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Research and Development Update – Q4 2025
Solvonis Therapeutics plc provided a Q4 2025 research and development update, highlighting progress in addiction and psychiatry with multiple anticipated catalysts in 2026. The lead program, SVN-001 for severe alcohol use disorder, is in a Phase 3 trial with top-line results expected late 2027 or early 2028. SVN-002, an oral esketamine thin-film for moderate-to-severe AUD, is progressing with pharmacokinetic bridging expected in Q1 2026, aiming for a US FDA Phase 2b trial. SVN-015, a novel compound for stimulant use disorder, was accepted into NIDA's Addiction Treatment Discovery Program, with initial results expected in Q1 2026. The SVN-SDN-14 program for PTSD is advancing through in-vivo studies, with lead-candidate selection anticipated in Q1 2026. The company's AI-enabled discovery platform continues to generate novel CNS candidates. Disclaimer*
About this update from Solvonis Therapeutics Plc
[{"type":"text","content":"\n\n22 December 2025\nSolvonis Therapeutics plc\n(\"Solvonis\" or the \"Company\")\n \nResearch and Development Update - Q4 2025\nPipeline advancing across addiction and psychiatry with multiple 2026 catalysts\n \nSolvonis Therapeutics plc (LSE: SVNS), an emerging biopharmaceutical company developing novel medicines for high-burden central nervous system (\"CNS\") disorders, provides an update on progress across its development pipeline and discovery programmes as the Company concludes 2025 and enters a catalyst-rich period in 2026.\n \nPipeline development advancing across addiction and psychiatry\n \nSVN-001 | Severe Alcohol Use Disorder (AUD) - UK & EU\n \nThe Company's lead programme, SVN-001, continues to advance through a potentially pivotal Phase 3 clinical trial for severe AUD in the United Kingdom, addressing a large and underserved patient population across the UK and EU. In parallel, the Company continues to progress licensing and commercial-partnership discussions.\n \nRecruitment remains ongoing in this NHS-based study, conducted in collaboration with the University of Exeter (\"UoE\") and co-funded by the National Institute for Health and Care Research (\"NIHR\"), the Medical Research Council (\"MRC\"), and Solvonis. Top-line results are anticipated in late 2027 / early 2028. In parallel, with potential partners in UK and internationally.\n \nSVN-002 | Moderate-to-Severe AUD - Global (ex-UK & EU) | Initial focus: United States\n \nSVN-002, Solvonis' proprietary esketamine oral thin-film programme, is being advanced under a planned U.S. FDA 505(b)(2) regulatory pathway referencing Johnson & Johnson's blockbuster esketamine product, Spravato®.\n \nDuring Q4 2025, preparatory work continued with WuXi AppTec on a pharmacokinetic bridging programme to support regulatory alignment. Initial data are expected in Q1 2026, with further progress through Q2 2026.\n \nIf the scientific bridge to Spravato® is successfully established the Company plans to promptly seek approval from the US Food and Drug Administration (\"FDA\") for a Phase 2b trial, thereby potentially avoiding the significant costs associated with pre-clinical programmes and Phase1 and Phase 2a trials.\n \nThe programme targets approximately 15 million adults in the United States living with mode...