Trial Profile

A 6 Month, Open Label, Ambulatory Blood Pressure Monitoring (ABPM) Extension Study

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 03 Dec 2025

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At a glance

Drugs Testosterone undecanoate (Primary)
Indications Hypogonadism
Focus Registrational; Therapeutic Use
Acronyms MRS-TU-2019EXT
Sponsors Marius Pharmaceuticals

Most Recent Events

12 Nov 2025 According to a Marius Pharmaceuticals media release, the company announce that Health Canada has approved KYZATREX (testosterone undecanoate) CIII capsules.
30 Jul 2024 According to a Marius Pharmaceuticals media release, the company announce the submission of its New Drug Submission (NDS) for KYZATREX (testosterone undecanoate) CIII capsules to Health Canada for approval with an anticipated approval date in Q2 of 2025.
11 Apr 2024 According to a Marius Pharmaceuticals media release, data from the study were presented in Therapeutic Advances in Urology,

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