Drugs / NTI164
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06713447 | Feb 2024 → Jun 2025 overdue | — | Fenix Innovation Group | Active not recruiting | No outcome recorded |
| Phase 1/22 trials · 1 met primary | ||||||
| Phase 1/2 | NCT06621043 | Sep 2023 → Dec 2025 overdue | Rett syndrome | Fenix Innovation Group | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06621888 | Jun 2023 → Dec 2025 overdue | pediatric acute-onset neuropsychiatric syndrome | Fenix Innovation Group | Active not recruiting | Met primary |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT05626959 | Nov 2022 → Mar 2023 | autism spectrum disorder | Fenix Innovation Group | Unknown | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT07257939 | Jul 2026 → Jul 2029 expected | autism | Fenix Innovation Group | Not yet recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2/3 | NCT07257978 Comparator | Jul 2026 → Oct 2028 expected | Rett syndrome | Fenix Innovation Group | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 52
| Date | Issuer | Release |
|---|---|---|
| 2026-07-14 | Neurotech International Limited | Regulatory US FDA clears IND for NTI164 investi.com.au ↗ |
| 2026-02-23 | Neurotech International Limited | Results Positive 90-day GLP toxicology study results in non-rodents investi.com.au ↗ |
| 2026-02-02 | Neurotech International Limited | Regulatory Approval received for NTI164 Phase 3 Clinical Study in ASD investi.com.au ↗
The HREC approval represents a critical regulatory and strategic milestone for Neurotech, enabling the initiation of clinical activities for the pivotal Beyond Harmony Registration Study, including site activation and participant recruitment. |
| 2026-01-15 | Neurotech International Limited | Results PANS Data Published in Leading Scientific Journal investi.com.au ↗ |
| 2025-10-08 | Neurotech International Limited | Regulatory US FDA Rare Pediatric Disease Designation in Rett syndrome investi.com.au ↗ |
| 2025-07-07 | Neurotech International Limited | Results New Scientific Publication of Phase I/II Rett Syndrome Trial investi.com.au ↗ |
| 2025-06-02 | Neurotech International Limited | Results Positive Human PK Study Results for NTI164 investi.com.au ↗
Comprehensive human pharmacokinetic (PK) study confirms rapid and predictable absorption of NTI164, with CBDA as the dominant circulating cannabinoid. |
| 2025-05-05 | Neurotech International Limited | Results NTI164 Preclinical Toxicology Studies Update investi.com.au ↗ |
| 2025-03-31 | Neurotech International Limited | Regulatory European Commission grants NTI164 ODD for Rett Syndrome investi.com.au ↗ |
| 2025-03-24 | Neurotech International Limited | Results New Scientific Publication of Phase I/II Autism Trial investi.com.au ↗
Neurotech International Limited (ASX: NTI) (‘Neurotech’, ’ NTI’ or ‘the Company ’) a clinical-stage biopharmaceutical development company focused predominately on paediatric neurological disorders, today announces the publication of the Phase I/II autism spectrum disorder (ASD) clinical trial results in the scientific journal Advances in Complimentary and Alternative Medicine (ACAM). |
| 2025-02-27 | Neurotech International Limited | Regulatory Positive Opinion on OMPD for NTI164 in Europe investi.com.au ↗
Neurotech International Limited (ASX: NTI) (‘Neurotech’, ’ NTI’ or ‘the Company ’) a clinical -stage biopharmaceutical development company focused predominately on paediatric neurological disorders, today announces the European Medicines Agency (EMA) has issued a positive opinion on the Company’s Orphan Medicinal Product Designation (OMPD) application of NTI164 for the treatment of Rett Syndrome. |
| 2024-11-26 | Neurotech International Limited | Regulatory Neurotech Receives US ODD in Rett Syndrome investi.com.au ↗
We are very pleased to have secured this orphan designation from the US FDA. |
| 2024-11-15 | Neurotech International Limited | Results Positive Genomic Effects of NTI164 in PANDAS/PANS Patients investi.com.au ↗
Genomic analysis in PANDAS/PANS patients who participated in Neurotech Phase I/II clinical trial shows reversal of immune system dysregulation – consistent with prior protein expression results |
| 2024-11-12 | Neurotech International Limited | Results New Scientific Publication Highlights Benefits of NTI164 investi.com.au ↗ |
| 2024-10-04 | Neurotech International Limited | Regulatory US FDA Response to Orphan Drug Request in PANDAS/PANS investi.com.au ↗ |
| 2024-09-09 | Neurotech International Limited | Results NTI164 Reverses Immune Dysregulation in PANDAS/PANS Children investi.com.au ↗
Certain important dysregulated pathways associated with immune function and gene translation significantly reversed with NTI164, including MECP2 (the defective gene in Rett Syndrome) |
| 2024-08-30 | Neurotech International Limited | Regulatory US FDA orphan drug designation requested for Rett Syndrome investi.com.au ↗
Neurotech International Limited (ASX: NTI) (‘Neurotech’, ’ NTI’ or ‘the Company ’) a clinical -stage biopharmaceutical development company focused predominately on paediatric neurological disorders, has today submitted a request with the US Food and Drug Administration (FDA) for orphan drug designation (ODD) for the use of NTI164 in children and adults diagnosed with Rett Syndrome. |
| 2024-07-31 | Neurotech International Limited | Results Further Significant Improvement in Rett Syndrome Patients investi.com.au ↗
Gold standard RSBQ measure of key Rett symptoms showed an improvement of 24% versus baseline (p<0.001), with no further improvement from week 12 to week 20 (p=0.08) |
| 2024-07-18 | Neurotech International Limited | Results Phase II/III autism trial shows further benefits investi.com.au ↗
Children receiving NTI164 showed significant clinical improvements on top of existing anxiety/depression medications (62% of NTI164 pts were on such treatments at enrolment) |
| 2024-07-10 | Neurotech International Limited | Results Significant improvement in Autism patients at 12 weeks investi.com.au ↗
For patients receiving NTI164 (n=26) there was a 36% improvement from week 8 to week 12 and 56% improvement from baseline (Day 0) to week 12 |
| 2024-07-09 | Neurotech International Limited | Regulatory US FDA orphan drug designation requested for PANDAS/PANS investi.com.au ↗
Neurotech Files for US Orphan Drug Designation in PANDAS/PANS |
| 2024-06-17 | Neurotech International Limited | Results Phase I/II Autism Patients Meet 2 Years of NTI164 Treatment investi.com.au ↗
There were no reportable serious adverse events or adverse events recorded from 90 weeks 1 to the 2-year milestone. |
| 2024-06-06 | Neurotech International Limited | Results Further clinical benefit at 52 weeks in PANDAS/PANS patients investi.com.au ↗
Neurotech Reports Continued Clinical Improvement in PANDAS/PANS Patients to 52 Weeks of NTI164 Treatment |
| 2024-05-06 | Neurotech International Limited | Results Investor Presentation investi.com.au ↗
Data reported (all with statistically significant primary endpoint results) |
| 2024-05-06 | Neurotech International Limited | Results Rett Syndrome Phase I/II trial shows significant benefits investi.com.au ↗
Further primary endpoint and secondary endpoint analysis on Neurotech’s NTIRTT1 trial has highlighted significant additional benefits in Rett Syndrome girls (n=14) after 12 weeks of daily oral treatment with Neurotech’s broad-spectrum cannabinoid drug therapy (NTI164) |
| 2024-04-17 | Neurotech International Limited | Results Positive Top-Line Rett Syndrome Clinical Trial Results investi.com.au ↗
Primary endpoint of Clinical Global Impression – Improvement (CGI -I) at 12 weeks versus baseline was met; mean improvement of -0.3, (p=0.04) |
| 2024-04-17 | Neurotech International Limited | Results Phase II/III ASD Trial Successfully Meets Primary Endpoint investi.com.au ↗
NTI164 group re-classified from markedly-severely ill (CGI-S: 5.54) at baseline to mild-moderately ill (CGI-S: 3.77) at 8 weeks, a very strong improvement |
| 2024-04-17 | Neurotech International Limited | Results Investor Presentation investi.com.au ↗
Initial Phase I/II data positive at 4 weeks, 20 weeks and 52 weeks…safety past 90 weeks |
| 2024-02-21 | Neurotech International Limited | Results PANDAS/PANS Patients Show Continued Clinical Improvement investi.com.au ↗
Neurotech today provides further evidence of the clinical utility of NTI164 in PANDAS/PANS with further improvements at 24 weeks v baseline relating to the gold -standard validated measure of anxiety/depression, RCADS-P (39% improvement, p=0.0008 v 30%, p=0.016 at week 12) |
| 2024-02-13 | Neurotech International Limited | Regulatory Neurotech Receives Additional HREC Approval in Autism investi.com.au ↗
today announces Human Research Ethics Committee (HREC) approval to extend the Phase I/II clinical trial in autism spectrum disorder (ASD) by another 52 weeks in total. |
| 2024-02-07 | Neurotech International Limited | Results ASD Phase I/II Patients Exceed Treatment Beyond 90 Weeks investi.com.au ↗ |
| 2024-01-29 | Neurotech International Limited | Regulatory NTI Receives HREC Approval for Cerebral Palsy Trial investi.com.au ↗
Neurotech Receives HREC Approval to Commence Phase I/II Cerebral Palsy Trial |
| 2023-12-04 | Neurotech International Limited | Regulatory HREC Approval to Extend Phase II/III ASD Trial to Adults investi.com.au ↗
The current HREC approval covers treatment with NTI164 in a paediatric population of ASD. |
| 2023-10-06 | Neurotech International Limited | Results Phase I/II PANDAS/PANS Clinical Trial Meets Primary Endpoint investi.com.au ↗ |
| 2023-10-06 | Neurotech International Limited | Results Investor Presentation - PANDAS/PANS Clinical Trials Results investi.com.au ↗
PANDAS/PANS Phase I/II Clinical Trial Results |
| 2023-07-10 | Neurotech International Limited | Regulatory NTI Receives HREC Approval for Rett Syndrome Clinical Trial investi.com.au ↗
Neurotech Receives HREC Approval for Phase I/II Clinical Trial in Rett Syndrome |
| 2023-05-31 | Neurotech International Limited | Regulatory NTI Granted 2 Year Extension of Treatment for ASD Patients investi.com.au ↗
Neurotech International Limited (ASX: NTI) (“Neurotech” or “the Company”) , a clinical -stage biopharmaceutical development company focused predominately on paediatric neurological disorders, today announces Human Research Ethics Committee (HREC) clearance that will allow 11 Autism Spectrum Disorder (ASD) patients who have continued daily oral NTI164 treatment beyond 1.5 years to remain on treatment for an additional two years. |
| 2023-05-30 | Neurotech International Limited | Regulatory NTI granted HREC Approval for PANDAS/PANS Trial Extension investi.com.au ↗
This HREC approval gives Neurotech utmost flexibility to treat our important PANDAS/PANS patients if they elect to continue daily oral NTI164 dosing beyond their 12-week treatment phase and into the fifty-four (54) weeks extension phase of the trial. |
| 2023-03-17 | Neurotech International Limited | Results Phase I/II ASD Clinical Trials Results at 52 Weeks investi.com.au ↗
Strong safety and efficacy effects of daily oral treatment with NTI164 maintained at 52 weeks in the treatment of children with Autism Spectrum Disorder (ASD) |
| 2023-03-17 | Neurotech International Limited | Results Investor Presentation investi.com.au ↗
Phase I/II ASD 52 Week Results |
| 2023-02-14 | Neurotech International Limited | Regulatory Approval for Additional Phase I/II ASD Trial Extension investi.com.au ↗
Based on the approved HREC extension, individual patients can continue to receive NTI164 for an additional six months over the 54 week treatment period. |
| 2023-01-27 | Neurotech International Limited | Regulatory HREC Approval for Phase I/II PANDAS/PANS Clinical Trial investi.com.au ↗
We appreciate the timely approval of our HREC filing at the Children’s Hospital at Westmead, along with CTN/TGA clearance. |
| 2022-11-17 | Neurotech International Limited | Regulatory NTI Receives HREC/TGA Approval for Phase II/III ASD Trial investi.com.au ↗
Neurotech Receives HREC/TGA Approval for Phase II/III ASD Trial |
| 2022-10-28 | Neurotech International Limited | Results Investor Presentation investi.com.au ↗
Phase I/II ASD 20 Week Results & Capital Raise: Investor Presentation |
| 2022-10-26 | Neurotech International Limited | Results 20 Week Data Shows Significant Improvement For ASD Children investi.com.au ↗ |
| 2022-07-22 | Neurotech International Limited | Results Q&A on NTI164 Breakthrough Clinical Trial Results in ASD investi.com.au ↗
The study showed that 93% of patients showed improvement relating to the severity of illness after 28 days of daily treatment with NTI164 |
| 2022-07-08 | Neurotech International Limited | Results BREAKTHROUGH RESULTS WITH NTI164 IN PAEDIATRIC ASD investi.com.au ↗ |
| 2022-07-08 | Neurotech International Limited | Results Investor Presentation investi.com.au ↗
93% of patients showed improvement |
| 2022-06-09 | Neurotech International Limited | Results Preclinical Success with Targeted Combination Therapies investi.com.au ↗ |
| 2022-04-05 | Neurotech International Limited | Results Successful Landmark Study in Paediatric ASD investi.com.au ↗ |
| 2021-12-01 | Neurotech International Limited | Results Preclinical Success with Targeted Combination Therapies investi.com.au ↗
When combined with N TI164, prednisone efficacy was significantly increased, showing a 33% in the reduction of TNF-alpha and 87% reduction in the suppression of IL-6. |
| 2021-10-22 | Neurotech International Limited | Results Successful Completion of Preclinical MS Studies investi.com.au ↗ |
All press releases naming this drug 58 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | NTI164 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07257978 ↗ |
| Modality | Traditional medicine (herbal / TCM) | “Full-Spectrum Medicinal Cannabis Plant Extract with less than 0.08% THC (NTI164)” NCT05626959 ↗ |
| Route | Oral | “administered orally” NCT06621043 ↗ |