Tonix Pharmaceuticals Holding Corp.
TNXPHealthcare|Biotechnology|US
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Clinical Trials (39)
| Trial | Conditions | Phase | Status | Enrollment | Design | Drug |
|---|---|---|---|---|---|---|
| NCT06636786 Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL) | Acute Stress Reaction, Acute Stress Disorder | P2 | Recruiting | 180 | RCT, Double-blind | Cyclobenzaprine HCl, Placebo |
| NCT07621237 A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD) | Major Depressive Episode (MDE), Major Depressive Disorder (MDD) | P2 | Recruiting | 360 | RCT, Double-blind | TNX-102 SL, Placebo sublingual tablet |
| NCT07730294 Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery | Pain, Pituitary Surgery | P2 | Recruiting | 75 | RCT, Double-blind | Oxytocin (Low dose), Oxytocin (High dose), Placebo (saline) |
| NCT04789148 Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency | Vasopressin Deficiency | P1 | Recruiting | 40 | RCT, Double-blind | Intranasal Oxytocin (IN-OXT) 6 IU single dose, Intranasal Oxytocin (IN-OXT) 6 IU repeat dose, Placebo repeat dose, Intranasal Oxytocin (IN-OXT) 24 IU single dose, Placebo single dose |
| NCT07413367 A Phase 1, Open-Label, Parallel-Group, Single-Dose Study To Compare The Pharmakokinetics Of TNX-102 SL (Cyclobenzaprine Hydrochloride Sublingual Tablet) In Non-Elderly Versus Elderly Participants | Pharmakokinetic, Open Label | P1 | Active | 50 | Open-label | TNX-102 SL Tablet |
| NCT04508621 A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia | Fibromyalgia | P3 | Completed | 514 | RCT, Double-blind | TNX-102 SL, Placebo SL Tablet |
| NCT02589275 A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients | Primary Fibromyalgia | P3 | Completed | 375 | Open-label | TNX-102 SL Tablet 2.8 mg |
| NCT01903265 BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT) | Primary Fibromyalgia | P2P3 | Completed | 205 | RCT, Double-blind | TNX-102 SL 2.8mg, Placebo |
| NCT02015234 12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients | Primary Fibromyalgia | P3 | Completed | 158 | Open-label | TNX-102 SL |
| NCT03508700 A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD | PTSD | P3 | Completed | 93 | Open-label | TNX-102 SL 5.6 mg |
| NCT03110575 12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients | PTSD | P3 | Terminated | 190 | Open-label | TNX-102 SL |
| NCT03062540 Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD | PTSD | P3 | Terminated | 358 | RCT, Double-blind | TNX-102 SL, Placebo SL Tablet |
| NCT02436096 A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia | Fibromyalgia, Myofascial Pain Syndromes | P3 | Completed | 519 | RCT, Double-blind | TNX-102 SL Tablet, 2.8mg, Placebo SL Tablet |
| NCT04172831 A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia | Fibromyalgia | P3 | Completed | 503 | RCT, Double-blind | TNX-102 SL, Placebo SL Tablet |
| NCT02829814 Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia | Fibromyalgia, Myofascial Pain Syndromes | P3 | Terminated | 51 | RCT, Double-blind | TNX-102 SL Tablet, 2.8 mg, Placebo SL Tablet |
| NCT05273749 A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia | Fibromyalgia | P3 | Completed | 457 | RCT, Double-blind | TNX-102 SL Tablet, 5.6 mg, Placebo SL Tablet |
| NCT03841773 A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD | PTSD | P3 | Terminated | 192 | RCT, Double-blind | TNX-102 SL, Placebo SL Tablets |
| NCT02423408 Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache | Tension-Type Headache | P2 | Completed | 165 | RCT, Double-blind | TNX-201, Placebo |
| NCT05472090 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 | Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection, COVID-19 | P2 | Completed | 63 | RCT, Double-blind | TNX-102 SL, Placebo SL Tablet |
| NCT05686408 Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD) | Depression, Depressive Disorder | P2 | Completed | 132 | RCT, Double-blind | TNX-601 ER, Placebo |
| NCT06045793 Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST) | Cocaine Use, Cocaine Intoxication | P2 | Terminated | 3 | RCT, Single-blind | TNX-1300 (Injection), Placebo (Injection) |
| NCT05679908 A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine | Chronic Migraine, Chronic Migraine, Headache | P2 | Completed | 88 | RCT, Double-blind | TNX-1900, Placebo Nasal Spray |
| NCT02421679 Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions | PTSD | P2 | Completed | 159 | Open-label | TNX-102 SL |
| NCT05372887 Safety and Efficacy Study of TNX-102 SL in Participants With PTSD | PTSD | P2 | Withdrawn | — | RCT, Double-blind | TNX-102 SL, Placebo |
| NCT07204080 (TNX-1500) in Kidney Transplant Recipients | Kidney Transplant, Kidney Transplant Failure and Rejection | P2 | Not Yet Recruiting | 5 | Open-label | TNX-1500 |
| NCT02277704 Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions | PTSD | P2 | Completed | 245 | RCT, Double-blind | TNX-102 SL, Placebo |
| NCT04996056 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 | Cocaine Intoxication | P2 | Withdrawn | — | RCT, Open-label | TNX-1300 |
| NCT03443960 Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER Capsules | Healthy Subjects | P1 | Completed | 60 | RCT, Open-label | TNX-102 SL 5.6 mg, Amrix 30 mg |
| NCT04164719 Dose-Proportionality and Food Effect Study of TNX-102 SL | Healthy Subjects | P1 | Completed | 16 | RCT, Open-label | TNX-102 SL |
| NCT01634412 Comparative Bioavailability of Sublingual TNX-102, Oral and Intravenous Cyclobenzaprine in Healthy Adults | Healthy Adults | P1 | Completed | 24 | RCT, Open-label | SL TNX-102 2.4 mg at pH 3.5, SL TNX-102 2.4 mg at pH 7.1, Cyclobenzaprine Tablet, Cyclobenzaprine IV |
| NCT01490788 A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults. | Healthy | P1 | Completed | 30 | RCT, Open-label | Treatment A, Treatment B, Treatment C |
| NCT07473752 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 | Phase 1 First-in-human Study Involving Healthy Subjects | P1 | Completed | 26 | RCT, Double-blind | TNX-1500, Placebo: USP 0.9% sterile saline for injection, Keyhole Limpet Hemocyanin (KLH) |
| NCT01689259 Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults | Healthy Adults | P1 | Completed | 24 | RCT, Open-label | SL TNX-102 at 2.4 mg, SL TNX-102 at 4.8 mg, SL TNX-102-A at 2.4 mg, Cyclobenzaprine tablets |
| NCT02290379 Phase 1 Single Ascending Dose Safety Study of TNX-201 Capsules in Healthy Volunteers | Healthy | P1 | Completed | 27 | RCT, Double-blind | TNX-201 35 mg, TNX-201 70 mg, TNX-201 140 mg, Racemic isometheptene 70 mg, Placebo |
| NCT03168022 Bioequivalence Study of TNX-102 SL 2.8 mg Sublingual Tablets From Two Manufacturers. | Healthy Adults | P1 | Completed | 43 | RCT, Open-label | Treatment A, Treatment B |
| NCT01889173 Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults | Healthy Adults | P1 | Completed | 24 | RCT, Open-label | TNX-102 SL Tablets at 2.8 mg, TNX-102-B SL Tablets at 2.8 mg, TNX-102-C SL Tablets at 2.8 mg, Cyclobenzaprine tablets |
| NCT07464535 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 | Healthy Subjects (HS) | P1 | Completed | 20 | RCT, Open-label | TNX-102 SL |
| NCT05216510 Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens | Detection of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 in Individuals Exposed to SARS-CoV-2 | P1 | Terminated | 9 | Open-label | TNX-2110, TNX-2120, TNX-2130, CANDIN, Diluent |
| NCT06955650 First-in-man Imaging of a New PET Radiotracer for Oxytocin Receptors | Pain, Face | Early P1 | Completed | 6 | Open-label | Imaging procedure to measure the distribution of a newly developed radiolabeled ligand for the oxytocin receptor |