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Label indication PEDMARK is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. Limitations of Use The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. FDA label
Also known as Pedmark® STS
Pedmark · 1 trial · 4 indications
| Name | Type | Description |
|---|---|---|
| Pedmark® STS | DRUG | Pedmark® STS (20 g/m2) will be given via intravenous infusion over 15-30 minutes, starting 6 hours after the completion of cisplatin infusion. Pedmark® STS will be given each day of cisplatin infusion. |
Pedmark is an investigational small molecule developed by Fennec Pharmaceuticals Inc. (ticker: FENC) for use in solid tumor malignancies. It is being studied for otoprotection, meaning protection against hearing damage, during cisplatin treatment. Pedmark is also known as Pedmark STS or Pedmark® STS.
Pedmark is being studied for otoprotection during cisplatin treatment in adults with solid tumor malignancies, including testicular cancer, head and neck cancer, and thoracic cancer. Cisplatin is a common chemotherapy agent, and Pedmark is intended to protect hearing in patients receiving it.
Pedmark is developed by Fennec Pharmaceuticals Inc., which trades under the ticker FENC. The company is running the clinical program for the drug in solid tumor malignancies.
Pedmark is in Phase 2 development. It is investigational and is not described as approved. The ongoing study is a Phase I/II trial, and no completed trials are listed for the program.
Pedmark is being studied in NCT07407582, titled Ph. I/II Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS). The trial has a planned enrollment of 25 participants, is not yet recruiting, and is being conducted in the United States in adults aged 18 years and older.
Yes. Pedmark is also known as Pedmark STS and Pedmark® STS. These names refer to the same investigational drug developed by Fennec Pharmaceuticals Inc. for otoprotection during cisplatin treatment in solid tumor malignancies.