Tonmya 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 Tonmya’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.

Tonmya overview

TNX-102 SL (cyclobenzaprine hydrochloride, Tonmya) is under development for the treatment of fibromyalgia, acute stress disorder, post-traumatic stress disorder (PTSD). The drug candidate is a non opioid centrally-acting analgesic that is administered through sublingual transmucosal 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. It was also under development for post-traumatic stress disorder (PTSD) and Long COVID Syndrome (Long COVID) also known as Post-Acute Sequelae of COVID-19 (PASC), agitation in Alzheimer’s disease and alcohol use disorder 

Tonix Pharmaceuticals Holding overview

Tonix Pharmaceuticals Holding (Tonix) 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 Central Nervous System Portfolio; TNX-102 SL, TNX-1300, TNX-1900, Immunology Portfolio; TNX-1500(Organ Transplant Rejection / Autoimmune Disorders), TNX-1850 COVID-19 Vaccine and Rare Disease Portfolio; TNX-2900 (Prader-Willi Syndrome). Its disintegrating sublingual tablets contain a dose and formulation of cyclobenzaprine and are 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 Tonmya’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.