Our Pipeline

Alzheon pipeline

Programs and status

Lead program
Valiltramiprosate ALZ-801 · oral · twice-daily
MCI due to AD in APOE4/4 homozygotes
Anti-amyloid oligomer inhibitor
DiscoveryPhase 1Phase 2Phase 3
Phase 3 in Early AD completed
Clinical
ALZ-507 oral · once-daily
Alzheimer’s disease prevention
Next-generation anti-amyloid aggregation inhibitor & APOE4 corrector mechanism
DiscoveryPhase 1Phase 2Phase 3
First subject dosed in Phase 1
Discovery
Undisclosed small-molecule anti-aggregation library
Neurodegenerative disorders
Enabled by our novel mechanism of action
DiscoveryPhase 1Phase 2Phase 3
Research

Valiltramiprosate has been granted Fast Track designation by the FDA for the treatment of Alzheimer’s disease.

Lead program

Valiltramiprosate / ALZ-801

An oral prodrug of tramiprosate: the addition of valine substantially improved pharmacokinetics and tolerability in AD patients.

FDA Fast Track designationPhase 3 completedLong-term safety evaluated in ~2,000 AD patients
  • High, sustained brain levels ~40%*
  • Lower inter-patient variability ~25%
  • Improved GI tolerability vs. tramiprosate
  • 265 mg tablet, twice daily fully inhibits Aβ oligomer formation
  • Commercial-ready tablet in Phase 3 trial

*Brain to plasma ratio; GI – gastrointestinal

ALZ-801 is a valine-conjugated prodrug of tramiprosate
ALZ-801: a valine-conjugated oral prodrug of tramiprosate.

Explore the science

The mechanism, clinical data, and peer-reviewed evidence behind the pipeline.

Mechanism of actionHow ALZ-801 is designed to block toxic oligomer formationScientific publicationsPeer-reviewed papers