NTI164
/ Neurotech International
- LARVOL DELTA
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December 03, 2025
TRANSCEND: Efficacy and Safety of NTI164 in Children and Young Adults With Rett Syndrome
(clinicaltrials.gov)
- P2/3 | N=40 | Not yet recruiting | Sponsor: Fenix Innovation Group
New P2/3 trial • Developmental Disorders • Movement Disorders
December 03, 2025
HarmonyPlus: NTI164 in Autism Spectrum Disorder
(clinicaltrials.gov)
- P3 | N=98 | Not yet recruiting | Sponsor: Fenix Innovation Group
New P3 trial • Autism Spectrum Disorder • Genetic Disorders
October 08, 2025
Neurotech International has passed an important regulatory milestone with the US Food and Drug Administration (FDA) granting Rare Paediatric Disease Designation (RPDD) for its lead drug candidate NTI164 for the treatment of Rett syndrome.
(The Australian)
FDA event • Rare Diseases
July 18, 2025
A Phase I/II study to assess the safety and efficacy of full-spectrum medicinal cannabis plant extract 0.08% THC (NTI164) in the treatment of Rett syndrome (RTT)
(ANZCTR)
- P1/2 | N=14 | Active, not recruiting | Sponsor: Fenix Innovation Group | Recruiting ➔ Active, not recruiting
Enrollment closed • Developmental Disorders • Movement Disorders
July 18, 2025
Investigating the effects of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on paediatric acute-onset neuropsychiatric syndrome (PANS): An open-label study.
(ANZCTR)
- P1/2 | N=15 | Active, not recruiting | Sponsor: Fenix Innovation Group | Not yet recruiting ➔ Active, not recruiting
Enrollment closed • Pediatrics • Psychiatry
July 11, 2025
Evaluating the Efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) in Young People with Autism Spectrum Disorder, a Double-Blind, Randomised and Controlled-to-Open-Label Study.
(ANZCTR)
- P2/3 | N=54 | Active, not recruiting | Sponsor: Fenix Innovation Group | Not yet recruiting ➔ Active, not recruiting
Enrollment closed • Autism Spectrum Disorder • Genetic Disorders
June 26, 2025
Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) Improves Symptoms of Rett Syndrome: An Open-Label Study.
(PubMed, J Paediatr Child Health)
- "NTI164 demonstrated safety and improved some clinical and functional outcomes in RTT. These improvements justify ongoing research into NTI164, which may be a potential adjunct therapy in RTT."
Journal • CNS Disorders • Developmental Disorders • Inflammation • Mood Disorders • Movement Disorders • Psychiatry • Respiratory Diseases
March 19, 2025
NTI164 Human PK Study
(clinicaltrials.gov)
- P1 | N=12 | Active, not recruiting | Sponsor: Fenix Innovation Group | Not yet recruiting ➔ Active, not recruiting | Initiation date: Dec 2024 ➔ Feb 2024
Enrollment closed • Trial initiation date
December 03, 2024
NTI164 Human PK Study
(clinicaltrials.gov)
- P1 | N=12 | Not yet recruiting | Sponsor: Fenix Innovation Group
New P1 trial
November 27, 2024
Evaluation of the Efficacy of a Full-Spectrum Low-THC Cannabis Plant Extract Using In Vitro Models of Inflammation and Excitotoxicity.
(PubMed, Biomolecules)
- "NTI-164 promoted undifferentiated neuron proliferation and differentiated neuron survival under excitotoxic conditions. These effects suggest the potential for NTI-164 as a treatment for neuropathologies."
Journal • Preclinical • Autism Spectrum Disorder • CNS Disorders • Developmental Disorders • Genetic Disorders • Inflammation • Psychiatry
October 01, 2024
CannaPANS: Investigating The Effects Of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) On Paediatric Acute-onset Neuropsychiatric Syndrome (PANS)
(clinicaltrials.gov)
- P1/2 | N=18 | Active, not recruiting | Sponsor: Fenix Innovation Group
New P1/2 trial • Pediatrics • Psychiatry
October 01, 2024
Assessing the Safety and Efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) in the Treatment of Rett Syndrome (RTT)
(clinicaltrials.gov)
- P1/2 | N=14 | Active, not recruiting | Sponsor: Fenix Innovation Group
New P1/2 trial • Developmental Disorders • Movement Disorders
November 03, 2023
A Phase I/II study to assess the safety and efficacy of full-spectrum medicinal cannabis plant extract 0.08% THC (NTI164) in the treatment of Rett syndrome (RTT)
(ANZCTR)
- P1/2 | N=14 | Recruiting | Sponsor: Fenix Innovation Group | Not yet recruiting ➔ Recruiting
Enrollment open • Trial initiation date • Developmental Disorders • Movement Disorders
September 13, 2023
A Phase I/II study to assess the safety and efficacy of full-spectrum medicinal cannabis plant extract 0.08% THC (NTI164) in the treatment of Rett syndrome (RTT)
(ANZCTR)
- P1/2 | N=14 | Not yet recruiting | Sponsor: Fenix Innovation Group
New P1/2 trial • Developmental Disorders • Movement Disorders
May 03, 2023
Neurotech International completes recruitment for PANDAS/PANS clinical trial
(SmallCap Network)
- "Neurotech International (ASX: NTI) has completed recruitment for a phase I/II trial assessing its lead candidate NTI164 in children with paediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) and paediatric acute-onset neuropsychiatric syndrome (PANS)."
Enrollment closed • Autism Spectrum Disorder • CNS Disorders • Developmental Disorders
November 25, 2022
Evaluating the Efficacy of NTI164 in Young People With Autism Spectrum Disorder
(clinicaltrials.gov)
- P2/3 | N=54 | Not yet recruiting | Sponsor: Fenix Innovation Group
New P2/3 trial • Autism Spectrum Disorder • Genetic Disorders
August 25, 2022
Safety and Efficacy of Oral Full-Spectrum Medicinal Cannabis Plant Extract in Children With Autism Spectrum Disorder.
(clinicaltrials.gov)
- P1/2 | N=18 | Active, not recruiting | Sponsor: Fenix Innovation Group
New P1/2 trial • Autism Spectrum Disorder • Genetic Disorders
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