Asset profile
Valiltramiprosate · ALZ-801
Small molecule
Evidence outlook · lead readout
APOLLOE4 (NCT04770220) · Early Alzheimer's Disease
The lead readout missed its primary endpoint. The grade and rationale below record what the trial was designed to show and what it found.
APOLLOE4 (NCT04770220): This was a randomized, quadruple-blind, placebo-controlled trial with 325 participants, providing a strong study design. However, the primary cognitive endpoint was not met: the adjusted ADAS-Cog13 difference between ALZ-801 and placebo was -0.51 points, with p=0.6058; favorable MRI findings were exploratory and did not establish a significant benefit on the primary endpoint.
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Featured trials
The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Competitive landscape
60 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 6 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| Valiltramiprosate (ALZ-801): this drug | Phase 3 | Small molecule | Amyloid-beta oligomerization | ||
| Benzgalantamine (Zunveyl) | Approved | Small molecule | Acetylcholinesterase/nicotinic receptor (prodrug) | ||
| Brexpiprazole (Rexulti) | Approved | Small molecule | Dopamine D2/D3 and serotonin 5-HT1A receptor | ||
| Dextromethorphan / Bupropion (Auvelity) | Approved | Small molecule | sigma-1/NMDA | ||
| Donanemab (Kisunla) | Approved | Monoclonal antibody | Amyloid-beta (monoclonal antibody) | ||
| Lecanemab (Leqembi) | Approved | Monoclonal antibody | Amyloid-beta (monoclonal antibody) | ||
| Xanomeline / Trospium Chloride (Cobenfy) | Approved | Small molecule | Muscarinic M1/M4 receptor (agonist/antagonist combination) | ||
| ACP-204 | Phase 3 | Small molecule | Serotonin 5-HT2A receptor (antagonist / inverse agonist) | ||
| AR1001 | Phase 3 | Small molecule | PDE5 | ||
| Bezisterim | Phase 3 | Small molecule | ERK/NF-kB inflammatory | ||
| Blarcamesine | Phase 3 | Small molecule | Sigma-1 receptor / muscarinic receptor (dual) | ||
| Buntanetap | Phase 3 | Small molecule | APP/tau/alpha-synuclein/TDP-43 (translation) | ||
| Cerebrolysin | Phase 3 | Peptide | Multi-target (ginsenoside) | ||
| GV1001 | Phase 3 | Peptide | Telomerase (hTERT) | ||
| Hydromethylthionine Mesylate | Phase 3 | Small molecule | Tau aggregation; Acetylcholine | ||
| Lemborexant (Dayvigo) | Phase 3 | Small molecule | Orexin receptor (repositioned) |
…and 45 more. Research shows the complete landscape.
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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.
Upcoming events
No upcoming readouts on record for this asset.
All registered studies
Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.