Drugs / Sodium Thiosulfate
Sodium Thiosulfate
also known as
STS · sodium thiosulphate · DB-020 · Pedmark · Seacalphyx · Sodium thiosulfate (STS) · sodium thiosulfate anhydrous · sodium thiosulfate pentahydrate injection BP · +1 more
Diagnostic / imaging agent targets ACE2, TMPRSS2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed cisplatin toxicity 3 milestones | |||||
| Rejected (CRL) | US (FDA) | PEDMARK | cisplatin toxicity | 2021-11-29 | “it received a Complete Response Letter (CRL) on November 29, 2021 from the U.S. Food and Drug Administration (FDA)” fennecpharma.com ↗ |
| Filed | US (FDA) | PEDMARK | cisplatin toxicity | 2021-05-28 | “today announced the resubmission of its New Drug Application (NDA ) to the U.S. Food and Drug Administration ( FDA ) for PEDMARK TM” fennecpharma.com ↗ |
| Filed | US (FDA) | PEDMARK | cisplatin toxicity | 2018-12-20 | “has initiated a rolling New Drug Application (NDA) for PEDMARK TM” fennecpharma.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Approved | EU (EMA) | Pedmarqsi | — | 2023-05-26 | europa.eu ↗ |
| Filed | EU (EMA) | PEDMARQSI | platinum-induced ototoxicity | 2020-02-11 | “Marketing Authorization Application (MAA) for its investigational drug, sodium thiosulfate (unique formulation) for infusion (tradename to be determined in EU), has passed validation” fennecpharma.com ↗ “The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename PEDMARQSI) is currently under evaluation by the European Medicines Agency (EMA).” fennecpharma.com ↗ “The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename PEDMARQSI) is currently under evaluation by the European Medicines Agency (EMA).” fennecpharma.com ↗ “submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sodium thiosulfate (tradename to be determined)” fennecpharma.com ↗ |
| Approved | US (FDA) | SODIUM THIOSULFATE | — | 1992-02-14 | fda.gov ↗ |
Trials 36
News releases announcing trial results or a regulatory action · 35
| Date | Issuer | Release |
|---|---|---|
| 2026-09-17 | Fennec Pharma | Results Fennec Pharmaceuticals Announces Oral Presentation of Detailed Results from Investigator-Initiated Phase 2 STS-J01 Clinical Study of Pedmark® in Japan at SIOP 2026 fennecpharma.com ↗
Primary Endpoint Met: American Speech-Language-Hearing Association (ASHA)-Defined Hearing Loss Occurred in 24.0% of Patients Versus the Prespecified Historical Benchmark of 56.4% (P=0.001) |
| 2026-05-21 | Fennec Pharma | Results Fennec Pharmaceuticals Announces New Research Supporting Integration and Use of PEDMARK® at the 2026 ASCO Annual Meeting fennecpharma.com ↗
Real-World Evidence Shows Administration of PEDMARK ® Approximately Six Hours After Cisplatin Can Be Safe & Easily Integrated into Patient Care and Does Not Compromise Cisplatin’s Established Antitumor Activity |
| 2026-03-24 | Fennec Pharma | Results Fennec Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update fennecpharma.com ↗
Announced Positive Topline Results from Investigator-Initiated Clinical Study of PEDMARK ® in Japan to Reduce Cisplatin-Induced Hearing Loss |
| 2026-02-20 | Fennec Pharma | Results Fennec Pharmaceuticals Presents Real World Data Supporting the Integration and Clinical Use of PEDMARK® in Treating Adults with Head & Neck Cancers fennecpharma.com ↗
This strict post-cisplatin timing is a validated approach intended to preserve cisplatin antitumor activity and no disruption to curative-intent cisplatin-based treatment delivery was observed as part of the study review. |
| 2025-12-02 | Fennec Pharma | Results Fennec Pharmaceuticals Announces Positive Topline Results From Investigator-Initiated Clinical Study of PEDMARK® in Japan to Reduce Cisplatin-Induced Hearing Loss fennecpharma.com ↗
The primary endpoint of the study was met |
| 2024-12-20 | Fennec Pharma | Regulatory Fennec Pharmaceuticals Announces Pedmarqsi® Positive Recommendation by NICE for the Prevention of Cisplatin-Induced Hearing Loss in England and Wales fennecpharma.com ↗ |
| 2024-02-01 | Fennec Pharma | Regulatory FDA Issues Reminder of Non-Substitution of PEDMARK® (sodium thiosulfate injection) for Pediatric Patients Receiving Cisplatin fennecpharma.com ↗ |
| 2023-06-06 | Fennec Pharma | Regulatory Fennec Pharmaceuticals Announces European Commission Marketing Authorization for Pedmarqsi™ (sodium thiosulfate) to Reduce the Risk of Hearing Loss in Pediatric Oncology Patients fennecpharma.com ↗
today announced Pedmarqsi™– known as PEDMARK ® in the U.S. – was granted marketing authorization by the European Commission . |
| 2023-03-31 | Fennec Pharma | Regulatory Fennec Pharmaceuticals Receives Positive CHMP Opinion for Pedmarqsi™ (sodium thiosulfate) to Reduce the Risk of Hearing Loss in Pediatric Oncology Patients fennecpharma.com ↗ |
| 2023-01-31 | Fennec Pharma | Regulatory Fennec Pharmaceuticals Announces PEDMARK® (sodium thiosulfate injection) Receives Orphan Drug Exclusivity from U.S. FDA fennecpharma.com ↗ |
| 2022-09-21 | Fennec Pharma | Regulatory Fennec Pharmaceuticals Announces FDA Approval of PEDMARK® (Sodium Thiosulfate Injection) fennecpharma.com ↗
This approval makes PEDMARK the first and only treatment approved by the FDA in this area of significant unmet medical need. |
| 2022-04-27 | Fennec Pharma | Regulatory Fennec Pharmaceuticals Announces FDA Acceptance for Filing of New Drug Application Resubmission for PEDMARK™ fennecpharma.com ↗ |
| 2022-03-24 | Fennec Pharma | Regulatory Fennec Pharmaceuticals Resubmits New Drug Application to U.S. Food and Drug Administration for Pedmark™ fennecpharma.com ↗ |
| 2021-11-30 | Fennec Pharma | Regulatory Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for PEDMARK™ to Prevent Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumors fennecpharma.com ↗
The CRL was issued as a result of identified manufacturing deficiencies which need to be satisfactorily resolved before the Pedmark NDA can be approved. |
| 2021-11-29 | Fennec Pharma | Regulatory Fennec Pharmaceuticals Expects to Receive Complete Response Letter from the FDA for its New Drug Application for PEDMARK™ to Prevent Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumors fennecpharma.com ↗
The FDA has indicated that, following a recent completion of a pre-approval inspection of the manufacturing facility of our drug product manufacturer, deficiencies have been identified. |
| 2021-06-22 | Fennec Pharma | Regulatory FENNEC PHARMACEUTICALS ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION RESUBMISSION FOR PEDMARK™ fennecpharma.com ↗
“We are pleased that the FDA has accepted our PEDMARK TM resubmission,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals, Inc. |
| 2021-05-28 | Fennec Pharma | Regulatory FENNEC PHARMACEUTICALS RESUBMITS NEW DRUG APPLICATION TO U.S. FOOD AND DRUG ADMINISTRATION FOR PEDMARK™ fennecpharma.com ↗
“We are pleased to have resubmitted the NDA for PEDMARK TM and look forward to working with the FDA through the review process,” |
| 2020-08-11 | Fennec Pharma | Regulatory Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for PEDMARK™ to Prevent Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumors fennecpharma.com ↗
Importantly, no clinical safety or efficacy issues were identified during the review and there is no requirement for further clinical data. |
| 2020-04-13 | Fennec Pharma | Regulatory Fennec Pharmaceuticals Announces FDA Filing Acceptance and Priority Review of New Drug Application for PEDMARK™ fennecpharma.com ↗ |
| 2020-02-28 | Fennec Pharma | Regulatory Fennec Pharmaceuticals Receives European Medicines Agency Validation for Marketing Authorization Application for Sodium Thiosulfate fennecpharma.com ↗ |
| 2020-02-11 | Fennec Pharma | Regulatory Fennec Pharmaceuticals Completes Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for PEDMARK™ and Also Submits Marketing Authorization Application (MAA) to European Medicines Agency fennecpharma.com ↗ |
| 2018-12-20 | Fennec Pharma | Regulatory Fennec Pharmaceuticals Initiates Rolling New Drug Application to U.s. Food and Drug Administration for PEDMARK™ fennecpharma.com ↗ |
| 2018-08-07 | Fennec Pharma | Regulatory Fennec Pharmaceuticals Receives Positive Opinion on the Pediatric Investigation Plan From European Medicines Agency for PEDMARK(TM) and Confirmation of Eligibility for a Pediatric Use Marketing Authorization fennecpharma.com ↗
The company was also advised that PEDMARK TM is eligible for submission of an application for a Pediatric Use Marketing Authorisation (PUMA). |
| 2018-06-21 | Fennec Pharma | Results Fennec Announces Publication of Pedmark(TM) Siopel 6 Clinical Data in the New England Journal of Medicine fennecpharma.com ↗
The NEJM publication provides the final results from the SIOPEL 6 study, a multi-centre open label randomized phase 3 study evaluating the efficacy of STS in reducing ototoxicity in patients receiving cisplatin monotherapy for standard risk hepatoblastoma. |
| 2018-03-27 | Fennec Pharma | Regulatory Fennec Pharmaceuticals Receives Breakthrough Therapy Designation by FDA for PEDMARK™ fennecpharma.com ↗ |
| 2018-03-21 | Fennec Pharma | Regulatory Fennec Pharmaceuticals Receives Fast Track Designation by FDA for PEDMARK fennecpharma.com ↗
Fennec Pharmaceuticals Inc. (NASDAQ:FENC) (TSX:FRX), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration ( FDA ) has granted PEDMARK (a unique formulation of sodium thiosulfate) Fast Track designation for prevention of cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma (SR-HB). |
| 2017-10-16 | Fennec Pharma | Results Fennec Announces Positive Results From Phase 3 SIOPEL 6 Study on PEDMARK™ (sodium thiosulfate) Presented at the 49th Congress of the International Society of Pediatric Oncology (SIOP) 2017 Meeting fennecpharma.com ↗
The study demonstrated that the addition of STS significantly reduces the incidence of cisplatin-induced hearing loss without any evidence of tumour protection. |
| 2017-09-13 | Fennec Pharma | Results FENNEC ANNOUNCES PRELIMINARY RESULTS OF SIOPEL 6 STUDY ON PEDMARK™ (SODIUM THIOSULFATE) TO BE PRESENTED AT THE 49TH CONGRESS OF THE INTERNATIONAL SOCIETY OF PEDIATRIC ONCOLOGY (SIOP) 2017 MEETING fennecpharma.com ↗
SIOPEL 6 shows that the addition of sodium thiosulfate significantly reduces the incidence of cisplatin-induced hearing loss without any evidence of tumor protection |
| 2016-12-01 | Fennec Pharma | Results FENNEC ANNOUNCES THE LANCET ONCOLOGY PUBLICATION OF CHILDREN’S ONCOLOGY GROUP STUDY OF SODIUM THIOSULFATE fennecpharma.com ↗
Through supporting and stimulating additional studies in this area, these results will contribute substantially to the ultimate goal of preventing cisplatin-induced hearing loss and its devastating consequences. |
| 2016-10-24 | Fennec Pharma | Results FENNEC ANNOUNCES UPDATE OF SIOPEL 6 STUDY ON SODIUM THIOSULFATE (STS) PRESENTED AT THE INTERNATIONAL SOCIETY OF PAEDIATRIC ONCOLOGY (SIOP) 2016 MEETING fennecpharma.com ↗
I am excited to show a positive extension of the results presented at ASCO demonstrating that the addition of STS to the treatment of standard risk hepatoblastoma has not adversely affected survival |
| 2016-06-06 | Fennec Pharma | Results FENNEC ANNOUNCES INTERIM RESULTS OF SIOPEL 6 STUDY ON SODIUM THIOSULFATE (STS) PRESENTED AT THE AMERICAN ASSOCIATION OF CLINICAL ONCOLOGY (ASCO) 2016 MEETING fennecpharma.com ↗
I am privileged to be able to show the 2 year clinical outcome data for SIOPEL 6 at ASCO and I am delighted that the addition of STS to the treatment of standard risk hepatoblastoma has not affected survival |
| 2015-05-31 | Fennec Pharma | Results FENNEC ANNOUNCES PRESENTATION OF POSITIVE INTERIM SODIUM THIOSULFATE PHASE III SAFETY DATA AT THE 2015 ASCO ANNUAL MEETING fennecpharma.com ↗
We are very pleased with the interim safety results presented at ASCO especially the conclusion, that, to date, STS as a chemoprotectant appears to have no adverse effect on the efficacy of cisplatin. |
| 2015-05-14 | Fennec Pharma | Results FENNEC ANNOUNCES AVAILABILITY OF SIOPEL 6 STUDY ABSTRACT FOR ASCO 2015 MEETING fennecpharma.com ↗
These results show no adverse outcome related to STS on the anti tumor efficacy in patients receiving cisplatin monotherapy for standard risk hepatoblastoma. |
| 2014-06-02 | Fennec Pharma | Results ADHEREX ANNOUNCES RESULTS FROM TWO SODIUM THIOSULFATE PHASE 3 STUDIES PRESENTED AT THE 50TH AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO) MEETING fennecpharma.com ↗
COG STUDY ACCL0431 meets primary endpoint for prevention of cisplatin-induced hearing loss in children |
| 2014-02-27 | Fennec Pharma | Results ADHEREX ANNOUNCES SODIUM THIOSULFATE CLINICAL STUDY UPDATE fennecpharma.com ↗
Adherex Technologies, Inc. ( AHX.TO )( ADHXF ) today announced that the Children’s Oncology Group (COG), posted top line results on http://clinicaltrials.gov/ under Study ACCL0431, A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children. |
All press releases naming this drug 44 releases
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 61 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sodium thiosulfate | “Sodium thiosulfate has previously been reported to reduce the incidence of acute kidney injury after HIPEC with cisplatin, but this finding has not been confirmed in a high-level study.” NCT05877911 ↗54“Sodium thiosulfate (STS) is currently used as a cyanide poisoning antagonist and a chemoprotectant against adverse effects of several chemotherapies such as Cisplatin.” NCT03582800 ↗ “Since the 7th amendment of the study, sodium thiosulfate as nephrtoxicity prevention has been administered concurrently with each PIPAC chemotherapy” NCT04811703 ↗ “During interval surgery the patient will undergo HIPEC (Cisplatin 100mg/m2, 1h 30 infusions with sodium thiosulfate renal protection).” NCT04282356 ↗ “Pedmark® sodium thiosulfate (STS) in reducing hearing impairment with standard of care cisplatin therapy.” NCT07407582 ↗ “along with an IV perfusion of sodium thiosulfate” NCT03842982 ↗ |
| Known as | DB-020 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04262336 ↗ |
| Known as | Pedmark | “receiving sodium thiosulfate anhydrous (Pedmark) plus cisplatin-based chemotherapy compared to those receiving cisplatin-based chemotherapy alone.” NCT07218913 ↗ |
| Known as | Seacalphyx | “Seacalphyx (sodium thiosulfate pentahydrate injection BP) 25%” NCT04292184 ↗ |
| Known as | Sodium thiosulfate (STS) | “Sodium thiosulfate (STS)” NCT04292184 ↗ |
| Known as | sodium thiosulfate anhydrous | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07218913 ↗ |
| Known as | sodium thiosulfate pentahydrate injection BP | “Seacalphyx (sodium thiosulfate pentahydrate injection BP) 25%” NCT04292184 ↗ |
| Known as | sodium thiosulphate | “Arm II (Neoadjuvant and adjuvant cisplatin and sodium thiosulphate): Patients receive cisplatin IV over 6 hours and sodium thiosulphate IV over 15 minutes (beginning 6 hours...” NCT00652132 ↗2“Another possibility is the use of sodium thiosulphate (Na2S2O3, STS), a major metabolite of H2S, commercially available compound and typically available as the pentahydrate,...” NCT04292184 ↗ |
| Known as | STS | “Efficacy of Sodium Thiosulfate (STS) compared to placebo, in reducing analgesic requirement in subjects with calcific uremic arteriolopathy (CUA) during an initial 28-day...” NCT02527213 ↗11“Sodium thiosulfate (STS) is currently used as a cyanide poisoning antagonist and a chemoprotectant against adverse effects of several chemotherapies such as Cisplatin.” NCT03582800 ↗ “Chronic treatment and prophylaxis of vessel and soft tissue calcification as well as of renal calculi could be a future indication for sodium thiosulfate (STS).” NCT02624479 ↗ “There are several case series that have shown the effectiveness of injecting a chemical compound called sodium thiosulfate (or "STS") into calcinosis lesions.” NCT06672822 ↗ “Sodium thiosulfate (STS) is a H2S-donor with known safety and efficacy profile in humans for other diseases, including calciphylaxis and cyanide poisoning.” NCT05277285 ↗ “Sodium thiosulfate (STS) has recently been used with success in the treatment of tumoral calcinosis.” PMID 31673978 ↗ Nov 2019 “Sodium thiosulfate solution (STS) has been used to neutralize iodine after Lugol's chromoendoscopy” PMID 34371004 ↗ Aug 2021 “Sodium thiosulfate (STS) (Na2S2O3) is primarily used to prevent and treat cyanide poisoning.” NCT04251832 ↗ “Transtympanic sodium thiosulphate (STS) 0.1M/0,5% hyaluronate” NCT07281508 ↗ “125mg/50ml sodium thiosulfate (STS) solution” NCT03639779 ↗ “H2S-donor sodium thiosulfate (STS)” PMID 34534493 ↗ Sep 2021 |
| Known as | Thiosulfuric Acid Disodium Salt | “Thiosulfuric Acid Disodium Salt” NCT00983398 ↗ |
| Action | Inhibit | “may block Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) entry into the host cells by interrupting Angiotensin-Converting Enzyme-2 (ACE2) and transmembrane...” NCT05277285 ↗ |
| Modality | Diagnostic / imaging agent | “Sodium thiosulfate-Methylene blue (DMB) staining solution was used as nerve staining agent.” NCT05232357 ↗ |
| Route | Intravenous | “Infused IV x 2 days” NCT00074165 ↗ |
| Target | ACE2 | “interrupting Angiotensin-Converting Enzyme-2 (ACE2) and transmembrane protease serine-2 (TMPRSS2)” NCT05277285 ↗ |
| Target | TMPRSS2 | “interrupting Angiotensin-Converting Enzyme-2 (ACE2) and transmembrane protease serine-2 (TMPRSS2)” NCT05277285 ↗ |