Solvonis TherapeuticsLSE: SVNS

Actual: Jan 1, 2021

KARE Phase 2 (UCL): 86% abstinence at 6 months in ketamine+therapy arm vs 2% pre-trial; 50% reduction in heavy drinking days vs placebo

Why it matters: The KARE Phase 2 produced one of the largest effect sizes ever reported in AUD treatment. 86% abstinence at 6 months far exceeds standard-of-care naltrexone or acamprosate. The key mechanism combines ketamine's memory reconsolidation blocking with behavioural therapy targeting reward memories.

Actual: Jul 1, 2024

More-KARE Phase 3 recruitment began at 8 NHS Trusts (ISRCTN85955128, n=280)

Why it matters: More-KARE is the largest ever randomised trial of ketamine-assisted therapy for AUD. NIHR co-funding alongside Solvonis reduces financial risk and gives the trial the highest NHS/academic credibility. Results expected late 2026/early 2027.

Watch next: More-KARE Phase 3 top-line results

Actual: Jun 22, 2026

Solvonis reported positive PK bridging data for SVN-002, supporting the planned 505(b)(2) path and preparation for FDA feedback followed by IND submission for Phase 2b.

Why it matters: Bridging studies establish PK/PD equivalence between SVN-002 OTF and Spravato — required for the 505(b)(2) submission. Successful bridging would allow Phase 2b to begin without a full Phase 1.

Watch next: Bridging study results and IND filing for Phase 2b

Actual: Dec 1, 2024

Pre-IND meeting with FDA: FDA supportive of 505(b)(2) pathway referencing Spravato (esketamine nasal spray) safety data

Why it matters: SVN-002 is a sublingual/buccal esketamine oral thin film (OTF) formulated with psychosocial support protocols. 505(b)(2) referencing Spravato dramatically reduces the safety data burden for IND and NDA filing. Oral thin film delivery enables home use without nasal spray administration — expanding the addressable AUD patient population.

Why it matters: SVN-SDN-14 is a series of SDN receptor modulators designed to promote pro-social behaviour for PTSD therapy. The design explicitly aims to improve on MDMA's safety profile — positioning it as a cleaner entactogen without MDMA's cardiovascular or neurotoxicity concerns.

Watch next: Lead compound selection and IND-enabling timeline

Actual: Dec 1, 2025

SVN-015 accepted into NIDA Addiction Treatment Discovery Program for methamphetamine and cocaine addiction

Why it matters: There are no FDA-approved medications for methamphetamine or cocaine use disorder — the largest unmet need in addiction medicine. NIDA program acceptance provides non-dilutive preclinical funding and regulatory pathway guidance, validating SVN-015's scientific premise. The programme was discovered via Solvonis's AI-driven drug discovery platform.

Watch next: Preclinical efficacy and cardio-safety results from NIDA programme (2026); IND-enabling timeline