Drugs / TNX-102 SL
last change Jun 2026 re-read 3 minutes ago

TNX-102 SL

also known as cyclobenzaprine
Developed for
fibromyalgia · post-traumatic stress disorder · long COVID-19 · major depressive disorder
Investigated by
Tonix Pharmaceuticals, Inc. · Premier Research

Trials 10

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT04164719 Oct → Dec 2019 — Tonix Pharmaceuticals, Inc. Completed No outcome recorded
Phase 23 trials · 1 met primary
Phase 2 NCT07621237 Jun 2026 → Feb 2028 expected major depressive disorder Tonix Pharmaceuticals, Inc. Recruiting No outcome recorded
Phase 2 NCT05472090 Aug 2022 → Jul 2023 COVID-19, long COVID-19 Tonix Pharmaceuticals, Inc. Completed No outcome recorded
Phase 2 NCT02421679 Apr 2015 → May 2016 post-traumatic stress disorder Tonix Pharmaceuticals, Inc. Completed Met primary
Phase 2/31 trial · 1 missed
Phase 2/3 NCT01903265 Sep 2013 → Jul 2014 fibromyalgia Tonix Pharmaceuticals, Inc. Completed Missed primary
Phase 35 trials · 1 met primary · 1 missed
Phase 3 NCT05273749 Apr 2022 → Nov 2023 fibromyalgia Tonix Pharmaceuticals, Inc. Completed Met primary
Phase 3 NCT04508621 Jul 2020 → Nov 2021 fibromyalgia Tonix Pharmaceuticals, Inc. Completed Missed primary
Phase 3 NCT03110575 Jun 2017 → Jul 2018 post-traumatic stress disorder Tonix Pharmaceuticals, Inc. Terminated No outcome recorded
Phase 3 NCT02589275 Aug 2015 → Sep 2016 fibromyalgia Tonix Pharmaceuticals, Inc. Completed No outcome recorded
Phase 3 NCT02015234 Dec 2013 → Aug 2015 fibromyalgia Tonix Pharmaceuticals, Inc. Completed No outcome recorded

Press releases naming this drug 111 releases

DateIssuerRelease
2026-06-29 Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Announces First Patient Enrolled in Phase 2 HORIZON Study of TNX-102 SL for the Treatment of Major Depressive Disorder (MDD) tonixpharma.com ↗
2026-01-30 Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Presented Phase 3 RESILIENT Data on TONMYA™ (Cyclobenzaprine HCl Sublingual Tablets) at the 2026 Non-Opioid Pain Therapeutics Summit tonixpharma.com ↗
2025-11-24 Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Announces FDA IND Clearance for Phase 2 Study of TNX-102 SL for the Treatment of Major Depressive Disorder tonixpharma.com ↗
2025-11-17 Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Announces U.S. Commercial Availability of TONMYA™ (cyclobenzaprine HCl sublingual tablets) as a First-in-Class Fibromyalgia Treatment tonixpharma.com ↗
2025-10-27 Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Presented Data on Tonmya™ (Cyclobenzaprine HCl Sublingual Tablets) at the 2025 American College of Rheumatology (ACR) Convergence tonixpharma.com ↗
2025-09-18 Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Announces Positive Pre-IND Meeting with FDA for TNX-102 SL for the Treatment of Major Depressive Disorder tonixpharma.com ↗
2025-08-15 Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia tonixpharma.com ↗
2025-07-09 Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Announces On-line Publication of Phase 3 RESILIENT Trial Results of TNX-102 SL for Fibromyalgia in the Peer Reviewed Journal, Pain Medicine tonixpharma.com ↗
2025-06-16 Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the Annual European Congress of Rheumatology (EULAR) 2025 tonixpharma.com ↗
2025-05-21 Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Announces First Patient Dosed in Phase 2 OASIS Study of TNX-102 SL for Reduction of Acute Stress Reaction tonixpharma.com ↗
2025-04-07 Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the American Academy of Pain Medicine (AAPM) 2025 Annual Meeting tonixpharma.com ↗
2025-03-24 Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Announces that FDA Will Not Require an Advisory Committee Meeting to Discuss New Drug Application for TNX-102 SL for the Management of Fibromyalgia tonixpharma.com ↗

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 11 sources stand behind the page.

FieldValueCited text
Known as TNX-102 SL ClinicalTrials.gov intervention name — accepted as the source's own label NCT02015234 ↗
9

NCT04508621 ↗

NCT05472090 ↗

NCT03110575 ↗

NCT05273749 ↗

NCT01903265 ↗

NCT02421679 ↗

NCT02589275 ↗

NCT07621237 ↗

NCT04164719 ↗

Known as cyclobenzaprine “We evaluated efficacy and safety of bedtime TNX-102 SL (sublingual cyclobenzaprine) 5.6 mg for treatment of fibromyalgia.” PMID 40627411 ↗ Jan 2026
Route Other “Subjects will place TNX-102 SL sublingual tablets under the tongue until dissolved” NCT04164719 ↗