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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Followed by an Open-Label Extension to Evaluate the Safety and Efficacy of Canvuparatide (MBX 2109) in Adult Patients With Hypoparathyroidism

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Followed by an Open-Label Extension to Evaluate the Safety and Efficacy of Canvuparatide (MBX 2109) in Adult Patients With Hypoparathyroidism

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Sep 2026

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At a glance

  • Drugs Canvuparatide (Primary)
  • Indications Hypoparathyroidism
  • Focus Registrational; Therapeutic Use
  • Acronyms oPTimize
  • Sponsors MBX Biosciences

Most Recent Events

  • 27 Aug 2026 According to a MBX Biosciences media release, the first patient has been dosed in this trial.
  • 13 Jul 2026 According to a MBX Biosciences media release, the trial initiation expected in second half of 2026.
  • 09 Mar 2026 According to a MBX Biosciences media release, the company expects first patient enrollment in this study in Q3 2026, since the regulatory path toward an NDA submission has been confirmed with USFDA. Phase 3 trial design elements have now been selected, including the number of patients, primary and key secondary endpoints as well as dose selection, titration schedule and trial duration.

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