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Lorundrostat - Mineralys Therapeutics

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Drug Profile

Lorundrostat - Mineralys Therapeutics

Alternative Names: MLS-101; MT-4129

Latest Information Update: 20 Mar 2026

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At a glance

  • Originator Mitsubishi Tanabe Pharma Corporation
  • Developer Mineralys Therapeutics; 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
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Hypertension
  • Phase II Renal failure; Sleep apnoea syndrome
  • No development reported Cardiovascular disorders

Most Recent Events

  • 10 Mar 2026 FDA assigns PDUFA action date of (22/12/2026) for Lorundrostat for Hypertension (Combination therapy) (PO)
  • 09 Mar 2026 Preregistration for Hypertension (Combination therapy) in USA (PO)
  • 09 Mar 2026 Topline efficacy and adverse event data from a phase II Explore-OSA trial in Hypertension released by Mineralys Therapeutics

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