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An Open-Labeled, Singled-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects With Advanced Prostate Carcinoma

Trial Profile

An Open-Labeled, Singled-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects With Advanced Prostate Carcinoma

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Mar 2019

At a glance

  • Drugs Leuprorelin (Primary)
  • Indications Carcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Foresee Pharmaceuticals
  • Most Recent Events

    • 29 Mar 2019 According to a Foresee Pharmaceuticals media release, the company has submitted to the U.S. Food and Drug Administration a 505(b)(2) New Drug Application for LMIS 50 mg, a ready-to-use 6-month depot formulation of leuprolide mesylate. The application seeks approval for the use of this product for the palliative treatment of advanced prostate cancer. This NDA submission is supported by data from this study.
    • 31 Aug 2018 Biomarkers information updated
    • 26 Jul 2018 Regulatory submissions planned in 2018, as reported in a Foresee Pharmaceuticals media release.
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