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Delix Therapeutics is harnessing the power of neuroplastogens, a novel class of compounds designed to bring about a new paradigm in brain health therapeutics with treatments intended to be safe, fast-acting, and long-lasting. Through its discovery platform, Delix has identified non-hallucinogenic versions of psychedelic compounds with favorable safety and therapeutic profiles. The company was co-founded in 2019 by David E. Olson and Nick Haft, building upon Olson's discovery at the University of California, Davis, of several novel psychoplastogens that have significant therapeutic potential in preclinical models, without hallucinogenic side effects. Delix's treatments are designed to address the root cause of neuropsychiatric conditions by repairing the underlying synaptic damage through targeted neuroplasticity. To date, the company has synthesized over 2000 novel psychoplastogens, many of which are analogs of known psychedelics such as ibogaine and 5-MeO-DMT. Their lead compound, zalsupindole (DLX-001), produces the same rapid and sustained structural and functional plasticity as ketamine, psilocybin, and DMT, without inducing hallucinations or dissociation. Recent Phase I data have demonstrated that DLX-001 is associated with robust signs of CNS engagement and a favorable safety and tolerability profile, with no serious adverse events reported to date. The company's compounds are tailored for swift neuronal repair and can be taken at-home, providing significant advantages to patients, their loved ones, and healthcare providers. Delix focuses on developing non-hallucinogenic psychoplastogens as scalable alternatives to first-generation hallucinogenic psychoplastogens like ketamine and psilocybin.

Development Programmes

2

DLX-001 (Zalsupindole)

Phase II

Major depressive disorder

Programme Tracker

Major Depressive Disorder (MDD)

Primary: US (FDA)
Phase IIActive

FDA-cleared Phase 2 IND for randomised, double-blind, placebo-controlled at-home multi-site trial; initiation anticipated 2026; 3 arms (placebo, once-daily, twice-weekly)

Milestones

Pre-clinical completed

Completed

Actual: Oct 16, 2025

Neuroplasticity study published: zalsupindole promotes neuroplasticity comparable to ketamine and psychedelics in preclinical models

Why it matters: Peer-reviewed validation that zalsupindole's neuroplasticity mechanism is quantitatively equivalent to ketamine and psilocybin strengthens the Phase 2 hypothesis and supports the mechanism-of-action story for investors and regulators.

Phase I topline

Completed

Actual: Dec 12, 2024

Phase 1a (healthy volunteers, 2–360 mg) full results presented at ACNP Annual Meeting: well-tolerated, no psychotomimetic/dissociative effects, dose-dependent PK/PD, CSF penetration confirmed, qEEG markers of synaptic potentiation

Why it matters: DLX-001 (zalsupindole) is a non-hallucinogenic 5-HT2A partial agonist (tabernanthalog analogue) — it promotes neuroplasticity via TrkB/BDNF signalling without activating the G-protein pathway that causes hallucinations. Phase 1a confirmed the non-hallucinogenic profile and CNS penetration at therapeutic doses.

Phase I topline

Completed

Actual: Oct 28, 2025

Phase 1b (MDD patients, n=18) positive results: mean −11.6 MADRS (≈50% improvement) by Day 8; sustained through Day 36 (4 weeks post-last dose); no SAEs; FDA Phase 2 IND cleared for at-home trial

Why it matters: A 50% MADRS improvement sustained 4 weeks after the last dose is a very large effect in MDD — comparable to MDMA and psilocybin data. The sustained effect suggests durable neuroplasticity, not just acute pharmacology. FDA clearance for at-home self-administration is a landmark for the non-hallucinogenic neuroplastogen class.

Watch next: Phase 2 trial initiation; first Phase 2 efficacy readout (2026–2027)

Recorded Events

Oct 28, 2025: Phase I topline

Oct 16, 2025: Pre-clinical completed

Dec 12, 2024: Phase I topline

Evidence Links

DLX-159

Pre-clinical

Neuropsychiatric disorders

Programme Tracker

Major Depressive Disorder (MDD)

Primary: US (FDA)
Pre-clinicalActive

IND-enabling studies; orally bioavailable non-hallucinogenic neuroplastogen; third Delix pipeline candidate

Quick Facts

Type
Private Biotech
Lead Stage
Phase II
HQ
20 Authors Road, Concord, MA, 01742, United States
Website
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Research Papers

1