Sodium Thiosulfate

(sodium thiosulfate)

ApprovedSmall molecule

Sodium Thiosulfate is one of 182 small molecule programs targeting Auditory System Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

181

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Auditory System DiseaseUnknown

Renal InsufficiencyActive, not recruiting

NephrolithiasisActive, not recruiting

Disorder of EarUnknown

Kidney FailureActive, not recruiting

MortalityActive, not recruiting

Kidney TransplantActive, not recruiting

Intraperitoneal ChemotherapyRecruiting

CalciphylaxisRecruiting

Newly DiagnosedRecruiting

Auditory System DiseasePreclinical

Unknown

Renal InsufficiencyPreclinical

Active, not recruiting

NephrolithiasisPreclinical

Active, not recruiting

Disorder of EarPreclinical

Unknown

Kidney FailurePreclinical

Active, not recruiting

MortalityPreclinical

Active, not recruiting

Kidney TransplantPreclinical

Active, not recruiting

Intraperitoneal ChemotherapyPhase 2

Recruiting

CalciphylaxisPhase 3

Recruiting

Newly DiagnosedPhase 3

Recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

121 competitors in Kidney Transplant

#DrugCompanyPhaseTrials

Sodium Thiosulfate

HHope Pharmaceuticals

Approved

1 2

Ultomiris

AstraZeneca

Phase 3

1 3

Prevymis

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 3

3 4

Felzartamab

Biogen

Phase 3

1 5

Biological/vaccine

Vertex Pharmaceuticals

Phase 3

1 6

Cytogam

JJohns Hopkins University

Phase 3

2 7

Zemplar

AbbVie

Preclinical

2 8

Cysteine Hydrochloride

Novartis

Preclinical

1 9

Sensipar

Amgen

Preclinical

1 10

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

N/ANot yet recruiting

Kidney Transplant

NCT06288152

Q3 2027

Phase 3Recruiting

Newly Diagnosed

NCT04478292

Q2 2029

Phase 2Recruiting

Calcinosis

NCT06672822

Q4 2029

Phase 3Recruiting

Calciphylaxis

NCT05018221

Phase 3Recruiting

Childhood Medulloblastoma

NCT05382338

Clinical

Trials by Indication[1]

Calcinosis4 trials

Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images

Recruiting·YYale University··NCT07228429·56 enrolled

Intralesional Injection of STS in Treatment of Calcinosis

Recruiting·RRobyn T. Domsic, MD, MPH·Phase 2·NCT06672822·20 enrolled

A Pilot Study to Evaluate Topical Sodium Thiosulfate Therapy for Calcinosis Cutis

Withdrawn·LLoyola University·Phase 2·NCT01918904

Show 1 more trial

Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Saline for Dystrophic and Idiopathic Calcinosis Cutis

Terminated·—·Phase 4·NCT03639779·5 enrolled

Malignant Pleural Mesothelioma2 trials

Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin for Malignant Pleural Mesothelioma

Completed·—·Phase 1·NCT00165555·70 enrolled

Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma

Completed·—·Phase 1·NCT00571298·141 enrolled

Dermatomyositis2 trials

Topical Sodium Thiosulfate and Fractional Carbon Dioxide Laser in Treating Dermatomyositis Associated Calcinosis

Completed·AAlison Ehrlich·Phase 2·NCT01572844·3 enrolled

Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis

Completed·NNational Institute of Environmental Health Sciences (NIEHS)·Phase 2/3·NCT03267277·15 enrolled

Germ Cell Tumor2 trials

Melphalan, Carboplatin, Mannitol, and Sodium Thiosulfate in Treating Patients With Recurrent or Progressive CNS Embryonal or Germ Cell Tumors

Unknown status·OOHSU Knight Cancer Institute·Phase 1/2·NCT00983398·17 enrolled

Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy

Completed·CChildren's Oncology Group·Phase 3·NCT00716976·131 enrolled

Malignant Brain Tumors2 trials

Combination Chemotherapy With or Without Sodium Thiosulfate in Preventing Low Platelet Count While Treating Patients With Malignant Brain Tumors

Unknown status·OOHSU Knight Cancer Institute·Phase 2·NCT00075387·48 enrolled

Acetylcysteine, Mannitol, Combination Chemotherapy, and Sodium Thiosulfate in Treating Children With Malignant Brain Tumors

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT00238173·2 enrolled

30 more indications

Intraperitoneal2 trials

Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate

Terminated·—·Phase 2·NCT00165503·16 enrolled

Extrapleural Pneumonectomy With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate

Completed·—·Phase 2·NCT00165516·85 enrolled

Gastric Cancer2 trials

Laparoscopic Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) for Metastatic Gastric Cancer

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02092298·21 enrolled

Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT03092518·27 enrolled

Brain Tumors1 trial

Carboplatin, Melphalan, Etoposide Phosphate, Mannitol, and Sodium Thiosulfate in Treating Patients With Previously Treated Brain Tumors

Completed·OOHSU Knight Cancer Institute·Phase 1/2·NCT00303849·33 enrolled

Double-blind1 trial

Double-blind Trial of Sodium Thiosulfate for the Treatment of Pain Associated With Calcific Uremic Arteriolopathy

Withdrawn·AAmerican Regent, Inc.·Phase 3·NCT02527213

Shoulder pain1 trial

Efficacy of Sodium Thiosulfate in Shoulder Pain in Calcific Tendinitis of the Rotator Cuff

Unknown status·SSoraia Azevedo·Phase 2·NCT04251832·80 enrolled

Adrenocortical Carcinoma1 trial

Surgery and Heated Chemotherapy for Adrenocortical Carcinoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01833832·11 enrolled

Newly Diagnosed1 trial

A Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy

Recruiting·SShanghai Children's Medical Center·Phase 3·NCT04478292·330 enrolled

Endoscopy1 trial

The Efficacy of N-acetylcysteine on Alleviating Symptom Caused by Lugol Chromoendoscopy

Completed·XXijing Hospital of Digestive Diseases·N/A·NCT04764643·140 enrolled

Hearing Loss1 trial

The Effect of Sodium Thiosulfate Eardrops on Hearing Loss in Patients Who Receive Cisplatin Therapy

Terminated·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·N/A·NCT01369641·1 enrolled

ESS1 trial

A Compassionate Use Program to Provide Access to Sodium Thiosulfate

Available·TTRPHARM··NCT04132882

Liver Cancer1 trial

Cisplatin With or Without Sodium Thiosulfate in Treating Young Patients With Stage I, II, or III Childhood Liver Cancer

Completed·UUniversity of Birmingham·Phase 3·NCT00652132·116 enrolled

Intraperitoneal Chemotherapy1 trial

Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma

Recruiting·—·Phase 2·NCT03127774·30 enrolled

Ototoxicity1 trial

Sodium Thiosulfate in Preventing Ototoxicity for Squamous Cell Cancer Patients Undergoing Chemoradiation With Cisplatin

Completed·—·Phase 2·NCT04541355·16 enrolled

Kidney Transplant1 trial

Evaluation of Thiosulfate Enhanced Organ Preservation Solution in Kidney Transplantation

Not yet recruiting·UUnknown Sponsor·N/A·NCT06288152·120 enrolled

Function1 trial

Sodium Thiosulfate to Preserve Cardiac Function in STEMI

Unknown status·UUniversity Medical Center Groningen·Phase 2·NCT02899364·380 enrolled

Cisplatin1 trial

Sodium Thiosulfate Otoprotection During Salvage Cisplatin Therapy

Suspended·—·Phase 1·NCT05756660·33 enrolled

Carboplatin1 trial

Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen

Terminated·OOHSU Knight Cancer Institute·Phase 2·NCT00074165·17 enrolled

Calcification1 trial

Sodium Thiosulfate Treatment of Vascular Calcification in ESRD

Completed·WWashington University School of Medicine·N/A·NCT00568399·48 enrolled

Calciphylaxis1 trial

Better Evidence and Translation for Calciphylaxis

Recruiting·UUniversity of Sydney·Phase 3·NCT05018221·350 enrolled

Clinical Trial1 trial

A Phase 3 Clinical Trial of Intravenous Sodium Thiosulfate in Acute Calciphylaxis Patients

Terminated·HHope Pharmaceuticals·Phase 3·NCT03150420·29 enrolled

Pediatric Patients1 trial

Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for Abdominal for Pelvic Tumors in Pediatric Patients

Terminated·MMayo Clinic·Phase 1·NCT04213794·2 enrolled

Oral1 trial

Pharmacokinetic Study to Investigate the Bioavailability and Tolerability of 3 Oral Formulations of Sodium Thiosulfate

Withdrawn·IInsel Gruppe AG, University Hospital Bern·Phase 1·NCT02624479

Renal Failure1 trial

The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers

Completed·IInsel Gruppe AG, University Hospital Bern·N/A·NCT01008631·19 enrolled

Mortality1 trial

The Early Administration of Sodium Thiosulfate Should Help to Reduce the Mortality of Dialysis Patients With Calciphylaxis, From a National Cohort

Unknown status·—··NCT03146793·600 enrolled

Central Nervous System Lymphoma1 trial

Methotrexate, Mannitol, Rituximab, and Carboplatin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

Unknown status·OOHSU Knight Cancer Institute·Phase 1/2·NCT00293475·81 enrolled

Breast Cancer1 trial

BBBD Followed By Methotrexate and Carboplatin With or Without Trastuzumab in Treating Women With Breast Cancer That Has Spread to the Brain

Withdrawn·OOHSU Knight Cancer Institute·Phase 1/2·NCT00397501

Tendinitis1 trial

Efficacy and Tolerance of Sodium Thiosulfate Injection After Ultrasound-guided Percutaneous Irrigation of Calcific Tendinopathy of the Rotator Cuff

Completed·NNantes University Hospital·Phase 2·NCT02538939·17 enrolled

Childhood Medulloblastoma1 trial

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

Recruiting·CChildren's Oncology Group·Phase 3·NCT05382338·225 enrolled

Peritoneal Mesothelioma1 trial

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

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04847063·60 enrolled

Unspecified1 trial

Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers

Completed·VVA New York Harbor Healthcare System·N/A·NCT01088555·10 enrolled

Regulatory

FDA Approval Timeline[4]

Feb 14, 1992

SODIUM THIOSULFATE

NDA NDA020166

Feb 14, 2012

SODIUM THIOSULFATE

NDA NDA203923

Sep 20, 2022

PEDMARK

NDA NDA212937

Sources

References

[1]
ClinicalTrials.gov — 44 trial records for sodium thiosulfate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — sodium thiosulfate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for sodium thiosulfate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA212937). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Hope Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: HHope Pharmaceuticals

Sodium Thiosulfate

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2027

Q2 2029

Q4 2029

Trials by Indication[1]

Calcinosis4 trials

Malignant Pleural Mesothelioma2 trials

Dermatomyositis2 trials

Germ Cell Tumor2 trials

Malignant Brain Tumors2 trials

Intraperitoneal2 trials

Gastric Cancer2 trials

Brain Tumors1 trial

Double-blind1 trial

Shoulder pain1 trial

Adrenocortical Carcinoma1 trial

Newly Diagnosed1 trial

Endoscopy1 trial

Hearing Loss1 trial

ESS1 trial

Liver Cancer1 trial

Intraperitoneal Chemotherapy1 trial

Ototoxicity1 trial

Kidney Transplant1 trial

Function1 trial

Cisplatin1 trial

Carboplatin1 trial

Calcification1 trial

Calciphylaxis1 trial

Clinical Trial1 trial

Pediatric Patients1 trial

Oral1 trial

Renal Failure1 trial

Mortality1 trial

Central Nervous System Lymphoma1 trial

Breast Cancer1 trial

Tendinitis1 trial

Childhood Medulloblastoma1 trial

Peritoneal Mesothelioma1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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