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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR GALLIUM NITRATE


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All Clinical Trials for Gallium Nitrate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002543 ↗ Gallium Nitrate in Treating Children With Brain Tumor, Neuroblastoma, Rhabdomyosarcoma, Non-Hodgkin's Lymphoma, or Refractory Solid Tumors Completed National Cancer Institute (NCI) Phase 1 1995-02-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: : Phase I trial to study the effectiveness of gallium nitrate in young patients who have malignant brain tumors, neuroblastoma, rhabdomyosarcoma, non-Hodgkin's lymphoma, or refractory solid tumor.
NCT00002543 ↗ Gallium Nitrate in Treating Children With Brain Tumor, Neuroblastoma, Rhabdomyosarcoma, Non-Hodgkin's Lymphoma, or Refractory Solid Tumors Completed Medical College of Wisconsin Phase 1 1995-02-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: : Phase I trial to study the effectiveness of gallium nitrate in young patients who have malignant brain tumors, neuroblastoma, rhabdomyosarcoma, non-Hodgkin's lymphoma, or refractory solid tumor.
NCT00002578 ↗ Gallium Nitrate in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma Completed National Cancer Institute (NCI) Phase 2 1994-08-01 RATIONALE: Chemotherapy uses different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of gallium nitrate in treating patients with AIDS-related non-Hodgkin's lymphoma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Gallium Nitrate

Condition Name

Condition Name for Gallium Nitrate
Intervention Trials
Lymphoma 2
Cystic Fibrosis 2
Neuroblastoma 1
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Condition MeSH

Condition MeSH for Gallium Nitrate
Intervention Trials
Lymphoma 4
Fibrosis 3
Cystic Fibrosis 3
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Clinical Trial Locations for Gallium Nitrate

Trials by Country

Trials by Country for Gallium Nitrate
Location Trials
United States 41
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Trials by US State

Trials by US State for Gallium Nitrate
Location Trials
Maryland 4
Washington 3
Florida 2
Colorado 2
Alabama 2
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Clinical Trial Progress for Gallium Nitrate

Clinical Trial Phase

Clinical Trial Phase for Gallium Nitrate
Clinical Trial Phase Trials
Phase 2 4
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for Gallium Nitrate
Clinical Trial Phase Trials
Completed 5
Withdrawn 1
Recruiting 1
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Clinical Trial Sponsors for Gallium Nitrate

Sponsor Name

Sponsor Name for Gallium Nitrate
Sponsor Trials
Cystic Fibrosis Foundation 3
Cystic Fibrosis Foundation Therapeutics 2
University of Washington 2
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Sponsor Type

Sponsor Type for Gallium Nitrate
Sponsor Trials
Other 11
NIH 2
Industry 2
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Gallium Nitrate: Clinical Trials, Market Analysis, and Projections

Introduction to Gallium Nitrate

Gallium nitrate is a compound that has been explored for its various therapeutic properties, including its antimicrobial and antineoplastic activities. Here, we will delve into the current clinical trials, market analysis, and future projections for gallium nitrate.

Clinical Trials: Gallium Nitrate in Medical Applications

Treatment of NTM Infections in Cystic Fibrosis

One of the notable clinical trials involving gallium nitrate is the ABATE Study, which focuses on its safety and efficacy in treating nontuberculous mycobacteria (NTM) infections in patients with cystic fibrosis (CF). Gallium nitrate, currently FDA-approved for treating high calcium levels in blood caused by cancer, is being tested for its antimicrobial properties against NTM infections. The study includes adults aged 18 and older with CF and NTM, requiring a lung function of 25% or higher and no NTM treatment for at least two years[1].

Acute Treatment of Cancer-Related Hypercalcemia

Gallium nitrate has been proven highly effective in controlling cancer-related hypercalcemia. A randomized, double-blind study compared gallium nitrate with calcitonin and found that gallium nitrate was superior in achieving normocalcemia and maintaining it for a longer duration[3].

Potential in Glioblastoma Multiforme

Although the primary focus here is on gallium nitrate, it's worth noting that another gallium compound, gallium maltolate, has been granted orphan drug designation for pediatric glioblastoma multiforme. This indicates the broader potential of gallium compounds in oncology, even if the specific compound in question is gallium nitrate[4].

Market Analysis for Gallium Nitrate

Current Market Status

The market for gallium nitrate is closely tied to its approved and experimental uses. As an FDA-approved treatment for cancer-related hypercalcemia, gallium nitrate has a established market presence. However, its potential expansion into treating NTM infections and other conditions could significantly impact its market size.

Market Size and Growth

While specific market size data for gallium nitrate alone is not readily available, the broader market for gallium compounds and related applications provides some context. The global gallium nitride (GaN) substrates market, for example, is projected to grow at a CAGR of 9.62% between 2025 and 2030, driven by advancements in semiconductor technology and consumer electronics[5].

Market Trends and Drivers

  • Expanding Therapeutic Uses: The exploration of gallium nitrate in new therapeutic areas, such as NTM infections, could drive market growth.
  • Technological Advancements: Advances in medical technology and the increasing demand for effective treatments for rare and complex conditions are key drivers.
  • Regulatory Support: Orphan drug designations and other regulatory approvals can significantly boost the market for specific gallium compounds.

Market Restraints and Challenges

  • Side Effects and Safety Concerns: Any new therapeutic use of gallium nitrate must undergo rigorous safety testing to ensure it does not pose significant risks to patients.
  • Competition from Other Treatments: The presence of other treatments for hypercalcemia and NTM infections could limit the market share of gallium nitrate.
  • Cost and Accessibility: The cost of gallium nitrate and its accessibility in various regions could be a restraint, especially in developing markets.

Projections for Gallium Nitrate

Future Therapeutic Applications

Given its antimicrobial and antineoplastic properties, gallium nitrate is likely to be explored in more therapeutic areas. The success of the ABATE Study could pave the way for its approval in treating NTM infections, expanding its market.

Market Expansion

As the global healthcare market continues to grow, driven by an aging population and increasing healthcare spending, the demand for effective treatments like gallium nitrate is expected to rise. The compound's potential in rare and complex conditions, such as glioblastoma multiforme (though currently being explored with gallium maltolate), further underscores its market potential.

Regulatory and Research Landscape

Continued research and favorable regulatory outcomes, such as orphan drug designations, will be crucial for the growth of the gallium nitrate market. These designations not only provide financial incentives but also expedite the development process.

"Gallium nitrate therapy is highly effective and superior to maximally approved doses of calcitonin for acute control of cancer-related hypercalcemia."[3]

Key Takeaways

  • Clinical Trials: Gallium nitrate is being tested for its safety and efficacy in treating NTM infections in CF patients and has proven effective in controlling cancer-related hypercalcemia.
  • Market Analysis: The market for gallium nitrate is influenced by its approved uses and potential expansion into new therapeutic areas.
  • Market Projections: The compound is expected to see increased demand driven by its therapeutic potential and favorable regulatory environments.
  • Challenges and Restraints: Safety concerns, competition from other treatments, and cost accessibility are key challenges that need to be addressed.

FAQs

What is the current primary use of gallium nitrate?

Gallium nitrate is currently FDA-approved for treating high calcium levels in blood caused by cancer.

What is the ABATE Study?

The ABATE Study is a clinical trial testing the safety and efficacy of gallium nitrate in treating nontuberculous mycobacteria (NTM) infections in patients with cystic fibrosis.

How does gallium nitrate compare to calcitonin in treating hypercalcemia?

Gallium nitrate has been shown to be more effective than calcitonin in achieving and maintaining normocalcemia in patients with cancer-related hypercalcemia.

What are the potential future therapeutic applications of gallium nitrate?

Gallium nitrate may be explored for treating other conditions, including NTM infections and potentially other rare and complex diseases.

What are the key drivers for the growth of the gallium nitrate market?

Key drivers include expanding therapeutic uses, technological advancements, and favorable regulatory support.

Sources

  1. National Jewish Health: "New Treatment for NTM Infections in CF | Clinical Trials"
  2. Cognitive Market Research: "Gallium Nitrate Market Report 2025 (Global Edition)"
  3. PubMed: "Gallium nitrate for acute treatment of cancer-related hypercalcemia"
  4. OncLive: "FDA Awards Orphan Drug Designation to Gallium Maltolate for Pediatric Glioblastoma Multiforme"
  5. Knowledge Sourcing: "Gallium Nitride (GaN) Substrates Market: Size, Share, Opportunities, And Trends By Type, By Production Process, By Product, By End-User, And By Geography - Forecasts From 2025 To 2030"

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