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Delix Therapeutics
Data updated
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
- Active candidates
- 2
- Active programmes
- 2
- Lead stage
- Phase II
- Forecast coverage
- 2 of 2
All tracked candidates active
All tracked programmes active
Multiple active stages
2 active programmes with forecast fields
Latest sourced update
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%
Development Programmes
2DLX-001 (Zalsupindole)
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)
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
CompletedActual: 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
CompletedActual: 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
CompletedActual: 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
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.
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.
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
Neuropsychiatric disorders
Programme Tracker
Major Depressive Disorder (MDD)
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
Press release - Delix Therapeutics - Dec 12, 2024 - Verified
Announcement describes DLX-159 as an orally bioavailable, non-hallucinogenic neuroplastogen and Delix third developmental candidate.
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
- Visit