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A randomized, double-blind, placebo-controlled phase II trial designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of PX578 in adults with POLG disease

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Trial Profile

A randomized, double-blind, placebo-controlled phase II trial designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of PX578 in adults with POLG disease

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 31 Aug 2026

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At a glance

  • Drugs PX 578 (Primary)
  • Indications Mitochondrial disorders
  • Focus Adverse reactions; Pharmacokinetics; Proof of concept
  • Acronyms POLARIS

Most Recent Events

  • 25 Aug 2026 According to the Pretzel Therapeutics media release, the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a first-in-patient clinical trial of PX578. The Phase 2 study, POLARIS (POLg Activation and Recovery In Subjects), will build on Phase 1 healthy volunteer study with PX578 conducted in New Zealand. The trial initiation planned in late 2026.
  • 20 Mar 2026 New trial record
  • 12 Mar 2026 According to the Pretzel Therapeutics media release, company will initiate a Phase 2 study in second half of 2026.

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