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About Tonix Pharmaceuticals
Tonix has a robust pipeline of programs in development stages ranging from preclinical to preparing for NDA submission, across multiple therapeutic modalities and including both small molecules and biologics. Tonix also markets two FDA-approved products for acute migraine in adults.
Tonix’s pipeline is managed by a team of passionate professionals that are adept at advancing innovative programs into the clinic and throughout the various stages of development with the goal of FDA approval and marketing to those in need.
While many of Tonix’s product candidates are proprietary, in-house developments, it also has collaborations with government institutions, world-class academic and non-profit research organizations, as well as license agreements with other biotech companies.
Therapeutic Areas
Central Nervous System
Tonix is dedicated to finding cures for difficult to treat, widely occurring, chronic disorders of the central nervous system including pain, neurological, psychiatric and addiction conditions.* Our goal is to heal sufferings of millions through scientific advancements.
Immunology
We are advancing scientific programs that focus on therapeutics to prevent organ transplant rejection, to manage autoimmune conditions, and to improve responses to immunotherapy in certain cancers.*
Infectious Disease
Tonix’s infectious disease portfolio targets pathogenic infections, including monkeypox and smallpox for biodefense. Through its live virus vaccine platform and in-house capabilities, Tonix strives to be prepared for future pandemics.
Rare Disease
Tonix is committed to improving patient care, including for those suffering from rare diseases and for which no drug has been approved. Rare diseases are often caused by genetic disorders and are characterized by complex symptoms. A rare disease is a condition that affects fewer than 200,000 people in the US as defined in the Orphan Drug Act of 1983.
Central Nervous System
Tonix is dedicated to finding cures for difficult to treat, widely occurring, chronic disorders of the central nervous system including pain, neurological, psychiatric and addiction conditions.* Our goal is to heal sufferings of millions through scientific advancements.
Immunology
We are advancing scientific programs that focus on therapeutics to prevent organ transplant rejection, to manage autoimmune conditions, and to improve responses to immunotherapy in certain cancers.*
Infectious Disease
Tonix’s infectious disease portfolio targets pathogenic infections, including the ongoing COVID-19 pandemic. Tonix is attacking COVID-19 using vaccines, antivirals and a Long COVID therapeutic.* Pandemic preparedness is necessary to combat infections like SARS-CoV-2.
Rare Disease
Tonix is committed to improving patient care, including for those suffering from rare diseases and for which no drug has been approved. Rare diseases are often caused by genetic disorders and are characterized by complex symptoms. A rare disease is a condition that affects fewer than 200,000 people in the US as defined in the Orphan Drug Act of 1983.
Pipeline Highlights
Using our integrated clinical development engine, we advance innovative programs into the clinic while maximizing asset potential.
Preclinical
Phase I
Phase II
Phase III
TNX-102 SL Fibromyalgia (FM)
Two statistically significant Phase III studies completed — PDUFA date of August 15, 2025 for a decision on marketing authorization
Mid-Phase III
TNX-1300 Cocaine Intoxication / Overdose
Phase II ongoing — Breakthrough Therapy Designation
Mid-Phase II
TNX-1500 Organ Transplant Rejection / Autoimmune Disorders
Phase I — Clinical phase complete
Preclinical
Management Team
“Many frontiers remain in the fields of medical science and drug development. At Tonix, we have carefully chosen pursuits in immunology, rare diseases, infectious diseases, and central nervous system disorders. We are building capabilities in synthetic biology, precision medicine, protein engineering, and vaccine manufacturing to develop better and safer medicines. Our ultimate goals are to improve and extend the lives of millions of people and, importantly, to reward the dedication and commitment of our stakeholders.”
— Dr. Seth Lederman, M.D., President and CEO, Tonix Pharmaceuticals