Recent Updates
Recently added Catalysts

GSK4527226

Phase 2

Alzheimer's Disease | Small molecule | Neurology |GSK plc|Last Updated: Feb 2, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment587
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07105709Open-label Extension Study in Participants With Early Alzheimer's DiseasePHASE2 RECRUITING 220Aug 14, 2025Dec 8, 2028Feb 2, 202633 United States, Argentina +9
NCT06079190Efficacy and Safety of GSK4527226 [AL101] in Participants With Early Alzheimer's DiseasePHASE2 ACTIVE NOT_RECRUITING 367Oct 20, 2023Nov 23, 2026Nov 14, 202597 United States, Argentina +14
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of Participants with Treatment Emergent Adverse Events (AEs) during the OLE
Up to 112 Weeks

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

Number of Participants with Adverse Event of Special Interest (AESIs) during the OLE
Up to 112 Weeks

AESIs includes Infusion-related reactions, Amyloid related imaging abnormalities (ARIA) and cerebral macrohemorrhage.

Number of Participants with Serious Adverse Events (SAEs) during the OLE
Up to 112 Weeks

A SAE is defined as any untoward medical occurrence that, at any dose, results in death and is life threatening requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect or congenital anomaly.

Number of Participants with Amyloid related imaging abnormalities (ARIAs) Including Severity during the OLE
Up to 112 Weeks

Magnetic resonance imaging (MRIs) will be used to monitor for abnormalities in the brain such as brain swelling and/or brain bleeding, which are termed as ARIAs.

Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score for Dose 1 vs Placebo Across Weeks 52, 64 and 76
Baseline, Week 52, 64 and 76

The CDR-SB score is a quantitative general index that provides more precision in participants with mild dementia. The CDR scale is a clinician-rated dementia staging system tracks the progression of. cognitive impairment in 6 categories (memory, orientation, judgment, and problem solving, community affairs, home and hobbies, and personal care). Each category is scored on a 5- point scale in which None=0, Questionable=0.5, Mild=1, Moderate=2, and Severe=3. The CDR-SB is obtained by adding the ratings in each of the 6 categories and ranges from 0 to 18 with higher scores indicative of greater impairment.

Secondary Endpoints
Change from OLE Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score Across Weeks 24, 52, 76, and 104
Baseline, Week 24, 52, 76, and 104
Change from OLE Baseline in AD Assessment Scale-Cognitive subscale (ADAS-Cog14) Score Across Weeks 24, 52, 76, and 104
Baseline, Week 24, 52, 76, and 104
Change from OLE Baseline in Mini - Mental State Exam (MMSE) Across Weeks 24, 52, 76, and 104
Baseline, Week 24, 52, 76, and 104
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GSK4527226EXPERIMENTALParticipants will receive GSK4527226.
GSK4527226 Dose 1EXPERIMENTALParticipants will receive GSK4527226 Dose 1
GSK4527226 Dose 2EXPERIMENTALParticipants will receive GSK4527226 Dose 2
PlaceboPLACEBO_COMPARATORParticipants will receive placebo.
Interventions
NameTypeDescription
GSK4527226DRUGGSK4527226 will be administered.
PlaceboOTHERPlacebo will be administered.
Unlock Study Design Details
Eligibility Criteria
Age Range50 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: * Completion of the Treatment Period in the parent study (NCT06079190). * Participants may have missed doses during the Treatment Period or may be on a temporary dose suspension but must not have been permanently discontinued early from study intervention or withdrawn from the p...

Countries:United StatesArgentinaAustraliaCanadaFinlandNorwaySouth KoreaSpainSwedenTaiwanUnited KingdomFranceGermanyItalyNetherlandsTurkey (Türkiye)
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07105709primaryCompletionDate: changed
LOWMay 26, 2026NCT06079190primaryCompletionDate: changed
LOWMay 24, 2026NCT07105709studyFirstPostDate: changed
LOWMay 24, 2026NCT06079190studyFirstPostDate: changed