Last reviewed 2026-05-18 · How we verify

IHL-42X High Dose

Incannex Healthcare Ltd · Phase 2 active Small molecule Quality 10/100

IHL-42X High Dose is a Small molecule drug developed by Incannex Healthcare Ltd. It is currently in Phase 2 development. Also known as: Phase 2 Investigational Product - IHL-42X High dose.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	IHL-42X High Dose
Also known as	Phase 2 Investigational Product - IHL-42X High dose
Sponsor	Incannex Healthcare Ltd
Modality	Small molecule
Phase	Phase 2

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA (PHASE2, PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

IHL-42X High Dose CI brief — competitive landscape report
IHL-42X High Dose updates RSS · CI watch RSS
Incannex Healthcare Ltd portfolio CI

Frequently asked questions about IHL-42X High Dose

What is IHL-42X High Dose?

IHL-42X High Dose is a Small molecule drug developed by Incannex Healthcare Ltd.

Who makes IHL-42X High Dose?

IHL-42X High Dose is developed by Incannex Healthcare Ltd (see full Incannex Healthcare Ltd pipeline at /company/incannex-healthcare-ltd).

Is IHL-42X High Dose also known as anything else?

IHL-42X High Dose is also known as Phase 2 Investigational Product - IHL-42X High dose.

What development phase is IHL-42X High Dose in?

IHL-42X High Dose is in Phase 2.

Manufacturer: Incannex Healthcare Ltd — full pipeline
Also known as: Phase 2 Investigational Product - IHL-42X High dose

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing