Pipeline
Therapeutic development pipeline
Program
Indication
Discovery
Lead Optimisation
Phase I
Phase II
Phase III
SVN-001
Racemic ketamine (IV) + manualised relapse prevention CBT
Severe AUD (UK & EU only)
SVN-002
Esketamine OTF + manualised alcohol education
Moderate to Severe AUD (US)
SVN-114
PTSD
SVN-015
Stimulant Use Disorder
SVN-015
Depression (MDD)
AI Novel Drug Discovery Programmes
Addiction, Psychiatry, and Neurology
SVN-001
SVN-001 is a first-of-its-kind combination therapy combining IV ketamine (an NMDA receptor antagonist) with copyrighted manualised relapse prevention cognitive behavioural therapy, targeting both the biological and psychosocial aspects of alcohol use disorder.
Clinical evidence
Phase 2 results demonstrated a 50% reduction in Heavy Drinking Days vs a placebo.
Long-term impact: 86% abstinence on average sustained for six months post-treatment, compared to just 2% pre-trial.
Clinical development & regulatory pathway
SVN-001 is in phase 3, with an n=280 two-armed active placebo-controlled ‘More Kare’ trial. It is co-funded by the UK National Institute for Health Research Efficacy and Mechanism Evaluation Program (NIHR150193) and Solvonis. It is being run by the University of Exeter Clinical Trials Unit.
Targeting a Regulation 52b hybrid application in the UK for approval as a new indication – to provide eight years of data exclusivity and two additional years of market protection.
SVN-002
Clinical evidence
Phase 1 was successfully completed by LTS Lohmann and in-licensed by Solvonis.
Clinical development & regulatory pathway
Now in Phase 2b planning, with a positive Pre-Investigational New Drug Application meeting with the US Food and Drug Administration (FDA) in December 2024, with support for a 505(b)(2) pathway.
Intellectual property
Formulation patents internationally by LTS Lohmann Systems AG.
Method of Use patents filed internationally by Solvonis.
A novel AI-discovered compound designed to modulate serotonin, dopamine and noradrenaline signalling, with the aim of supporting improved emotional processing and engagement with therapy in individuals living with trauma-related disorders.
These neurotransmitter systems are central to the neurobiology of trauma and social behaviour, and targeting them in a controlled way may open an important new therapeutic avenue for PTSD.
Intellectual property
Composition of matter patents filed internationally by Solvonis.
SVN-015
A novel selective serotonin and dopamine re-uptake inhibitor for Stimulant (cocaine and methamphetamine) Use Disorder and Major Depressive Disorder.
SVN-AI-Enabled Discovery Programme
Multiple novel chemical series generated via AI-enabled discovery, targeting serotonin, dopamine and noradrenaline transporters. The core engine for Solvonis’ preclinical pipeline, providing a renewable source of proprietary IP for expansion and future partnerships.
Intellectual property
Patents filed covering novel CNS-active chemical matter.