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ALN-5288

Phase 1

Alzheimer's Disease | Small molecule | Neurology |Alnylam Pharmaceuticals, Inc.|Last Updated: May 14, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07214727A Study to Evaluate ALN-5288 in Patients With Alzheimer's DiseasePHASE1 RECRUITING 50 — — Oct 15, 2025Mar 6, 2030May 14, 202613 Canada, Netherlands +2
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Study Endpoints
Primary Endpoints
Frequency of Adverse Events (AEs)
Up to 32 months
Severity of AEs
Up to 32 months
Secondary Endpoints
Concentration of Total Tau (t-Tau) Protein in CSF Over Time
Up to 32 months
Change from Baseline in Concentration of t-Tau Protein in CSF Over Time
Up to 32 months
Concentration of ALN-5288 in Plasma Over Time (Ct)
Up to 32 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ALN-5288EXPERIMENTALParticipants will be administered ALN-5288 in the Double-blind (DB) Period and Open-Label Extension (OLE) Period.
Placebo + ALN-5288PLACEBO_COMPARATORParticipants will be administered placebo in the DB Period and ALN-5288 in the OLE Period.
Interventions
NameTypeDescription
ALN-5288DRUGALN-5288 will be administered IT.
PlaceboDRUGPlacebo will be administered IT.
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Eligibility Criteria
Age Range40 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Is able and willing to meet all study requirements in the opinion of the Investigator * Has a diagnosis of Alzheimer's disease (AD) based on clinical findings supported by cerebrospinal fluid (CSF) biomarkers or positive positron emission tomography (PET) amyloid imaging withi...

Countries:CanadaNetherlandsSpainUnited Kingdom
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Competitive Landscape -Alzheimer's Disease 68 trials
CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY9PHASE3KarXT, KarX-EC, Xanomeline/Trospium Chloride, Xanomeline Enteric, BMS-986446
Eli Lilly and CompanyLLY13PHASE3Donanemab, Dexamethasone, Remternetug, Mevidalen, LY3954068
Biogen Inc.BIIB2PHASE3Lecanemab
Annovis Bio IncANVS1PHASE3buntanetap/posiphen
ACADIA Pharmaceuticals Inc.ACAD2PHASE3ACP-204
Novartis AG Sponsored ADRNVS2PHASE2VHB937, NIO752
Merck & Co., Inc.MRK2PHASE2MK-1167, MK-2214
GSK plc Sponsored ADRGSK2PHASE2GSK4527226
Cognition Therapeutics, Inc.CGTX2PHASE2CT1812
Johnson & JohnsonJNJ1PHASE2JNJ-64042056
Acumen Pharmaceuticals, Inc.ABOS1PHASE2sabirnetug
Lantheus Holdings IncLNTH2PHASE3Nilotinib BE, PI-2620
Aclaris Therapeutics, Inc.ACRS1PHASE2ATI-045
IGC Pharma, LLCIGC1PHASE2IGC-AD1-Active
Alnylam Pharmaceuticals, IncALNY2PHASE1ALN-5288, ALN-APP
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE1ARO-MAPT-
Denali Therapeutics Inc.DNLI1PHASE1DNL628
AC Immune SAACIU2PHASE1ACI-24.060 at Dose A in Study Part 1a, ACI-24.060 at Dose B in Study Part 1a, ACI-24.060 at Dose C in Study Part 1a, ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b, ACI-24.060 at Dose A in Study Part 2
Alzamend Neuro, Inc.ALZN1PHASE1ALZN002 .
Voyager Therapeutics, Inc.VYGR1PHASE1VY7523
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07214727primaryCompletionDate: changed
LOWMay 24, 2026NCT07214727studyFirstPostDate: changed