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ClinicalTrials.gov public records Last synced Oct 17, 2026, 5:48 AM EDT

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Showing 1–24 of 28 matching trials from the live ClinicalTrials.gov search.
Filters: Sponsor: Tonix Pharmaceuticals, Inc. Clear all
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 11, 2026 · Synced Oct 17, 2026, 5:48 AM 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 17, 2025 · Synced Oct 17, 2026, 5:48 AM EDT
Completed Phase 3 Interventional Results available

A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

NCT04508621
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
514 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
36
States / cities
Birmingham, Alabama • Phoenix, Arizona • Oceanside, California + 33 more
Source: ClinicalTrials.gov public record
Updated Dec 18, 2023 · Synced Oct 17, 2026, 5:48 AM 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 28, 2026 · Synced Oct 17, 2026, 5:48 AM EDT
Completed Phase 2 Interventional Results available

A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine

NCT05679908
View directory record Official record
Conditions
Chronic Migraine, Chronic Migraine, Headache, Chronic Migraine Without Aura, Aura Migraine
Interventions
TNX-1900, Placebo Nasal Spray
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
88 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
26
States / cities
Little Rock, Arkansas • Lemon Grove, California • Oceanside, California + 23 more
Source: ClinicalTrials.gov public record
Updated Feb 25, 2025 · Synced Oct 17, 2026, 5:48 AM 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 16, 2026 · Synced Oct 17, 2026, 5:48 AM 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 23, 2016 · Synced Oct 17, 2026, 5:48 AM 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 19, 2026 · Synced Oct 17, 2026, 5:48 AM 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 5, 2025 · Synced Oct 17, 2026, 5:48 AM 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 7, 2025 · Synced Oct 17, 2026, 5:48 AM 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 Sep 1, 2026 · Synced Oct 17, 2026, 5:48 AM EDT
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 22, 2024 · Synced Oct 17, 2026, 5:48 AM EDT
Completed Phase 2 Interventional Results available

Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions

NCT02277704
View directory record Official record
Conditions
PTSD
Interventions
TNX-102 SL, Placebo
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
245 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
23
States / cities
Tuscaloosa, Alabama • Phoenix, Arizona • Imperial, California + 20 more
Source: ClinicalTrials.gov public record
Updated Jun 20, 2024 · Synced Oct 17, 2026, 5:48 AM 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 6, 2025 · Synced Oct 17, 2026, 5:48 AM 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 29, 2022 · Synced Oct 17, 2026, 5:48 AM 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 11, 2017 · Synced Oct 17, 2026, 5:48 AM 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 8, 2022 · Synced Oct 17, 2026, 5:48 AM 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 24, 2025 · Synced Oct 17, 2026, 5:48 AM 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 6, 2024 · Synced Oct 17, 2026, 5:48 AM 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 6, 2025 · Synced Oct 17, 2026, 5:48 AM 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 26, 2024 · Synced Oct 17, 2026, 5:48 AM EDT
Completed Phase 3 Interventional Results available

A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia

NCT05273749
View directory record Official record
Conditions
Fibromyalgia
Interventions
TNX-102 SL Tablet, 5.6 mg, Placebo SL Tablet
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
457 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
33
States / cities
Phoenix, Arizona • Oceanside, California • Santa Ana, California + 30 more
Source: ClinicalTrials.gov public record
Updated Jan 22, 2025 · Synced Oct 17, 2026, 5:48 AM 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 25, 2025 · Synced Oct 17, 2026, 5:48 AM 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 20, 2025 · Synced Oct 17, 2026, 5:48 AM EDT