---
schema_version: "secwatch.filing_event.v1"
accession: "0001933414-25-000002"
form_type: "8-K"
ticker: "MLYS"
cik: "0001933414"
company_name: "Mineralys Therapeutics, Inc."
filed_at: "2025-01-08T23:59:59+00:00"
generated_at: "2026-05-28T07:14:50.703126+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA clears IND for Mineralys' lorundrostat Phase 2 trial in obstructive sleep apnea with hypertension

## Summary
- FDA cleared IND for Phase 2 trial of lorundrostat in moderate-to-severe OSA with hypertension.
- Trial to evaluate effect on apnea-hypopnea frequency & nocturnal hypertension; initiation expected Q1 2025.
- Approximately 40 subjects, placebo-controlled crossover design at up to 40 sites.
- Cash, cash equivalents & investments expected to fund operations through Q1 2026.
- This is the third targeted indication for lorundrostat, following hypertension and CKD.

## SEC filing metadata
- accession: 0001933414-25-000002
- form_type: 8-K
- ticker: MLYS
- cik: 0001933414
- company_name: Mineralys Therapeutics, Inc.
- filed_at: 2025-01-08T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1933414/000193341425000002/0001933414-25-000002-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1933414/000193341425000002/mlys-20250108.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001933414-25-000002
- JSON: https://secwatch.observer/filing/0001933414-25-000002.json
- Plain text: https://secwatch.observer/filing/0001933414-25-000002.txt

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