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Tonix Pharmaceuticals (TNXP)
:TNXP
Tnx-1300 (Injection)
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
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Tnx-601 Er
Depression, Depressive Disorder, Depressive Disorder, Major, Depressive Symptoms, Depressive Episode, Depression Severe
Phase II
Completed
Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)
Jan 06, 2023
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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
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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
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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
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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
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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
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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
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TNX-102 SL
Ptsd
Phase III
Terminated
12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients
Mar 31, 2017
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Tnx-102 Sl Tablet, 2.8 Mg
Neuromuscular Diseases, Fibromyalgia, Musculoskeletal Diseases, Rheumatic Diseases, Nervous System Diseases, Myofascial Pain Syndromes, Muscular Diseases
Phase III
Terminated
Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia
Jul 08, 2016
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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
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 (TNXP) have in its pipeline
TNXP is currently developing the following drugs: Tnx-1300 (Injection), Tnx-601 Er, Tnx-1900. These drug candidates are in various stages of clinical development as the company works toward FDA approval.