Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Revusiran · 3 trials · 11 indications
The difference between revusiran and placebo group in change from baseline to 18 months in the total distance walked in 6 minutes
The difference between revusiran (ALN-TTRSC) and placebo group in the percent reduction in serum TTR levels over 18 months
A negative percentage change from baseline at Month 6 indicates a reduction in serum TTR level.
The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs) and study \[drug\] discontinuation.
| Arm | Type | Description |
|---|---|---|
| Revusiran (ALN-TTRSC) | ACTIVE_COMPARATOR | administered by subcutaneous (SC) injection |
| Sterile Normal Saline (0.9% NaCl) | PLACEBO_COMPARATOR | administered by subcutaneous (SC) injection |
| All Patients | EXPERIMENTAL | All patients who received at least 1 dose of revusiran (ALN-TTRSC) |
| Name | Type | Description |
|---|---|---|
| Revusiran (ALN-TTRSC) | DRUG | - |
| Sterile Normal Saline (0.9% NaCl) | DRUG | - |
| Revusiran | DRUG | 500mg Revusiran by subcutaneous (sc) injection |
Inclusion Criteria: * Documented TTR mutation * Amyloid deposits in cardiac or non-cardiac tissue * Medical history of heart failure * Evidence of cardiac involvement by echocardiogram Exclusion Criteria: * Has known primary amyloidosis (AL), leptomeningeal amyloidosis, non-FAC hereditary cardiom...
Revusiran is an investigational drug being developed for transthyretin (TTR)-mediated amyloidosis, including TTR-mediated familial amyloidotic cardiomyopathy (FAC) and TTR-mediated amyloidosis in patients whose disease worsened after liver transplant. It is a small molecule being studied in clinical trials for these rare disease indications.
Revusiran is being developed by Alnylam Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALNY. Alnylam is conducting clinical trials to evaluate Revusiran for the treatment of transthyretin-mediated amyloidosis conditions.
Revusiran has been studied in Phase 2 and Phase 3 clinical trials. The Phase 3 ENDEAVOUR study evaluated Revusiran in patients with transthyretin-mediated familial amyloidotic cardiomyopathy, while Phase 2 trials assessed it in TTR-mediated amyloidosis. All trials listed are completed, and Revusiran remains investigational.
Revusiran has been studied in three completed clinical trials: NCT02292186, a Phase 2 extension study in TTR cardiac amyloidosis; NCT02319005, the Phase 3 ENDEAVOUR study in TTR-mediated familial amyloidotic cardiomyopathy; and NCT02595983, a Phase 2 study in TTR-mediated amyloidosis patients whose disease worsened after liver transplant.
Yes, Revusiran is also known as ALN-TTRSC. Clinical trial records refer to Revusiran as ALN-TTRSC, and the drug has been evaluated under this name in studies for transthyretin-mediated amyloidosis, including familial amyloidotic cardiomyopathy and amyloidosis after liver transplant.