Lorundrostat - Mineralys Therapeutics
Alternative Names: MLS-101; MT-4129Latest Information Update: 11 Sep 2025
At a glance
- Originator Mitsubishi Tanabe Pharma Corporation
- Developer Mineralys Therapeutics; Mitsubishi Tanabe Pharma Corporation
- Class Acetamides; Amides; Antihypertensives; Benzene derivatives; Cardiovascular therapies; Cyclohexylamines; Sleep disorder therapies; Small molecules; Triazines; Urologics
- Mechanism of Action Cytochrome P-450 CYP11B2 inhibitors
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Phase III Hypertension
- Phase II Renal failure; Sleep apnoea syndrome
- No development reported Cardiovascular disorders
Most Recent Events
- 05 Sep 2025 Mineralys Therapeutics announces intention to submit NDA to FDA for Hypertension in the fourth quarter of 2025 or the first quarter of 2026
- 05 Sep 2025 Mineralys Therapeutics plans a pre-NDA meeting with the FDA in the fourth quarter of 2025
- 30 Jun 2025 Adverse events and efficacy data from a phase II LAUNCH-HTN trial in Hypertension released by Mineralys Therapeutics