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A Multi-centre Open-label Randomised Phase III Trial of the Efficacy of Sodium Thiosulphate in Reducing Ototoxicity in Patients Receiving Cisplatin Chemotherapy for Standard Risk Hepatoblastoma

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Trial Profile

A Multi-centre Open-label Randomised Phase III Trial of the Efficacy of Sodium Thiosulphate in Reducing Ototoxicity in Patients Receiving Cisplatin Chemotherapy for Standard Risk Hepatoblastoma

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 May 2026

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At a glance

  • Drugs Sodium thiosulfate (Primary)
  • Indications Sensorineural hearing loss
  • Focus Registrational; Therapeutic Use
  • Acronyms SIOPEL 6
  • Sponsors Fennec Pharmaceuticals

Most Recent Events

  • 06 May 2026 According to Norgine media release, based on the data from SIOPEL-6 and COG-ACCL0431 trials, The Australian Therapeutic Goods Administration (TGA) has approved PEDMARQSI (sodium thiosulfate anhydrous) to prevent hearing loss (ototoxicity) caused by cisplatin chemotherapy.
  • 26 Mar 2026 According to Norgine media release, company announced that Swissmedic has granted marketing authorisation for PEDMARQSI (sodium thiosulfate solution for infusion) indicated for the prevention of cisplatin induced ototoxicity (hearing loss) in patients aged 1 month to <18 years with localised, non-metastatic solid tumours.
  • 07 Feb 2025 According to a Fennec Pharmaceuticals media release, a Norgine Pharmaceuticals Ltd., a leading European specialist pharmaceutical company, has commercially launched PEDMARQSI (sodium thiosulfate injection) in Germany.

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