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Drug

Sodium thiosulfate

Approved · EMA
Emerging researchLate-stage development
Also known as Exoderm, Pedmark, Versiclear, Sodium hyposulfite+1 more

Exoderm, Pedmark, Versiclear, Sodium hyposulfite, thiosulfuric acid, disodium salt.

RxNorm36726
1
Research papers
7
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Individualized Response Assessment to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for the Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Primaries

Clinical trial2026-07-08Results expected Q4 2033 · ClinicalTrials.gov

Phase II Trial of Surgical Resection and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for Adrenocortical Carcinoma

Clinical trial2026-05-06Results expected Q4 2026 · ClinicalTrials.gov

A Phase 3 Study of Sodium Thiosulfate for Reduction of Cisplatin-Induced Ototoxicity in Children With Average-Risk Medulloblastoma and Reduced Therapy in Children With Medulloblastoma With Low-Risk Features

Clinical trial2026-05-05Results expected Q4 2029 · ClinicalTrials.gov

An Open Label Evaluation of Intralesional Injection of Sodium Thiosulfate in the Treatment of Cutaneous or Tendon Calcinosis in Connective Tissue Disease

Clinical trial2026-05-05Results expected Q3 2028 · ClinicalTrials.gov

A Phase 3 Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy Incorporating a Randomized Assessment of Sodium Thiosulfate as Otoprotection for Children With Localized Disease, and Response Adapted Therapy for Patients With Metastatic Disease

Clinical trial2026-05-04Results expected Q1 2027 · ClinicalTrials.gov

Evaluation of Thiosulfate Enhanced Organ Preservation Solution in Kidney Transplantation

Clinical trial2026-04-13Results expected Q1 2027 · ClinicalTrials.gov

Better Evidence and Translation for Calciphylaxis

Clinical trial2025-08-13Results expected Q4 2029 · ClinicalTrials.gov

Phase II Trial of Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology

Clinical trial2025-02-19Results posted · ClinicalTrials.gov

An Open-label Study of Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis

Clinical trial2024-11-26Results posted · ClinicalTrials.gov

A Prospective Study of Heated Intra-Peritoneal Chemotherapy (H.I.P.E.C.) With Doxorubicin and Cisplatin in Pediatric Patients With Pelvic and Abdominal Tumors. The TOAST IT Trial (Trial Of Adjuvant Surgical Treatment With Intraperitoneal Chemotherapy)

Clinical trial2024-10-03Terminated · ClinicalTrials.gov

Approval: Pedmarqsi (EMA)

Regulatory2023-05-26EMA

Effects of sodium thiosulfate versus observation on development of cisplatin-induced hearing loss in children with cancer (ACCL0431): a multicentre, randomised, controlled, open-label, phase 3 trial.

Research2016-12-01The Lancet. Oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Sodium thiosulfate
Aliases & brands
ExodermPedmarkVersiclearSodium hyposulfitethiosulfuric acid, disodium salt
RxNorm CUI
36726
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2023-05-26
Latest approval
2023-05-26
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2023-05-26Approval
Approval: Pedmarqsi (EMA)
Indication: Pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid… Show full indication

Pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

41 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
41
registered trials across all phases
LATEST COMPLETION 2024
7
Active studies
6
Recruiting
15
Late-stage (III+)
17
Completed
17
Discontinued
PHASE DISTRIBUTIONn = 41
Early Phase 12Phase 15Phase 1 / 24Phase 215Phase 2 / 31Phase 37Phase 41Phase N / A6

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Comparative Study of the Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Normal Saline for the Treatment of Dystrophic and Idiopathic Calcinosis Cutis, A Double-Blind Randomized Placebo-Controlled Trial

TerminatedPH IVUniversity of Central Floridan=52019

A Phase 3 Study of Sodium Thiosulfate for Reduction of Cisplatin-Induced Ototoxicity in Children With Average-Risk Medulloblastoma and Reduced Therapy in Children With Medulloblastoma With Low-Risk Features

RecruitingPH IIIChildren's Oncology Groupn=2252029

Better Evidence and Translation for Calciphylaxis

RecruitingPH IIIUniversity of Sydneyn=3502029

A Phase 3 Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy Incorporating a Randomized Assessment of Sodium Thiosulfate as Otoprotection for Children With Localized Disease, and Response Adapted Therapy for Patients With Metastatic Disease

RecruitingPH IIIShanghai Children's Medical Centern=3302027

An Open-label Study of Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis

CompletedPH II/IIINational Institute of Environmental Health Sciences (NIEHS)n=152023

Recent completions

Trials that read out recently, adding to the completed evidence base.

Phase II Trial of Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology

CompletedPH IINational Cancer Institute (NCI)n=272024

An Open-label Study of Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis

CompletedPH II/IIINational Institute of Environmental Health Sciences (NIEHS)n=152023

A Phase II Study of Sodium Thiosulfate (STS) for Prevention of Ototoxicity in Patients With Locally Advanced Squamous Cell Carcinoma of Head and Neck (SCCHN) Undergoing Concurrent Chemoradiation With Cisplatin

CompletedPH IIHyunseok Kang, MDn=162023

A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children

CompletedPH IIIChildren's Oncology Groupn=1312021

The Efficacy of N-acetylcysteine on Alleviating Symptom Caused by Lugol Chromoendoscopy: a Prospective, Non-inferiority, Randomized Controlled Trial

CompletedN/AXijing Hospital of Digestive Diseasesn=1402021

Phase I/II Study of Carboplatin, Melphalan and Etoposide Phosphate in Conjunction With Osmotic Opening of the Blood-Brain Barrier and Delayed Intravenous Sodium Thiosulfate Chemoprotection, in Previously Treated Subjects With Anaplastic Oligodendroglioma or Oligoastrocytoma

CompletedPH I/IIOHSU Knight Cancer Instituten=332021

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes6
Antineoplastic Agents1Antioxidants1Cisplatin1Hearing Loss1Neoplasms1Thiosulfates1
Journals, researchers & institutions
Top journals
  • The Lancet. Oncology1
Leading researchers
  • Bliss B1
  • Chen L1
  • Freyer DR1
  • Knight K1
  • Krailo MD1
  • Lange B1
  • Neuwelt EA1
  • Pollock BH1
Leading institutions
free-text, unnormalised
  • Children's Center for Cancer and Blood Diseases1
  • Children's Hospital of Philadelphia1
  • Doernbecher Children's Hospital1
  • Geisinger Medical Center1
  • Helen DeVos Children's Hospital1
  • Hospital for Sick Children1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.