drugset
Drugs / SPG601
last change Jul 2026 re-read 3 minutes ago

SPG601

Small molecule

Developed for
fragile X syndrome

Trials 0

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Comparator or background therapy2 trials
Phase 2 NCT06413537 Comparator Jul → Dec 2024 fragile X syndrome Spinogenix Completed No outcome recorded
Phase 2/3 NCT07439510 Comparator Mar 2026 → Feb 2030 expected fragile X syndrome Spinogenix Not yet recruiting No outcome recorded

Press releases naming this drug 12 releases

DateIssuerRelease
2026-07-16 Spinogenix Spinogenix Announces World Health Organization Approval of "Codabakalner" as International Nonproprietary Name for SPG601 spinogenix.com ↗
2026-04-23 Spinogenix Spinogenix Announces CLARITY: a Phase 2b/3 trial of SPG601 for the Treatment of Fragile X Syndrome spinogenix.com ↗
2026-04-09 Spinogenix New Peer-Reviewed Research Demonstrates Neurophysiological Efficacy of Spinogenix’s SPG601 in Patients with Fragile X Syndrome spinogenix.com ↗
2026-03-02 Spinogenix Spinogenix Announces FRAXA Research Foundation Support for PIs Leading Phase 2b Trial of Investigational Therapy SPG601 for People with Fragile X Syndrome (FXS) spinogenix.com ↗
2025-10-22 Spinogenix Spinogenix to Present Complete Phase 2a Clinical Trial Results for SPG601, a First-in-Class Fragile X Syndrome Treatment, at AACAP Conference spinogenix.com ↗
2025-09-02 Spinogenix Spinogenix Announces Positive Type C Meeting with the FDA for SPG601 in Patients with Fragile X Syndrome (FXS) spinogenix.com ↗
2025-07-07 Spinogenix European Medicines Agency Grants Orphan Drug Designation to Spinogenix's SPG601 for Treatment of Fragile X Syndrome (FXS) spinogenix.com ↗
2025-02-11 Spinogenix 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 spinogenix.com ↗
2025-01-13 Spinogenix FDA Grants Fast Track Designation to Spinogenix's SPG601 for Treatment of Fragile X Syndrome, a Common Inherited Form of Autism spinogenix.com ↗
2024-07-23 Spinogenix Spinogenix Announces Enrollment is Open for its Phase 2 Clinical Trial of SPG601 Fragile X syndrome spinogenix.com ↗
2024-05-20 Spinogenix Spinogenix Announces U.S. FDA Orphan Drug Designation Granted to SPG601 for the Treatment of Fragile X syndrome spinogenix.com ↗
2024-04-12 Spinogenix Spinogenix Announces U.S. FDA Approval of its Investigational New DrugApplication for its Phase 2a Clinical Trial of SPG601 for Fragile X syndrome spinogenix.com ↗

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as SPG601 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06413537 ↗
1

NCT07439510 ↗
Modality Small molecule “synthetic small molecule” NCT06413537 ↗
Route Oral “This study will entail 2 in person clinic visits to administer oral doses of SPG601 or matching placebo.” NCT06413537 ↗