AL001 (lithium–salicylate–L-proline)

Mechanism of action#

The active moiety is lithium, whose canonical molecular actions include direct inhibition of glycogen synthase kinase-3 (GSK-3) and of inositol monophosphatase (IMPase). In Alzheimer's disease the rationale leans on lithium's GSK-3β inhibition — GSK-3β is a principal tau kinase, and low-dose lithium has been repeatedly explored as a disease-modifying candidate in AD — combined with AL001's delivery premise: an ionic cocrystal of lithium with salicylate and L-proline engineered to raise brain lithium relative to systemic exposure versus lithium carbonate, potentially enabling chronic dosing in an elderly population without the toxicity and therapeutic-drug-monitoring burden of marketed lithium salts.

Formulations#

AL001 (lithium–salicylate–L-proline) for Bipolar disorder#

Phase 1/2RecruitingBipolar disorder indication →

Alzamend Neuro's AL001 — an ionic-cocrystal lithium-delivery system (lithium with salicylate and L-proline) — in bipolar I disorder, the first patient population of its 'Lithium in Brain' program at Massachusetts General Hospital. The recruiting Phase 1/2 crossover study (NCT07540338, AL001-BD01; registry Phase 1|2, sponsor-branded Phase II) randomizes bipolar I patients in six-subject cohorts to AL001 then lithium carbonate or the reverse — 14 days of three-times-daily dosing per period with a 14-day washout — comparing 24-hour lithium blood PK paired with MRI/MRS brain imaging on days 14–15 of each period. It builds directly on the healthy-subjects study (NCT06921590, clinical phase completed November 2025), whose qualitative pharmacodynamic data (April 2026) showed AL001 reduced myo-inositol in 17 of 18 brain regions versus 8 of 18 for lithium carbonate and left glutamate largely unperturbed where lithium carbonate reduced it across all 18 regions. The sponsor guided bipolar topline data to Q3 2026 at initiation (March 2026); registry first-participant date 2026-05-11, estimated primary completion December 2026. MDD, PTSD and Alzheimer's studies are announced to follow (not yet registered).

AL001 (lithium–salicylate–L-proline) for Alzheimer's disease#

Phase 1/2ActiveAlzheimer's disease indication →

Alzamend Neuro's AL001 lithium ionic cocrystal in Alzheimer's disease — the company's founding indication. The Phase 1/2A multiple-ascending-dose study (NCT05363293, AL001-ALZ02; 65 participants, mild-to-moderate AD patients plus healthy non-elderly and elderly adults) completed in April 2023, establishing safety/tolerability of ascending oral doses. The subsequent healthy-subjects 'Lithium in Brain' PK/MRS crossover study (NCT06921590, attached to the bipolar record as its direct design precursor) completed its clinical phase in November 2025. Alzamend has stated (2026 press releases) that an Alzheimer's patient 'Lithium in Brain' study will follow the recruiting bipolar I study, alongside announced MDD and PTSD studies — but no AD trial is registered as of 2026-08-31, so this program's phase reflects the completed Phase 1/2A. Status 'active' rests on the sponsor's explicit continued-development statements; revisit if no AD study registers.

Clinical trials#