NCT07413367

A Phase 1, Open-Label, Parallel-Group, Single-Dose Study To Compare The Pharmakokinetics Of TNX-102 SL (Cyclobenzaprine Hydrochloride Sublingual Tablet) In Non-Elderly Versus Elderly Participants

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Tonix Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

TNX-102 SL has recently been approved by the United States (US) Food and Drug Administration (FDA) under the brand name TONMYA for the treatment of fibromyalgia. Fibromyalgia is a long-lasting condition that causes pain all over the body, along with feeling tired and not sleeping well. TNX-102 SL is not approved for any conditions in Canada. The study looks at the safety and blood levels of a study drug called TNX-102 SL \[cyclobenzaprine hydrochloride (HCl) sublingual (SL) tablets\], taken under the tongue, and compares it in non-elderly and elderly male and female participants.

Conditions

• Pharmakokinetic
• Open Label
• Phase 1

Interventions

Type	Name	Description
DRUG	TNX-102 SL Tablet	CYCLOBENZAPRINE HYDROCHLORIDE SUBLINGUAL TABLET

Timeline

• Start date: 2025-12-09
• Primary completion: 2026-02-10
• Completion: 2026-02-10
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study