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.
NCT00165503 ↗	Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate	Terminated	Brigham and Women's Hospital	Phase 2	2004-04-01	The purposes of this study are: to determine the feasibility of administering adjuvant cisplatin plus ALIMTA to patients who undergo surgery with heated cisplatin during surgery; to determine the effects (good and bad) of this combined modality approach in patients with mesothelioma; to evaluate cisplatin effects by determining where it goes and how it is excreted in the body from the collection of tissues and cisplatin samples; to collect and analyze discarded samples of mesothelioma tumor during surgery to help determine the genetic make-up of the disease.

Clinical Trial Conditions for sodium thiosulfate

Condition Name

Condition Name for sodium thiosulfate
Intervention	Trials
Ototoxicity	4
Malignant Pleural Mesothelioma	4
Calciphylaxis	3
Sarcoma	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
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
Pennsylvania	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

Last updated: May 22, 2026

Sodium Thiosulfate Clinical Trials Update, Market Analysis and Revenue Projections (2026–2035)

Sodium thiosulfate is a mature, off-patent active pharmaceutical ingredient (API) used across multiple indications, including cyanide antidote protocols, cisplatin-related toxicity management, and select dermatology and off-label supportive care. The clinical-trials and market picture is fragmented: ongoing activity is concentrated in toxicology protocols, oncology supportive care (especially cisplatin-induced ototoxicity and nephrotoxicity strategies), and device-and-regimen studies. Market projections depend more on hospital adoption patterns, guideline inclusion, and reimbursement than on new proprietary entrants because generic sodium thiosulfate is widely available.

Core market and clinical takeaways

• The dominant demand driver is hospital use in acute toxicology pathways and oncology supportive care where clinicians use sodium thiosulfate as an antidote adjunct or toxicity mitigation.
• Competitive pressure is structural: multiple manufacturers supply generic sodium thiosulfate injection in the US and other markets, limiting pricing power.
• “Pipeline value” is mostly incremental: new trials tend to refine dosing, timing, and combination regimens rather than create new, patent-protected drug products.
• Growth is likely to track (1) emergency medicine and toxicology guideline uptake, and (2) oncology prescribing volumes for cisplatin-based regimens in settings where thiosulfate protocols are used.

What clinical trials are recruiting or ongoing for sodium thiosulfate?

No complete, reliable global “clinical trials update” can be produced from the information available in this prompt alone. A defensible update requires a current, trial-by-trial pull from registries (ClinicalTrials.gov, EU CTR, ISRCTN) and then mapping each study to indication, phase, enrollment status, endpoints, and sites. Without registry-level source data and dates, a complete and accurate trials update cannot be generated.

Which indications drive sodium thiosulfate trials and near-term evidence?

A high-level indication map exists, but a clinical-trials update with timing and outcomes requires registry-backed specifics.

Indication clusters commonly tested in practice

• Acute cyanide poisoning protocols (adjunct timing, dosing regimens, and supportive measures).
• Cisplatin-related toxicity mitigation in oncology (renal protection, ototoxicity risk reduction, and regimen-specific timing).
• Dermatology and vasculopathy-adjacent uses (often smaller studies, sometimes off-label and investigator-led).
• Radiology adjunct concepts and other supportive-care pathways (less consistent evidence base across geographies).

What is the current market size and growth outlook for sodium thiosulfate?

A quantitative market analysis and projection requires current market sizing, shipment data, pricing, and forecast methodology inputs. The prompt does not provide those figures, and producing them without source-backed inputs would not meet an “actionable insights” standard for investment, licensing, or litigation work.

How do sodium thiosulfate price and competition trends affect revenue projections?

Generic structure typically drives the economics:

• Pricing compression is expected because sodium thiosulfate injection is widely manufacturable and available as generics across markets.
• Revenue is volume-driven: hospital procurement contracts, tender cycles, and formulary status determine sales more than differentiation.
• Bulk and hospital channels dominate demand, so forecast sensitivity is high to procurement volume and conversion of supportive-care pathways into standardized order sets.

Because no manufacturer-level or geography-level sales data is provided, a quantified forecast cannot be prepared.

When do sodium thiosulfate exclusivity and patent expirations matter?

Sodium thiosulfate as an API is generally off-patent, so exclusivity issues tend to be formulation- or product-specific rather than API-wide. A correct exclusivity timeline requires identifying the exact marketed products, their Orange Book entries (US), and corresponding patent estates by label, dosage form, and NDC. This cannot be generated accurately from the prompt alone.

What is the Orange Book status of sodium thiosulfate products?

A product-level Orange Book status requires NDC-linked searches. The prompt does not include any NDCs, product names, label strengths, or holders to map to Orange Book records, so a complete Orange Book analysis cannot be produced.

What formulations of sodium thiosulfate are used commercially and in trials?

Clinically, sodium thiosulfate is used primarily as an injectable (including IV administration). Trials and protocols may test:

• IV infusion vs IV push delivery timing
• Weight-based vs fixed dosing regimens
• Co-administration with other antidotes or supportive measures

A formulation-level commercial mapping requires product-level data (strengths, dosage forms, and manufacturers) not supplied here.

How does sodium thiosulfate compare with other antidotes and supportive-care agents?

Comparison requires:

• indication-by-indication competitor set (cyanide antidotes: hydroxocobalamin, amyl nitrite, sodium bicarbonate regimens, etc.; oncology supportive care: other nephro/otoprotection approaches)
• trial endpoints and guideline positions
• cost and formulary status

No such source-backed data is present in the prompt, preventing a complete comparison.

What generic entry risks exist for sodium thiosulfate?

Generic “entry risk” is usually low for an off-patent API, but real risk depends on:

• whether any product has still-active patents or exclusivities
• whether supply constraints exist (sterility, manufacturing capacity, raw material sourcing)
• whether there are product-specific regulatory or CMC barriers

Without product and regulatory detail, a risk assessment cannot be made without fabricating facts.

Which companies supply sodium thiosulfate and how concentrated is the market?

A concentration analysis requires:

• manufacturer lists by geography
• NDC and label strength mapping
• procurement footprint

The prompt does not provide these data, so concentration cannot be quantified.

What regulatory milestones affect sodium thiosulfate market access?

Regulatory milestones vary by country and by product. For the US, milestone relevance is linked to:

• FDA approval history by product and NDC
• any supplements affecting labeling, dosing, or manufacturing
• any REMS (unlikely for this class) or shortages affecting supply

No product identifiers are provided, so regulatory milestones cannot be reliably enumerated.

Market projection framework for sodium thiosulfate (what drives the forecast)

A credible projection model needs input variables such as baseline unit sales, average selling price (ASP), market share by manufacturer, and volume elasticity to guideline shifts. Without those, only a generic qualitative framework can be described, which is not sufficient for “revenue projections.”

Still, the projection drivers that typically control sodium thiosulfate sales are:

• Acute care episode volume (emergency and toxicology)
• Cisplatin utilization rates in oncology settings where thiosulfate protocols are adopted
• Hospital formulary adoption and order-set standardization
• Tender and procurement cycles by major purchasing groups
• Supply stability, including sterility and CMC batch release capacity
• Reimbursement patterns for hospital-administered injectables

Key Takeaways

• Sodium thiosulfate demand is primarily hospital-driven and tied to acute toxicology and oncology supportive-care pathways.
• Competitive dynamics are structurally generic, with pricing power constrained by multiple suppliers and tender-based procurement.
• A true clinical-trials update and quantified market projections require registry-level trial data and product-level market data; neither is present in the prompt, so a complete, accurate, and actionable update cannot be generated here.

FAQs

1. Is sodium thiosulfate still used as a cyanide antidote in current protocols?
2. Do cisplatin-supportive-care studies show benefits of sodium thiosulfate for kidney toxicity or hearing loss?
3. How does sodium thiosulfate dosing timing impact clinical outcomes in toxicology?
4. What are the main manufacturing bottlenecks for sterile sodium thiosulfate injection supply?
5. Which hospital procurement factors most influence sodium thiosulfate market share by manufacturer?

References

No sources were provided in the prompt, and no registry or FDA product data can be cited accurately without external lookup.