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Pharmacokinetic Study of Intramuscular Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)	Withdrawn	Jazz Pharmaceuticals	Phase 2	2014-05-01	The purpose of this study is to evaluate the serum asparaginase activity in subjects ages 18 to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.
NCT02553460 ↗	Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I	Recruiting	Baylor College of Medicine	Phase 1/Phase 2	2016-01-29	The purpose of this study is to test the good and bad effects of the study drugs bortezomib and vorinostat when they are given in combination with chemotherapy commonly used to treat acute lymphoblastic leukemia (ALL) in infants. For example, adding these drugs could decrease the number of leukemia cells, but it could also cause additional side effects. Bortezomib and vorinostat have been approved by the US Food and Drug Administration (FDA) to treat other cancers in adults, but they have not been approved for treating children with leukemia. With this research, we plan to meet the following goals: PRIMARY OBJECTIVE: - Determine the tolerability of incorporating bortezomib and vorinostat into an ALL chemotherapy backbone for newly diagnosed infants with ALL. SECONDARY OBJECTIVES: - Estimate the event-free survival and overall survival of infants with ALL who are treated with bortezomib and vorinostat in combination with an ALL chemotherapy backbone. - Measure minimal residual disease (MRD) positivity using both flow cytometry and PCR. - Compare end of induction, end of consolidation, and end of reinduction MRD levels to Interfant99 (ClinicalTrials.gov registration ID number NCT00015873) participant outcomes.
NCT02553460 ↗	Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I	Recruiting	Gateway for Cancer Research	Phase 1/Phase 2	2016-01-29	The purpose of this study is to test the good and bad effects of the study drugs bortezomib and vorinostat when they are given in combination with chemotherapy commonly used to treat acute lymphoblastic leukemia (ALL) in infants. For example, adding these drugs could decrease the number of leukemia cells, but it could also cause additional side effects. Bortezomib and vorinostat have been approved by the US Food and Drug Administration (FDA) to treat other cancers in adults, but they have not been approved for treating children with leukemia. With this research, we plan to meet the following goals: PRIMARY OBJECTIVE: - Determine the tolerability of incorporating bortezomib and vorinostat into an ALL chemotherapy backbone for newly diagnosed infants with ALL. SECONDARY OBJECTIVES: - Estimate the event-free survival and overall survival of infants with ALL who are treated with bortezomib and vorinostat in combination with an ALL chemotherapy backbone. - Measure minimal residual disease (MRD) positivity using both flow cytometry and PCR. - Compare end of induction, end of consolidation, and end of reinduction MRD levels to Interfant99 (ClinicalTrials.gov registration ID number NCT00015873) participant outcomes.

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

Last updated: May 23, 2026

Asparaginase Erwinia Chrysanthemi Clinical Trials Update, Market Analysis, and Sales Projection

Asparaginase erwinia chrysanthemi (E. coli asparaginase alternative), a pegylated or non-pegylated bacterial asparaginase product used in acute lymphoblastic leukemia (ALL) regimens when hypersensitivity develops, has limited direct trial proliferation in recent years, with clinical activity concentrated in comparative PK, immunogenicity, and switching/continuation strategies within oncology combination protocols. Market growth is constrained by (1) reliance on treatment-line patterns where it is used after E. coli-derived asparaginase hypersensitivity, (2) payer and guideline variability across geographies, and (3) competition from other asparaginase formulations and alternative switching options.

Commercial takeaway: Near- to mid-term market outlook depends more on ALL treatment incidence, use of E. coli asparaginase upfront, and the rate of asparaginase substitution after hypersensitivity than on broad new indications. Sales projection is therefore scenario-driven around hypersensitivity prevalence, regimen adherence, and biosupply continuity.

---

What clinical trial updates exist for asparaginase erwinia chrysanthemi?

Answer: Recent “updates” in asparaginase erwinia chrysanthemi are mostly incremental and operational rather than regimen-defining: switching studies, tolerability/PK substudies, and continuation strategies in ALL where E. coli asparaginase is discontinued for hypersensitivity or silent inactivation.

Where are trials usually focused?

1. Switching after hypersensitivity
   • Study endpoints typically include ASNase activity, asparaginase half-life, anti-ASNase antibodies, and clinical safety in continuation of induction or consolidation.
2. Immunogenicity and PK comparability
   • Comparative assessments against prior asparaginase exposure (E. coli ASNase) to support protocol switching.
3. Dosing schedule optimization
   • Trials often evaluate whether alternative schedules maintain sufficient therapeutic asparagine depletion and manage toxicities.

What to look for in the trial pipeline (high-signal indicators)

• Enrollment in ongoing ALL phase 2/3 combination protocols rather than single-agent trials.
• Inclusion of PK endpoints tied to asparaginase activity thresholds, not only adverse events.
• Protocol-level acceptance of continuation using E. chrysanthemi after prior exposure.

---

Which patents protect asparaginase erwinia chrysanthemi and how do they expire?

Answer: The core product (often referenced under brand equivalents such as “Erwinase”) has largely aged out of primary composition and initial process protection in key jurisdictions; remaining enforceable rights, where they exist, tend to cluster around formulation-specific or manufacturing/process claims and sometimes use in specific regimen contexts.

Typical patent estate contours for older asparaginase products

• Composition of matter
  • Usually early-expiring.
• Manufacturing processes and purification
  • Process patents can extend the practical barrier if manufacturing steps are protected.
• Formulation and stability
  • Freeze-dried product specs, reconstitution behavior, and excipient systems can drive residual exclusivity.

How this affects clinical and commercial strategy

• Companies compete mainly through supply reliability, therapeutic equivalence, and immunogenicity outcomes rather than new clinical claims.
• Litigation and licensing are more likely around process equivalence and device-like manufacturing steps than around novel clinical indications.

---

What is the Orange Book status of asparaginase erwinia chrysanthemi and what generic entry risks exist?

Answer: Orange Book status for this class is typically mature, with multiple manufacturers or authorized generics present historically depending on approval type and product availability. Generic entry risk is driven by FDA-listed patents at submission and the availability of current-use product supply.

Paragraph IV risk drivers

• Remaining FDA-listed patents (if any) that still cover manufacturing or formulation.
• Approval timing relative to patent expiration and any pediatric exclusivity or patent term adjustments (where applicable).

Practical generic entry constraints

• Cold chain and lyophilized product handling requirements.
• Batch-to-batch consistency of enzyme activity and potency.
• Analytical control of immunogenicity risk via consistent enzyme preparation.

---

How does asparaginase erwinia chrysanthemi compare with pegylated asparaginase or other asparaginase options?

Answer: E. chrysanthemi is used as a switch when patients develop hypersensitivity to E. coli-derived asparaginase. Compared with pegylated asparaginase, it is generally positioned around replacement after intolerance rather than first-line convenience, with regimen-level dosing differences and toxicity profiles that clinicians manage through monitoring.

Key differentiators clinicians and payers use

• Indication placement: hypersensitivity substitution in ALL protocols.
• PK/PD management: maintenance of asparagine depletion with dosing frequency and measured enzyme activity.
• Tolerability profile: hypersensitivity and immunogenicity management.

---

When does asparaginase erwinia chrysanthemi lose exclusivity in major markets?

Answer: For older asparaginase erwinia chrysanthemi products, exclusivity is generally tied to late-expiring process/formulation IP and any regulatory exclusivities. In most cases, the commercial market has already transitioned to multi-source supply, with residual barriers affecting only specific product/route/format.

What “loss of exclusivity” means operationally

• Regulatory exclusivity may end on a calendar basis, but practical exclusivity persists if manufacturers do not supply consistently due to:
  • enzyme production capacity,
  • lyophilization scale constraints,
  • stability and potency validation demands.

---

What formulation and manufacturing methods are protected for asparaginase erwinia chrysanthemi?

Answer: Remaining patent protection, where enforceable, typically covers:

• lyophilized composition specifications (protein stability, reconstitution),
• manufacturing steps for consistent enzyme activity (upstream fermentation, purification, filtration),
• quality control methods tied to potency and impurity profile.

Why formulation patents matter for market access

• Generic substitution can be delayed by the need to demonstrate comparability in potency, stability, and process impurities.
• If process claims exist, licensing can be required for certain manufacturing workflows.

---

What FDA regulatory status applies to asparaginase erwinia chrysanthemi?

Answer: The product is used in oncology under established labeling for asparaginase replacement/switching in ALL contexts, and FDA-related competitive pathways are typically generics/authorized generics or 505(b)(2)-type applications when reformulation or manufacturing changes are made.

Regulatory constraints that affect launch timing

• Potency assays, stability bridging data, and packaging/handling demonstration for lyophilized enzymes.
• Consistent enzyme activity and impurity profiles across manufacturing sites.

---

What market size, competitive landscape, and payer dynamics apply to asparaginase erwinia chrysanthemi?

Answer: Demand is primarily driven by:

• the number of ALL patients receiving asparaginase-containing regimens,
• the proportion who develop hypersensitivity (or silent inactivation) requiring substitution,
• protocol-specific acceptance of substitution schedules and product availability,
• drug pricing and reimbursement mechanisms for oncology infusion therapies.

Competitive set

• Other asparaginase preparations used for hypersensitivity management (pegylated asparaginase and other alternatives depending on protocol and toxicity).
• Multi-source supply where generics/authorized suppliers exist.

Pricing and reimbursement

• Pricing is influenced by oncology drug reimbursement practices and tender or formulary contracting in major hospital systems.
• Short supply events can increase realized pricing power temporarily, but they also create replacement switching behavior.

---

How big is the commercial opportunity and how should sales be projected?

Answer: The market is structurally “end-use constrained” and does not behave like a broad chronic market. A practical projection method is to model:

1. ALL incidence and treatment coverage (diagnosed and treated),
2. asparaginase regimen uptake,
3. rate of hypersensitivity/silent inactivation leading to substitution,
4. number of doses per patient in the regimen and proportion of dosing cycles captured by E. chrysanthemi,
5. market share versus other asparaginase alternatives and multi-source competition,
6. pricing assumptions net of discounts and contracting.

Scenario model template (used by analysts for oncology substitution products)

Driver	Base case	Downside	Upside
Substitution rate after E. coli asparaginase hypersensitivity	Medium	Lower	Higher
Protocol share using E. chrysanthemi after switch	Stable	Reduced	Increased
Net price (annual average)	Flat	Down on competition	Up on supply tightness
Supply reliability	Normal	Disruptions reduce realized doses	Capacity expansions improve fill

Revenue formula

Annual revenue ≈ (ALL patients treated) × (ASNase substitution rate) × (E. chrysanthemi patient share post-switch) × (doses per patient) × (net price per dose)

What changes the forecast most

• Shifts in induction/consolidation protocol design that change how often patients are switched.
• Improvements in management of hypersensitivity that allow more patients to stay on original E. coli asparaginase (reducing substitution volume).
• Competitive supply constraints and manufacturing outages.

---

What patent litigation or settlements affect market availability?

Answer: In older asparaginase products, the most commercially meaningful litigation typically involves:

• disputes over process equivalence and patent infringement of manufacturing/formulation claims,
• settlement agreements that govern launch timing of competing products.

Where settlements matter

• They can delay first commercial sale, limit distributor ramp-up, or create “design-around” manufacturing pathways.

---

What generic entry risks exist for asparaginase erwinia chrysanthemi?

Answer: Risks center on:

• whether remaining FDA-listed patents exist for the specific dosage form and manufacturing approach,
• whether challengers can navigate process/formulation comparability requirements fast enough to meet supply and potency targets,
• whether exclusivity or settlement stay provisions prevent launch.

Launch-limiting factors

• Analytical comparability (potency/activity, impurity, stability).
• Lyophilized handling validation and packaging.
• Regulatory review timelines for biosimilarity-like comparability standards, even where not a biologic follow-on framework.

---

How does asparaginase erwinia chrysanthemi compare on immunogenicity and safety in real-world substitution?

Answer: Clinical and post-marketing practice focuses on immunogenicity monitoring and management of hypersensitivity. Switching outcomes are judged by recurrence of hypersensitivity, tolerability during induction/consolidation, and whether asparaginase activity remains within therapeutic windows.

Operational monitoring that supports dosing

• Enzyme activity monitoring and antibody testing where protocols require.
• Dose schedule adjustments based on activity and adverse events.

---

Key Takeaways

• Clinical updates are mainly protocol-level switching and operational PK/immunogenicity studies rather than new broad indications.
• The market is substitution-driven: growth hinges on ALL regimen patterns, hypersensitivity incidence, and the share of patients switched to E. chrysanthemi.
• Exclusivity is largely mature; any remaining enforceable rights typically cluster around manufacturing/formulation and can still shape launch schedules and supply competition.
• Sales projections should be modeled on patient-to-dose conversion using substitution rates, regimen dose counts, and net price after contracting.

---

FAQs

1. Do clinicians use asparaginase erwinia chrysanthemi for silent inactivation, not just hypersensitivity?
2. What PK or asparaginase activity thresholds are typically targeted when switching to E. chrysanthemi in ALL protocols?
3. How do supply disruptions of lyophilized asparaginase products affect dosing continuity and substitution decisions?
4. What factors most influence net pricing for asparaginase erwinia chrysanthemi in US hospital contracting?
5. Are formulation or manufacturing comparability data usually the main bottlenecks for generic entry of asparaginase erwinia chrysanthemi?

---

References (APA)

1. FDA. (n.d.). Drug approvals and related information for asparaginase-containing oncology products. U.S. Food and Drug Administration.
2. FDA. (n.d.). Drugs@FDA database. U.S. Food and Drug Administration.
3. U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov. ClinicalTrials.gov.
4. EMA. (n.d.). EPAR and product information for asparaginase-containing therapies. European Medicines Agency.