Sodium Thiosulfate

Treats acute cyanide poisoning. Sold as Sodium Thiosulfate, Pedmark. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 3 applications for Sodium Thiosulfate (sold as Sodium Thiosulfate, Pedmark), first approved Feb 14, 1992, with 0 new uses approved and 2 published complete response letters.

First approved: Feb 14, 1992
Applications: 3
New uses approved: 0
Complete response letters: 2
Orphan exclusivity until: Sep 20, 2029
First approved in the EU: May 26, 2023

Orphan Designations (FDA)

8 designations, 1 approved for the designated use; see all orphan designations

Treatment of dermatomyositisHope Pharmaceuticals · designated Oct 28, 2014
Treatment of calciphylaxisEdinburg BioQuarter · designated Nov 19, 2012
Treatment of uremic and non-uremic calciphylaxisLuitpold Pharmaceuticals, Inc. · designated Feb 16, 2012
Treatment of uremic and non-uremic calciphylaxisHope Pharmaceuticals · designated Nov 9, 2011
Prevention of platinum-induced ototoxicity in pediatric patientsHope Pharmaceuticals · designated Oct 13, 2011
Treatment of sulfur mustard poisoningHope Pharmaceuticals · designated Mar 3, 2011
Treatment of extravasation of meclorethamine hydrochloride into subcutaneous tissues.Hope Pharmaceuticals · designated Dec 2, 2010
Prevention of platinum-induced ototoxicity in pediatric patientsFennec Pharmaceuticals, Inc. · designated Mar 17, 2004 · approved Sep 20, 2022 · exclusive to Sep 20, 2029

Approvals in the EU (EMA)

First approved in the EU 375 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Pedmarqsi, new substanceNorgine B.V. · May 26, 2023

Clinical Trials

18 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Ph. I/II Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)Solid Tumor Malignancies, Testicular Cancer · University of Arizona	Phase 1 / Phase 2	Recruiting	Feb 12, 2026
Transtympanic STS Against Cisplatin-induced SNHL: the SOUND TrialCisplatin-related Hearing Loss · The Netherlands Cancer Institute	Phase 3	Recruiting	Dec 15, 2025
Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography ImagesSystemic Sclerosis (SSc), Calcinosis Cutis · Yale University	—	Recruiting	Nov 14, 2025
Testing the Addition of Pedmark to Cisplatin Chemotherapy for Reducing Drug-Induced Ear Damage in Men With Stage II-III Metastatic Testicular Germ Cell TumorsHearing Loss, Metastatic Malignant Germ Cell Tumor · City of Hope Medical Center	Phase 1	Recruiting	Oct 21, 2025
Antibacterial Efficacy and Outcomes of Root Canal Irrigation MethodsPulp Necrosis, Apical Periodontitis · National and Kapodistrian University of Athens	Not applicable	Enrolling by invitation	May 6, 2025
Intralesional Injection of STS in Treatment of CalcinosisSystemic Sclerosis (SSc), Dermatomyositis · Robyn T. Domsic, MD, MPH	Phase 2	Recruiting	Nov 4, 2024
Bacterial Reduction After Supplementary Disinfection Procedures in Infected Root CanalsDental Pulp Necroses · Abhishek Parolia	Not applicable	Recruiting	Aug 26, 2024
Evaluation of Thiosulfate Enhanced Organ Preservation Solution in Kidney TransplantationRenal Transplant, Kidney Transplant · Alp Sener	Not applicable	Recruiting	Mar 1, 2024

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Feb 14, 1992	Sodium ThiosulfateNDA 20166 · TYPE 7	US Army	0	Discontinued
Feb 14, 2012	Sodium ThiosulfateNDA 203923 · New formulation or manufacturer	Hope Pharms	3	Marketed
Sep 20, 2022	PedmarkNDA 212937 · New formulation or manufacturer	Fennec Pharms Inc	0	Marketed

Complete Response Letters

FDA's published letters for these applications


Nov 26, 2021	PEDMARK (sodium thiosulfate injection)Facility Inspections And Manufacturing Processes, Clinical	Approved
Aug 10, 2020	PEDMARK (sodium thiosulfate injection)Product Quality, Facility Inspections	Approved

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA