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Clinical trials
catalyst calendar across sponsors →Studies where TNXP is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
34 interventional · 21 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)NCT07621237Change from Baseline (Visit 2) in the MADRS total score at Week 6.Randomized · Quadruple-masked · Treatment | Phase 2 | Recruiting | Drug: TNX-102 SL, Placebo sublingual tablet | Major Depressive Episode (MDE), Major Depressive Disorder (MDD), Depression | 360 | Feb 2028 | ≤ 558 d | 2026-06-02 |
| 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 ParticipantsNCT07413367AUC0-inf: Area Under the curve from time zero to infinityOpen-label · Basic science | Phase 1 | Active, not recruiting | Drug: TNX-102 SL Tablet | Pharmakokinetic, Open Label, Phase 1 | 50 | 2026-02-10 | — | 2026-02-17 |
| Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST)NCT06045793Change from Baseline in Systolic BP at 60 minutes after dosing, comparing TNX-1300 to placebo with UCRandomized · Single-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Tonix has discontinued enrollment and terminated the Phase 2 CATALYST study (TNX-CE-CI202) because enrollment in this emergency department-based study was slower than projected. The study was not discontinued for safety or efficacy reasons. | Drug: TNX-1300 (Injection), Placebo (Injection) | Cocaine Use, Cocaine Intoxication, Cocaine Toxicity, Cocaine Abuse, Cocaine Adverse Reaction | 3 | 2025-04-21actual | — | 2025-06-24 |
| 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 SubjectsNCT07473752Nature, frequency, and severity of treatment-emergent adverse events (TEAEs)Randomized · Quadruple-masked · Basic science | Phase 1 | Completed | Drug: TNX-1500, Placebo: USP 0.9% sterile saline for injection · Biological: Keyhole Limpet Hemocyanin (KLH) | Phase 1 First-in-human Study Involving Healthy Subjects | 26 | 2024-02-22actual | — | 2026-03-16 |
| A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With FibromyalgiaNCT05273749results2024-12-20Change From Baseline to the Week 14 Endpoint in the Diary NRS Weekly Average of Daily Self Reported Average Pain Severity Scores.Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: TNX-102 SL Tablet, 5.6 mg, Placebo SL Tablet | Fibromyalgia | 457 | 2023-11-14actual | — | 2025-01-22 |
| A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic MigraineNCT05679908results2025-02-25Mean Change in the Number of Monthly Migraine Headache DaysRandomized · Quadruple-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: TNX-1900, Placebo Nasal Spray | Chronic Migraine, Chronic Migraine, Headache, Chronic Migraine Without Aura, Aura Migraine | 88 | 2023-10-08actual | — | 2025-02-25 |
| Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)NCT05686408results2025-02-17Montgomery Asberg Depression Rating Scale (MADRS)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: TNX-601 ER, Placebo | Depression, Depressive Disorder, Depressive Symptoms, Depressive Disorder, Major, Depressive Episode, Depression Severe | 132 | 2023-09-29actual | — | 2025-02-17 |
| 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 InfectionNCT05472090results2024-11-26Daily Diary Pain NRSRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: TNX-102 SL, Placebo SL Tablet | Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection, COVID-19, Long COVID, Long Haul COVID | 63 | 2023-07-12actual | — | 2024-11-26 |
| Safety and Efficacy Study of TNX-102 SL in Participants With PTSDNCT05372887Mean change from baseline in the total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12.Randomized · Quadruple-masked · Treatment | Phase 2 | Withdrawnsponsor's stated reason: The study was stopped due to business reasons. | Drug: TNX-102 SL, Placebo | PTSD | 0 | 2022-11-08actual | — | 2023-12-11 |
| Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide AntigensNCT05216510results2024-11-06Assessment of Delayed-type Hypersensitivity ReactionsNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Terminatedsponsor's stated reason: Lack of efficacy | Biological: TNX-2110, TNX-2120, TNX-2130, CANDIN, Diluent | Detection of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 in Individuals Exposed to SARS-CoV-2 | 9 | 2022-09-17actual | — | 2024-11-06 |
| 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) SubjectsNCT04996056Incidence of Treatment Emergent Adverse Events, Adverse Events of Special Interests, and Adverse Drug ReactionsRandomized · Open-label · Treatment | Phase 2 | Withdrawnsponsor's stated reason: Not able to recruit qualified participants | Drug: TNX-1300 · Other: Usual Care | Cocaine Intoxication | 0 | 2022-06-16actual | — | 2022-06-29 |
| 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 SubjectsNCT07464535AUC0-∞: Area Under the curve from time zero to infinityRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: TNX-102 SL | Healthy Subjects (HS) | 20 | 2022-04-30actual | — | 2026-03-11 |
| A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With FibromyalgiaNCT04508621results2022-12-02Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores.Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: TNX-102 SL, Placebo SL Tablet | Fibromyalgia | 514 | 2021-11-01actual | — | 2023-12-18 |
| A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With FibromyalgiaNCT04172831results2022-08-08Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores.Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: TNX-102 SL, Placebo SL Tablet | Fibromyalgia | 503 | 2020-10-29actual | — | 2022-08-08 |
| A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSDNCT03841773results2025-02-06Mean Change From Baseline in the Total CAPS-5 ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Interim Analysis results | Drug: TNX-102 SL, Placebo SL Tablets | PTSD | 192 | 2020-04-24actual | — | 2025-02-06 |
| Dose-Proportionality and Food Effect Study of TNX-102 SLNCT04164719Area Under the Plasma Concentration Versus Time Curve (AUC) of TNX-102 SL 5.6 mg versus TNX-102 SL 2.8 mg under fasting conditionsRandomized · Open-label · Other | Phase 1 | Completed | Drug: TNX-102 SL | Healthy Subjects | 16 | 2019-12-24actual | — | 2020-01-06 |
| A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSDNCT03508700results2025-02-05Incidence of Newly Emergent Adverse EventsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: TNX-102 SL 5.6 mg | PTSD | 93 | 2019-09-30actual | — | 2025-02-05 |
| Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSDNCT03062540results2024-05-22Mean Change From Baseline in the Total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12.Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Stopped early due to inadequate separation on primary efficacy endpoint at Week 12 according to Interim Analysis conducted on the first 274 (50%) patients. | Drug: TNX-102 SL, Placebo SL Tablet | PTSD | 358 | 2018-07-27actual | — | 2024-05-22 |
| 12-Week Open-Label Extension Study of TNX-102 SL in PTSD PatientsNCT03110575results2025-02-06Incidence of Newly Emergent Adverse Events of TNX-102 SL Tablets Taken Daily at Bedtime Over an Additional 12 Weeks in Patients With PTSD Who Have Completed a Double-blinded lead-in StudyOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Stopped early due to inadequate separation on primary efficacy endpoint in the lead-in HONOR study, TNX-CY-P301 | Drug: TNX-102 SL | PTSD | 190 | 2018-07-27actual | — | 2025-02-06 |
| Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER CapsulesNCT03443960Steady-State Area Under the Plasma Concentration Versus Time Curve (AUC-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mgRandomized · Open-label · Other | Phase 1 | Completed | Drug: TNX-102 SL 5.6 mg, Amrix 30 mg | Healthy Subjects | 60 | 2018-04-09actual | — | 2018-04-24 |
| A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgiaNCT02436096results2025-02-07Proportion of Patients With ≥30% Pain ImprovementRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: TNX-102 SL Tablet, 2.8mg, Placebo SL Tablet | Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases, Musculoskeletal Diseases, Nervous System Diseases, Neuromuscular Diseases, Rheumatic Diseases | 519 | Sep 2016actual | — | 2025-02-07 |
| A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia PatientsNCT02589275results2024-12-11Newly Emergent Adverse EventsOpen-label · Treatment | Phase 3 | Completed | Drug: TNX-102 SL Tablet 2.8 mg | Primary Fibromyalgia | 375 | 2016-09-28actual | — | 2025-02-20 |
| Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With FibromyalgiaNCT02829814results2025-02-25Weekly Mean Pain ScoreRandomized · Quadruple-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: For business reason unrelated to safety or tolerability,Tonix discontinued this study. | Drug: TNX-102 SL Tablet, 2.8 mg, Placebo SL Tablet | Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases, Nervous System Diseases, Neuromuscular Diseases, Rheumatic Diseases, Musculoskeletal Diseases | 51 | 2016-09-13actual | — | 2025-02-25 |
| Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related ConditionsNCT02277704results2024-06-20The Mean Change From Baseline (Visit 2) in the Total CAPS-5 Score After 12 Weeks of Treatment Evaluated at Visit 9 (Week 12).Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: TNX-102 SL, Placebo | PTSD | 245 | May 2016actual | — | 2024-06-20 |
| Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related ConditionsNCT02421679results2025-02-06Newly Treatment Emergent Adverse EventsOpen-label · Treatment | Phase 2 | Completed | Drug: TNX-102 SL | PTSD | 159 | 2016-05-26actual | — | 2025-02-06 |
| Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type HeadacheNCT02423408results2017-02-17Number of Subjects Pain FreeRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: TNX-201, Placebo | Tension-Type Headache | 165 | Feb 2016actual | — | 2017-04-11 |
| Bioequivalence Study of TNX-102 SL 2.8 mg Sublingual Tablets From Two Manufacturers.NCT03168022results2019-07-11Mean Plasma Concentration (AUC) of CyclobenzaprineRandomized · Open-label · Other | Phase 1 | Completed | Drug: Treatment A, Treatment B | Healthy Adults | 43 | 2016-01-26actual | — | 2019-07-11 |
| 12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia PatientsNCT02015234results2017-07-07Newly-emergent Adverse Events (NEAEs) During Treatment With TNX-102 SL Tablets Taken Daily at Bedtime Over 12 Months in Patients With Fibromyalgia.Open-label · Treatment | Phase 3 | Completed | Drug: TNX-102 SL | Primary Fibromyalgia | 158 | Aug 2015actual | — | 2017-07-07 |
| Phase 1 Single Ascending Dose Safety Study of TNX-201 Capsules in Healthy VolunteersNCT02290379Plasma levels of isometheptene or metabolites.Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: TNX-201 35 mg, TNX-201 70 mg, TNX-201 140 mg, Racemic isometheptene 70 mg, Placebo | Healthy | 27 | May 2015actual | — | 2016-05-17 |
| BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)NCT01903265results2016-12-23Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12Randomized · Quadruple-masked · Treatment | Phase 2/3 | Completed | Drug: TNX-102 SL 2.8mg, Placebo | Primary Fibromyalgia | 205 | Jul 2014actual | — | 2016-12-23 |
| Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy AdultsNCT01689259Measured levels of cyclobenzaprine and norcyclobenzaprine in plasma and urineRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: SL TNX-102 at 2.4 mg, SL TNX-102 at 4.8 mg, SL TNX-102-A at 2.4 mg, Cyclobenzaprine tablets | Healthy Adults | 24 | Dec 2013actual | — | 2014-09-26 |
| Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy AdultsNCT01889173Measured levels of cyclobenzaprine and norcyclobenzaprine in plasma and urineRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: 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 | Healthy Adults | 24 | Dec 2013actual | — | 2014-09-26 |
| Comparative Bioavailability of Sublingual TNX-102, Oral and Intravenous Cyclobenzaprine in Healthy AdultsNCT01634412• Measured levels of cyclobenzaprine and norcyclobenzaprine in plasma and urineRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: SL TNX-102 2.4 mg at pH 3.5, SL TNX-102 2.4 mg at pH 7.1, Cyclobenzaprine Tablet, Cyclobenzaprine IV | Healthy Adults | 24 | Sep 2013actual | — | 2014-09-26 |
| A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.NCT01490788results2018-11-02Mean Plasma Concentration (AUC) of CyclobenzaprineRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Treatment A, Treatment B, Treatment C | Healthy | 30 | 2011-12-30actual | — | 2019-09-11 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19