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TNX-102 SL

DRUG13 trials

Sponsors

Tonix Pharmaceuticals, Inc.

Conditions

COVID-19DepressionFibromyalgiaHealthy SubjectsHealthy Subjects (HS)Long COVIDLong Haul COVIDMajor Depressive Disorder (MDD)

Phase 1

Dose-Proportionality and Food Effect Study of TNX-102 SL
CompletedNCT04164719
Tonix Pharmaceuticals, Inc.Healthy Subjects
Start: 2019-10-14End: 2019-12-24Updated: 2020-01-06
A Single-Dose, Randomized, Open-Label, 2-Way Crossover Study to Evaluate the Dose-Proportionality, Safety, and Tolerability of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) in Healthy Japanese and Chinese Subjects
CompletedNCT07464535
Tonix Pharmaceuticals, Inc.Healthy Subjects (HS)
Start: 2022-03-18End: 2022-04-30Updated: 2026-03-11

Phase 2

Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions
CompletedNCT02277704
Tonix Pharmaceuticals, Inc.PTSD
Start: 2014-10-31End: 2016-05-31Updated: 2024-06-20
Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions
CompletedNCT02421679
Tonix Pharmaceuticals, Inc.PTSD
Start: 2015-04-14End: 2016-05-26Updated: 2025-02-06
Safety and Efficacy Study of TNX-102 SL in Participants With PTSD
WithdrawnNCT05372887
Tonix Pharmaceuticals, Inc.PTSD
Start: 2022-10-14End: 2022-11-08Updated: 2023-12-11
A Phase 2 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Patients With Multi-Site Pain Associated With Post-Acute Sequelae of SARS-CoV-2 Infection
CompletedNCT05472090
Tonix Pharmaceuticals, Inc.COVID-19, Long COVID, Long Haul COVID +1
Start: 2022-08-18End: 2023-07-27Updated: 2024-11-26
A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
RecruitingNCT07621237
Tonix Pharmaceuticals, Inc.Depression, Major Depressive Disorder (MDD), Major Depressive Episode (MDE)
Start: 2026-06-01End: 2028-02-01Target: 360Updated: 2026-06-02

Phase 3

12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients
CompletedNCT02015234
Tonix Pharmaceuticals, Inc.Primary Fibromyalgia
Start: 2013-12-31End: 2015-08-31Updated: 2017-07-07
Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD
TerminatedNCT03062540
Tonix Pharmaceuticals, Inc.PTSD
Start: 2017-03-27End: 2018-07-27Updated: 2024-05-22
12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients
TerminatedNCT03110575
Tonix Pharmaceuticals, Inc.PTSD
Start: 2017-06-20End: 2018-07-27Updated: 2025-02-06
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD
TerminatedNCT03841773
Tonix Pharmaceuticals, Inc.PTSD
Start: 2019-03-07End: 2020-04-24Updated: 2025-02-06
A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
CompletedNCT04172831
Tonix Pharmaceuticals, Inc.Fibromyalgia
Start: 2019-12-09End: 2020-10-29Updated: 2022-08-08
A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
CompletedNCT04508621
Tonix Pharmaceuticals, Inc.Fibromyalgia
Start: 2020-07-22End: 2021-11-01Updated: 2023-12-18

Related Papers

Randomized clinical trial of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related PTSD and the role of sleep quality in treatment response.
2021-04-309 citations