Kuleon Bioscience

Actual: Oct 1, 2023

Kuleon Bioscience (f/k/a PsiloSterics) emerged from stealth; announced KB-128 as world's first trifunctional 5-HT2C full agonist / 5-HT2A and 5-HT2B full antagonist

Why it matters: KB-128 is a first-in-class molecule with a unique triple receptor profile: full agonism at 5-HT2C (reduces alcohol craving/reward) combined with full antagonism at 5-HT2A (blocks hallucinations) and 5-HT2B (avoids cardiac valvulopathy risk). This trifunctional design is non-hallucinogenic by mechanism, not by dose reduction. Strong G-protein signaling bias with minimal beta-arrestin recruitment at 5-HT2C reduces receptor desensitization.

Actual: Jun 1, 2024

Preclinical data: high efficacy reducing alcohol self-administration in rodent models; passed ADME/PK profiling (high free drug in plasma, high half-life, excellent brain Kp); initial tox shows limited off-target activity including minimal hERG liability

Why it matters: Strong preclinical package: efficacy in AUD animal models + favorable PK (brain-penetrant, long half-life) + clean safety (minimal hERG = low cardiac risk). This data supports progression to IND-enabling GLP tox studies.

Actual: Sep 23, 2025

$2M NIAAA/NIH grant awarded to advance KB-128 for AUD

Why it matters: First disclosed external funding. NIAAA (National Institute on Alcohol Abuse and Alcoholism) grant validates KB-128's scientific approach and provides non-dilutive capital for IND-enabling studies. Company was previously self-funded by founders.

Watch next: IND filing; Phase 1 FIH initiation (likely 2026-2027)