---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-048507"
form_type: "8-K"
ticker: "IXHL"
cik: "0001873875"
company_name: "Incannex Healthcare Inc."
filed_at: "2025-05-29T23:59:59+00:00"
generated_at: "2026-05-20T06:37:22.534925+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Incannex Healthcare advances IHL-42X RePOSA trial to Phase 3 after FDA clearance

## Summary
- FDA cleared Phase 3 protocol for IHL-42X under IND; trial for obstructive sleep apnea (OSA) with no approved oral therapy.
- Phase 3 will be US-only, leveraging Phase 2 infrastructure; ~20 existing sites roll over, 10 new sites added.
- Study design: randomized, placebo-controlled, 12 months, including head-to-head against monotherapy components.
- Primary endpoint: change in Apnea-Hypopnea Index (AHI); top-line Phase 2 results due in coming weeks.
- CEO cites potential to become first FDA-approved oral therapy for OSA; commercial discussions underway.

## SEC filing metadata
- accession: 0001213900-25-048507
- form_type: 8-K
- ticker: IXHL
- cik: 0001873875
- company_name: Incannex Healthcare Inc.
- filed_at: 2025-05-29T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1873875/000121390025048507/0001213900-25-048507-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1873875/000121390025048507/ea0243466-8k_incannex.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-048507
- JSON: https://secwatch.observer/filing/0001213900-25-048507.json
- Plain text: https://secwatch.observer/filing/0001213900-25-048507.txt

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