CLINICAL TRIALS PROFILE FOR PENTETATE CALCIUM TRISODIUM YB-169

All Clinical Trials for pentetate calcium trisodium yb-169

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001575 ↗	Anti-Tac(90 Y-HAT) to Treat Hodgkin's Disease, Non-Hodgkin's Lymphoma and Lymphoid Leukemia	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	1997-04-01	This study will examine the use of a radioactive monoclonal antibody called yttrium 90-labeled humanized anti-Tac (90 Y-HAT) for treating certain cancers. Monoclonal antibodies are genetically engineered proteins made in large quantities and directed against a specific target in the body. The anti-Tac antibody in this study is targeted to tumor cells and is tagged (labeled) with a radioactive substance called Yttrium-90 (Y-90). The study will determine the maximum tolerated dose of 90Y-HAT and examine its safety and effectiveness. Patients 18 years of age and older with Hodgkin's disease, non-Hodgkin's lymphoma and lymphoid leukemia who have proteins on their cancer cells that react with anti-Tac may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram (EKG), chest x-ray, computed tomography (CT) scan or ultrasound of the abdomen, positron emission tomography (PET) scan of the neck and body, and skin test for immune reactivity to antigens (similar to skin tuberculin test). Before beginning treatment, participants may undergo additional procedures, including the following: - Patients with suspicious skin lesions have a skin biopsy. An area of skin is numbed and a circular piece of skin about 1/4-inch diameter is removed with a cookie cutter-like instrument. - Patients with hearing loss have a hearing test. - Patients with neurological symptoms have a lumbar puncture (spinal tap). A local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle. - Patients who have not had a bone marrow biopsy within 6 months of screening also undergo this procedure. The skin and bone at the back of the hip are numbed with a local anesthetic and a small piece of bone is withdrawn through a needle. Patients receive 90 Y-HAT in escalating doses to determine the highest dose that can be safely given. The first group of three patients receives a low dose and, if there are no significant side effects at that dose, the next three patients receive a higher dose. This continues with subsequent groups until the maximum study dose is reached. 90 Y-HAT is given through a vein (intravenous (IV)) over a 2-hour period. In addition, a drug called Pentetate Calcium Trisodium Inj (Ca-DTPA) is given via IV over 5 hours for 3 days to help reduce the side effects of the 90Y-HAT. In some patients, the 90 Y-HAT may also be attached to a radioactive metal called Indium-111 to monitor what happens to the injected material. During infusion of the drug, patients undergo PET scanning to trace the path of the injected material in the body. For this procedure, the patient lies in the scanner, remaining in one position during the entire infusion. Blood and urine specimens are collected periodically over a 6-week period following the infusion to determine the level of the radioactive antibody. Bone marrow, lymph node, or skin biopsies may be done to determine how much of the antibody entered these sites. Patients whose disease remains stable or improves with therapy may receive up to six more infusions of 90 Y-HAT, with at least a 6-week interval between treatments.

Clinical Trial Conditions for pentetate calcium trisodium yb-169

Condition Name

Condition Name for pentetate calcium trisodium yb-169
Intervention	Trials
Hodgkin's Disease	1
Lymphoma, Non-Hodgkin	1

Condition MeSH

Condition MeSH for pentetate calcium trisodium yb-169
Intervention	Trials
Lymphoma	1
Hodgkin Disease	1
Lymphoma, Non-Hodgkin	1

Clinical Trial Locations for pentetate calcium trisodium yb-169

Trials by Country

Trials by Country for pentetate calcium trisodium yb-169
Location	Trials
United States	1

Trials by US State

Trials by US State for pentetate calcium trisodium yb-169
Location	Trials
Maryland	1

Clinical Trial Progress for pentetate calcium trisodium yb-169

Clinical Trial Phase

Clinical Trial Phase for pentetate calcium trisodium yb-169
Clinical Trial Phase	Trials
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for pentetate calcium trisodium yb-169
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for pentetate calcium trisodium yb-169

Sponsor Name

Sponsor Name for pentetate calcium trisodium yb-169
Sponsor	Trials
National Cancer Institute (NCI)	1

Sponsor Type

Sponsor Type for pentetate calcium trisodium yb-169
Sponsor	Trials
NIH	1

Pentetate calcium trisodium yb-169 Market Analysis and Financial Projection

Last updated: May 3, 2026

What do recent clinical trials and market projections say about pentetate calcium trisodium YB-169?

What is pentetate calcium trisodium YB-169 and what is the current clinical signal?

Pentetate calcium trisodium YB-169 is an injectable chelation therapy (calcium trisodium pentetate) used to enhance elimination of radionuclides via chelation. Market-facing development and clinical updates for this specific proprietary labeling (YB-169) are typically tied to regulatory filings and trial registries that distinguish between (1) approved comparator chelators and (2) the branded/product-specific formulation and manufacturing.

No reliable, complete, and source-verifiable trial timeline or outcome dataset for “pentetate calcium trisodium YB-169” was provided in the prompt, and no trial registry record set can be confirmed from the information available in this chat. Under this operating constraint, a complete clinical-trials update cannot be produced without inserting non-evidenced claims.

Which trials matter commercially, and what endpoints drive payer and hospital decisions?

For radionuclide chelation injectables, commercial adoption is driven by predictable clinical and operational endpoints:

• Efficacy in radionuclide elimination
  Commonly measured via urine/blood kinetics and dose reduction. In practice, regulators and payers look for consistent reduction of retained activity over time.

• Safety and tolerability
  Typical attention centers on infusion reactions, renal and electrolyte effects, and hypocalcemia risk due to chelation mechanics. Label-concordant monitoring protocols strongly affect real-world uptake.

• Administration workflow
  Hospital adoption depends on infusion time, compatibility with radiation-injury protocols, and availability of dosing calculators.

• Use-case alignment
  Uptake varies across nuclear medicine therapeutic exposure management, radiological incidents, and occupational or accidental exposures. The market size forecast depends on which of these use cases the product is positioned for.

What is the market structure for calcium trisodium pentetate chelation therapy?

The chelation segment for radioactive contamination is typically characterized by:

• Government and hospital procurement tied to emergency readiness
• Low chronic-use volume, high incident-driven demand
• Competition from established chelators and generic supply
• Regulatory and stockpiling behavior influencing near-term utilization more than longitudinal uptake

Pentetate calcium trisodium formulations are part of a category that often competes on readiness and supply reliability rather than broad outpatient market expansion.

How do you project a radionuclide chelator market without manufacturing assumptions?

A credible projection requires anchoring to incident incidence, stockpiling cycles, government tender patterns, and hospital emergency inventory practices. Without source-verifiable inputs for YB-169-specific adoption (stockpiling agreements, labeled indication geography, and realized tender wins), any numerical forecast would be fabricated.

Given the constraint that a complete and accurate response requires sufficient evidence, the market analysis and projection for pentetate calcium trisodium YB-169 cannot be produced in a way that would meet professional patent-and-commercial standards.

What commercial milestones would move YB-169 valuation (and how they are measured)?

Even without injecting unverified trial results, decision-grade milestones for a chelation injectable typically include:

• Regulatory status by geography
  Approval, label scope (indications and age limits), and manufacturing authorization.

• Stockpiling or government tender inclusion
  Measured by contract award announcements and procurement database entries.

• Hospital formulary adoption
  Measured via formulary listings, emergency department protocol inclusion, and distribution channel onboarding.

• Safety profile alignment with standard chelation monitoring
  Measured by post-authorization surveillance and label-concordant adverse event profiles.

What does a defensible “trial update” deliver to investors and BD?

A trial update that changes decisions should include, at minimum:

• Trial phase and design (randomized vs single-arm; comparator vs placebo; historical control)
• Enrollment status and dosing regimen
• Primary endpoint definition and achieved results
• Key safety signals with event rates
• Regulatory milestones tied to readouts

No such itemized dataset for YB-169 is present in the prompt, and no source-backed trial record can be confirmed from within this chat. Therefore, a structured clinical update with numbers is not possible under the accuracy constraint.

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Key Takeaways

• Pentetate calcium trisodium YB-169 is a chelation injectable used to enhance elimination of radionuclides, but the prompt does not provide source-verifiable clinical trial readouts or regulatory milestones for YB-169 specifically.
• A complete, evidence-grade clinical trials update and a numerical market projection for YB-169 cannot be produced without injecting unverified facts.
• A decision-grade BD and investment view for chelation injectables depends on labeled indication scope, safety monitoring fit, and procurement or stockpiling adoption, not on chronic-volume commercialization logic.

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FAQs

1. What class of drug is pentetate calcium trisodium YB-169?
   It is a chelation therapy formulation (calcium trisodium pentetate) intended to bind radionuclides to enhance elimination.

2. Which trial endpoints are most important for radionuclide chelators?
   Radionuclide elimination kinetics, safety (especially renal and electrolyte effects), and workflow-related administration parameters.

3. Why are market volumes for chelation therapies different from typical oncology or chronic drugs?
   Demand is incident- and readiness-driven, with government stockpiling and hospital emergency protocols materially affecting utilization.

4. What milestones typically drive valuation for a chelation injectable?
   Regulatory label scope, tender or stockpiling inclusion, formulary adoption, and consistent post-authorization safety signal management.

5. Can a numerical market forecast be produced without stockpiling and adoption data?
   A defensible projection requires evidence on geography, labeled use, procurement inclusion, and realized tender uptake.

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References

[1] No external sources were provided in the prompt, and no source-verifiable clinical or market record for “pentetate calcium trisodium YB-169” could be cited from within this chat.