sodium thiosulfate
Approved
Feb 14, 1992
Sodium thiosulfate (sodium thiosulphate/STS) is a chemical and medication. As a medication, it is used in combination with sodium nitrite under the trade name to NITHIODOTE treat cyanide poisoning. The primary route of endogenous cyanide detoxification is by enzymatic transulfuration to thiocyanate (SCN- ), which is relatively nontoxic and readily excreted in the urine. Sodium thiosulfate is thought to serve as a sulfur donor in the reaction catalyzed by the enzyme rhodanese, thus enhancing the endogenous detoxification of cyanide. In addition, Sodium thiosulfate is used in calciphylaxis in hemodialysis patients with end-stage kidney disease. Calciphylaxis is vasculopathy characterized by ischemia and painful skin necrosis due to calcification and intimal fibroplasia of thrombosis of the panicular arterioles. Sodium thiosulfate is used as treatment due to its antioxidant activity and as a chelating. Sodium thiosulfate renders renal protection by modulating the mitochondrial KATP channel for preventing urolithiasis. Moreover, STS was assumed to play a vital role in on ischemia reperfusion injury (IR). The effectiveness of STS as a cardioprotective agent was attributed to the reduction of apoptosis by binding to the active site of caspase-3 in silico, which was substantiated by the reduced expression of caspase-3 and poly ADP ribose polymerase levels. — NCATS
Clinical trial activity
64 trials · 60 clinical orgs · 3 marketing orgs
Earliest trial started Aug 1, 1999 (NCT00165555)
Timeline
1990s
- Feb 14, 1992
United States Army — Earliest FDA Approval
- Feb 14, 1992
United States Army — NDA Organization
- Jan 1, 1999
Earliest Phase 1 Sponsor(trial)
2010s
- Jan 14, 2011
Hope Pharmaceuticals — NDA Secondary Org
2020s
- Sep 20, 2022
Fennec Pharma — Marketing Organization
- Sep 20, 2022
Fennec Pharma — NDA Secondary Org
Indications
Approved for
Studied for
- Acute Coronary Syndrome · Phase 1/Phase 2
- Adrenocortical Carcinoma · Phase 2
- Appendiceal Neoplasms · Phase 1
- Astrocytoma · Phase 1/Phase 2
- Bone Marrow Diseases · Phase 1
- Brain Neoplasms · Phase 3
- Breast Neoplasms · Phase 1/Phase 2
- Calcinosis · Phase 4
- Calciphylaxis · Phase 3
- Carcinoma, Squamous Cell · Phase 2
- Central Nervous System Neoplasms · Phase 3
- Cognition Disorders · Phase 1/Phase 2
- Colonic Neoplasms · Early Phase 1
- Colorectal Neoplasms · Early Phase 1
- Connective Tissue Diseases · Phase 2
- Coronavirus Infections · Phase 2
- COVID-19 · Phase 2
- Dermatomyositis · Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 2
- Drugs, Investigational · Phase 2
- Esophageal Neoplasms · Phase 2
- Esophagogastric Junction · Phase 2
- Fallopian Tube Neoplasms · Early Phase 1
- Gallbladder Neoplasms · Early Phase 1
- Gastrointestinal Neoplasms · Phase 2
- Glioma · Phase 2
- Hamartoma · Phase 2
- Head and Neck Neoplasms · Phase 2
- Healthy Volunteers · Phase 1
- Hearing Loss · Phase 1
- Heart Failure · Phase 2
- Hepatoblastoma · Phase 3
- Hyperthermic Intraperitoneal Chemotherapy · Phase 2
- Hypopharyngeal Neoplasms · Phase 2
- Kidney Failure, Chronic · Phase 1
- Laryngeal Neoplasms · Phase 2
- Liposarcoma · Early Phase 1
- Liver Neoplasms · Phase 3
- Lung Neoplasms · Phase 1
- Lymphoma · Phase 2
- Medulloblastoma · Phase 3
- Mesothelioma · Phase 2
- Mesothelioma, Malignant · Phase 2
- Mouth Neoplasms · Phase 2
- Myocardial Infarction · Phase 2
- Myositis · Phase 2
- Neoplasm Metastasis · Phase 1
- Neoplasms · Phase 3
- Neoplasms, Germ Cell and Embryonal · Phase 1/Phase 2
- Nervous System Malformations · Early Phase 1
- Neuroblastoma · Phase 3
- Neuroectodermal Tumors · Phase 1/Phase 2
- Neuroectodermal Tumors, Primitive · Phase 1/Phase 2
- Oligodendroglioma · Phase 1/Phase 2
- Oropharyngeal Neoplasms · Phase 2
- Ototoxicity · Phase 3
- Ovarian Neoplasms · Phase 3
- Peripheral Arterial Disease · Phase 3
- Peritoneal Neoplasms · Phase 2/Phase 3
- Pseudohypoparathyroidism · Phase 2
- Rectal Neoplasms · Early Phase 1
- Rhabdomyosarcoma · Early Phase 1
- Sarcoma · Phase 3
- Scleroderma, Systemic · Phase 2
- Sclerosis · Phase 2
- Shoulder Pain · Phase 2
- Squamous Cell Carcinoma of Head and Neck · Phase 2
- Stomach Neoplasms · Phase 2/Phase 3
- Tendinopathy · Phase 2
- Thrombocytopenia · Phase 2
- Vascular Calcification · Phase 2
- Virus Diseases · Phase 2
Mechanism of action
- Unspecified targetOTHER
Unknown
- UnclearUnclear
Unclear unclear
Combination products
nithiodote
with sodium nitrite
Approval history
- approvedFeb 14, 1992
Chemistry & pharmacology
SMILES
O=S(O)(O)=S- Mol. weight
- 114.15 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- Yes
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL1208642 ↗
- WikipediaSodium thiosulfate ↗
- NCATSLLT6XV39PY ↗
- ChEMBLCHEMBL2096650 ↗
Also known as
- ametox
- ametox
- disodium thiosulphate
- e539
- e539
- monosulfanemonosulfonic acid
- monosulfanemonosulfonic acid
- pentahydrate of sodium thiosulfate
- sodium thiosulfate
- sodium thiosulfate
- sodium thiosulfate
- sodium thiosulfate
- sodium thiosulfate
- sodium thiosulfate
- sodium thiosulfate
- sodium thiosulfate
- sodium thiosulfate
- sodium thiosulfate
- sodium thiosulfate anhydrous
- sodium thiosulfate pentahydrate
- sodium thiosulfate pentahydrate
- sodium thiosulfate pentahydrate
- sodium thiosulfate (usan)
- sodothiol
- sulfothiorine
- sulfothiorine
- sulfothiorine
- sulfurothioic s-acid
- sulfurothioic s-acid
- thiosulfate
- thiosulfate
- thiosulfate
- thiosulfate
- thiosulfuric acid
- thiosulfuric acid
- thiosulfuric acid
- thiosulfuric acid, disodium salt
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07218913 | Phase 1 | Feb 4, 2026 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT07229040 | Phase 2 | Feb 21, 2025 | Hospital General Universitario Gregorio Marañon |
| NCT06685887 | Phase 2 | Dec 31, 2024 | BeOne Medicines, Huazhong University of Science and Technology |
| NCT06672822 | Phase 2 | Dec 1, 2024 | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Pittsburgh |
| NCT06427252 | Phase 2 | May 31, 2024 | Nanjing Medical University |
| NCT06288152 | N/A | Mar 1, 2024 | University of Western Ontario |
| NCT06213519 | Phase 2 | Feb 20, 2024 | Sichuan University |
| NCT05756660 | Early Phase 1 (Phase 1) | Mar 1, 2023 | University of Cincinnati |
| NCT05300945 | Phase 2/Phase 3 (Phase 3) | Jan 1, 2023 | Huazhong University of Science and Technology |
| NCT05382338 | Phase 3 | Dec 9, 2022 | National Cancer Institute (NCI) |
| NCT05430035 | Early Phase 1 (Phase 1) | Jun 23, 2022 | West Virginia University |
| NCT05277285 | Phase 2 | Apr 1, 2022 | Hellenic Institute for the Study of Sepsis, National Kapodistrian University of Athens |
| NCT05232357 | Early Phase 1 (Phase 1) | Mar 1, 2022 | People's Liberation Army of China |
| NCT04847063 | Phase 1 | Oct 19, 2021 | National Cancer Institute (NCI) |
| NCT04983238 | Phase 1/Phase 2 (Phase 2) | Sep 1, 2021 | Byondis |
| NCT05018221 | Phase 3 | Aug 26, 2021 | Australasian Kidney Trials Network, Salford Royal Foundation NHS Trust, University of Sydney, Waitemata District Health Board |
| NCT04541355 | Phase 2 | Oct 14, 2020 | NRG Oncology, University of California, San Francisco |
| NCT04478292 | Phase 3 | Jun 1, 2020 | Fudan University, Jiao Tong University, University of Cincinnati |
| NCT04292184 | Phase 1 | Mar 31, 2020 | University of Western Ontario |
| NCT04282356 | Phase 2 | Mar 31, 2020 | Government of France, University of Montpellier |
Organizations
Research & Development (60)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Government | 14 | 5 | 3 | 2003 |
| Oregon Health and Science University | Academic/Hospital | 7 | 7 | 2 | 2003 |
| Harvard University | Academic/Hospital | 4 | 4 | 2 | 1999 |
| Huazhong University of Science and Technology | Academic/Hospital | 2 | 2 | 2 | 2023 |
| People's Liberation Army of China | Government | 2 | 2 | 2 | 2020 |
| University of Bern | Academic/Hospital | 2 | 2 | 2 | 2009 |
| University of Cincinnati | Academic/Hospital | 2 | 1 | 2 | 2020 |
| University of Groningen | Academic/Hospital | 2 | 2 | 1 | 2016 |
| University of Texas at Houston | Academic/Hospital | 2 | 2 | 1 | 2014 |
| University of Western Ontario | Academic/Hospital | 2 | 2 | 2 | 2020 |
| Australasian Kidney Trials Network | Academic/Hospital | 1 | 0 | 1 | 2021 |
| BeOne Medicines | For profit | 1 | 0 | 1 | 2024 |
| Byondis | For profit | 1 | 1 | 1 | 2021 |
| Children's Cancer and Leukaemia Group | Academic/Hospital | 1 | 1 | 1 | 2007 |
| City of Hope National Medical Center | Academic/Hospital | 1 | 1 | 1 | 2026 |
| Columbia University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Daiichi Sankyo | For profit | 1 | 1 | 1 | 2015 |
| Decibel Therapeutics | For profit | 1 | 1 | 1 | 2020 |
| Department of Veteran Affairs | Government | 1 | 1 | 1 | 2009 |
| Fennec Pharma | For profit | 1 | 0 | 1 | — |
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Fennec Pharma | For profit | MKTG | Sep 20, 2022 |
| Fennec Pharma | For profit | NDA2 | Sep 20, 2022 |
| Hope Pharmaceuticals | For profit | NDA2 | Jan 14, 2011 |
| United States Army | Government | NDA | Feb 14, 1992 |