Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Rilapladib (SB-659032), SB-659032
Rilapladib · 5 trials · 3 indications
CSF Abeta biomarkers (Abeta42, Abeta40) were assessed at Baseline visit (Day 0) and Week 24 (Day 168). Change from Baseline in CSF Abeta42 and Abeta40 are summarized. Baseline and Week 24 study visits were taken place at approximately the same time of day in the morning (preferably between 08:00 and 12:00) to improve the reliability of CSF. Baseline value was defined as the latest Day 0 value. Change from Baseline was calculated as post-dose (Week 24) visit value minus Baseline value. The data is presented in for adjusted mean and standard error of adjusted mean.
CSF Abeta biomarkers (Abeta42, Abeta40) were assessed at Baseline visit (Day 0) and Week 24 (Day 168). Change from Baseline in CSF Abeta42/Abeta40 ratio is summarized. Baseline and Week 24 study visits were taken place at approximately the same time of day in the morning (preferably between 08:00 and 12:00) to improve the reliability of CSF. Baseline value was defined as the latest Day 0 value. Change from Baseline was calculated as post-dose (Week 24) visit value minus Baseline value. The data is presented in for adjusted mean and standard error of adjusted mean.
CSF tau and P-tau were assessed at Baseline visit (Day 0) and Week 24 (Day 168). Change from Baseline in CSF tau and P-tau was summarized. Baseline and Week 24 study visits were taken place at approximately the same time of day in the morning (preferably between 08:00 and 12:00) to improve the reliability of CSF. Baseline value was defined as the latest Day 0 value. Change from Baseline was calculated as post-dose (Week 24) visit value minus Baseline value. The data is presented in for adjusted mean and standard error of adjusted mean.
The WM/EF composite score was comprised of 5 functional tests including 1) Controlled oral word association which measured language fluency, planning and working memory, 2) Category naming: It measures semantic fluency, planning and working memory, 3) One-back: This is a measure of working memory. 4) Trail B: This is a measure of motor speed, visual scanning, and visual-motor integration. This test required attention and cognitive flexibility. 5) Go No-Go task: This test evaluate accuracy and reaction time for each response. The composite score calculated by standardizing the total score: sum of all responses obtained from these 5 functional test by using the formula (Total score of ITT population at baseline - Total score at Week 24) /standard deviation of mean total mean score at baseline. The observed composite score ranged from minimum -1.474 and maximum 1.596. Lower score means better cognitive status. Change from Baseline was calculated as post-dose visit minus Baseline value.
Percent maximum platelet aggregation following ADP- and collagen-induced aggregation
Urinary 11-dehydrothromboxane B2 and blood CD62 concentrations
| Arm | Type | Description |
|---|---|---|
| 250mg rilapladib | EXPERIMENTAL | Experimental drug |
| placebo | PLACEBO_COMPARATOR | Placebo comparator |
| rilapladib | ACTIVE_COMPARATOR | 250 mg/day |
| SB-659032 | EXPERIMENTAL | 250 mg non-enteric coated SB-659032 |
| Name | Type | Description |
|---|---|---|
| 250mg rilapladib | DRUG | Experimental Drug |
| placebo | DRUG | Placebo comparator |
| rilapladib | DRUG | 250 mg oral dose once daily |
| 18F Fluorodeoxylucose (FDG)-PET | OTHER | FDG-PET |
| Rilapladib (SB-659032) | DRUG | - |
| SB-659032 | DRUG | - |
| SB659032 | DRUG | single dose |
Inclusion Criteria: 1. A clinical diagnosis of possible Alzheimer's disease in accordance with the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with radiological (Magnetic Resonance Imaging \[...
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Rilapladib is an investigational small molecule developed by GSK plc (ticker GSK) as a PLA2G7 inhibitor. It has been studied in Phase 2 clinical trials for Alzheimer's disease and atherosclerosis. It is not approved and remains in clinical development.
Rilapladib has been studied for Alzheimer's disease and atherosclerosis. A Phase 2a trial evaluated it in Alzheimer's disease, and a separate Phase 2 imaging study evaluated it in patients with atherosclerosis over 12 weeks. Both indications remain investigational.
Rilapladib targets PLA2G7, also known as lipoprotein-associated phospholipase A2. It acts as an inhibitor of this enzyme. This target class places rilapladib among PLA2G7 inhibitor compounds developed for neurological and cardiovascular indications.
Rilapladib is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 2a Alzheimer's disease study and the Phase 2 atherosclerosis imaging study, as well as an earlier Phase 1 platelet aggregation study.
Rilapladib is in Phase 2 development. It has completed two Phase 2 trials and one Phase 1 trial, with no active trials currently listed. It is investigational and has not been approved for any indication.
Rilapladib has been studied in NCT01428453, a Phase 2a trial in Alzheimer's disease enrolling 124 patients across Europe and Canada, and NCT00695305, a Phase 2 imaging study in atherosclerosis enrolling 83 patients in the United States. Both are completed.
Yes, rilapladib is also known as SB-659032. The 250mg rilapladib dose has been referenced in study documentation. These names refer to the same investigational PLA2G7 inhibitor developed by GSK.