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A Phase III trial of ST-62516 to improve cardiorenal outcomes in patients undergoing percutaneous coronary intervention (PCI)

Trial Profile

A Phase III trial of ST-62516 to improve cardiorenal outcomes in patients undergoing percutaneous coronary intervention (PCI)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 14 Mar 2024

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At a glance

  • Drugs ST-62516 (Primary)
  • Indications Acute kidney injury
  • Focus Therapeutic Use
  • Sponsors Saghmos Therapeutics
  • Most Recent Events

    • 12 Mar 2024 According to a Saghmos Therapeutics media release, company announced that it has received a Notice of Allowance from the Japanese Patent Office for a patent for its Phase 3-ready product, ST-62516 (trimetazidine). The patent will provide exclusivity through 2037, with broad claims for the reduction of acute kidney injury in patients with chronic kidney disease (CKD) undergoing procedures with contrast dyes.
    • 21 Feb 2024 According to a Saghmos Therapeutics media release, IND for ST-62516 was cleared by the FDA in 2023.
    • 03 Oct 2023 According to a Saghmos Therapeutics media release, the company anticipates that its Phase 3 study can be initiated in 2024 after finalization of a Special Protocol Assessment.
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