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A Phase 2b/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SPG601 in Male Participants With Fragile X Syndrome

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Trial Profile

A Phase 2b/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SPG601 in Male Participants With Fragile X Syndrome

Status: Not yet recruiting
Phase of Trial: Phase II/III

Latest Information Update: 04 Mar 2026

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At a glance

  • Drugs SPG 601 (Primary)
  • Indications Fragile X syndrome
  • Focus Registrational; Therapeutic Use
  • Sponsors Spinogenix

Most Recent Events

  • 04 Mar 2026 New trial record
  • 02 Mar 2026 According to Spinogenix media release, plans for a registrational-directed Phase 2b/3 trial have been agreed to with the FDA.
  • 02 Mar 2026 According to Spinogenix media release, company announced that a grant from the FRAXA Research Foundation will support the site principal investigators (PIs) in the Phase 2b trial of SPG601, a first-in-class treatment for Fragile X syndrome (FXS), assessing its safety and efficacy in patients with FXS. The planned Phase 2b adaptive trial design will allow a seamless transition into a Phase 3 trial.

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