Tonix Pharma (TPM0) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Tnx-102 Sl | Depression, Major Depressive Disorder (Mdd), Major Depressive Episode (Mde) | Phase II | Recruiting | A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD) | May 27, 2026 | ― |
| Tnx-1300 | Cocaine Use, Cocaine Intoxication, Cocaine Toxicity, Cocaine Abuse, Cocaine Adverse Reaction | Phase II | Terminated | Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST) | Sep 13, 2023 | ― |
| Tnx-601 Er | Depressive Symptoms, Depressive Episode, Depression Severe, Depressive Disorder, Depressive Disorder, Major, Depression | Phase II | Completed | Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD) | Jan 06, 2023 | ― |
| Tnx-1900 | Chronic Migraine, Chronic Migraine, Headache, Chronic Migraine Without Aura, Aura Migraine | Phase II | Completed | A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine | Dec 19, 2022 | ― |
| Tnx-102 Sl | Covid-19, Long Covid, Post-Acute Sequelae Of Sars-Cov-2 (Pasc) Infection, Long Haul Covid | Phase II | Completed | 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 | Jul 21, 2022 | ― |
| Tnx-102 Sl Tablet, 5.6 Mg | Fibromyalgia | Phase III | Completed | A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia | Mar 01, 2022 | ― |
| Diluent, Tnx-2110, Tnx-2120, Tnx-2130, Candin | Detection Of Delayed-Type Hypersensitivity Reactions To Sars-Cov-2 In Individuals Exposed To Sars-Cov-2 | Phase I | Terminated | Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens | Jan 28, 2022 | ― |
| Tnx-102 Sl | Ptsd | Phase III | Terminated | A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD | Feb 12, 2019 | ― |
| Tnx-102 Sl 5.6 Mg | Ptsd | Phase III | Completed | A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD | Apr 12, 2018 | ― |
| Tnx-102 Sl | Ptsd | Phase III | Terminated | 12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients | Mar 31, 2017 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Tnx-102 Sl | Phase II | Depression, Major Depressive Disorder (Mdd), Major Depressive Episode (Mde) | Recruiting | A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD) | May 27, 2026 | ― |
| Tnx-1300 | Phase II | Cocaine Use, Cocaine Intoxication, Cocaine Toxicity, Cocaine Abuse, Cocaine Adverse Reaction | Terminated | Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST) | Sep 13, 2023 | ― |
| Tnx-601 Er | Phase II | Depressive Symptoms, Depressive Episode, Depression Severe, Depressive Disorder, Depressive Disorder, Major, Depression | Completed | Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD) | Jan 06, 2023 | ― |
| Tnx-1900 | Phase II | Chronic Migraine, Chronic Migraine, Headache, Chronic Migraine Without Aura, Aura Migraine | Completed | A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine | Dec 19, 2022 | ― |
| Tnx-102 Sl | Phase II | Covid-19, Long Covid, Post-Acute Sequelae Of Sars-Cov-2 (Pasc) Infection, Long Haul Covid | Completed | 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 | Jul 21, 2022 | ― |
| Tnx-102 Sl Tablet, 5.6 Mg | Phase III | Fibromyalgia | Completed | A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia | Mar 01, 2022 | ― |
| Diluent, Tnx-2110, Tnx-2120, Tnx-2130, Candin | Phase I | Detection Of Delayed-Type Hypersensitivity Reactions To Sars-Cov-2 In Individuals Exposed To Sars-Cov-2 | Terminated | Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens | Jan 28, 2022 | ― |
| Tnx-102 Sl | Phase III | Ptsd | Terminated | A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD | Feb 12, 2019 | ― |
| Tnx-102 Sl 5.6 Mg | Phase III | Ptsd | Completed | A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD | Apr 12, 2018 | ― |
| Tnx-102 Sl | Phase III | Ptsd | Terminated | 12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients | Mar 31, 2017 | ― |
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Tonix Pharmaceuticals (DE:TPM0) have in its pipeline
Tonix Pharma DE:TPM0 is currently developing the following drugs: Tnx-102 Sl, Tnx-1300, Tnx-601 Er, Tnx-1900, Tnx-102 Sl Tablet, 5.6 Mg, Diluent, Tnx-2110, Tnx-2120, Tnx-2130, Candin, Tnx-102 Sl 5.6 Mg, Tnx-102 Sl Tablet, 2.8 Mg, Tnx-102 Sl Tablet, 2.8Mg. These drug candidates are in various stages of clinical development as the company works toward FDA approval.
