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An Open-Label, Single-Arm Study of The Efficacy, Safety, and Pharmacokinetic Behavior of Leuprolide Mesylate Injectable Suspension (LMIS 25 mg) in Subjects With Prostate Cancer

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Trial Profile

An Open-Label, Single-Arm Study of The Efficacy, Safety, and Pharmacokinetic Behavior of Leuprolide Mesylate Injectable Suspension (LMIS 25 mg) in Subjects With Prostate Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jan 2025

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At a glance

  • Drugs Leuprorelin (Primary)
  • Indications Prostate cancer
  • Focus Therapeutic Use
  • Sponsors Foresee Pharmaceuticals

    • Most Recent Events

    • 13 Jan 2025 According to a Foresee Pharmaceuticals media release, company that the U.S. Food and Drug Administration (FDA) issued a Day-74 letter. The Day-74 letter states that the PDUFA goal date for a decision on marketing approval for the 3-month version of CAMCEVI for the treatment of adult patients with advanced prostate cancer is August 29, 2025.
    • 29 Oct 2024 According to a Foresee Pharmaceuticals media release, company has announced that it has submitted a 505(b)(2) New Drug Application for the 3-month version of CAMCEVI, a ready-to-use 3-month depot formulation of leuprolide mesylate, to the U.S. Food and Drug Administration (FDA) on basis of this trial.
    • 30 Apr 2019 This trial has been completed in Slovakia as per European Clinical Trials Database record.

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