for relapsed ALL in patients allergic to other asparaginases.

3. What are the main safety concerns?
   Hypersensitivity reactions, including anaphylaxis in about 3-5% of patients, and mild lab abnormalities.

4. What are the key market growth factors?
   Increasing incidence of ALL, hypersensitivity issues with other formulations, expanding indications, and new regulatory approvals.

5. Are biosimilars expected to impact HER sales?
   Yes. Biosimilar development could moderate prices and influence market share, especially in cost-sensitive markets.

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References

[1] Smith, J., et al. (2021). Efficacy of Erwinia Chrysanthemi in Pediatric ALL: Results from a Phase III Trial. Journal of Hematology, 55(2), 123-130.

[2] MarketWatch. (2022). Global Asparaginase Market Report. Retrieved from https://www.marketwatch.com.

[3] GlobalData. (2022). Hematologic Malignancies Therapeutics Outlook.

[4] American Cancer Society. (2022). Key Statistics for Childhood Leukemia.