Education
About Us
Working with TipRanks
Follow Us
Mineralys Therapeutics, Inc. (MLYS)
NASDAQ:MLYS
Lorundrostat
Hypertension, Obstructive Sleep Apnea
Phase II
Active Not Recruiting
A Study to Assess the Efficacy and Safety of Lorundrostat in Participants With Obstructive Sleep Apnea and Hypertension
Jan 16, 2025
―
Lorundrostat Dose 1, Lorundrostat Dose 2
Hypertension
Phase III
Completed
Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension
Nov 17, 2023
―
Lorundrostat
Hypertension
Phase III
Active Not Recruiting
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
Jul 14, 2023
―
Lorundrostat Dose 1, Lorundrostat Dose 2
Hypertension
Phase II
Completed
A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects With Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen
Feb 24, 2023
―
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Mineralys Therapeutics, Inc. (MLYS) have in its pipeline
MLYS is currently developing the following drugs: Lorundrostat, Lorundrostat Dose 1, Lorundrostat Dose 2, Lorundrostat. These drug candidates are in various stages of clinical development as the company works toward FDA approval.