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Sodium thiosulfate - Fennec Pharmaceuticals

Drug Profile

Sodium thiosulfate - Fennec Pharmaceuticals

Alternative Names: PEDMARK; sodium-hyposulfite; STS - Fennec

Latest Information Update: 28 Dec 2018

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At a glance

  • Originator Oregon Health & Science University
  • Developer Fennec Pharmaceuticals
  • Class Antidotes; Antituberculars; Chemoprotectants; Thiosulfates; Vasodilators
  • Mechanism of Action Antioxidants; Chelating agents
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Sensorineural hearing loss
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Sensorineural hearing loss

Most Recent Events

  • 21 Dec 2018 Preregistration (rolling NDA) for Sensorineural hearing loss (In children, Prevention, Chemotherapy-induced, In neonates, In infants, In adolescents) in USA (IV)
  • 20 Dec 2018 Fennec Pharmaceuticals intends to submit MAA for Sensorineural hearing loss (Prevention, Chemotherapy induced) through the EMA's Paediatric-use marketing authorisation pathway in 2019
  • 07 Aug 2018 Pediatric Committee (PDCO) of the European Medicines Agency (EMA) accepts Fennec Pharmaceteuticals paediatric investigation plan (PIP) for PEDMARKTM for prevention of platinum-induced ototoxic hearing loss
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