CLINICAL TRIALS PROFILE FOR SODIUM PHOSPHATE P 32

505(b)(2) Clinical Trials for Sodium Phosphate P 32

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
New Formulation	NCT01889173 ↗	Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults	Completed	Tonix Pharmaceuticals, Inc.	Phase 1	2013-06-01	Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of 3 different formulations of TNX-102 2.8 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) and to compare the bio-availability of 3 different formulations of TNX-102 2.8 mg SL Tablets (TNX-102 with potassium phosphate, TNX-102-B with sodium phosphate, and TNX-102-C with trisodium citrate) to that of cyclobenzaprine (5 mg tablets).
OTC	NCT03707795 ↗	Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study	Completed	Edward Kasaraskis	Early Phase 1	2017-08-21	By doing this study the investigator hopes to learn more about a potential cause of amyotrophic lateral sclerosis (ALS) called "oxidative stress". Oxidative stress is essentially an imbalance between the production of certain chemicals in the body called "free radicals" and the ability of the body to counteract or detoxify their harmful effects through neutralization by antioxidants. It is thought that factors such as environmental exposure (chemicals and lead), diet, smoking,alcohol consumption, physical activity and psychological stress cause oxidative stress to occur inside the body. By doing this study, the investigator hopes to learn whether the FDA-approved steroid medication called Betamethasone will restore overall antioxidant activity fALS patients with mutations in the Fused in Sarcoma gene (FUS gene). Participants who agree to take part in this research study, agree to the following responsibilities: - Attend all scheduled visits - Notify the study doctor of any illnesses, unexpected or troublesome side effects, or any other medical problems that occur during the study - Be completely honest with their answers to all questions - Check with the study doctor before taking any new medications, whether prescribed or "over the counter," even vitamins and herbal supplements.
OTC	NCT03707795 ↗	Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study	Completed	University of Kentucky	Early Phase 1	2017-08-21	By doing this study the investigator hopes to learn more about a potential cause of amyotrophic lateral sclerosis (ALS) called "oxidative stress". Oxidative stress is essentially an imbalance between the production of certain chemicals in the body called "free radicals" and the ability of the body to counteract or detoxify their harmful effects through neutralization by antioxidants. It is thought that factors such as environmental exposure (chemicals and lead), diet, smoking,alcohol consumption, physical activity and psychological stress cause oxidative stress to occur inside the body. By doing this study, the investigator hopes to learn whether the FDA-approved steroid medication called Betamethasone will restore overall antioxidant activity fALS patients with mutations in the Fused in Sarcoma gene (FUS gene). Participants who agree to take part in this research study, agree to the following responsibilities: - Attend all scheduled visits - Notify the study doctor of any illnesses, unexpected or troublesome side effects, or any other medical problems that occur during the study - Be completely honest with their answers to all questions - Check with the study doctor before taking any new medications, whether prescribed or "over the counter," even vitamins and herbal supplements.

All Clinical Trials for Sodium Phosphate P 32

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004767 ↗	Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders	Completed	Johns Hopkins University	Phase 2	1985-01-01	OBJECTIVES: I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.
NCT00004767 ↗	Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders	Completed	National Center for Research Resources (NCRR)	Phase 2	1985-01-01	OBJECTIVES: I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.
NCT00074165 ↗	Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen	Terminated	National Cancer Institute (NCI)	Phase 2	2003-01-01	RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, etoposide phosphate, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain tumor. Chemoprotective drugs such as sodium thiosulfate may protect normal cells from the side effects of carboplatin-based chemotherapy. Combining rituximab with chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in treating patients who have refractory or recurrent primary CNS lymphoma.

Clinical Trial Conditions for Sodium Phosphate P 32

Condition Name

Condition Name for Sodium Phosphate P 32
Intervention	Trials
Colonoscopy	10
Healthy	7
Early Childhood Caries	4

Condition MeSH

Condition MeSH for Sodium Phosphate P 32
Intervention	Trials
Syndrome	7
Dental Caries	6
Renal Insufficiency, Chronic	6

Clinical Trial Locations for Sodium Phosphate P 32

Trials by Country

Trials by Country for Sodium Phosphate P 32
Location	Trials
United States	172
Germany	12
India	9
China	9
Israel	7

Trials by US State

Trials by US State for Sodium Phosphate P 32
Location	Trials
New York	14
California	12
Texas	12
North Carolina	8
Connecticut	8

Clinical Trial Progress for Sodium Phosphate P 32

Clinical Trial Phase

Clinical Trial Phase for Sodium Phosphate P 32
Clinical Trial Phase	Trials
Phase 4	41
Phase 3	25
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for Sodium Phosphate P 32
Clinical Trial Phase	Trials
Completed	90
Recruiting	23
Unknown status	20

Clinical Trial Sponsors for Sodium Phosphate P 32

Sponsor Name

Sponsor Name for Sodium Phosphate P 32
Sponsor	Trials
National Cancer Institute (NCI)	9
OHSU Knight Cancer Institute	5
University of California, San Francisco	4

Sponsor Type

Sponsor Type for Sodium Phosphate P 32
Sponsor	Trials
Other	186
Industry	50
NIH	20

Sodium Phosphate P-32: Clinical Trials, Market Analysis, and Projections

Introduction to Sodium Phosphate P-32

Sodium Phosphate P-32, or Phosphorus-32, is a radioactive isotope of phosphorus that has been utilized in various medical and therapeutic applications. It is particularly notable for its use in treating certain hematological conditions and palliating bone pain.

Clinical Trials and Efficacy

Treatment of Myeloproliferative Neoplasms (MPNs)

Phosphorus-32 has been used to treat myeloproliferative neoplasms (MPNs), such as polycythemia vera (PV), especially in patients who are unresponsive or intolerant to other therapies like hydroxyurea, interferon, or ruxolitinib. It is administered intravenously and accumulates in dividing cells, delivering radiation to cancerous tissues in the bone marrow, thereby killing these cells by interfering with their DNA[1].

Intratumoral Injection for Solid Tumors

In an early Phase II study, intratumoral injection of P-32 chromic phosphate showed promising results in patients with refractory solid tumors or solitary metastases. The study reported a 71% response rate, with complete remission in 41% of patients and partial remissions in 29%. The treatment was well-tolerated, with minimal side effects[3].

Palliation of Bone Pain

Sodium Phosphate P-32 is also used for the palliation of bone pain in patients with prostate and breast cancers who do not respond to conventional analgesics. It delivers beta electron radiation directly to bone lesions, providing pain relief in about half of the patients. Pain relief typically begins within two weeks and can last for an average of five months[5].

Side Effects and Safety Considerations

While Sodium Phosphate P-32 is effective, it comes with several side effects and safety considerations. Common side effects include decreased blood counts, diarrhea, fever, and nausea or vomiting. There is also a risk of leukemic transformation, particularly at higher doses, which is why it is often reserved for older patients or those with limited therapeutic options[1].

Market Analysis

Global Sodium Phosphate Market

The global sodium phosphate market, which includes various forms of sodium phosphate, was valued at USD 7.03 billion in 2023 and is expected to grow at a CAGR of 5.67% from 2024 to 2030, reaching nearly USD 10.34 billion. The market is driven by increasing demand in the food and beverages sector, as well as in fertilizers, detergents, and metal finishing. The Asia Pacific region leads the demand due to the growing population and increasing inclination towards processed foods[2].

Specific Market for Sodium Phosphate P-32

While the broader sodium phosphate market is significant, the specific market for Sodium Phosphate P-32 is more niche, focusing on its therapeutic applications. The demand for this product is influenced by its clinical efficacy, safety profile, and the availability of alternative treatments. In low- to middle-income regions, Sodium Phosphate P-32 is favored due to its cost-effectiveness and relatively easy accessibility compared to newer, more advanced radiopharmaceuticals[5].

Projections and Future Outlook

Therapeutic Applications

Given its established role in palliating bone pain and treating hematological conditions like polycythemia vera, Sodium Phosphate P-32 is expected to continue as a valuable therapeutic option. Its use is likely to be sustained, especially in regions where access to more advanced treatments is limited.

Market Growth

The growth of the Sodium Phosphate P-32 market will be influenced by the overall growth in the healthcare sector, particularly in oncology and hematology. As the global population ages and the incidence of cancers and hematological disorders increases, the demand for effective and cost-efficient treatments like Sodium Phosphate P-32 is expected to rise.

Economic and Accessibility Factors

Economic considerations will continue to play a crucial role in the adoption of Sodium Phosphate P-32. Its production and storage processes are well-established, making it a more accessible option in regions with limited healthcare infrastructure. This factor will contribute to its continued use in low- to middle-income countries[5].

Conclusion

Sodium Phosphate P-32 remains a significant therapeutic agent in the treatment of certain hematological conditions and the palliation of bone pain. Its efficacy, cost-effectiveness, and relatively easy accessibility make it a valuable option, particularly in regions with limited access to advanced healthcare facilities.

Key Takeaways

• Clinical Efficacy: Sodium Phosphate P-32 is effective in treating MPNs and palliating bone pain, with notable response rates and pain relief.
• Side Effects: Common side effects include decreased blood counts, diarrhea, fever, and nausea or vomiting, with a risk of leukemic transformation at higher doses.
• Market Analysis: The global sodium phosphate market is growing, driven by demand in various sectors, with the Asia Pacific region leading the demand.
• Future Outlook: Sodium Phosphate P-32 is expected to continue as a valuable therapeutic option, especially in low- to middle-income regions due to its cost-effectiveness and accessibility.

FAQs

What is Sodium Phosphate P-32 used for?

Sodium Phosphate P-32 is used to treat myeloproliferative neoplasms (MPNs) like polycythemia vera and to palliate bone pain in patients with prostate and breast cancers.

What are the common side effects of Sodium Phosphate P-32?

Common side effects include decreased blood counts, diarrhea, fever, and nausea or vomiting. There is also a risk of leukemic transformation at higher doses.

How does Sodium Phosphate P-32 work?

It accumulates in dividing cells and delivers radiation to cancerous tissues, killing these cells by interfering with their DNA.

What is the market size of the global sodium phosphate market?

The global sodium phosphate market was valued at USD 7.03 billion in 2023 and is expected to grow to nearly USD 10.34 billion by 2030.

Why is Sodium Phosphate P-32 preferred in low- to middle-income regions?

It is preferred due to its cost-effectiveness and relatively easy accessibility compared to newer, more advanced radiopharmaceuticals.

Sources

1. Richard T. Silver MD Myeloproliferative Neoplasms Center, "Phosphorous-32"
2. Maximize Market Research, "Global Sodium Phosphate Market – Global Industry Analysis and Forecast"
3. PubMed, "An early phase II study of intratumoral P-32 chromic phosphate"
4. PubMed, "Clinical trial: sodium phosphate tablets are preferred and better tolerated"
5. Open MedScience, "32P-Sodium Phosphate in Palliating Bone Pain"