Drug Profile

Testosterone undecanoate - Marius Pharmaceuticals

Alternative Names: KYZATREX; MRS 2012; SOV-2012-F1; T-replacement therapy - Marius

Latest Information Update: 20 Nov 2025

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At a glance

Originator SOV Therapeutics
Developer Marius Pharmaceuticals
Class Anabolic steroids; Androstenols; Hormonal replacements; Small molecules; Testosterone congeners
Mechanism of Action Testosterone replacements

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Hypogonadism
New Molecular Entity No
Available For Licensing Yes

Highest Development Phases

Marketed Hypogonadism

Most Recent Events

12 Nov 2025 Registered for Hypogonadism in Canada (PO)
25 Mar 2025 Marius Pharmaceuticals receives patent allowance for KYZATREX® (testosterone undecanoate) CIII Capsules
30 Jul 2024 Preregistration for Hypogonadism in Canada (PO)

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