MedPath

Marius Pharmaceuticals LLC

Marius Pharmaceuticals LLC logo
🇺🇸United States
Ownership
Private
Established
2017-01-01
Employees
11
Market Cap
-
Website
http://www.mariuspharma.com

Clinical Trials

2

Active:0
Completed:2

Trial Phases

1 Phases

Phase 3:2

Drug Approvals

1

FDA:1

Drug Approvals

Kyzatrex

Approval Date
Oct 26, 2023
FDA

Clinical Trials

Distribution across different clinical trial phases (2 trials with phase data)• Click on a phase to view related trials

Phase 3
2 (100.0%)

Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men

Phase 3
Completed
Conditions
Hypogonadism, Male
Interventions
Drug: SOV2012-F1
First Posted Date
2020-07-13
Last Posted Date
2024-06-28
Lead Sponsor
Marius Pharmaceuticals
Target Recruit Count
155
Registration Number
NCT04467697
Locations
🇺🇸

Alabama Clinical Therapeutics, LLC, Birmingham, Alabama, United States

🇺🇸

Coastal Clinic Research Inc, Mobile, Alabama, United States

🇺🇸

South Florida Medical Research, Aventura, Florida, United States

and more 15 locations

Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men

Phase 3
Completed
Conditions
Hypogonadism, Male
Interventions
Drug: SOV2012-F1
First Posted Date
2017-06-26
Last Posted Date
2023-06-28
Lead Sponsor
Marius Pharmaceuticals
Target Recruit Count
314
Registration Number
NCT03198728
Locations
🇺🇸

Central Research Associates, Inc., Birmingham, Alabama, United States

🇺🇸

Alabama Clinical Therapeutics, LLC, Birmingham, Alabama, United States

🇺🇸

Coastal Clinical Research, Inc., Mobile, Alabama, United States

and more 30 locations

News

KYZATREX Oral Testosterone Therapy Achieves 96% Efficacy Rate in Phase 3 Trials for Hypogonadism Treatment

KYZATREX, developed by Marius Pharmaceuticals, received FDA approval in 2022 as the first oral testosterone replacement therapy utilizing phytosterols for lymphatic absorption.

FDA Removes Cardiovascular Black Box Warning from Testosterone Products Following TRAVERSE Trial Results

The FDA has eliminated the cardiovascular black box warning from testosterone replacement therapy products, following conclusive evidence from the 5,000-patient TRAVERSE trial showing no increased cardiovascular risks.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.