Follow the latest press releases from Spinogenix as we advance our clinical trials progress.
Spinogenix Reports Evidence of Rapid, Sustained Cognitive Improvement in Alzheimer’s Patients from Phase 2a Trial of TAZBENTETOL (formerly SPG302)
December 8, 2025
Tazbentetol, a Potential First-in-Class, Oral Synaptic Regenerative Investigational Therapy, Showed a Favorable Safety Profile and Promising Benefits in Multiple Outcome Measures. Subset Exhibited Significant Improvement in AD-Related Brain Activity, As...
Spinogenix Announces World Health Organization Approval of ‘tazbentetol’ as International Non-Proprietary Name for SPG302
December 1, 2025
Tazbentetol is a First-in-Class, Synaptic Regenerative Investigation Therapy for Alzheimer’s disease, ALS, Schizophrenia and Glaucoma
Spinogenix Presents Topline Phase 2a Clinical Trial Results for SPG302, a First-in-Class ALS Treatment
November 4, 2025
The First Synaptic Regenerative Drug, SPG302, Led to Slowed Disease Progression in ALS Patients
Spinogenix to Present Complete Phase 2a Clinical Trial Results for SPG601, a First-in-Class Fragile X Syndrome Treatment, at AACAP Conference
October 22, 2025
SPG601, Granted Fast Track Designation by the FDA, Reduced Signature Changes in High-Frequency Gamma Band Activity in Fragile X Syndrome Patients, a Common Inherited Form of Intellectual Disability and Autism,...
Spinogenix Announces Publication of Preclinical Study Demonstrating Neuroprotective Effects of SPG302 in a Model of Glaucoma
October 16, 2025
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
Spinogenix Announces Positive Type C Meeting with the FDA for SPG601 in Patients with Fragile X Syndrome (FXS)
September 2, 2025
Spinogenix has reached agreement with the FDA on important design elements for a Phase 2B/3 clinical trial of SPG601 for the treatment of FXS There Are No FDA-Approved Treatments for...
Spinogenix Announces Positive First Cohort Results from Phase 2a Trial Evaluating SPG302 for Alzheimer’s Disease
August 7, 2025
SPG302, a Potential First-in-Class Synaptic Regenerative Therapy, Showed Progress in Cognitive Outcome Measures and a Favorable Safety Profile
European Medicines Agency Grants Orphan Drug Designation to Spinogenix’s SPG601 for Treatment of Fragile X Syndrome (FXS)
July 7, 2025
FXS is a Common Inherited Form of Autism EMA Designation Offers People with FXS Throughout European Union Access to Novel Therapeutic
Spinogenix Announces Full Enrollment in its Phase 2 Trial Evaluating SPG302 as a First-in-Class Synaptic Regenerative Therapy for Alzheimer’s Disease
June 24, 2025
First Cohort Results to be Presented at AAIC in Toronto, July 2025 FDA Clears IND in Alzheimer's Disease, Enabling Future Expansion to U.S.
Spinogenix’s SPG302, the First Synaptic Regenerative Therapy to Treat ALS, Granted Orphan Drug Designation by the European Medicines Agency
June 3, 2025
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...
Spinogenix Announces FDA-Authorized Expanded Access Program for SPG302, the First Synaptic Regenerative Therapy to Treat ALS
May 5, 2025
FDA Authorizes Expanded Access Program (EAP) to Help Provide Access to SPG302 for 200 ALS Individuals Ineligible for Clinical Study EAP Supports Real-world Data Collection Concurrent to Ongoing Clinical Studies...
Spinogenix Announces Open Enrollment for Phase 2 US Trial Following FDA Clearance of IND Application for SPG302, the First Synaptic Regenerative Therapy for Schizophrenia
March 30, 2025
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...
Spinogenix Completes Phase 2 Study of SPG601 for Treatment of Fragile X Syndrome, a Common Inherited Form of Autism, Showing Strong Efficacy Signal in Measures of Abnormal Brain Activity
February 11, 2025
Topline Results Announced at NIH Fragile X Centers of Excellence Conference U.S. FDA Previously Granted Orphan Disease Designation and Fast Track Designation to SPG601
FDA Grants Fast Track Designation to Spinogenix’s SPG601 for Treatment of Fragile X Syndrome, a Common Inherited Form of Autism
January 13, 2025
Milestone Highlights Urgent Need for a Novel Therapeutic to Treat People with FXS. FDA Designation Enables Expedited Clinical Development and Regulatory Review Timelines for SPG601
Spinogenix Appoints American Football Hall of Famer and Health Advocate Steve Young to its Board of Directors
November 25, 2024
Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering first-in-class therapeutics that restore synapses to improve the lives of people worldwide, today announced the appointment of Steve Young, hall of fame former...
Spinogenix Announces Launch of Glaucoma Program and Addition of World-Renowned Expert Dr. Robert Weinreb to its Science Advisory Board
October 16, 2024
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 Dr. Robert N. Weinreb, MD, has joined its...
Spinogenix Announces Launch of a Phase 2 Clinical Trial Evaluating SPG302 for the Treatment of Schizophrenia
September 25, 2024
Phase 2 trial is designed to evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia
Spinogenix Announces Open Enrollment for Phase 2 Study Evaluating SPG302 for the Treatment of Alzheimer’s Disease
August 1, 2024
SPG302 is a once-a-day pill with the potential to regenerate synapses to reverse declines in cognitive function in people with Alzheimer’s disease
Spinogenix Announces Enrollment is Open for its Phase 2 Clinical Trial of SPG601 Fragile X syndrome
July 23, 2024
U.S. FDA has granted Orphan Drug Designation to SPG601 for the Treatment of Fragile X SPG601 is a novel small molecule that works by correcting specific synaptic dysfunctions in the brain...
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
June 20, 2024
Phase 2 study is designed to evaluate the safety, tolerability, and pharmacodynamics of SPG302 in adult participants with mild-to-moderate Alzheimer’s disease. SPG302 is also being evaluated in a Phase 1/2...
Spinogenix Announces FDA Clearance of IND Application for SPG302, a Novel Therapy for the Treatment of ALS
May 29, 2024
SPG302 is being developed as a once-a-day pill with the potential to regenerate synapses to reverse declines in cognitive and motor function in people with ALS
Spinogenix Announces U.S. FDA Orphan Drug Designation Granted to SPG601 for the Treatment of Fragile X syndrome
May 20, 2024
Receiving Orphan Drug Designation for SPG601 emphasizes the pressing demand for novel therapies for individuals living with Fragile X syndrome
Spinogenix Announces U.S. FDA Approval of its Investigational New DrugApplication for its Phase 2a Clinical Trial of SPG601 for Fragile X syndrome
April 12, 2024
SPG601 is a once-a-day pill that works by restoring synaptic function to address core symptoms of Fragile X syndrome
Spinogenix Announces Second Grant Award from U.S. Department of Defense to Further Advance SPG302, the First Synaptic Regenerative Drug to Treat Amyotrophic Lateral Sclerosis (ALS)
September 26, 2023
Spinogenix, Inc., a clinical-stage biopharmaceutical company developing novel small molecule drugs for neurodegenerative conditions, today announced that it has been awarded a new grant for nearly $1 million from the...
Spinogenix Awarded $3 Million NIH Grant to Support Continued Development of SPG302, the First Synaptic Regenerative Therapeutic for Alzheimer’s Disease
September 12, 2023
Treatment Could Help Restore Brain Functions Lost in Many Neurodegenerative Disorders
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)
July 10, 2023
Treatment Could Help Restore Brain Functions Lost in Many Neurodegenerative Disorders
Spinogenix Granted FDA Orphan Drug Designation for SPG302 for the Treatment of Amyotrophic Lateral Sclerosis
June 7, 2021
Treatment Could Help Restore Brain Functions Lost in Many Neurodegenerative Disorders
Spinogenix Announces Grant by U.S. Department of Defense to Advance Novel Drug Candidate in Amyotrophic Lateral Sclerosis (ALS)
June 5, 2021
Treatment Could Help Restore Brain Functions Lost in Many Neurodegenerative Disorders