TNX-102 is under clinical development by Tonix Pharmaceuticals Holding and currently in the Phase I and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect TNX-102’s likelihood of approval (LoA) and phase transition for Fibromyalgia (Fibromyalgia Syndrome) took place on 28 Mar 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their TNX-102 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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

Quick View TNX-102 LOA Data

Report Segments
  • Innovator
Drug Name
  • TNX-102
Administration Pathway
  • Sublingual
Therapeutic Areas
  • Central Nervous System
  • Infectious Disease
Key Developers
Highest Development Stage
  • Phase III

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.