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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR SODIUM FLUORIDE F 18


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505(b)(2) Clinical Trials for Sodium Fluoride F 18

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT03774498 ↗ Effect of Different Over-the-counter Toothpastes on Enamel Remineralization Unknown status Cairo University N/A 2019-01-01 This study will be conducted to compare between recent over-the-counter toothpaste (Novamin & Fluoride) and regular over-the-counter toothpaste (Sodium Fluoride) in remineralization potential, so as to be able to know which of the toothpastes will have a better remineralization potential on demineralized enamel.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Sodium Fluoride F 18

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00005006 ↗ Parathyroid Hormone (PTH) With Alendronate for Osteoporosis Completed National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Phase 2 1987-09-01 This study investigates the effectiveness of parathyroid hormone (PTH) in combination with alendronate, a standard treatment for osteoporosis that blocks or reduces bone loss. We are using alendronate because it may help protect patients against any possible harmful effects of PTH in cortical bone such as the long bones or hip. We are testing two different treatment schedules of PTH-one in which we give PTH daily and one in which we give PTH for 3 out of every 6 months in a cyclical fashion. The entire study is 21 months long; the active treatment period is 18 months with a 6-month followup period. The main effects we will look for in this study are changes in body chemicals that are signs of bone formation or bone breakdown, and changes in bone density throughout the skeleton. We will randomly assign all study participants, who are women aged 50 and over, to either stay on alendronate alone, receive daily continuous PTH plus alendronate, or receive daily PTH for 3 months out of every 6 for a total of three separate 3-month cycles of PTH plus daily alendronate.
NCT00005006 ↗ Parathyroid Hormone (PTH) With Alendronate for Osteoporosis Completed Helen Hayes Hospital Phase 2 1987-09-01 This study investigates the effectiveness of parathyroid hormone (PTH) in combination with alendronate, a standard treatment for osteoporosis that blocks or reduces bone loss. We are using alendronate because it may help protect patients against any possible harmful effects of PTH in cortical bone such as the long bones or hip. We are testing two different treatment schedules of PTH-one in which we give PTH daily and one in which we give PTH for 3 out of every 6 months in a cyclical fashion. The entire study is 21 months long; the active treatment period is 18 months with a 6-month followup period. The main effects we will look for in this study are changes in body chemicals that are signs of bone formation or bone breakdown, and changes in bone density throughout the skeleton. We will randomly assign all study participants, who are women aged 50 and over, to either stay on alendronate alone, receive daily continuous PTH plus alendronate, or receive daily PTH for 3 months out of every 6 for a total of three separate 3-month cycles of PTH plus daily alendronate.
NCT00078026 ↗ An Investigation Into the Short Term Effect of APOMINE in Patients With Osteoporosis or Low Bone Mass Terminated Genzyme, a Sanofi Company Phase 1/Phase 2 2003-08-01 Osteoporosis affects millions of postmenopausal women in the USA. The current approved treatments are all drugs that prevent bone loss and possibly result in small gains in bone mass. Another possible treatment consists of drugs that increase bone formation. There are currently two drugs that stimulate bone formation, sodium fluoride and human parathyroid hormone (hPTH). Neither of these two drugs has been approved by the FDA. APOMINE has shown significant bone formation in animal studies. In this study we plan to test whether APOMINE is able to stimulate new bone formation in women with osteoporosis or low bone mass.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sodium Fluoride F 18

Condition Name

Condition Name for Sodium Fluoride F 18
Intervention Trials
Dental Caries 13
Dentin Sensitivity 9
Dental Caries in Children 8
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Condition MeSH

Condition MeSH for Sodium Fluoride F 18
Intervention Trials
Dental Caries 25
Hypersensitivity 14
Dentin Sensitivity 14
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Clinical Trial Locations for Sodium Fluoride F 18

Trials by Country

Trials by Country for Sodium Fluoride F 18
Location Trials
United States 183
Canada 11
Brazil 11
Egypt 9
China 8
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Trials by US State

Trials by US State for Sodium Fluoride F 18
Location Trials
Indiana 17
Maryland 12
New York 9
New Jersey 8
California 7
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Clinical Trial Progress for Sodium Fluoride F 18

Clinical Trial Phase

Clinical Trial Phase for Sodium Fluoride F 18
Clinical Trial Phase Trials
Phase 4 20
Phase 3 24
Phase 2/Phase 3 8
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Clinical Trial Status

Clinical Trial Status for Sodium Fluoride F 18
Clinical Trial Phase Trials
Completed 76
Not yet recruiting 10
Recruiting 10
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Clinical Trial Sponsors for Sodium Fluoride F 18

Sponsor Name

Sponsor Name for Sodium Fluoride F 18
Sponsor Trials
GlaxoSmithKline 15
National Cancer Institute (NCI) 13
Colgate Palmolive 9
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Sponsor Type

Sponsor Type for Sodium Fluoride F 18
Sponsor Trials
Other 96
Industry 50
NIH 16
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Sodium Fluoride F 18: Clinical Trials, Market Analysis, and Projections

Introduction

Sodium Fluoride F 18 (18F-NaF) is a radiopharmaceutical that has garnered significant attention in the medical and pharmaceutical industries due to its versatile applications, particularly in diagnostic imaging. Here, we delve into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Applications

Diagnostic Imaging in Cancer

18F-NaF is primarily used in positron emission tomography/computed tomography (PET/CT) scans for diagnosing and monitoring bone tumors and metastases. Clinical trials have shown its efficacy in detecting skeletal cancer and metastatic disease, especially in prostate cancer patients.

  • A clinical trial (NCT01541358) focused on the use of 18F-NaF PET/CT for evaluating skeletal cancer, highlighting its potential in diagnosing bone tumors and metastases accurately[4].
  • Studies have also compared 18F-NaF PET/CT with other radiopharmaceuticals like 18F-fluorocholine, showing similar diagnostic accuracy for staging and follow-up in prostate cancer patients[3].

Bone Scans

The FDA approved a new strength of 18F-NaF injection for bone scans in 2011, marking a significant milestone in its clinical use. This approval was granted to PETNET Solutions Inc., a subsidiary of Siemens Medical Solutions USA Inc.[1].

Market Analysis

Global Market Size and Growth

The global sodium fluoride market is expected to experience robust growth, driven by a compound annual growth rate (CAGR) of 5.5% from 2024 to 2029. The market is projected to reach $915.78 million by 2029, up from $698.87 million in 2024[2].

Industrial and Medical Applications

Sodium fluoride's extensive use in various industries, including water treatment, glass manufacturing, metallurgy, and agriculture, contributes to its market growth. However, its role in dental products and community water fluoridation programs remains a key driver, particularly in combating dental caries globally[2].

Regional Insights

The Asia Pacific region is a significant growth area for the sodium fluoride market, driven by the burgeoning steel industry in countries like India and China. Increased healthcare expenditure and infrastructure expansions also contribute to the regional market growth[2].

Market Projections

Fluorine-18 Market

The global fluorine-18 market, which includes 18F-NaF, is expected to grow from $1.4 billion in 2020 to $3 billion by 2030, with a CAGR of 7.4%. This growth is largely driven by the increasing demand for PET/CT scans in oncology and other non-oncologic specialties like cardiology and neurology[5].

End User Segmentation

Hospitals are expected to be the major end users of fluorine-18 isotopes, including 18F-NaF, due to the increasing installation of new PET/CT machines in hospital projects globally. Diagnostic centers also play a significant role in driving the demand for these isotopes[5].

Regional Dominance

North America currently dominates the global fluorine-18 market, followed by Europe. However, the Asia Pacific region is projected to expand at a high CAGR from 2021 to 2030, driven by product launches, acquisitions, and geographical expansion by local players[5].

Key Players and Competitive Landscape

The market for 18F-NaF and other fluorine-18 isotopes is competitive, with key players including Lantheus Holdings, Inc., Siemens Healthineers, Advanced Accelerator Applications (a Novartis AG Company), GE Healthcare, and Blue Earth Diagnostics. These companies are involved in various strategies such as product launches, acquisitions, and distribution agreements to maintain their market share[5].

Strategic Business Implications

For companies operating in this market, understanding the diverse applications and growing demand for sodium fluoride and fluorine-18 isotopes is crucial. The market analysis provides insights into customer segments, emerging trends, and the competitive landscape, enabling informed decision-making for market entries, product launches, and geographical expansion[2].

Key Takeaways

  • Clinical Trials: 18F-NaF is effective in diagnosing and monitoring bone tumors and metastases, particularly in prostate cancer.
  • Market Growth: The global sodium fluoride market is projected to reach $915.78 million by 2029, with a CAGR of 5.5%.
  • Regional Growth: The Asia Pacific region is a significant growth area, driven by industrial and healthcare demands.
  • End User Demand: Hospitals are the major end users of fluorine-18 isotopes, including 18F-NaF.
  • Competitive Landscape: Key players are engaging in various strategies to maintain market share in a competitive environment.

FAQs

What is the primary use of Sodium Fluoride F 18 in medical diagnostics?

Sodium Fluoride F 18 is primarily used in PET/CT scans for diagnosing and monitoring bone tumors and metastases, especially in prostate cancer patients.

Which regions are driving the growth of the sodium fluoride market?

The Asia Pacific region, particularly countries like India and China, is driving the growth due to the burgeoning steel industry and increased healthcare expenditure.

What is the projected market size of the global fluorine-18 market by 2030?

The global fluorine-18 market is expected to reach $3 billion by 2030, growing at a CAGR of 7.4% from 2021 to 2030.

Who are the key players in the fluorine-18 market?

Key players include Lantheus Holdings, Inc., Siemens Healthineers, Advanced Accelerator Applications, GE Healthcare, and Blue Earth Diagnostics.

What are the main industrial applications of sodium fluoride?

Sodium fluoride is extensively used in water treatment, glass manufacturing, metallurgy, and agriculture, in addition to its role in dental products and community water fluoridation programs.

Sources

  1. FDA Approves NDA for Sodium Fluoride F 18 Injection - IT Nonline
  2. Global Sodium Fluoride Market Projected to Reach US$915.781 Million by 2029 - GlobeNewswire
  3. A Retrospective Comparative Study of Sodium Fluoride (NaF-18)-PET/CT and Fluorocholine (F-18-CH) PET/CT - MDPI
  4. Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer - ClinicalTrials.gov
  5. Fluorine-18 Market Size Worth Around US$ 3 Billion by 2030 - BioSpace

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