Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SB424323 · 2 trials · 3 indications
Incidence of VTE during the 28-day treatment period, including death due to VTE
| Arm | Type | Description |
|---|---|---|
| SB424323, 500 mg BID | EXPERIMENTAL | - |
| SB424323, 125 mg BID | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SB424323 | DRUG | - |
| SB-424323 | DRUG | 500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days |
| Placebo | DRUG | matching placebo, oral, BID for 28 days |
Inclusion Criteria: * Patients with non valvular atrial fibrillation and any of the following: * \</= 60 years old with no heart disease. * 60 years old with heart disease but no risk factors. * \>/=60 years old and \</=75 years old with no risk factors and no heart disease. * Must be able to take ...
SB424323 is an investigational small molecule developed by GSK plc (ticker GSK). It has been studied in Phase 2 clinical trials for atrial fibrillation and for thromboprophylaxis after arthroplasty. It is not described as approved and remains an investigational agent in clinical development.
SB424323 was studied in non-valvular atrial fibrillation in patients at low or intermediate risk for stroke, in combination with aspirin. The Phase 2 trial NCT00240643 enrolled 640 patients across many countries. It has also been studied for thromboembolism prevention after arthroplasty in the TEMPEST trial.
SB424323 is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 2 clinical program for the compound, including the atrial fibrillation trial NCT00240643 and the arthroplasty trial NCT00041509.
SB424323 is in Phase 2. Both listed trials, NCT00240643 in atrial fibrillation and NCT00041509 in arthroplasty, were Phase 2 studies. Both are completed, and no active trials are listed, so the compound is not described as approved and remains investigational.
SB424323 has been evaluated in two completed Phase 2 trials. NCT00240643 tested SB424323 with aspirin in non-valvular atrial fibrillation in 640 patients at low or intermediate stroke risk. NCT00041509, the TEMPEST trial, studied thromboembolism prevention in 343 arthroplasty patients.
Yes, SB424323 and SB-424323 refer to the same investigational compound developed by GSK plc. The hyphenated form is an alternative spelling used in some references, and both names identify the same small molecule studied in Phase 2 trials for atrial fibrillation and arthroplasty.