8 completed, 3 terminated, 2 recruiting, 1 withdrawn. 6 Phase 2, 6 Phase 3, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 3, Recruiting 2, Withdrawn 1 |
| Phase 3 | 6 | Completed 3, Terminated 3 |
| Phase 1 | 2 | Completed 2 |
Follow TNX-102 SL: new trials by email Literature Review of TNX-102 SL trials Research Report on TNX-102 SL
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD) TNX-102 SL, Placebo sublingual tablet - Major Depressive Episode (MDE), Major Depressive Disorder (MDD) | Phase 2 | Recruiting | Tonix Pharmaceuticals, Inc. | 360 | 2026-06-25 | 2026-09-25 |
| Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL) Cyclobenzaprine HCl, Placebo - Acute Stress Reaction, Acute Stress Disorder | Phase 2 | Recruiting | University of North Carolina, Chapel Hill | 180 | 2025-03-25 | 2026-10-22 |
| Safety and Efficacy Study of TNX-102 SL in Participants With PTSD TNX-102 SL, Placebo - PTSD | Phase 2 | Withdrawn | Tonix Pharmaceuticals, Inc. | 2022-10-14 | 2023-12-11 | |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 TNX-102 SL, Placebo SL Tablet - Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection, COVID-19 | Phase 2 | Completed | Tonix Pharmaceuticals, Inc. | 63 | 2022-08-18 | 2024-11-26 |
| 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 TNX-102 SL - Healthy Subjects (HS) | Phase 1 | Completed | Tonix Pharmaceuticals, Inc. | 20 | 2022-03-18 | 2026-03-11 |
| A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia TNX-102 SL, Placebo SL Tablet - Fibromyalgia | Phase 3 | Completed | Tonix Pharmaceuticals, Inc. | 514 | 2020-07-22 | 2023-12-18 |
| A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia TNX-102 SL, Placebo SL Tablet - Fibromyalgia | Phase 3 | Completed | Tonix Pharmaceuticals, Inc. | 503 | 2019-12-09 | 2022-08-08 |
| Dose-Proportionality and Food Effect Study of TNX-102 SL TNX-102 SL - Healthy Subjects | Phase 1 | Completed | Tonix Pharmaceuticals, Inc. | 16 | 2019-10-14 | 2020-01-06 |
| A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD TNX-102 SL, Placebo SL Tablets - PTSD | Phase 3 | Terminated | Tonix Pharmaceuticals, Inc. | 192 | 2019-03-07 | 2025-02-06 |
| 12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients TNX-102 SL - PTSD | Phase 3 | Terminated | Tonix Pharmaceuticals, Inc. | 190 | 2017-06-20 | 2025-02-06 |
| Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD TNX-102 SL, Placebo SL Tablet - PTSD | Phase 3 | Terminated | Tonix Pharmaceuticals, Inc. | 358 | 2017-03-27 | 2024-05-22 |
| Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions TNX-102 SL - PTSD | Phase 2 | Completed | Tonix Pharmaceuticals, Inc. | 159 | 2015-04-14 | 2025-02-06 |
| Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions TNX-102 SL, Placebo - PTSD | Phase 2 | Completed | Tonix Pharmaceuticals, Inc. | 245 | 2014-10-01 | 2024-06-20 |
| 12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients TNX-102 SL - Primary Fibromyalgia | Phase 3 | Completed | Tonix Pharmaceuticals, Inc. | 158 | 2013-12-01 | 2017-07-07 |
Stress Disorders, Post-Traumatic (6) · Fibromyalgia (3) · Pain (2) · COVID-19 (1) · Coronavirus Infections (1) · Depression (1) · Depressive Disorder, Major (1) · Infections (1) · Parasomnias (1) · Post-Acute COVID-19 Syndrome (1) · Stress Disorders, Traumatic, Acute (1)
Tonix Pharmaceuticals, Inc. (13) · University of North Carolina, Chapel Hill (1)
United States (12) · Canada (1) · Kenya (1)
Denise Bedoya (3) · Gregory Sullivan, MD (3) · Christopher Jones, MD (1) · Denis Audet, MD (1) · Greg Sullivan, MD (1) · Gregory M Sullivan, MD (1) · Gregory Sullivan (1) · Herb Harris, MD, PhD (1) · Samuel McLean, MD (1)