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Showing 1–24 of 28 matching trials from the live ClinicalTrials.gov search.
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Filters: Sponsor: Tonix Pharmaceuticals, Inc. Clear all
Terminated Phase 3 Interventional Results available

Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD

NCT03062540
View directory record Official record
Conditions
PTSD
Interventions
TNX-102 SL, Placebo SL Tablet
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
358 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
44
States / cities
Phoenix, Arizona • Little Rock, Arkansas • Rogers, Arkansas + 40 more
Source: ClinicalTrials.gov public record
Updated May 21, 2024 · Synced Sep 1, 2026, 10:07 PM EDT
Completed Phase 2Phase 3 Interventional Results available

BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)

NCT01903265
View directory record Official record
Conditions
Primary Fibromyalgia
Interventions
TNX-102 SL 2.8mg, Placebo
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
205 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
17
States / cities
Sacramento, California • Denver, Colorado • Brooksville, Florida + 14 more
Source: ClinicalTrials.gov public record
Updated Dec 22, 2016 · Synced Sep 1, 2026, 10:07 PM EDT
Terminated Phase 1 Interventional Accepts healthy volunteers Results available

Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens

NCT05216510
View directory record Official record
Conditions
Detection of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 in Individuals Exposed to SARS-CoV-2
Interventions
TNX-2110, TNX-2120, TNX-2130, CANDIN, Diluent
Biological
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
9 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022
U.S. locations
1
States / cities
Berlin, New Jersey
Source: ClinicalTrials.gov public record
Updated Nov 5, 2024 · Synced Sep 1, 2026, 10:07 PM EDT
Withdrawn Phase 2 Interventional

An Open-Label, Randomized Pilot Study Comparing the Safety of a Single Dose of TNX-1300 to Usual Care (UC) Alone for the Treatment of Signs and Symptoms of Acute Cocaine Intoxication in Male Emergency Department (ED) Subjects

NCT04996056
View directory record Official record
Conditions
Cocaine Intoxication
Interventions
TNX-1300, Usual Care
Drug · Other
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 50 Years · Male only
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
2
States / cities
Detroit, Michigan • St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Jun 28, 2022 · Synced Sep 1, 2026, 10:07 PM EDT
Not yet recruiting Phase 2 Interventional

(TNX-1500) in Kidney Transplant Recipients

NCT07204080
View directory record Official record
Conditions
Kidney Transplant, Kidney Transplant Failure and Rejection, Immunosuppression, Immunosuppression After Kidney Transplantation
Interventions
TNX-1500, Kidney Transplant
Drug · Procedure
Lead sponsor
Ayman Al Jurdi, MD
Other
Eligibility
18 Years to 75 Years
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Aug 18, 2026 · Synced Sep 1, 2026, 10:07 PM EDT
Completed Phase 2 Interventional Results available

Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)

NCT05686408
View directory record Official record
Conditions
Depression, Depressive Disorder, Depressive Symptoms, Depressive Disorder, Major, Depressive Episode, Depression Severe
Interventions
TNX-601 ER, Placebo
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
132 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023
U.S. locations
27
States / cities
Little Rock, Arkansas • Bellflower, California • Glendale, California + 24 more
Source: ClinicalTrials.gov public record
Updated Feb 16, 2025 · Synced Sep 1, 2026, 10:07 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT07464535
View directory record Official record
Conditions
Healthy Subjects (HS)
Interventions
TNX-102 SL
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022
U.S. locations
1
States / cities
Cypress, California
Source: ClinicalTrials.gov public record
Updated Mar 10, 2026 · Synced Sep 1, 2026, 10:07 PM EDT
Terminated Phase 3 Interventional Results available

12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients

NCT03110575
View directory record Official record
Conditions
PTSD
Interventions
TNX-102 SL
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
190 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
32
States / cities
Phoenix, Arizona • Rogers, Arkansas • Beverly Hills, California + 28 more
Source: ClinicalTrials.gov public record
Updated Feb 5, 2025 · Synced Sep 1, 2026, 10:07 PM EDT
Completed Phase 3 Interventional Results available

A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients

NCT02589275
View directory record Official record
Conditions
Primary Fibromyalgia
Interventions
TNX-102 SL Tablet 2.8 mg
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
375 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
33
States / cities
Birmingham, Alabama • Phoenix, Arizona • Sacramento, California + 30 more
Source: ClinicalTrials.gov public record
Updated Feb 19, 2025 · Synced Sep 1, 2026, 10:07 PM EDT
Terminated Phase 3 Interventional Results available

A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD

NCT03841773
View directory record Official record
Conditions
PTSD
Interventions
TNX-102 SL, Placebo SL Tablets
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
192 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
30
States / cities
Phoenix, Arizona • Little Rock, Arkansas • Rogers, Arkansas + 27 more
Source: ClinicalTrials.gov public record
Updated Feb 5, 2025 · Synced Sep 1, 2026, 10:07 PM EDT
Completed Phase 3 Interventional Results available

A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia

NCT02436096
View directory record Official record
Conditions
Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases, Musculoskeletal Diseases, Nervous System Diseases, Neuromuscular Diseases, Rheumatic Diseases
Interventions
TNX-102 SL Tablet, 2.8mg, Placebo SL Tablet
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
519 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
35
States / cities
Birmingham, Alabama • Phoenix, Arizona • Sacramento, California + 31 more
Source: ClinicalTrials.gov public record
Updated Feb 6, 2025 · Synced Sep 1, 2026, 10:07 PM EDT
Terminated Phase 2 Interventional

Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST)

NCT06045793
View directory record Official record
Conditions
Cocaine Use, Cocaine Intoxication, Cocaine Toxicity, Cocaine Abuse, Cocaine Adverse Reaction
Interventions
TNX-1300 (Injection), Placebo (Injection)
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 64 Years
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
6
States / cities
Lexington, Kentucky • Baltimore, Maryland • Detroit, Michigan + 2 more
Source: ClinicalTrials.gov public record
Updated Jun 23, 2025 · Synced Sep 1, 2026, 10:07 PM EDT
Recruiting Phase 2 Interventional

Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)

NCT06636786
View directory record Official record
Conditions
Acute Stress Reaction, Acute Stress Disorder, Neurocognitive Function, Post-traumatic Stress
Interventions
Cyclobenzaprine HCl, Placebo
Drug
Lead sponsor
University of North Carolina, Chapel Hill
Other
Eligibility
18 Years to 55 Years
Enrollment
180 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
9
States / cities
Birmingham, Alabama • Indianapolis, Indiana • Kansas City, Kansas + 5 more
Source: ClinicalTrials.gov public record
Updated Aug 31, 2026 · Synced Sep 1, 2026, 10:07 PM EDT
Recruiting Phase 2 Interventional

A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)

NCT07621237
View directory record Official record
Conditions
Major Depressive Episode (MDE), Major Depressive Disorder (MDD), Depression
Interventions
TNX-102 SL, Placebo sublingual tablet
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
360 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
25
States / cities
Phoenix, Arizona • Chino, California • Lemon Grove, California + 22 more
Source: ClinicalTrials.gov public record
Updated Jun 1, 2026 · Synced Sep 1, 2026, 10:07 PM EDT
Not yet recruiting Phase 2 Interventional

Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery

NCT07730294
View directory record Official record
Conditions
Pain, Pituitary Surgery
Interventions
Oxytocin (Low dose), Oxytocin (High dose), Placebo (saline)
Drug
Lead sponsor
Yale University
Other
Eligibility
30 Years to 75 Years
Enrollment
75 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Jul 27, 2026 · Synced Sep 1, 2026, 10:07 PM EDT
Terminated Phase 3 Interventional Results available

Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia

NCT02829814
View directory record Official record
Conditions
Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases, Nervous System Diseases, Neuromuscular Diseases, Rheumatic Diseases, Musculoskeletal Diseases
Interventions
TNX-102 SL Tablet, 2.8 mg, Placebo SL Tablet
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
51 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016
U.S. locations
32
States / cities
Birmingham, Alabama • Phoenix, Arizona • Oceanside, California + 28 more
Source: ClinicalTrials.gov public record
Updated Feb 24, 2025 · Synced Sep 1, 2026, 10:07 PM EDT
Completed Phase 2 Interventional Results available

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

NCT05472090
View directory record Official record
Conditions
Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection, COVID-19, Long COVID, Long Haul COVID
Interventions
TNX-102 SL, Placebo SL Tablet
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
63 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
29
States / cities
Birmingham, Alabama • Oceanside, California • Santa Ana, California + 25 more
Source: ClinicalTrials.gov public record
Updated Nov 25, 2024 · Synced Sep 1, 2026, 10:07 PM EDT
Completed Phase 3 Interventional Results available

A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

NCT04172831
View directory record Official record
Conditions
Fibromyalgia
Interventions
TNX-102 SL, Placebo SL Tablet
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
503 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
39
States / cities
Birmingham, Alabama • Phoenix, Arizona • Oceanside, California + 36 more
Source: ClinicalTrials.gov public record
Updated Aug 7, 2022 · Synced Sep 1, 2026, 10:07 PM EDT
Recruiting Phase 1 Interventional

Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency

NCT04789148
View directory record Official record
Conditions
Vasopressin Deficiency
Interventions
Intranasal Oxytocin (IN-OXT), Placebo
Drug
Lead sponsor
Elizabeth Austen Lawson
Other
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jul 22, 2026 · Synced Sep 1, 2026, 10:07 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TNX-1500 in Healthy Subjects

NCT07473752
View directory record Official record
Conditions
Phase 1 First-in-human Study Involving Healthy Subjects
Interventions
TNX-1500, Placebo: USP 0.9% sterile saline for injection, Keyhole Limpet Hemocyanin (KLH)
Drug · Biological
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
26 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2024
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Mar 15, 2026 · Synced Sep 1, 2026, 10:07 PM EDT
Completed Phase 2 Interventional Results available

Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions

NCT02421679
View directory record Official record
Conditions
PTSD
Interventions
TNX-102 SL
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
159 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
22
States / cities
Tuscaloosa, Alabama • Phoenix, Arizona • Imperial, California + 19 more
Source: ClinicalTrials.gov public record
Updated Feb 5, 2025 · Synced Sep 1, 2026, 10:07 PM EDT
Completed Phase 2 Interventional Results available

Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache

NCT02423408
View directory record Official record
Conditions
Tension-Type Headache
Interventions
TNX-201, Placebo
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
165 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
10
States / cities
San Jose, California • DeLand, Florida • Stockbridge, Georgia + 7 more
Source: ClinicalTrials.gov public record
Updated Apr 10, 2017 · Synced Sep 1, 2026, 10:07 PM EDT
Completed Phase 3 Interventional Results available

12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients

NCT02015234
View directory record Official record
Conditions
Primary Fibromyalgia
Interventions
TNX-102 SL
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
158 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
13
States / cities
Denver, Colorado • Brooksville, Florida • Orlando, Florida + 10 more
Source: ClinicalTrials.gov public record
Updated Jul 6, 2017 · Synced Sep 1, 2026, 10:07 PM EDT
Completed Phase 3 Interventional Results available

A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD

NCT03508700
View directory record Official record
Conditions
PTSD
Interventions
TNX-102 SL 5.6 mg
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
93 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
16
States / cities
Little Rock, Arkansas • Beverly Hills, California • Oceanside, California + 13 more
Source: ClinicalTrials.gov public record
Updated Feb 4, 2025 · Synced Sep 1, 2026, 10:07 PM EDT