Tonix Pharmaceuticals, Inc.

Pharma

Pipeline Programs↗

Distinct drugs in development (Preclinical–Phase 3)

Indications↗

Distinct diseases across all programs

Clinical Trials↗

All sponsored trials (all statuses)

Orange Book Patents

Across 1 drug with upcoming expirations

Pipeline

Pipeline Snapshot

By Phase

1 drugs in development

No phase data available.

By Therapeutic Area

top 1

Musculoskeletal

1100%

R&D Momentum

12/100

Pipeline Velocity

6/100

Trial Completion Rate

75/100

Pipeline Concentration

100/100

Pipeline Freshness

94/100

Activity

Key Events

Dec 9, 2025TrialA 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

Aug 15, 2025FDAAmrix — TONMYA

Aug 16, 2024TrialComparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST)

Jul 18, 2023TrialA 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

Mar 2, 2023TrialStudy to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)

Dec 6, 2022TrialA Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine

Oct 14, 2022TrialSafety and Efficacy Study of TNX-102 SL in Participants With PTSD

Aug 18, 2022TrialA 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

4 more events

Apr 6, 2022TrialA Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia

Mar 18, 2022TrialA 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

Jan 7, 2022TrialAssessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens

Sep 3, 2021TrialAn 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

Details

Company Info

Company Overview

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Mkt Cap

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Revenue

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Cash

Patent Expirations

1 patent group across drugs · Source: FDA Orange Book

DrugExpires

Amrix4 patentsMar 14, 2034

Pipeline

Drug Pipeline

Indication

Preclinical

Phase 1

Phase 2

Phase 3

Approved

Musculoskeletal

Fibromyalgia

TNX-102 SL

Musculoskeletal

Fibromyalgia

TNX-102 SLPhase 3

Regulatory

Regulatory Timeline

19821 event

FDAJan 1

Amrix — FLEXERIL

Application NDA017821 (NDA)

20071 event

FDAFeb 1

Amrix — AMRIX

Application NDA021777 (NDA)

20251 event

FDAAug 15

Amrix — TONMYA

Application NDA219428 (NDA)

Data sources: ClinicalTrials.gov (NIH) · OpenFDA (FDA) · ChEMBL (EMBL-EBI) · Open Targets (EBI/Sanger) · MedlinePlus (NIH) · PubMed (NIH) · SEC EDGAR (SEC)