Tonix is a biopharmaceutical company focused on developing novel therapeutics to prevent and treat central nervous system disorders, immunology conditions, infectious diseases, and rare diseases.
Tonix’s development portfolio is focused on central nervous system disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA for TNX-102 SL (cyclobenzaprine HCl sublingual tablet), which has completed two positive Phase 3 studies for the management of fibromyalgia. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and acute stress disorder (ASD). Our pipeline is also comprised of immunology, rare disease, and infectious disease product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Our rare disease portfolio includes therapeutics to treat rare genetic conditions. Tonix’s infectious disease portfolio includes a live virus vaccine platform.
Central Nervous System
Tonix’s lead CNS candidate, TNX-102 SL1 (sublingual formulation of cyclobenzaprine) has completed two positive Phase 3 studies for the management of fibromyalgia, a disorder characterized by chronic musculoskeletal pain, sleep deprivation, fatigue and mood changes. TNX-102 SL is also being developed for Long COVID and acute stress disorder (ASD)
Tonix’s lead infectious disease product candidate, TNX-8012, is a live horsepox virus vaccine for percutaneous administration in development to protect against smallpox and monkeypox. Tonix will continue work on this live virus vector technology as a platform for rapid response to new pathogens.
TNX-2900, Tonix’s proprietary potentiated intranasal oxytocin, is in development for the treatment of Prader-Willi syndrome (PWS), the most common genetic cause of life-threatening childhood obesity. TNX-2900 has been granted Orphan Drug Designation (ODD) in the US by the FDA for the treatment of PWS.