Developer · ALZN · United States

Alzamend Neuro, Inc.

Clinical-stage biopharmaceutical company (Nasdaq: ALZN) developing novel products for Alzheimer's disease, bipolar disorder, major depressive disorder and PTSD. Its lead candidate AL001 is a patented ionic-cocrystal lithium-delivery system (lithium with salicylate and L-proline) aiming to deliver therapeutic brain lithium with less systemic exposure than lithium carbonate; a second program, ALZN002 (autologous mutanome vaccine), is in Phase 1/2 for Alzheimer's. Its AL001 'Lithium in Brain' clinical studies run in collaboration with Massachusetts General Hospital.

alzamend.com ↗

1compound
2programs
2indications
Phase 1/2lead asset

Phase distribution

  • Phase 1/22

Modality

  • Small molecule 1

Mechanism focus

Pipeline (1)

Catalysts · 1 upcoming · 1 reported

Recently reported

  • 2026-04-07pending

    AL001 (lithium–salicylate–L-proline)forBipolar disorderTopline data

    Healthy-subjects 'Lithium in Brain' study: qualitative MRS pharmacodynamics show AL001 reduced myo-inositol in 17 of 18 brain regions (vs 8 of 18 for lithium carbonate) with minimal glutamate effects, where lithium carbonate reduced glutamate across all 18 regions.

    source ↗

Recent activity

  • May 11, 2026Phase changeAL001 (lithium–salicylate–L-proline)·Bipolar disorderPhase 1/2Bipolar I 'Lithium in Brain' study (NCT07540338, AL001-BD01) reached its registry actual start date and is recruiting at MGH. Alzamend announced initiation on 2026-03-16 with topline guided to Q3 2026; the registry's actual start (first participant) is 2026-05-11, the date used here.source ↗
  • Apr 7, 2026ReadoutAL001 (lithium–salicylate–L-proline)·Bipolar disorderpendingHealthy-subjects 'Lithium in Brain' study: qualitative MRS pharmacodynamics show AL001 reduced myo-inositol in 17 of 18 brain regions (vs 8 of 18 for lithium carbonate) with minimal glutamate effects, where lithium carbonate reduced glutamate across all 18 regions.source ↗
  • Apr 14, 2023Phase changeAL001 (lithium–salicylate–L-proline)·Alzheimer's diseasePhase 1/2The MAD study reached primary completion (registry actual date; study completion 2023-05-15). Since then the AD program has advanced through platform-level work — the healthy-subjects 'Lithium in Brain' PK/MRS study (clinical phase completed November 2025) and the recruiting bipolar I study — with an AD patient imaging study announced to follow; none registered yet as of 2026-08-31.source ↗
  • May 4, 2022Phase changeAL001 (lithium–salicylate–L-proline)·Alzheimer's diseasePhase 1/2Phase 1/2A multiple-ascending-dose study of AL001 (NCT05363293, AL001-ALZ02) started: safety, tolerability and PK of ascending oral doses in mild-to-moderate Alzheimer's patients and healthy non-elderly/elderly adults, 65 participants.source ↗

Trials recruiting · 1 recruiting of 4 sponsored

  • Phase 1/2AL001 (lithium–salicylate–L-proline)n=201 site · United States

    A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I Disorder

    Bipolar I DisorderNCT07540338 ↗

Competitive landscape

Other companies developing against Alzamend Neuro, Inc.'s targets or indications.