SPG302 · program
Tazbentetol for Schizophrenia
Tazbentetol (SPG302), Spinogenix's synaptic regenerative small molecule, in adults with schizophrenia. The randomized, double-blind, placebo-controlled Phase 2 study NCT06442462 (SPG302-SCZ-201) started on 2024-08-01 at sites in Australia and the United States and completed enrollment of 32 adults in March 2026; participants received 300 mg tazbentetol or placebo orally once daily for six weeks. Endpoints include change in PANSS, CGI-I, EEG measures and smooth pursuit eye tracking. A prespecified interim analysis of 16 participants (8 per arm), presented at SIRS 2026 on 2026-03-26, reported a PANSS total change of -11.9 vs -5.6 for placebo, a PANSS positive subscale difference of -3.2 (p=0.01), a smaller negative subscale difference (-0.8), several EEG band-power changes, and no severe adverse events. Full results have not been reported; the principal investigator said the full dataset is expected in 2026. No regulatory designations exist for this indication.
Development timeline
- UpcomingFull-cohort results (32 participants) from the Phase 2 study of tazbentetol in schizophrenia, expected in 2026.↗
- pendingInterim Phase 2 data (16 of 32 participants) for tazbentetol 300 mg vs placebo in schizophrenia: PANSS total -11.9 vs -5.6; PANSS positive -3.3 vs -0.1 (p=0.01); PANSS negative -1.8 vs -1.0; EEG gamma/alpha band-power changes; no severe adverse events.↗
- Spinogenix announced completion of enrollment of 32 adults in the Phase 2 schizophrenia study; CT.gov lists the study as Active, not recruiting.↗
- Phase 2 study NCT06442462 (SPG302-SCZ-201) started per ClinicalTrials.gov (actual start date). Spinogenix announced the launch on 2024-09-25, with sites enrolling under Australian HREC approval.
- Trial startedPhase 2 study of SPG302 in schizophrenia starts
- Trial registeredPhase 2 study of SPG302 in schizophrenia registered on ClinicalTrials.gov (NCT06442462)
Readouts
- 2026 (per principal investigator)AnticipatedFull resultsNCT06442462
Full-cohort results (32 participants) from the Phase 2 study of tazbentetol in schizophrenia, expected in 2026. ↗
- 2026-03-26ReportedInterim analysispendingNCT06442462
Interim Phase 2 data (16 of 32 participants) for tazbentetol 300 mg vs placebo in schizophrenia: PANSS total -11.9 vs -5.6; PANSS positive -3.3 vs -0.1 (p=0.01); PANSS negative -1.8 vs -1.0; EEG gamma/alpha band-power changes; no severe adverse events. ↗
Clinical trials in Schizophrenia
NCT06442462SPG302-SCZ-201Phase 2Activen=32
A Randomized, Placebo-controlled, Double-blind Phase 2 Study to Assess the Efficacy, Safety, Tolerability, and Pharmacodynamics of SPG302 in Adult Participants Diagnosed With Schizophrenia
Formulations
| Formulation | Route | Regimen | Pharmacokinetics |
|---|---|---|---|
| Tazbentetol oral (300 mg once daily) 300 mg orally once daily (two 150 mg capsules) for six weeks in the Phase 2 schizophrenia study NCT06442462. | Oral | Once daily | — |
Mechanism of action
Described by its sponsor as a synaptic regenerative therapy designed to trigger neurons to produce new glutamatergic synapses. It is a 3rd-generation pegylated benzothiazole derivative; this compound class is reported to target an undisclosed regulator of the F-actin-based cytoskeleton. In female 3xTg-AD mice, SPG302 (3 and 30 mg/kg i.p. daily for 4 weeks) restored CA1 dendritic spine density and PSD95 puncta and reversed deficits in the Morris water maze and contextual fear conditioning without altering amyloid-beta or tau pathology. The specific molecular target of SPG302 has not been publicly disclosed, so no target is recorded. The clinical rationale in schizophrenia is that loss of glutamatergic synapses contributes to positive, negative and cognitive symptoms.
| Target | Action | Affinity |
|---|
← Full SPG302 compound page (identity, identifiers, all indications)
Sources
- Frontiers in Synaptic Regeneration: Tazbentetol for Schizophrenia (2026-04-29) — Psychiatric Times
- NCT06442462 (SPG302-SCZ-201) - A Randomized, Placebo-controlled, Double-blind Phase 2 Study to Assess the Efficacy, Safety, Tolerability, and Pharmacodynamics of SPG302 in Adult Participants Diagnosed With Schizophrenia — ClinicalTrials.gov (U.S. National Library of Medicine)
- Spinogenix Completes Enrollment in Phase 2 Clinical Trial of Tazbentetol for Schizophrenia Treatment (2026-03-11) — Spinogenix, Inc. (via PR Newswire)
- Spinogenix Reports Early Improvements in Phase 2 Trial of Tazbentetol in Patients with Schizophrenia at the SIRS 2026 Annual Congress (2026-03-26) — Spinogenix, Inc.