Solvonis Therapeutics
R&D | Pipeline

Five programmes: an alcohol use disorder franchise and a de novo engine

Two complementary strategies: value-added medicines, the AUD franchise, for nearer-term clinical and regulatory catalysts; and de novo drug development, the engine, for longer-duration IP and early-stage upside.

AUD franchise
De novo engine
Programme and indication
Discovery
Lead optimisation
Phase 1
Phase 2
Phase 3
SVN-001
Severe AUD | UK (EU sites proposed)
Ongoing UK Phase 3; MoU signed to assess Portuguese sites
SVN-002
Esketamine oral thin film (OTF) | moderate-to-severe AUD | U.S.
Phase 2b planning
SVN-015 StUD
Stimulant use disorder (StUD)
Encouraging initial NIDA-funded screening (Aug 2026); advanced into further NIDA-funded studies
Lead selected
SVN-015 MDD
Depression with anhedonia (MDD)
Preclinical; antidepressant-like signal in rodent model

Sources: Company programme information; UK Health Research Authority (HRA), MORE-KARE study summary; Solvonis announcements dated 6 August, 25 August and 13 October 2026. MoU: memorandum of understanding with ICAD (Portugal’s public addiction institute) and Panegreen (Lisbon clinical partner) to assess Portuguese trial sites. Status as at 16 October 2026.

Catalyst roadmap

Where each programme stands and what comes next

All milestones and timings are prospective, and subject to the availability of capital, regulatory feedback and trial progress.

Programme
Delivered (as at 16 October 2026)
Next milestone
Indicative timing
SVN-001
DeliveredUK Phase 3 recruiting (280 planned); MoU signed to assess Portuguese sites (Oct 2026)
Next milestonePhase 3 readout; EU site expansion (proposed)
Indicative timing2029–30 readout (indicative)
SVN-002
DeliveredPositive preclinical bridging data (Jun 2026)
Next milestoneFurther FDA engagement; Investigational New Drug (IND) submission
Indicative timing2027: IND for the U.S. Phase 2b
SVN-015 StUD
DeliveredEncouraging initial NIDA-funded screening; advanced into further NIDA-funded studies (Aug 2026)
Next milestoneNIDA confirmatory dopamine transporter (DAT) studies; mouse locomotor study; 5-HT₂B follow-up
Indicative timingTo be announced
SVN-114
DeliveredLead selected (Mar 2026)
Next milestoneDose response, pharmacokinetics and brain exposure
Indicative timingTo be announced
SVN-015 MDD
DeliveredAntidepressant-like signal in a mouse model (Jan 2026)
Next milestoneAnhedonia-specific models
Indicative timingTo be announced

Indicative Company planning dates as at 16 October 2026, subject to the availability of capital, regulatory feedback and trial progress. Sources: ISRCTN85955128; Ulysses Neuroscience UNL094; Solvonis RNS, 21 January 2025, 3 December 2025, 28 January 2026, 10 March 2026, 22 June 2026, 6 August 2026, 25 August 2026 and 13 October 2026; Company data on file.

De novo engine

A de novo engine of proprietary new medicines across addiction and psychiatry

Proprietary new chemical entities from Solvonis’ own discovery work, each with a composition-of-matter filing. NIDA funds and conducts the SVN-015 studies; Solvonis retains ownership and IP.

Programme
Compound
Delivered
Protection
SVN-015 StUD
CompoundA new dopamine and serotonin reuptake inhibitor, for cocaine and methamphetamine addiction
DeliveredEncouraging initial NIDA-funded screening (Aug 2026); advanced into further NIDA-funded studies
ProtectionComposition-of-matter patent filed
SVN-114
CompoundA preclinical novel entactogen for PTSD, designed around MDMA’s limitations
DeliveredLead selected from a six-analogue series (Mar 2026); rat microdialysis completed
ProtectionComposition-of-matter patent filed
SVN-015 MDD
CompoundThe same molecule as SVN-015 StUD, in depression with anhedonia
DeliveredAntidepressant-like signal in a mouse model (Jan 2026)
ProtectionCovered by the SVN-015 composition-of-matter filing

Preliminary preclinical findings do not establish safety or efficacy in humans. Patent grant and scope are not assured. Sources: Solvonis RNS, 3 December 2025, 28 January 2026, 10 March 2026 and 6 August 2026; Company patent data and data on file.

Partners

Supported by U.S. federal, UK government and academic partners

SVN-001 Phase 3

Co-funded by the National Institute for Health and Care Research (NIHR), the Medical Research Council (MRC) and Solvonis, and sponsored by the University of Exeter.

SVN-015 evaluation

Funded and conducted by the U.S. National Institute on Drug Abuse (NIDA) through its preclinical Addiction Treatment Discovery Program. Solvonis retains ownership of SVN-015 and its intellectual property.