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An Open-label, Single Arm, Multicenter, Phase III Study on the Efficacy, Safety, and Pharmacokinetics of FP-001 42 mg Controlled Release in Patients With Central (Gonadotropin-Dependent) Precocious Puberty (Casppian Study)

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Trial Profile

An Open-label, Single Arm, Multicenter, Phase III Study on the Efficacy, Safety, and Pharmacokinetics of FP-001 42 mg Controlled Release in Patients With Central (Gonadotropin-Dependent) Precocious Puberty (Casppian Study)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Jul 2025

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At a glance

  • Drugs Leuprorelin (Primary)
  • Indications Precocious puberty
  • Focus Registrational; Therapeutic Use
  • Acronyms Casppian
  • Sponsors Foresee Pharmaceuticals

Most Recent Events

  • 17 Jun 2025 According to a Foresee Pharmaceuticals media release, the company announced that based on the successful outcomes of the study completion by mid-2026, Foresee plans to submit a comprehensive New Drug Application (NDA) package to regulatory authorities by Q3 2026.
  • 17 Jun 2025 According to a Foresee Pharmaceuticals media release, the company announced the completion of enrollment in this phase 3 trial, and topline data from this trial is expected by the end of 2025.
  • 17 Jun 2025 Status changed from recruiting to active, no longer recruiting, according to a Foresee Pharmaceuticals media release.

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