Developer · NTI · Australia

Neurotech International Limited

Clinical-stage biopharmaceutical company headquartered in Melbourne, Australia (ASX: NTI), focused on paediatric neurological disorders. Its lead drug candidate is NTI164, a broad-spectrum oral cannabinoid extract in Phase 3 for autism spectrum disorder, with completed earlier-phase studies in PANDAS/PANS and Rett syndrome. NTI164's cannabis strains are exclusively licensed worldwide from Dolce Cann Global for neurological uses; development and manufacturing are run with its strategic partner Fenix Innovation Group, the registered sponsor of the NTI164 trials.

neurotechinternational.com ↗

1compound
2programs
2indications
Phase 3lead asset

Phase distribution

  • Phase 31
  • Phase 1/21

Modality

  • Natural product 1

Pipeline (1)

Deals & partnerships

  • Aug 4, 2026FinancingNeurotech secures ~A$4.5 million placement to fund the NTI164 Phase 3 autism trialBinding commitments for about A$4.5 million (before costs) at A$0.014 per share. Neurotech expects the proceeds, with existing cash, to fund it through the topline readout of the Phase 3 Beyond Harmony trial.NTI164source ↗
  • Feb 2026PartnershipNeurotech and the University of Sydney collaborate on NTI164 for Rett syndromeResearch collaboration led by Professor Wendy Gold to define how NTI164 modulates disease mechanisms in human Rett syndrome (MECP2-deficient) neuronal models.NTI164source ↗

Catalysts · 2 upcoming · 2 reported

  • October 2028Anticipated

    NTI164forRett syndromeRegistry results

    ClinicalTrials.gov estimated primary completion of the Phase II/III placebo-controlled crossover study of NTI164 in Rett syndrome: October 2028 (not yet recruiting; estimated start July 2027).

    NCT07257978source ↗

  • July 2029Anticipated

    NTI164forAutism spectrum disorderRegistry results

    ClinicalTrials.gov estimated primary completion of the Phase 3 Beyond Harmony study of NTI164 in autism spectrum disorder: July 2029.

    NCT07257939source ↗

Recently reported

  • 2026-08-06met

    NTI164forAutism spectrum disorderFull results

    HARMONY Phase II/III (54 children with Level II/III ASD, NTI164 up to 20 mg/kg/day vs placebo for 8 weeks) published: statistically significant improvements over placebo in overall clinical severity, adaptive functioning, social responsiveness and affective symptoms, with a favourable safety profile.

    source ↗

  • 2025-06-26met

    NTI164forRett syndromeFull results

    Open-label Phase I/II study of NTI164 in 11 girls with Rett syndrome published: improvement on CGI-I (p=0.028), CGI-S, RSBQ total score and caregiver burden after 12 weeks; well tolerated.

    source ↗

Recent activity

  • Sep 21, 2026Phase changeNTI164·Autism spectrum disorderPhase 3All six Australian sites initiated and the first patient dosed in the Phase 3 Beyond Harmony study; enrollment target raised to up to 200 under the adaptive design.source ↗
  • Aug 6, 2026ReadoutNTI164·Autism spectrum disordermetHARMONY Phase II/III (54 children with Level II/III ASD, NTI164 up to 20 mg/kg/day vs placebo for 8 weeks) published: statistically significant improvements over placebo in overall clinical severity, adaptive functioning, social responsiveness and affective symptoms, with a favourable safety profile.source ↗
  • Mar 17, 2026Phase changeNTI164·Autism spectrum disorderPhase 2/3First Beyond Harmony site (Monash Children's Hospital) initiated and open for screening and recruitment; 150 patients planned at that time.source ↗
  • Feb 2, 2026Phase changeNTI164·Autism spectrum disorderPhase 2/3Human Research Ethics Committee approval received to start the Beyond Harmony Phase 3 study in ASD Levels 2 and 3, led by Professor Michael Fahey; designed to support TGA and FDA submissions.source ↗
  • Jun 26, 2025ReadoutNTI164·Rett syndromemetOpen-label Phase I/II study of NTI164 in 11 girls with Rett syndrome published: improvement on CGI-I (p=0.028), CGI-S, RSBQ total score and caregiver burden after 12 weeks; well tolerated.source ↗
  • Sep 20, 2023Phase changeNTI164·Rett syndromePhase 1/2Open-label Phase I/II study of NTI164 in Rett syndrome (NCT06621043) started per ClinicalTrials.gov.source ↗
  • Nov 30, 2022Phase changeNTI164·Autism spectrum disorderPhase 2/3Randomised, double-blind, placebo-controlled Phase II/III HARMONY study (NCT05626959, 54 participants) started per ClinicalTrials.gov; primary completion 2024-03.source ↗
  • Apr 1, 2021Phase changeNTI164·Autism spectrum disorderPhase 1/2Open-label Phase I/II study of NTI164 (then FEN164) in children with ASD (NCT05516407, 18 participants) started per ClinicalTrials.gov; primary completion 2022-09.source ↗

Competitive landscape

Other companies developing against Neurotech International Limited's targets or indications.