---
schema_version: "secwatch.filing_event.v1"
accession: "0001933414-23-000028"
form_type: "8-K"
ticker: "MLYS"
cik: "0001933414"
company_name: "Mineralys Therapeutics, Inc."
filed_at: "2023-05-02T23:59:59+00:00"
generated_at: "2026-06-16T03:52:55.414139+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Mineralys first patient dosed in ADVANCE-HTN pivotal trial of lorundrostat for hypertension

## Summary
- ADVANCE-HTN trial to enroll up to 300 adults with uncontrolled or resistant hypertension.
- Primary endpoint: change in systolic BP vs placebo after 12 weeks (24-hr ambulatory monitoring).
- Topline data from ADVANCE-HTN expected in first half of 2024.
- Second pivotal Phase 3 trial to begin enrolling H2 2023, data anticipated mid-2025.
- Phase 2 CKD trial for lorundrostat expected to start mid-2023, topline data H1 2024.

## SEC filing metadata
- accession: 0001933414-23-000028
- form_type: 8-K
- ticker: MLYS
- cik: 0001933414
- company_name: Mineralys Therapeutics, Inc.
- filed_at: 2023-05-02T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1933414/000193341423000028/0001933414-23-000028-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1933414/000193341423000028/mlys202305028k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001933414-23-000028
- JSON: https://secwatch.observer/filing/0001933414-23-000028.json
- Plain text: https://secwatch.observer/filing/0001933414-23-000028.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.