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Lead program: Phase II
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Delix Therapeutics

Data updated

20 Authors Road, Concord, MA, 01742, United States
2 Drug Candidates1 Paper

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.

Pipeline Intelligence

Developer Momentum

Programme tracker
Active candidates
2

All tracked candidates active

Active programmes
2

All tracked programmes active

Lead stage
Phase II

Multiple active stages

Forecast coverage
2 of 2

2 active programmes with forecast fields

Latest sourced update

Delix Therapeutics Company Site

Jun 26, 2026 - company-website - Delix Therapeutics - DLX-159

Next known catalyst

Phase II started

Q4 2026 - DLX-001 (Zalsupindole) / Zalsupindole Phase 2 Programme (MDD, at-home) - Confidence: 55%

5 sources0 pipeline-linked trials0 pipeline-linked papers1 Phase II1 Preclinical

Development Programmes

2

DLX-001 (Zalsupindole)

Phase II

DLX-001 (zalsupindole) is an oral, non-hallucinogenic neuroplastogen for major depressive disorder. Delix announced positive Phase 1b MDD data and FDA clearance of a randomized Phase 2 design with at-home self-administration in October 2025; no first-patient-in announcement for Phase 2 was found in this pass.

Programme Tracker

Major Depressive Disorder (MDD)

Primary: US (FDA)
Phase IIActive

Forecast

Phase II started - Likely: Q4 2026

FDA has cleared Delix's randomized, double-blind, placebo-controlled Phase 2 design for DLX-001 in MDD, including at-home self-administration. The next public watch item is Phase 2 first-patient-in or trial registration.

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

Delix announces positive DLX-001 Phase 1b efficacy data and FDA-cleared Phase 2 design

Press release - Delix Therapeutics - Oct 28, 2025 - Verified

Company release reports Phase 1b MDD efficacy/safety signals and FDA clearance of a Phase 2 protocol that includes at-home self-administration.

Cumulus/Delix ASCP 2026 poster update for zalsupindole Phase 1b and upcoming Phase 2

Press release - Cumulus Neuroscience / PR Newswire - May 28, 2026 - Verified

Release reports Delix-presented ASCP 2026 Phase 1b biomarker/safety data for zalsupindole and references the upcoming placebo-controlled Phase 2 study.

Delix reports zalsupindole preclinical publication and Phase 1b efficacy data

Press release - Delix Therapeutics - Oct 28, 2025 - Verified

Release references a recent publication showing zalsupindole promotes neuroplasticity as quickly and robustly as ketamine and serotonergic psychedelics.

DLX-159

Preclinical

Neuropsychiatric disorders

Programme Tracker

Major Depressive Disorder (MDD)

Primary: US (FDA)
Pre-clinicalActive

Forecast

preclinical-data

DLX-159 remains a preclinical Delix developmental candidate; Delix presented preclinical findings at ACNP 2024 and described it as orally bioavailable and non-hallucinogenic.

Evidence Links

Delix Presents Full Results from DLX-001 Phase 1 Trial and DLX-159 Preclinical Findings

Press release - Delix Therapeutics - Dec 12, 2024 - Verified

Announcement describes DLX-159 as an orally bioavailable, non-hallucinogenic neuroplastogen and Delix third developmental candidate.

Delix Therapeutics Company Site

company-website - Delix Therapeutics - Jun 26, 2026 - Verified

Company site supports Delix focus on non-hallucinogenic neuroplastogens for neuropsychiatric disorders.

Similar Developers

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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