TNX-102 is under clinical development by Tonix Pharmaceuticals Holding and currently in Phase III for Fibromyalgia (Fibromyalgia Syndrome). According to GlobalData, Phase III drugs for Fibromyalgia (Fibromyalgia Syndrome) have a 67% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how TNX-102’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

TNX-102 overview

TNX-102 SL (cyclobenzaprine hydrochloride, Tonmya) is under development for the treatment of post-traumatic stress disorder (PTSD), fibromyalgia, Long COVID Syndrome (Long COVID) also known as Post-Acute Sequelae of COVID-19 (PASC), agitation in Alzheimer’s disease and alcohol use disorder. The the drug candidate is administered through sublingual route as tablet. It acts by targeting serotonin receptor type 2a (5HT2a), alpha-1 adrenergic receptor and histamine H1 receptor and muscarinic receptor (M1). The drug candidate is developed based on technology that involves a mixture of cyclobenzaprine and lipids.

Tonix Pharmaceuticals Holding overview

Tonix Pharmaceuticals Holding (Tonix) is a developer of pharmaceutical products to address public health challenges. The company offers pharmaceutical products and treatments for disorders of the central nervous system including fibromyalgia, post traumatic stress disorder and episodic tension-type headache. Its products include oral formulation, smallpox vaccine, disintegrating sublingual tablets and tonmya. Tonix’s tonmya is a lead product candidate, designed as a bedtime treatment for post traumatic stress disorder. Its disintegrating sublingual tablets contain a dose and formulation of cyclobenzaprine and is used for the treatment of fibromyalgia and post-traumatic stress disorder. It markets its products through a network of distributors across the US. It has operations in Ireland, Canada and the US. Tonix is headquartered in New York, the US

For a complete picture of TNX-102’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.