Investigational Drug Information for tozuleristide

What is the development status for investigational drug tozuleristide?

tozuleristide is an investigational drug.

There have been 4 clinical trials for tozuleristide. The most recent clinical trial was a Phase 1 trial, which was initiated on November 26^th 2018.

The most common disease conditions in clinical trials are Nervous System Neoplasms, Central Nervous System Neoplasms, and Squamous Cell Carcinoma of Head and Neck. The leading clinical trial sponsors are Blaze Bioscience Inc., Pacific Pediatric Neuro-Oncology Consortium, and John Yu.

There are seven US patents protecting this investigational drug.

Summary for tozuleristide

US Patents	7
International Patents	0
US Patent Applications	25
WIPO Patent Applications	8
Japanese Patent Applications	1
Clinical Trial Progress	Phase 1 (2018-11-26)
Vendors	1

Recent Clinical Trials for tozuleristide

Title	Sponsor	Phase
A Fluorescent Tumor Marking Agent, Tozuleristide, for Imaging Oral Cavity Squamous Cell Cancer and High-Grade Oral Cavity Dysplasia During Surgery	Blaze Bioscience Inc.	Phase 1/Phase 2
A Fluorescent Tumor Marking Agent, Tozuleristide, for Imaging Oral Cavity Squamous Cell Cancer and High-Grade Oral Cavity Dysplasia During Surgery	University of Washington	Phase 1/Phase 2
Fluorescence Detection of Adult Primary Central Nervous System Tumors With Tozuleristide and the Canvas System	Blaze Bioscience Inc.	Phase 2

See all tozuleristide clinical trials

Clinical Trial Summary for tozuleristide

Top disease conditions for tozuleristide

Top clinical trial sponsors for tozuleristide

See all tozuleristide clinical trials

US Patents for tozuleristide

Drugname	Patent Number	Patent Title	Patent Assignee	Estimated Expiration
tozuleristide		Process for the preparation of double crosslinked core-shell polymeric nanoparticles for multimodal imaging and theranostic applications	Fondazione Istituto Italiano di Tecnologia
tozuleristide		Peptide compositions and methods of use thereof for disrupting TEAD interactions	Fred Hutchinson Cancer Center
tozuleristide		Tissue-homing peptide conjugates and methods of use thereof	Blaze Bioscience Inc
tozuleristide		Tumor homing and cell penetrating peptide-immuno-oncology agent complexes and methods of use thereof	Blaze Bioscience Inc

Last updated: April 28, 2026

Tozuleristide Development Update and Market Projection

What is tozuleristide and what stage is it in?

No development and regulatory status data for tozuleristide was provided in the input, and no reliable, citable source is available in the provided context to determine:

• current clinical phase (e.g., Phase 1/2/3),
• trial identifiers,
• enrollment status or readouts,
• labeling, approval pathway, or regulatory milestones,
• the reference indication(s),
• sponsor and geography-specific status.

Because a complete, accurate response requires verifiable inputs for development stage and timeline, a market projection cannot be made without confirmed indication, trial phase, and probability of technical/regulatory success.

What indication, route, and differentiation define the addressable market?

A credible market projection depends on the commercial “anchor” facts:

• target indication and line of therapy,
• mechanism of action and target patient population,
• administration route and dosing frequency,
• comparator set (standard of care and branded landscape),
• reimbursement and access constraints,
• expected time-to-peak sales and adoption curve.

Those inputs were not provided, and no citable details are available in the input context for tozuleristide.

What is the pricing and treatment-cost basis for revenue forecasting?

A market projection typically requires at least one of the following, tied to a validated indication:

• expected US launch price (or international price levels),
• modeled annual treatment cost based on dosing schedule,
• expected payer reimbursement terms (e.g., specialty pharmacy vs hospital outpatient),
• time on therapy and discontinuation assumptions.

The input does not include any of these for tozuleristide, and no citable pricing benchmarks are present in the provided context.

What does the pipeline timeline imply for market entry and ramp?

Without confirmed clinical phase, trial readout dates, or regulatory submission timing, any estimate of launch year would be non-actionable.

A market forecast is mathematically tied to these milestones:

• Phase completion dates and interim readout schedule,
• pivotal trial initiation and completion,
• NDA/BLA submission and review period,
• potential label expansion timing.

No such dated milestones were included in the input.

Market projection: base case, upside, and downside

A market projection requires:

• addressable population estimate,
• penetration assumptions vs standard of care,
• duration of therapy and discontinuation,
• pricing and reimbursement assumptions,
• probability-weighted success based on clinical stage.

No validated indication, stage, or numerical development parameters were supplied for tozuleristide. A projection would be speculative and cannot be produced as a complete and accurate business case.

Commercial risks that would normally drive the forecast

For a drug candidate forecast, the key risk drivers usually map to:

• efficacy durability vs comparators,
• safety profile and monitoring burden,
• manufacturing scale-up and supply constraints,
• immunogenicity or class-specific liabilities (if applicable),
• payer scrutiny tied to clinical endpoints and budget impact.

No tozuleristide-specific safety or efficacy profile is provided in the input.

Regulatory and competitive landscape

A market forecast also requires:

• competitors with phase-of-development alignment,
• patent and exclusivity landscape that shapes forecastable pricing power,
• likely label scope and physician adoption barriers.

None of these are included for tozuleristide in the provided context.

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Key Takeaways

• A complete development update and market projection for tozuleristide cannot be produced from the information provided.
• A projection requires confirmed indication, dosing/admin details, clinical stage, dated milestones, and pricing/reimbursement assumptions; none are available in the input context.
• Proceeding without validated anchor facts would produce a non-citable, non-actionable forecast.

FAQs

1. Is tozuleristide approved anywhere?
   No approval status is provided in the input context.

2. What clinical phase is tozuleristide in?
   Clinical phase and trial milestones are not provided in the input context.

3. What indication does tozuleristide target?
   The indication is not provided in the input context.

4. What is the expected dosing schedule and route?
   Dosing and route details are not provided in the input context.

5. Can you provide revenue projections by year for tozuleristide?
   Not without validated inputs on indication, stage, and commercial assumptions.

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References

No sources were cited because no citable development, regulatory, or commercial data for tozuleristide was provided in the input context.