Marius Pharmaceuticals LLC
- Country
- 🇺🇸United States
- Ownership
- Private
- Established
- 2017-01-01
- Employees
- 11
- Market Cap
- -
- Website
- http://www.mariuspharma.com
Clinical Trials
2
Trial Phases
1 Phases
Drug Approvals
1
Drug Approvals
Clinical Trials
Distribution across different clinical trial phases (2 trials with phase data)• Click on a phase to view related trials
Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men
- 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
Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men
- 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
News
Oral Testosterone Undecanoate Shows Superior Sexual Function Improvements in Phase 3 Trial
Oral testosterone undecanoate (Jatenzo) significantly improved serum testosterone levels, with 92% of men achieving levels of 450 ng/dL or higher by day 105 in the inTUne phase 3 trial.
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.