Drugs / ZANDATRIGINE
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03467100 | Feb → Dec 2018 | — | Xenon Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 24 trials · 1 missed | ||||||
| Phase 2 | NCT05493293 | Nov 2022 → Mar 2024 | focal epilepsy | Neurocrine Biosciences | Terminated | No outcome recorded |
| Phase 2 | NCT05226780 | Jul 2022 → Nov 2025 | developmental and epileptic encephalopathy, 13 | Neurocrine Biosciences | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04873869 | Jan 2022 → Mar 2023 | developmental and epileptic encephalopathy, 13 | Neurocrine Biosciences | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT05159908 | Nov 2021 → Aug 2023 | focal epilepsy | Neurocrine Biosciences | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2023-11-09 | Xenon Pharmaceuticals Inc. | Results Xenon Pharmaceuticals Provides Update on Partnered Program with Neurocrine Biosciences xenon-pharma.com ↗
Neurocrine Biosciences, Inc., reported today that the Phase 2 clinical trial evaluating NBI-921352 in adult patients with focal onset seizures (FOS) failed to demonstrate meaningful reduction in seizure frequency. |
| 2022-01-12 | Xenon Pharmaceuticals Inc. | Regulatory Xenon Pharmaceuticals Announces Collaboration with Neurocrine Biosciences Achieves $15.0 Million Regulatory Milestone xenon-pharma.com ↗
With the acceptance of this protocol amendment, children over the age of two can now be included in the ongoing Phase 2 clinical trial evaluating NBI-921352 as a treatment of SCN8A-DEE. |
| 2021-09-08 | Xenon Pharmaceuticals Inc. | Regulatory Xenon Pharmaceuticals Announces Collaboration with Neurocrine Biosciences Achieves $10.0 Million Regulatory Milestone xenon-pharma.com ↗ |
| 2020-10-08 | Neurocrine Biosciences | Regulatory Neurocrine Biosciences and Xenon Pharmaceuticals Provide Regulatory Update on Ongoing Collaboration to Develop First-In-Class Treatment for Epilepsy gcs-web.com ↗
As part of its review of the IND, the FDA is requesting additional non-clinical data to support dose justification in this pediatric study. |
| 2020-10-08 | Xenon Pharmaceuticals Inc. | Regulatory Neurocrine Biosciences and Xenon Pharmaceuticals Provide Regulatory Update on Ongoing Collaboration to Develop First-In-Class Treatment for Epilepsy xenon-pharma.com ↗
As part of its review of the IND, the FDA is requesting additional non-clinical data to support dose justification in this pediatric study. |
| 2018-12-03 | Xenon Pharmaceuticals Inc. | Results Xenon Announces Final Results of XEN1101 Phase 1 Clinical Trial and Update on XEN901 Phase 1 Clinical Trial at the American Epilepsy Society (AES) Annual Meeting xenon-pharma.com ↗
Xenon announced final results from its XEN1101 Phase 1 clinical trial and the related transcranial magnetic stimulation (TMS) studies, along with interim results from its XEN901 Phase 1 clinical trial, in posters at the American Epilepsy Society (AES) Annual Meeting held in New Orleans, LA. |
| 2018-05-15 | Xenon Pharmaceuticals Inc. | Results Xenon Presents XEN901 Phase 1 Clinical Update and Supporting Pre-clinical Data at 14th Eilat Conference xenon-pharma.com ↗ |
| 2017-12-04 | Xenon Pharmaceuticals Inc. | Results Positive Preclinical Data from Xenon’s XEN901 Epilepsy Program to be Presented at the 71st American Epilepsy Society Annual Meeting xenon-pharma.com ↗
Data Suggest Xenon’s Selective Nav1.6 Sodium Channel Inhibitor, XEN901, Provides Efficacy with a Potentially Improved Safety Profile over Other Non-Selective, Sodium Channel Blocker Anti-Epileptic Drugs (AEDs) |
All press releases naming this drug 10 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ZANDATRIGINE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650313 ↗ |
| Known as | NBI-921352 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05159908 ↗ |
| Known as | XEN901 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03467100 ↗ |
| Known as | Zandatrigina | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650313 ↗ |
| Action | Inhibit | “Sodium channel protein type VIII alpha subunit inhibitor” CHEMBL4650313 ↗ |
| Modality | Small molecule | — CHEMBL4650313 ↗ |
| Route | Oral | “Single oral dose for each cohort” NCT03467100 ↗ |
| Target | SCN8A | “Sodium channel protein type VIII alpha subunit inhibitor” CHEMBL4650313 ↗ |