Spinogenix Secures INN Approval for Tazbentetol — A New Era in Synaptic Regeneration

Spinogenix just scored a major milestone. The WHO’s INN Expert Committee has officially approved “tazbentetol” as the non-proprietary name for SPG302, the company’s first-in-class synaptic regenerative therapy. This approval signals growing momentum behind Spinogenix’s mission: restore lost synapses and give patients real functional recovery, not just slower decline.

What Is Tazbentetol?

Tazbentetol is an oral investigational therapy designed to regenerate synapses.
That’s a big deal because synapses are the connections responsible for thinking, memory, planning, movement, and sensory processing.

The therapy is being developed for three major conditions:

• Alzheimer’s disease
• Amyotrophic lateral sclerosis (ALS)
• Schizophrenia

Unlike current treatments that mostly slow damage, tazbentetol aims to restore function—cognitive, motor, respiratory, and sensory.

If successful, it would represent a first-in-class regenerative approach.

Why the INN Matters?

An INN — the global standard for generic drug names — ensures:

• Clear identification
• Safe prescribing
• Uniform global recognition

Every active pharmaceutical ingredient needs one before it can be widely commercialized. So this approval is not paperwork. It’s a step toward future market presence.

What Spinogenix Says About the Milestone?

Spinogenix CEO and Founder, Dr. Stella Sarraf, calls the approval a key moment.

The timing is strategic:

• Phase 2a Alzheimer’s results expected at CTAD
• Phase 2a ALS results expected at MNDA
• Phase 2 schizophrenia trial near full enrollment

Momentum is clearly building.

The Science Behind Tazbentetol

Tazbentetol works by stimulating neurons to produce new glutamatergic synapses. This is the core pathway that drives thinking, memory, and motor coordination. Its regenerative potential could help patients regain functions considered permanently lost.

Current trials include:

• Alzheimer’s disease — NCT06427668
• ALS — NCT05882695
• Schizophrenia — NCT06442462

It also holds FDA and EMA Orphan Drug Designation for ALS.

About Spinogenix

Most therapies for neurodegenerative or neuropsychiatric diseases focus on slowing damage. Spinogenix wants to reverse it. That’s a seismic shift.

The company is developing two lead therapeutics:

1. Tazbentetol

A regenerative treatment for ALS, Alzheimer’s, schizophrenia, and related disorders. Its goal is to restore synapses and improve real-world function.

2. SPG601

A synaptic corrective therapy for Fragile X Syndrome. It has FDA Orphan Drug and Fast Track designation.

Spinogenix is aiming for a world where synaptic loss isn’t the end, but a condition that can be repaired.

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