NCT05372887 is a Phase 2 clinical trial of TNX-102 SL in PTSD, sponsored by Tonix Pharmaceuticals, Inc..

Who is sponsoring NCT05372887?

NCT05372887 is sponsored by Tonix Pharmaceuticals, Inc..

What drugs are being tested in NCT05372887?

Interventions in NCT05372887: TNX-102 SL, Placebo.

Is NCT05372887 still recruiting?

NCT05372887 is currently withdrawn. Last updated 11 December 2023.

Last reviewed 2023-12-11 · How we verify

NCT05372887

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Efficacy Study of TNX-102 SL in Participants With PTSD

Withdrawn Phase 2 Last updated 11 December 2023

What this trial tests

Phase 2 trial testing TNX-102 SL in PTSD. Withdrawn.

Timeline

14 October 2022

Primary endpoint
8 November 2022

8 November 2022

Quick facts

Lead sponsor	Tonix Pharmaceuticals, Inc.
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Start date	14 October 2022
Primary completion	8 November 2022
Estimated completion	8 November 2022
Sites	3 locations across Kenya

Drugs / interventions tested

TNX-102 SL — full drug profile →
Placebo

Conditions studied

PTSD — all drugs for PTSD →

Sponsor

Tonix Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with PTSD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (2 x 2.8 mg tablets)-a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Alleviating anxiety and taming trauma: Novel pharmacotherapeutics for anxiety disorders and posttraumatic stress disorder.
Singewald N, Sartori SB, Reif A, Holmes A. · · 2023 · cited 40× · PMID 36623804 · DOI 10.1016/j.neuropharm.2023.109418

Verify or expand the search:

Other trials of TNX-102 SL

Trials testing the same drug.

NCT05472090 — A Phase 2 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Patients With Multi-Site Pain Associated With Post- · Phase 2 · completed
NCT07464535 — A Single-Dose, Randomized, Open-Label, 2-Way Crossover Study to Evaluate the Dose-Proportionality, Safety, and Tolerabil · Phase 1 · completed
NCT04508621 — A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia · Phase 3 · completed
NCT04172831 — A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia · Phase 3 · completed
NCT04164719 — Dose-Proportionality and Food Effect Study of TNX-102 SL · Phase 1 · completed

Other recruiting trials for PTSD

Currently open trials in the same condition.

NCT07473505 — Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospect · recruiting
NCT07010757 — Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial · NA · recruiting
NCT07372586 — Behavioral Health Collaborative Care Model in an ICU Recovery Clinic · NA · recruiting
NCT07390786 — Behavioral Health Collaborative Care Model in Post-ICU Clinic Family Pilot · NA · recruiting
NCT07469098 — Group vs Individual MDMA-Assisted Therapy for PTSD After the October 7, 2023 Events · Phase 2 · recruiting

Other Tonix Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT07413367 — A Phase 1, Open-Label, Parallel-Group, Single-Dose Study To Compare The Pharmakokinetics Of TNX-102 SL (Cyclobenzaprine · Phase 1 · active not recruiting
NCT06045793 — Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (C · Phase 2 · terminated
NCT07473752 — A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Escalation Study to Evaluate the Safety, · Phase 1 · completed
NCT05686408 — Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD) · Phase 2 · completed
NCT05679908 — A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05372887 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tonix Pharmaceuticals, Inc.
Last refreshed: 11 December 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05372887.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing