PEDMARK (sodium thiosulfate)
Pedmark helps pediatric patients aged one month and older reduce the risk of hearing loss while undergoing cisplatin chemotherapy. It is used specifically for those with localized, non-metastatic solid tumors. This medication is intended for use with cisplatin infusions lasting six hours or less, as it may not be effective if permanent ear damage has already occurred during longer infusions.
How PEDMARK Works
Sodium thiosulfate works by interacting directly with cisplatin to create an inactive platinum species. It also enters cells to increase antioxidant glutathione levels and block oxidative stress, which prevents the death of hair cells in the cochlea.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2022-09-20
- Patent Cliff
- 2039
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
PEDMARK Approval History
What PEDMARK Treats
2 indicationsPEDMARK is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ototoxicity
- Solid Tumors
PEDMARK Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to PEDMARK
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03127774 | AAAQ9194 | Ph 2 | active not recruiting | Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma |
| NCT05382338 | ACNS2031 NCI-2022-04866, ACNS2031 | Ph 3 | recruiting | A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss |
| NCT04847063 | 210012 21-C-0012 | Ph 1 | recruiting | Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies |
| NCT05018221 BEAT-Calci | BEAT-Calci | Ph 3 | recruiting | Better Evidence and Translation for Calciphylaxis |
| NCT02527213 | 1STS12001 | Ph 3 | withdrawn | Double-blind Trial of Sodium Thiosulfate for the Treatment of Pain Associated With Calcific Uremic Arteriolopathy |
| NCT03092518 results posted | 170070 17-C-0070 | Ph 2 | completed | Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology |
| NCT03267277 results posted | 170161 17-E-0161 | Ph 2, Ph 3 | completed | Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis |
| NCT04541355 results posted | 20208 NCI-2020-05752 | Ph 2 | completed | Sodium Thiosulfate in Preventing Ototoxicity for Squamous Cell Cancer Patients Undergoing Chemoradiation With Cisplatin |
| NCT00716976 results posted | ACCL0431 COG-ACCL0431, CDR0000588655 | Ph 3 | completed | Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy |
| NCT02624479 TSTS | 009_15 | Ph 1 | withdrawn | Pharmacokinetic Study to Investigate the Bioavailability and Tolerability of 3 Oral Formulations of Sodium Thiosulfate |
| NCT03639779 results posted | BIO-18-14095 | Ph 4 | terminated | Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Saline for Dystrophic and Idiopathic Calcinosis Cutis |
| NCT02092298 results posted | 2013-0989 NCI-2014-01105 | Ph 2 | completed | Laparoscopic Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) for Metastatic Gastric Cancer |
| NCT03150420 CALISTA | ST-001 | Ph 3 | terminated | A Phase 3 Clinical Trial of Intravenous Sodium Thiosulfate in Acute Calciphylaxis Patients |
| NCT01833832 results posted | 130114 13-C-0114 | Ph 2 | completed | Surgery and Heated Chemotherapy for Adrenocortical Carcinoma |
| NCT02538939 THIOCAL | RC14_0394 | Ph 2 | completed | Efficacy and Tolerance of Sodium Thiosulfate Injection After Ultrasound-guided Percutaneous Irrigation of Calcific Tendinopathy of the Rotator Cuff |
| NCT01572844 results posted | 121131 | Ph 2 | completed | Topical Sodium Thiosulfate and Fractional Carbon Dioxide Laser in Treating Dermatomyositis Associated Calcinosis |
| NCT00397501 | IRB00002188 2188, SOL-06015 | Ph 1, Ph 2 | withdrawn | BBBD Followed By Methotrexate and Carboplatin With or Without Trastuzumab in Treating Women With Breast Cancer That Has Spread to the Brain |
| NCT01918904 STS-CALC | 205683 | Ph 2 | withdrawn | A Pilot Study to Evaluate Topical Sodium Thiosulfate Therapy for Calcinosis Cutis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PEDMARK FDA Label Details
Indications & Usage
FDA Label (PDF)PEDMARK is indicated for the treatment of Ototoxicity; Solid Tumors.
PEDMARK Patents & Exclusivity
Patents (6 active)
Exclusivity
Pro Intelligence Preview
Deep insights for PEDMARK
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 6 active patents
Trial Analysis
- • 18 total trials
- • Stage: Stable
Competitive Landscape
- • 5 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment