CLINICAL TRIALS PROFILE FOR SODIUM THIOSULFATE

All Clinical Trials for SODIUM THIOSULFATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004547 ↗	Treatment of Peritoneal Cancer With Surgery, Perfused Heated Cisplatin and Chemotherapy	Completed	National Cancer Institute (NCI)	Phase 2	2000-01-01	This study will test the effectiveness of an experimental treatment for peritoneal cancer involving surgical removal of the tumor, perfusion of the abdomen during surgery with a heated solution of the drug cisplatin, and post-surgery combination chemotherapy in the abdomen with fluorouracil (5-FU) and paclitaxel. Patients with certain peritoneal cancer whose tumors are confined to the abdomen may be eligible for this study. Candidates are screened with a medical history and physical examination, including blood tests, electrocardiogram and possibly bone scan, brain magnetic resonance imaging (MRI), and chest, abdomen and pelvic CT scans. Participants undergo surgery to remove as much tumor as possible. Part of the intestines, pancreas, stomach or the entire spleen may also be removed if they are affected. During surgery, after the tumor has been removed, two catheters (thin plastic tubes) are placed in the abdomen. A chemotherapy solution containing the anti-cancer drug cisplatin heated to a temperature of about 108.6 degrees (10 degrees above normal body temperature) is then delivered into the abdomen through one catheter and drained through another. During treatment, a drug called sodium thiosulfate is given through a vein to reduce the risk of side effects of cisplatin, particularly kidney damage. After 90 minutes of bathing the abdomen with this solution, the drug is rinsed from the abdomen and the catheters removed. Another small catheter is then placed and left inside the abdomen with one end coming out through the skin. Seven to 12 days after the operation, the anti-cancer drugs 5-FU and paclitaxel are given through this catheter. After complete recovery from the surgery, the catheter is removed and the patient is discharged from the hospital. Clinic visits are scheduled for periodic follow-up examination, imaging, and tests 3 and 6 months after surgery and every 6 months for up to 5 years as long as the disease does not worsen. Patients whose disease progresses are taken off the study and referred back to their local physician or referred for alternative care or other research studies. Patients are also asked to assess how this therapy affects their general health and well being. This will require filling out two quality-of-life (QOL) questionnaires before surgery and again at each follow-up visit after surgery. Each questionnaire takes about 15 minutes to complete.
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.
NCT00074165 ↗	Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen	Terminated	OHSU Knight Cancer Institute	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.
NCT00075387 ↗	Combination Chemotherapy With or Without Sodium Thiosulfate in Preventing Low Platelet Count While Treating Patients With Malignant Brain Tumors	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2003-03-07	This randomized phase II trial studies how well giving combination chemotherapy with or without sodium thiosulfate works in preventing low platelet count while treating patients with malignant brain tumors. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Sodium thiosulfate may prevent low platelet counts in patients receiving chemotherapy. It is not yet known whether combination chemotherapy is more effective with or without sodium thiosulfate in preventing low platelet count during treatment for brain tumors.
NCT00075387 ↗	Combination Chemotherapy With or Without Sodium Thiosulfate in Preventing Low Platelet Count While Treating Patients With Malignant Brain Tumors	Active, not recruiting	Oregon Health and Science University	Phase 2	2003-03-07	This randomized phase II trial studies how well giving combination chemotherapy with or without sodium thiosulfate works in preventing low platelet count while treating patients with malignant brain tumors. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Sodium thiosulfate may prevent low platelet counts in patients receiving chemotherapy. It is not yet known whether combination chemotherapy is more effective with or without sodium thiosulfate in preventing low platelet count during treatment for brain tumors.

Clinical Trial Conditions for SODIUM THIOSULFATE

Condition Name

Condition Name for SODIUM THIOSULFATE
Intervention	Trials
Ototoxicity	4
Malignant Pleural Mesothelioma	4
Sarcoma	3
Calciphylaxis	3

Condition MeSH

Condition MeSH for SODIUM THIOSULFATE
Intervention	Trials
Calcinosis	9
Mesothelioma	8
Ototoxicity	8
Mesothelioma, Malignant	7

Clinical Trial Locations for SODIUM THIOSULFATE

Trials by Country

Trials by Country for SODIUM THIOSULFATE
Location	Trials
United States	89
Canada	13
United Kingdom	5
Australia	5
China	4

Trials by US State

Trials by US State for SODIUM THIOSULFATE
Location	Trials
Oregon	8
Minnesota	6
Ohio	6
Maryland	6
Texas	5

Clinical Trial Progress for SODIUM THIOSULFATE

Clinical Trial Phase

Clinical Trial Phase for SODIUM THIOSULFATE
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 4	4

Clinical Trial Status

Clinical Trial Status for SODIUM THIOSULFATE
Clinical Trial Phase	Trials
Completed	20
Recruiting	16
Terminated	10

Clinical Trial Sponsors for SODIUM THIOSULFATE

Sponsor Name

Sponsor Name for SODIUM THIOSULFATE
Sponsor	Trials
National Cancer Institute (NCI)	15
OHSU Knight Cancer Institute	7
Oregon Health and Science University	4

Sponsor Type

Sponsor Type for SODIUM THIOSULFATE
Sponsor	Trials
Other	83
NIH	18
Industry	7

Clinical Trials Update, Market Analysis, and Projection for Sodium Thiosulfate

Last updated: October 28, 2025

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Introduction

Sodium Thiosulfate (STS) is a pharmaceutical compound with a well-established profile as an antidote for cyanide poisoning and a therapeutic agent for various clinical conditions. Over recent years, the drug has gained increased attention beyond its traditional use, driven by evolving clinical research and expanding indications. This comprehensive analysis focuses on current clinical trials, market dynamics, and future projections for Sodium Thiosulfate, serving as a critical resource for pharmaceutical stakeholders, investors, and healthcare providers.

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Clinical Trials Landscape: Status and Developments

Ongoing and Recent Clinical Trials

The landscape of Sodium Thiosulfate research has broadened significantly, with multiple active clinical trials registered on ClinicalTrials.gov (as of late 2022). These trials predominantly explore novel applications, including:

• Neuroprotection in Acute Kidney Injury (AKI): Several studies investigate whether STS can mitigate oxidative stress and improve renal outcomes in patients undergoing cardiothoracic surgery or nephrotoxic chemotherapy (e.g., cisplatin). For example, a phase II trial in India evaluated STS as a protective agent during cisplatin therapy, showing promising renal function preservation.

• Treatment of Cisplatin-Accurate Ototoxicity: Trials are examining whether STS administered post-chemotherapy reduces hearing loss associated with cisplatin, with initial results suggesting potential neuroprotective effects.

• Management of Calciphylaxis in End-Stage Renal Disease (ESRD): A small but growing number of trials assess STS’s efficacy in treating calciphylaxis, a rare but fatal disorder characterized by calcification of small blood vessels.

• Potential Oncology Applications: Preliminary investigations explore whether STS facilitates the detoxification of chemotherapeutic agents or protects healthy tissues, though these remain in early phases.

Regulatory and Development Milestones

While Sodium Thiosulfate is FDA-approved primarily as an antidote, no extensive Phase III trials are currently ongoing for new indications, reflecting its established safety profile and prior approvals. The drug’s development trajectory is expected to shift towards expanded indications, contingent on positive outcomes from ongoing clinical evaluations.

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Market Analysis

Current Market Size

The global sodium thiosulfate market was valued at approximately USD 200 million in 2021, primarily driven by its use in emergency antidotal therapy for cyanide poisoning, which remains a critical pharmaceutical application worldwide (IQVIA). The Asia-Pacific region commands a significant portion owing to the higher prevalence of industries involving cyanide-utilizing processes, such as mining and chemical manufacturing.

Market Drivers

• Expanding Clinical Indications: Growing evidence supporting nephroprotective and otoprotective applications is expected to catalyze market growth.

• Regulatory Approvals and Off-label Use: Countries are increasingly recognizing STS for adjunct treatments, particularly in oncology supportive care, enhancing demand.

• Rising Incidence of Nephrotoxicity and Calciphylaxis: An aging global population with comorbidities such as ESRD and increased use of nephrotoxic chemotherapeutics elevate demand.

• Advancements in Drug Delivery: Innovations such as intravenous formulations with improved bioavailability and stability aid market expansion.

Market Challenges

• Limited Indication Expansion: Regulatory hurdles for new indications limit widespread market penetration without substantial clinical evidence.

• Competition with Alternative Agents: The presence of other antidotes and nephroprotective drugs constrains market growth.

• Manufacturing Constraints: Ensuring consistent quality, especially for high-purity applications, can hamper supply.

Market Forecasts

The sodium thiosulfate market is projected to grow at a compound annual growth rate (CAGR) of approximately 8% from 2022 to 2030, reaching an estimated USD 400 million by 2030. The growth is underpinned by the ongoing clinical trials supporting expanded therapeutic areas, regulatory approvals, and increasing global healthcare expenditure.

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Future Outlook and Strategic Implications

Pipeline and Innovation

• Enhanced Formulations: Novel delivery systems, including liposomal and sustained-release preparations, are under research to maximize efficacy and patient compliance.

• Biomarker-guided Therapy: The integration of biomarkers to identify patients most likely to benefit from STS therapy could personalize treatment approaches and improve outcomes.

• Combination Therapy: Trials assessing the synergy of STS with other nephroprotective or neuroprotective agents could expand its clinical utility.

Regulatory and Market Entry

Progression of clinical trials toward Phase III will be pivotal for obtaining regulatory approvals for new indications. Strategic collaborations with academic institutions and life sciences companies could accelerate development timelines.

Commercial Strategies

Manufacturers should focus on establishing scalable, high-quality production processes, especially as demand for expanded indications rises. Market education about novel uses and safety profiles will be essential to facilitate adoption among clinicians.

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Key Takeaways

• Sodium Thiosulfate continues to evolve from an emergency antidote toward a multi-indication therapeutic, driven by promising clinical trials in nephrology, oncology, and otolaryngology.

• The market is expected to nearly double by 2030, supported by expanding indications, higher prevalence of relevant diseases, and improved formulations.

• Regulatory pathways and robust evidence from ongoing trials are critical to unlocking new market segments.

• Stakeholders should prioritize collaborative research, innovative formulations, and education to capitalize on future opportunities.

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FAQs

1. What are the primary current medical uses of Sodium Thiosulfate?
Its principal application is as an antidote for cyanide poisoning. Off-label, it is used in treating calciphylaxis in ESRD patients and under investigation for nephroprotection during chemotherapy.

2. Are there ongoing clinical trials exploring new indications for Sodium Thiosulfate?
Yes, multiple trials are examining its role in reducing nephrotoxicity in chemotherapy, preventing ototoxicity, and treating calciphylaxis, indicating a trajectory toward broader clinical use.

3. How does the market size of Sodium Thiosulfate look for the next decade?
The market is projected to grow at a CAGR of approximately 8%, reaching about USD 400 million by 2030, driven by new indications and increased clinical research.

4. What regulatory challenges could impact the expansion of Sodium Thiosulfate indications?
Regulatory approval for new indications requires robust clinical evidence demonstrating efficacy and safety. Lack of large-scale Phase III trials could delay or limit approvals.

5. What are the key factors influencing the competitive landscape of Sodium Thiosulfate?
Efficacy in new indications, formulation improvements, manufacturing capacity, and regulatory approvals are critical for market positioning amidst competition from alternative therapies.

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References

1. ClinicalTrials.gov. Sodium Thiosulfate Trials. https://clinicaltrials.gov.
2. IQVIA. Global Pharmacovigilance and Market Data, 2022.
3. MarketWatch. "Sodium Thiosulfate Market Analysis," 2022.
4. U.S. Food and Drug Administration. Sodium Thiosulfate Label.

Note: Figures and projections are estimates based on current trends and available data, subject to change with emerging research and regulatory developments.