Highlights

  • Neurotech International (ASX:NTI) has received FDA clearance for its Investigational New Drug (IND) application for NTI164.
  • The clearance allows the company to establish a U.S. clinical development pathway alongside its Australian Phase 3 trial.
  • NTI164 is being developed as a cannabinoid-based candidate targeting autism spectrum disorder and related neurodevelopmental conditions.
  • The company may commence a U.S. population pharmacokinetic study to support future clinical development activities.
  • Neurotech continues progressing its Australian Phase 3 “Beyond Harmony” trial, which is intended to provide pivotal efficacy and safety data.

Neurotech International Limited (ASX:NTI) has reached a regulatory milestone for its NTI164 Drug Development program after the U.S. Food and Drug Administration (FDA) cleared the company’s Investigational New Drug (IND) application.

The clearance allows Neurotech to establish a clinical development pathway in the United States for NTI164, a cannabinoid-based candidate being developed for autism spectrum disorder (ASD) and related neurodevelopmental conditions.

The FDA IND clearance provides regulatory approval to begin human studies in the U.S. but does not represent Marketing approval or confirmation that the treatment will ultimately achieve registration.

FDA Clearance Opens U.S. Development Pathway

An Investigational New Drug clearance is a key regulatory step that enables companies to conduct clinical studies in the United States.

Neurotech said its IND submission included chemistry, Manufacturing and controls (CMC) information, non-clinical data and clinical evidence relating to NTI164.

The company describes NTI164 as a proprietary, GMP-grade standardised formulation containing CBDA-rich cannabinoid extracts and selected minor cannabinoids. The treatment is designed to target neuroinflammatory signalling and immune dysregulation associated with neurodevelopmental disorders.

Following the IND clearance, Neurotech may elect to commence a population pharmacokinetic (PopPK) study in the U.S. This type of study evaluates how a drug is absorbed, distributed and cleared across a patient population and may assist with future dosing decisions.

Australian Phase 3 Trial Remains Key Development Milestone

The U.S. regulatory pathway will operate alongside Neurotech’s ongoing Australian Phase 3 “Beyond Harmony” trial in paediatric ASD patients.

The Phase 3 study is intended to generate the pivotal efficacy and safety data required for any future registration pathway.

Neurotech has previously conducted earlier-stage studies involving NTI164 across ASD, PANDAS/PANS and Rett Syndrome. The company has stated that the current Phase 3 trial is expected to provide the key data package for future regulatory discussions.

While the FDA IND clearance allows U.S. clinical development activities to proceed, Neurotech has noted that clinical trial outcomes and future regulatory approval remain subject to further evaluation.

Potential Expansion of Global Regulatory Strategy

The FDA clearance allows Neurotech to pursue a coordinated regulatory approach across the U.S. and Australia.

The company has stated that it is engaging with both the FDA and the Therapeutic Goods Administration (TGA) as it advances the NTI164 program.

For a clinical-stage biotechnology company, access to multiple regulatory pathways may provide additional Options as it progresses development activities.

Neurotech is also continuing to develop its intellectual property portfolio around NTI164, including recent patent-related progress in the United States.

Funding Position Supports Development Activities

Neurotech has funded its clinical programs through a combination of existing cash reserves, Research and Development tax incentive rebates and Capital raisings.

In August 2026, the company completed a Placement raising approximately $4.5 million through the issue of approximately 321.4 million new shares at $0.014 per share.

Neurotech stated that the proceeds, together with existing cash reserves, are expected to support operations through to topline data from the Phase 3 NTI164 ASD trial.

The company remains a pre-revenue biotechnology business, with ongoing development activities dependent on clinical progress, regulatory outcomes and access to funding.

What Investors Are Watching

The next key developments for Neurotech include potential commencement of the U.S. PopPK study, continued enrolment and progress in the Australian Phase 3 “Beyond Harmony” trial, and future regulatory engagement.

The company’s NTI164 program remains focused on generating clinical data to support potential future registration pathways. The FDA IND clearance provides access to a U.S. development route, while future clinical results and regulatory assessments will determine the next stages of the program.