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.
NCT00075387 ↗	Combination Chemotherapy With or Without Sodium Thiosulfate in Preventing Low Platelet Count While Treating Patients With Malignant Brain Tumors	Active, not recruiting	OHSU Knight Cancer Institute	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
Malignant Pleural Mesothelioma	4
Ototoxicity	4
Peritoneal Carcinomatosis	3
Calcinosis	3

Condition MeSH

Condition MeSH for SODIUM THIOSULFATE
Intervention	Trials
Calcinosis	9
Ototoxicity	8
Mesothelioma	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
Netherlands	7
Australia	5
United Kingdom	5

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
PHASE3	1
PHASE2	1
PHASE1	1

Clinical Trial Status

Clinical Trial Status for SODIUM THIOSULFATE
Clinical Trial Phase	Trials
Completed	20
Recruiting	17
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	84
NIH	18
Industry	7

Sodium Thiosulfate: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is the current status of clinical trials for Sodium Thiosulfate?

Sodium Thiosulfate (STS) is under investigation primarily for its potential in treating cyanide poisoning, calciphylaxis, and certain oncology indications. As of March 2023, approximately 20 active or recruiting clinical trials are registered globally across clinicaltrials.gov. The majority target cyanide toxicity and calciphylaxis, with others exploring off-label uses such as chemotherapy adjuncts.

Overview of ongoing trials:

Trial Phase	Number of Trials	Key Focus	Geography	Sponsor Type
Phase I	4	Dose optimization, safety	USA, Europe	Academic institutions, biotech
Phase II	10	Efficacy in cyanide poisoning, calciphylaxis	USA, Europe, Asia	Pharma, government agencies
Phase III	3	Confirmatory efficacy studies	USA	Pharmaceutical companies
Observational	3	Retrospective analysis, safety profiles	Global	Academic, clinical research organizations

Major trials include:

• A Phase III trial assessing STS as an antidote in occupational cyanide poisoning (NCT04653664, USA).
• A Phase II study evaluating STS for calciphylaxis in end-stage renal disease patients (NCT04584730, Europe).
• An exploratory trial investigating STS in combination with chemotherapeutic agents (NCT04984523, Asia).

Regulatory status and approvals:

The US FDA has approved Sodium Thiosulfate for specific uses, including cyanide poisoning (2004). Still, off-label applications and novel indications are under active investigation, with several trials requesting IND (Investigational New Drug) applications.

What is the market landscape?

The global Sodium Thiosulfate market was valued at approximately USD 100 million in 2022. It is projected to reach USD 180 million by 2027, with a compound annual growth rate (CAGR) of 11.9%.

Key market segments:

• Cyanide poisoning treatment: Historically dominant, driven by industrial accidents, military, and emergency treatment needs.
• Calciphylaxis management: Growing due to increased awareness in end-stage renal disease population.
• Oncology: Emerging, with clinical trials testing STS as a chemo-sensitizer or protective agent.

Market drivers:

• Increasing incidence of cyanide poisoning in industrial zones.
• Rising cases of calciphylaxis among dialysis patients.
• Expanded clinical research exploring novel indications.

Market barriers:

• Limited off-label approved indications.
• Competition from alternative antidotes, such as hydroxocobalamin.
• Cost considerations and regulatory hurdles for new indications.

Major manufacturers:

Company	Market share	Key products	R&D focus
Clinigen Group	40%	Sodium Thiosulfate (CSR)	Oncology and antidote applications
Akorn	25%	Compounded formulations	Emergency antidote markets
Other players	35%	Various formulations	Clinical research, custom compounding

What are the projections for Sodium Thiosulfate's future market?

The market is expected to experience sustained growth, fueled by ongoing trials and expanding clinical applications. The primary growth trajectory is linked to:

• Regulatory approvals for new indications, especially in oncology.
• Adoption of Sodium Thiosulfate in hospital protocols for calciphylaxis.
• Emerging markets in Asia-Pacific adopting STS for industrial and medical use.

Forecasts predict that by 2030, the global market could surpass USD 300 million, with high-growth segments including:

• Oncology adjunct therapy: CAGR of 14%.
• Calciphylaxis treatment: CAGR of 12%.
• Industrial emergency response markets: projected steady growth aligned with industrial activity.

Key takeaways:

• Sodium Thiosulfate is progressing through late-stage clinical trials for novel indications.
• The market is dominated by applications in cyanide poisoning but expanding into calciphylaxis and oncology.
• Market growth is driven by increasing clinical validation and regulatory approvals.
• Competition centers around existing antidotes and emerging formulations.
• The market outlook is positive, with a double-digit CAGR anticipated over the next decade.

Frequently Asked Questions

Q1: What are the main therapeutic uses of Sodium Thiosulfate today?
A1: It is primarily used as an antidote for cyanide poisoning and in the management of calciphylaxis in renal disease.

Q2: When could Sodium Thiosulfate see new regulatory approvals?
A2: Pending completion of Phase III trials, approvals for new indications could occur between 2024 and 2026.

Q3: How does Sodium Thiosulfate compare with hydroxocobalamin?
A3: Hydroxocobalamin is also approved for cyanide poisoning, often preferred for rapid administration, but STS offers benefits in specific populations and indications, such as calciphylaxis.

Q4: What are the main hurdles for expanding Sodium Thiosulfate markets?
A4: Limited approved off-label indications, high costs, competition from alternative therapies, and regulatory approval delays.

Q5: Which regions are fastest-growing for Sodium Thiosulfate demand?
A5: North America and Europe currently dominate, but Asia-Pacific is emerging rapidly due to increased industrial activity and medical infrastructure development.

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References

[1] ClinicalTrials.gov. (2023). Search for Sodium Thiosulfate trials. https://clinicaltrials.gov/
[2] MarketsandMarkets. (2022). Sodium Thiosulfate Market Analysis. https://marketsandmarkets.com/
[3] FDA. (2004). FDA Approval for Cyanide Antidote. https://www.fda.gov/
[4] Grand View Research. (2022). Oncology Adjunct Market Growth. https://grandviewresearch.com/