Zynerba Pharmaceuticals’ pipeline drug Zygel is expected to achieve $18.1 million in sales by 2030, according to GlobalData, due to its potential to help fragile X syndrome (FXS) patients with irritability or aggression symptoms. The leading data and analytics company notes that Zygel is one of four novel pipeline products set to make a huge impact on the treatment of this underserved genetic condition. Of the four, Zygel is expected to lead the market.

FXS causes a range of developmental problems, including learning disabilities and cognitive impairment. Zygel is an in-development gel applied to the skin that could be beneficial for the population of FXS patients with symptoms of irritability, social avoidance, hyperactivity, and inappropriate speech. It is expected to launch in the US and Germany in 2025 and 2026, respectively.

Christie Wong, Pharma Analyst at GlobalData comments: “There are currently no approved therapies available for FXS. As such, the FXS market is dominated by off-label drugs that target individual psychiatric and neurological symptoms of the disease. Despite combining these symptomatic treatments with behavioral and educational interventions, FXS continues to significantly impair patients’ everyday lives, as patients can suffer from sudden and uncontrollable bursts of anger, for example.”

Key Opinion Leaders (KOL) interviewed by GlobalData highlighted that irritability and aggression are two of the behavioral symptoms of FXS that are not adequately addressed with current therapeutic options.

Wong continues: “Although atypical antipsychotics suppress aggressive and disruptive behavior, they are often sedating, which can diminish patients’ experiences of the world. A therapy that could address aggression without sedation would significantly improve patients’ quality of life and could help relieve the burden of care on caregivers.”

According to GlobalData’s latest report, ‘Fragile X Syndrome – Market Size and Trend Report, 2021 – 2030’, the FXS market across the US and Germany is expected to grow at a compound annual growth rate (CAGR) of 7.6% from $21.9 million in 2020 to $45.8 million in 2030. Such growth is driven by the launch of four novel pipeline agents— Zynerba Pharmaceuticals’ Zygel, Tetra Therapeutics’ zatolmilast, Neuren Pharmaceuticals’, Acadia Pharmaceuticals’ trofinetide, and Confluence Pharmaceuticals’ Acamprosate Calcium SR—and an increase in the prevalent patient population.

Wong adds: “KOLs were hopeful that these four late-stage pipeline agents will help to improve the FXS treatment landscape in the coming years. GlobalData forecasts that three of them, which aim to improve patients’ cognitive skills, language, adaptive behavior, and intelligence quotient. —zatolmilast, trofinetide, and acamprosate calcium SR—will modestly shape the US FXS market over the next decade, contributing 11.3% of total sales in 2030. GlobalData anticipates that the fourth drug, Zatolmilast, will launch in Q3 2029, with a sales forecast of $3.3 million by 2030.

“GlobalData anticipates a dynamic market with more treatment options for FXS patients soon. All four pipeline products have been granted orphan drug designation by the Food and Drug Administration (FDA) and will enjoy patent protection for seven years after approval.”