Drugs / SPG302
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05882695 | Jul 2023 → Jun 2025 | amyotrophic lateral sclerosis | Spinogenix | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06903286 | May → Jun 2025 | amyotrophic lateral sclerosis | Spinogenix | Terminated | No outcome recorded |
| Phase 2 | NCT06833281 | Mar → Jul 2025 | Alzheimer disease | Spinogenix | Terminated | No outcome recorded |
| Phase 2 | NCT06427668 | Jul 2024 → Dec 2025 overdue | Alzheimer disease | Spinogenix | Active not recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT06442462 Comparator | Aug 2024 → Mar 2026 overdue | schizophrenia | Spinogenix | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2026-07-14 | Spinogenix | Results Spinogenix Reports Positive Data on Alzheimer’s Patients Who Continued Treatment With Tazbentetol For Up To 84 Weeks spinogenix.com ↗ |
| 2026-05-05 | Spinogenix | Regulatory Spinogenix Receives U.S. FDA Fast Track Designation for Tazbentetol for the Treatment of ALS spinogenix.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to tazbentetol for the treatment of people with amyotrophic lateral sclerosis (ALS). |
| 2026-05-03 | Spinogenix | Results Spinogenix to Present Preclinical Results at ARVO 2026 Demonstrating Neuroprotective Effects of Tazbentetol in Glaucoma and Diabetic Retinopathy Models spinogenix.com ↗
New Preclinical Data Show Tazbentetol Reduces Retinal Cell Loss and Preserves Visual Function in Glaucoma and Diabetic Retinopathy Models |
| 2026-03-26 | Spinogenix | Results Spinogenix Reports Early Improvements in Phase 2 Trial of Tazbentetol in Patients with Schizophrenia at the Schizophrenia International Research Society (SIRS) 2026 Annual Congress spinogenix.com ↗ |
| 2025-12-08 | Spinogenix | Results Spinogenix Reports Evidence of Rapid, Sustained Cognitive Improvement in Alzheimer’s Patients from Phase 2a Trial of TAZBENTETOL (formerly SPG302) spinogenix.com ↗
Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering first-in-class therapeutics that restore synapses to improve the lives of patients worldwide, today announced encouraging results from its completed Phase 2a trial evaluating Tazbentetol (formerly named SPG302) for the treatment of Alzheimer’s disease (AD). |
| 2025-12-01 | Spinogenix | Regulatory Spinogenix Announces World Health Organization Approval of ‘tazbentetol’ as International Non-Proprietary Name for SPG302 spinogenix.com ↗ |
| 2025-11-04 | Spinogenix | Results Spinogenix Presents Topline Phase 2a Clinical Trial Results for SPG302, a First-in-Class ALS Treatment spinogenix.com ↗
Topline results from the trial presented as a poster at the recent Northeast Amyotrophic Lateral Sclerosis Consortium (NEALS) Annual Meeting, indicated: SPG302 was well tolerated with no treatment-related serious adverse events over 6 months of oral daily dosing of 300mg |
| 2025-10-16 | Spinogenix | Results Spinogenix Announces Publication of Preclinical Study Demonstrating Neuroprotective Effects of SPG302 in a Model of Glaucoma spinogenix.com ↗
The Study Results, Published in Experimental Eye Research journal, Found SPG302 Protected Retinal Ganglion Cells and Their Axons in the Glaucomatous Retina and Improved Retinal Function |
| 2025-08-07 | Spinogenix | Results Spinogenix Announces Positive First Cohort Results from Phase 2a Trial Evaluating SPG302 for Alzheimer's Disease spinogenix.com ↗ |
| 2025-06-03 | Spinogenix | Regulatory Spinogenix's SPG302, the First Synaptic Regenerative Therapy to Treat ALS, Granted Orphan Drug Designation by the European Medicines Agency spinogenix.com ↗
Spinogenix, Inc ., a clinical-stage biopharmaceutical company pioneering first-in-class therapeutics that restore synapses to improve the lives of patients worldwide, today announced that the European Medicines Agency (EMA) has granted orphan drug designation (ODD) to SPG302 for the treatment of people living with Amyotrophic Lateral Sclerosis (ALS). |
| 2025-05-05 | Spinogenix | Regulatory Spinogenix Announces FDA-Authorized Expanded Access Program for SPG302, the First Synaptic Regenerative Therapy to Treat ALS spinogenix.com ↗
FDA clearance to launch this new EAP supports its awareness of SPG302’s safety and potential efficacy, and the need for ALS patients to have access to novel treatments. |
| 2025-03-30 | Spinogenix | Regulatory Spinogenix Announces Open Enrollment for Phase 2 US Trial Following FDA Clearance of IND Application for SPG302, the First Synaptic Regenerative Therapy for Schizophrenia spinogenix.com ↗
Spinogenix, Inc. , a clinical-stage biopharmaceutical company pioneering first-in-class therapeutics that restore synapses to improve the lives of patients worldwide, today announced open enrollment for its Phase 2 trial of SPG302 for the treatment of people with schizophrenia, following clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA). |
| 2024-06-20 | Spinogenix | Regulatory Spinogenix Announces Approval from the Australia Human Research Ethics Committee to Initiate a Phase 2 Human Clinical Trial of SPG302 for the Treatment of Alzheimer’s Disease spinogenix.com ↗ |
| 2024-05-29 | Spinogenix | Regulatory Spinogenix Announces FDA Clearance of IND Application for SPG302, a Novel Therapy for the Treatment of ALS spinogenix.com ↗ |
| 2023-07-10 | Spinogenix | Regulatory Spinogenix Receives Approval from the Australia Human Research Ethics Committee to Initiate a Phase 1 Human Clinical Trial of SPG302, a Novel Regenerative Drug for the Treatment of Amyotrophic Lateral Sclerosis (ALS) spinogenix.com ↗ |
| 2021-06-07 | Spinogenix | Regulatory Spinogenix Granted FDA Orphan Drug Designation for SPG302 for the Treatment of Amyotrophic Lateral Sclerosis spinogenix.com ↗
Spinogenix, Inc. a pharmaceutical company focused on the development of novel synaptogenic small molecule therapies for central nervous system disorders and rare diseases, today announced it has been granted Orphan Drug Designation (ODD) for SPG302 in amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease) by the U.S. Food and Drug Administration (FDA). |
All press releases naming this drug 21 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SPG302 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06427668 ↗ |
| Modality | Small molecule | “synthetic small molecule” NCT05882695 ↗ |
| Route | Oral | “Study intervention will be administered orally once.” NCT05882695 ↗ |