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AL001 Phase

Updated ยทnext FDA decision on the calendar

AL001 Phase is a Alzamend Neuro, Inc. program. Its next catalyst is a Readout in Q3 2026. Every date links its source.

ALZN catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Alzamend Neuro, Inc. (ALZN). Review status: Company guidance: Phase II bipolar disorder topline in Q3 2026. (A separate AL001 study, the 'Lithium in Brain' bioequivalence trial, already reported in March 2026.) We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

Readout · Q3 2026ALZN

Questions

When is AL001 Phase's next FDA decision or readout?

The next tracked catalyst for AL001 Phase is a Readout in Q3 2026.

What happened at AL001 Phase's most recent FDA decision?

No FDA decision for AL001 Phase is in our archive yet.

Who makes AL001 Phase?

Alzamend Neuro, Inc. (ALZN).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.