CLINICAL TRIALS PROFILE FOR SODIUM FLUORIDE F 18

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.
OTC	NCT07356271 ↗	Effects of Mouthwashes on the Oral Microbiome and Systemic Health	NOT_YET_RECRUITING	University of Plymouth	EARLY_PHASE1	2026-02-01	OVERVIEW While antimicrobial mouthwashes are proven to be clinically effective for management of certain oral microbial diseases, recent studies (Bescos et al 2025, Gallard et al 2025) suggest tha, in addition to targeting bacteria responsible for gum diseases such as gingivitis and periodontitis, they may harm healthy bacteria and disturb the balance and protective role of the oral microbiome (dysbiosis). Most findings on the oral microbiome and mouthwashes involve chlorhexidine use, demonstrating that it may induce dysbiosis and compromise the host oral microenvironment (Bescos et al 2020). A recent study completed in 2025 (Gallardo et al 2025) has shown that CPC mouthwash can also inhibit nitrate synthesis in the mouth. However there remains a need for further research on other agents used in mouthrinses, such as hydrogen peroxide, essential oils, or saline mouthwashes, to determine whether their clinical effectiveness in managing oral disease is accompanied by changes to the oral microbiome. In dentistry, despite this being the place where most people are treated, there are very few research studies that have been performed in primary care settings. Hence this study will be designed for delivery in primary care, to produce 'real-life' data on a patient cohort more typical of general dental practice. This PhD project will select several of the most commonly used over the counter (OTC) mouthwash constituents, used by the general public, that have a limited evidence base, regarding their effects on the oral microbiome in vivo. The first agent to be studied is physiological saline (sodium chloride), as this is the mouthwash advised by dental guidelines for use after tooth extractions, yet there is little evidence to support this approach. No previous studies have previously quantified its effects on clinical outcomes and the oral microbiome. All mouthwashes will be tested in people with, or without, gum disease (gingivitis and periodontitis) to determine which interventions are best used in either health or disease.

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.

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
Dental Caries in Children	8

Condition MeSH

Condition MeSH for SODIUM FLUORIDE F 18
Intervention	Trials
Dental Caries	29
Dentin Sensitivity	18
Hypersensitivity	15

Clinical Trial Locations for SODIUM FLUORIDE F 18

Trials by Country

Trials by Country for SODIUM FLUORIDE F 18
Location	Trials
United States	188
Egypt	13
Brazil	12
Canada	12
China	8

Trials by US State

Trials by US State for SODIUM FLUORIDE F 18
Location	Trials
Indiana	19
Maryland	12
New Jersey	9
New York	9
California	8

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	5

Clinical Trial Status

Clinical Trial Status for SODIUM FLUORIDE F 18
Clinical Trial Phase	Trials
Completed	84
Recruiting	16
Not yet recruiting	10

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

Sponsor Type

Sponsor Type for SODIUM FLUORIDE F 18
Sponsor	Trials
Other	113
Industry	59
NIH	17

Last updated: July 28, 2026

Sodium Fluoride F 18 Clinical Trials Update, Market Analysis, and Forecast: Competitive Landscape, Exclusivity, and Commercial Outlook

Sodium fluoride F 18 (typically delivered as an injectable radiopharmaceutical for PET imaging, often for bone turnover assessment) is a niche, supply-constrained product where demand is driven by PET scanner penetration, regional tracer supply, and imaging protocol adoption rather than broad oncology-style diffusion. Near-term commercial trajectory is most sensitive to radiochemistry manufacturing capacity, regulatory supply continuity, and payer behavior for bone imaging indications, with longer-horizon risk tied to generator availability, cyclotron scheduling, and potential substitution with competing bone PET tracers.

What is sodium fluoride F 18 used for in PET imaging, and where is demand concentrated?

Core use Sodium fluoride F 18 is used as a PET radiotracer for imaging bone metabolism and osteoblastic activity, commonly in contexts that include evaluation of bone metastases and assessment of skeletal involvement.

Demand drivers

1. PET scanner installed base and regional PET center capacity.
2. Adoption of bone PET protocols for staging, response assessment, and suspected skeletal metastases.
3. Radiopharmacy throughput and turnaround time (batch scheduling around cyclotron availability).
4. Reimbursement coverage and local coverage determinations for PET tracers for bone imaging.

Market structure Supply and pricing are typically shaped by:

• Limited number of commercial manufacturers and licensed radiopharmacies.
• High operational dependence on cyclotron uptime and radiochemistry staffing.
• Inventory and logistics constraints for short half-life materials.

What does the clinical trials landscape look like for sodium fluoride F 18?

Trial activity profile Sodium fluoride F 18 is an established PET tracer with long-standing clinical use. Trial activity for established tracers tends to cluster around:

• New clinical settings (new endpoints, new patient stratification).
• Protocol optimization (imaging timepoints, quantification methods).
• Comparative effectiveness against other bone imaging modalities (including other PET tracers and SPECT).

What typically changes in “clinical trials updates” for this category

• Evidence generation for specific diagnostic pathways: initial staging vs. recurrence evaluation, or selection for therapy decisions.
• Quantitative imaging metrics validation (standard uptake value analogs, lesion detection performance).
• Reader variability and standardization efforts that support guideline adoption.

Clinical development implication Unlike new molecular entities, sodium fluoride F 18 growth usually depends on:

• Evidence supporting guideline inclusion for specific indications.
• Expanded access through reimbursement and center adoption.
• Supply reliability rather than novel product differentiation.

What is the current regulatory status in the US (FDA approvals and pathway)?

Sodium fluoride F 18 products are regulated as PET radiopharmaceuticals under FDA frameworks applicable to imaging drugs. Clinical and commercial access is governed by:

• FDA-approved product labeling and compendial use permissions where relevant.
• Manufacturer-specific chemistry and manufacturing controls.
• Radiopharmacy dispensing rules, including validated procedures and release testing.

Regulatory bottlenecks that matter for supply

• Short half-life logistics and batch release timelines.
• Sterility, radiochemical purity, radionuclidic purity, and identity testing.
• Quality system consistency across manufacturing and distribution nodes.

What is the Orange Book status for sodium fluoride F 18, and what does that imply for generic competition?

Key commercialization reality For radiopharmaceuticals, exclusivity and patent coverage can be fragmented and product-specific. Generic entry is often less about “tablet-style” generic freedom and more about:

• Ability to produce with validated processes at scale.
• Ability to meet release specifications consistently.
• Authorization for distribution and radiopharmacy integration.

Patent and exclusivity implications for investors and competitors

• If additional patents cover specific formulations, dosing, packaging, or manufacturing methods, generic equivalence alone may not remove barriers.
• If patent scope is narrow or largely process-based, the primary risk becomes manufacturing readiness and regulatory acceptance rather than full freedom-to-operate.

Which companies supply sodium fluoride F 18, and how does the competitive landscape shape pricing?

Market structure The competitive landscape is usually defined by:

• Manufacturer availability by region.
• Distribution footprint to PET centers.
• Contracting arrangements with radiopharmacies and hospital nuclear medicine departments.
• Reliability of supply and service-level agreements tied to scanner schedules.

Commercial constraints

• Production depends on cyclotron capacity planning.
• Time-to-ship and chain-of-custody logistics are material to center workflows.
• Substitution decisions depend on scanner compatibility, imaging protocol fit, and operational experience.

Pricing sensitivity

• Radiopharmaceutical pricing is constrained by supply chain economics and batch scheduling, not by payer negotiation alone.
• Centers pay for both the tracer and the scheduling reliability that reduces missed appointments.

What are the strongest market demand drivers for sodium fluoride F 18 through 2028?

1) PET adoption in skeletal imaging Bone imaging using PET expands where centers shift from conventional imaging (or supplement it) for metastatic workups and monitoring.

2) Increasing emphasis on quantitative imaging Where protocols require quantification and standardized uptake measures, consistent tracer performance improves utility and supports broader adoption.

3) Operational scaling at radiopharmacies Radiopharmacy expansion and regional tracer distribution reduces appointment friction and improves patient access.

4) Institutional protocols and guideline influence Even for established tracers, uptake is sensitive to guideline alignment in specific diagnostic pathways.

What could constrain growth for sodium fluoride F 18?

1) Supply continuity risk

• Cyclotron downtime.
• Radiochemistry staffing and reagent supply constraints.
• Batch failures that lead to replacement supply costs.

2) Competitive tracer substitution Competing bone PET tracers (and certain imaging alternatives) can displace usage if they provide improved lesion detection performance, better kinetics for specific scenarios, or better reimbursement.

3) Reimbursement and coverage variability If payers restrict indications or require prior authorization, volumes can plateau even when clinical interest remains.

4) Workflow friction Short half-life demands tight scheduling and may create barriers for smaller PET centers.

How does sodium fluoride F 18 compare with other bone PET tracers?

Competitive comparison dimensions

• Lesion detection sensitivity for osteoblastic disease patterns.
• Imaging timepoint suitability and logistics.
• Standardization of quantitative readouts.
• Reimbursement coverage and payer policies.
• Center experience and protocol integration.

Practical result for market share Centers tend to prefer tracers that:

• Fit existing PET scheduling workflows.
• Deliver consistent radiochemical quality and imaging characteristics.
• Are supported by reading workflows and standardized reporting.

What clinical endpoints matter most for sodium fluoride F 18 adoption?

Across radiotracer adoption, the endpoints that drive uptake are typically:

• Diagnostic performance metrics (lesion detection rates, sensitivity/specificity, ROC analysis).
• Diagnostic confidence and reader agreement.
• Impact on clinical decision-making (management changes).
• Quantitative repeatability for therapy monitoring.
• Safety and radiation dosimetry consistency for intended populations.

What is the 3- to 5-year market projection for sodium fluoride F 18?

Base-case view Growth is expected to track:

• Incremental PET center additions.
• Expansion in skeletal imaging utilization.
• Improved operational distribution and higher radiopharmacy throughput.

Where volume growth likely comes from

• Increased use in oncology bone metastasis workflows.
• More repeat studies where tracer repeatability supports monitoring.
• Broader use in multidisciplinary oncology pathways that rely on PET for staging.

Where revenue growth may diverge from volume

• Pricing may face pressure if supply expands or if substitution by competitors increases.
• Conversely, pricing may remain firm if supply remains capacity-constrained or if quality systems limit batch throughput.

What is the likely value chain economics for sodium fluoride F 18?

Cost drivers

• Production infrastructure and cyclotron operations.
• Radiochemical synthesis inputs and consumables.
• QA release testing.
• Logistics for short half-life distribution.
• Radiopharmacy labor for preparation and coordination.

Economic bottleneck The binding constraint is often cyclotron scheduling and validated manufacturing capacity, not demand. When capacity is constrained, pricing can hold despite moderate growth.

What generic entry risks exist for sodium fluoride F 18?

Generic entry is constrained by radiopharmaceutical production realities For sodium fluoride F 18, “generic risk” is typically determined by:

• Availability of manufacturing-ready processes that achieve release specifications.
• FDA acceptance of chemistry and manufacturing equivalence.
• Radiopharmacy integration readiness and validated dispensing workflow.

Practical risk profile

• If patent coverage is narrow, entry can occur sooner from a legal standpoint.
• If process validation and supply chain readiness lag, entry timing shifts despite legal freedom.

What litigation or settlement activity affects sodium fluoride F 18?

Litigation relevance For radiopharmaceuticals, litigation typically centers on:

• Patent claims tied to manufacturing methods, formulations, or compendial usage.
• Regulatory exclusivities and exclusivity-protecting labeling.
• Licensing disputes with production technology holders.

Market impact When litigation affects supply readiness, it can delay entry and maintain price levels through capacity tightness.

Key Takeaways

• Sodium fluoride F 18 demand is driven by PET center growth, skeletal imaging protocol adoption, and reimbursement coverage for bone PET workflows rather than a broad market like high-prevalence oncology drugs.
• Clinical development emphasis is usually on evidence generation for specific clinical pathways and standardized quantitative readouts, not on redefining the core tracer.
• Commercial outlook is primarily constrained by manufacturing and cyclotron capacity planning, radiopharmacy throughput, and supply continuity for a short half-life product.
• Competitive positioning is shaped by substitution dynamics with other bone PET tracers and by operational fit within PET center scheduling and imaging workflows.
• Near-term market value is sensitive to supply reliability; volume growth depends on PET adoption and payer coverage in skeletal imaging indications.

FAQs

1) What indications most influence US demand for sodium fluoride F 18 PET imaging?

Oncology bone metastasis workflows and skeletal evaluation pathways where PET imaging is used for staging and monitoring.

2) How do cyclotron and radiochemistry capacity constraints affect sodium fluoride F 18 availability?

Batch scheduling and cyclotron uptime can limit supply even when demand is stable, creating appointment delays or regional allocation.

3) Do sodium fluoride F 18 prescriptions face prior authorization or coverage restrictions?

Coverage varies by payer and indication; restrictions can cap utilization even with clinical support.

4) What manufacturing and QA requirements most affect regulatory approval for sodium fluoride F 18 products?

Radiochemical purity, radionuclidic purity, identity, sterility, and validated release testing under GMP and radiopharmaceutical-specific controls.

5) Which factors drive substitution between sodium fluoride F 18 and competing bone PET tracers?

Diagnostic performance in target use cases, imaging timepoint practicality, reimbursement, and integration into existing center workflows.

References

1. FDA. Drug Products and Biological Products with Therapeutic Equivalence Evaluations (Orange Book). U.S. Food and Drug Administration.
2. FDA. Radiopharmaceuticals: Current Good Manufacturing Practice and Quality Considerations (guidance and related materials). U.S. Food and Drug Administration.
3. Society of Nuclear Medicine and Molecular Imaging (SNMMI). PET radiotracer imaging guidance and technical documentation relevant to bone imaging protocols.