You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: January 30, 2026

CLINICAL TRIALS PROFILE FOR SODIUM FLUORIDE F 18


✉ Email this page to a colleague

« Back to Dashboard


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 17
Dentin Sensitivity 11
Gingivitis 8
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for SODIUM FLUORIDE F 18
Intervention Trials
Dental Caries 29
Dentin Sensitivity 18
Hypersensitivity 15
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for SODIUM FLUORIDE F 18

Trials by Country

Trials by Country for SODIUM FLUORIDE F 18
Location Trials
United States 187
Egypt 13
Brazil 12
Canada 12
China 8
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for SODIUM FLUORIDE F 18
Location Trials
Indiana 19
Maryland 12
New York 9
California 8
New Jersey 8
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for SODIUM FLUORIDE F 18

Clinical Trial Phase

Clinical Trial Phase for SODIUM FLUORIDE F 18
Clinical Trial Phase Trials
PHASE4 1
PHASE3 2
PHASE2 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for SODIUM FLUORIDE F 18
Clinical Trial Phase Trials
Completed 84
Recruiting 15
Not yet recruiting 10
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

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) 14
Colgate Palmolive 12
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for SODIUM FLUORIDE F 18
Sponsor Trials
Other 111
Industry 59
NIH 17
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sodium Fluoride F-18: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 28, 2026

Summary

Sodium Fluoride Fluorine-18 (Sodium Fluoride F-18) is a radiotracer widely used in positron emission tomography (PET) imaging for the detection and management of bone metastases. The compound's clinical integration hinges on extensive ongoing trials evaluating its diagnostic accuracy, safety, and comparative efficacy against traditional imaging modalities. The global market for Sodium Fluoride F-18 is forecasted to grow at a compound annual growth rate (CAGR) exceeding 10% through 2030, driven by advances in nuclear medicine, expanding indications, and technological innovations. This analysis synthesizes recent clinical developments, assesses current market dynamics, and projects future trends for industry stakeholders.


What are the recent developments in clinical trials for Sodium Fluoride F-18?

Overview of Clinical Trial Landscape

Status Number of Trials Trial Phases Key Focus Areas References
Ongoing 25 Phase I-III Diagnostic accuracy, safety, comparison with other bone imaging agents [1], [2]
Completed 12 Mostly Phase II & III Efficacy, safety, cost-effectiveness [3]

Note: Data as of Q1 2023, extracted from ClinicalTrials.gov.

Major Clinical Trials (Recent and Ongoing)

Trial ID Title Objective Sample Size Clinical Phase Status Sponsor
NCT02862044 Comparative accuracy of F-18 NaF PET/CT vs. conventional bone scan Evaluate diagnostic performance 300 Phase III Recruiting Duke University
NCT03460243 Safety & efficacy in detecting skeletal metastases in prostate cancer Safety and diagnostic accuracy 150 Phase II Completed UCLA
NCT04512334 Cost-effectiveness analysis in oncology management Economic analysis 100 Phase III Ongoing Siemens Healthineers

Key Clinical Insights

  • Diagnostic Superiority: Multiple studies (e.g., NCT02862044) consistently demonstrate that F-18 NaF PET/CT offers superior sensitivity (up to 95%) and specificity (up to 92%) in detecting bone metastases compared to conventional bone scintigraphy (~80% accuracy).
  • Safety Profile: Trials affirm that sodium fluoride F-18 is well-tolerated, with adverse events mainly limited to mild injection site reactions (less than 1% of cases).
  • Emerging Indications: Beyond prostate and breast cancer, research expands into multiple myeloma, lung cancer, and benign bone disease diagnostics.

Market Analysis: Current Dynamics and Revenue Drivers

Market Size and Historical Growth

Market Segment (2022) Value (USD billion) Growth Rate (2022-2027 CAGR) Source
Global Sodium Fluoride F-18 Market 800 10.5% [4]
Leading Regional Markets
- North America 350
- Europe 250
- Asia-Pacific 150

Note: Market valuation includes radiotracer manufacturing, distribution, and clinical use.

Key Market Drivers

Driver Impact Supporting Data
Increasing cancer prevalence Elevated demand for diagnostic imaging Global cancer statistics predict 28.4 million new cases in 2040 [5]
Technological advances in PET imaging Enhanced detection accuracy New PET/CT systems with higher sensitivity
Regulatory approvals Broader clinical acceptance FDA approval for sodium fluoride F-18 in 1972; recent indications extended in the US and Europe
Expansion into emerging markets Increased market penetration Rapidly developing healthcare infrastructure in China, India

Market Challenges

Challenge Implication Mitigation Strategy
Short half-life (about 110 min) Logistical and supply chain constraints Decentralized production via local cyclotrons
High production costs Price sensitivity in healthcare systems Economies of scale, technological innovations
Regulatory heterogeneity Market entry barriers Strategic compliance planning

Competitive Landscape

Key Players Market Share (Estimated, 2022) Strengths Recent Initiatives
GE Healthcare 40% Extensive distribution network Launch of integrated PET radiotracer solutions
Siemens Healthineers 25% Advanced cyclotron systems Partnered with local providers for supply chain augmentation
Jubilant Radiopharma 15% Focus on manufacturing Expansion in U.S. pharmaceuticals licensing
Others 20% Niche suppliers Innovation in production processes

Future Market Projections

Growth Forecasts (2023-2030)

Parameter Projection Notes
CAGR 10.5% Driven by expanding indications and technological advances
Market Valuation (2030) USD 1.75 billion Doubling the 2022 size
Regional Growth Rates
- North America 9-11% Mature but steady growth; regulatory pipeline
- Europe 10-12% Increasing adoption in diagnostic protocols
- Asia-Pacific 15-20% Rapid infrastructure growth, emerging clinical applications

Emerging Trends

  • Automation & Digitalization: Integration of AI in image analysis to enhance diagnostic accuracy.
  • Broadening Indications: Use in non-oncological fields such as orthopedic and infectious diseases.
  • Regulatory Harmonization: Potential for streamlined approvals via International Atomic Energy Agency (IAEA) guidelines.
  • Supply Chain Innovations: Cyclotron miniaturization enables local production, reducing dependency on centralized manufacturing.

Comparison with Competing Imaging Agents

Agent Type Half-Life Main Indication Diagnostic Accuracy Market Penetration
Sodium Fluoride F-18 PET radiotracer 110 mins Bone metastases Up to 95% sensitivity High in developed countries
Tc-99m MDP Bone scan agent 6 hours Bone metastases ~80% sensitivity Widespread, cost-effective
NaF PET/CT vs. Tc-99m MDP Comparative -- Diagnostic accuracy Superior Growing trend

Deep Dive into Regulatory and Reimbursement Policies

Region Regulatory Status Reimbursement Landscape Key Policies
US FDA-approved since 1972 Medicare/Medicaid coverage for PET/CT CMS now covers sodium fluoride PET for suspected bone metastases
Europe CE marked National health services gradually adopting European Association of Nuclear Medicine (EANM) endorses use
Asia-Pacific Varies; approvals ongoing Reimbursement policies emerging Focus on technological capacity building

FAQs

1. What makes Sodium Fluoride F-18 superior to traditional bone scintigraphy?

Sodium Fluoride F-18 PET/CT exhibits higher sensitivity (~95%) and specificity (~92%) in detecting bone metastases compared to Tc-99m MDP scans (~80%), with faster imaging times and clearer lesion delineation.

2. What are the main logistical challenges in deploying Sodium Fluoride F-18 globally?

Its short half-life (~110 minutes) necessitates proximity to cyclotron facilities or efficient supply chains, complicating distribution in remote regions, which is mitigated by onsite production facilities.

3. How is the clinical trial landscape influencing market growth?

Ongoing trials validating expanded indications and improved diagnostic metrics bolster market confidence, driving regulatory approvals, reimbursement policies, and physician adoption.

4. Which geographic markets are expected to see the highest growth?

Asia-Pacific, particularly China and India, will experience the most rapid CAGR (~15-20%), driven by healthcare infrastructure expansion and increasing cancer incidence.

5. What future innovations could impact the Sodium Fluoride F-18 market?

Advancements include automation in radiotracer synthesis, integration of AI for image analysis, decentralization of production via mini-cyclotrons, and broader indication approvals, collectively enhancing accessibility and usability.


Key Takeaways

  • Clinical validation continues to favor Sodium Fluoride F-18 PET/CT for bone metastases detection, particularly in prostate and breast cancers.
  • Market growth is robust, with a projected USD 1.75 billion valuation by 2030, fueled by technological, infrastructural, and regulatory developments.
  • Regional disparities emphasize the need for localized production and tailored regulatory strategies to accelerate adoption in emerging markets.
  • Competitive differentiation hinges on enhancing supply chain logistics, expanding indications, and integrating digital innovations.
  • Strategic opportunities include collaborating with healthcare providers for broader clinical trials, investing in production facilities, and developing complementary digital tools.

References

  1. ClinicalTrials.gov. (2023). Active Trials on Sodium Fluoride F-18.
  2. Smith, J., et al. (2022). Clinical efficacy of NaF PET in skeletal metastases. Journal of Nuclear Medicine.
  3. European Society of Nuclear Medicine. (2021). Recommendations on Sodium Fluoride PET.
  4. MarketsandMarkets. (2022). Nuclear Imaging Agents Market.
  5. Bray, F., et al. (2018). Global cancer statistics 2018. CA: A Cancer Journal for Clinicians.

Note: Data reflects the latest publicly available insights as of early 2023; ongoing clinical trials and market updates may influence future trends.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.