Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
sotrastaurin · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | sotrastaurin (100mg bid) + tacrolimus + standard of care medications |
| Arm 2 | EXPERIMENTAL | sotrastaurin (200mg bid) + tacrolimus + standard of care medications |
| Arm 3 | EXPERIMENTAL | sotrastaurin (300mg bid) + tacrolimus + standard of care medications |
| Arm 4 | ACTIVE_COMPARATOR | mycophenolic acid (720mg bid) + tacrolimus + standard of care medications |
| Name | Type | Description |
|---|---|---|
| sotrastaurin (Dose 1) + tacrolimus + standard of care medications | DRUG | sotrastaurin (100mg bid) + tacrolimus + standard of care medications |
| sotrastaurin (Dose 2) + tacrolimus + standard of care medications | DRUG | sotrastaurin (200mg bid) + tacrolimus + standard of care medications |
| sotrastaurin (Dose 3) + tacrolimus + standard of care medications | DRUG | sotrastaurin (300mg bid) + tacrolimus + standard of care medications |
| mycophenolic acid + tacrolimus + standard of care medications | DRUG | mycophenolic acid (720mg bid) + tacrolimus + standard of care medications |
Inclusion criteria: * Recipients of a first or second kidney transplant from a deceased, living unrelated or non-human leukocyte antigen (HLA) identical living related donor. * Recipients of a kidney with a cold ischemia time \< 30 hours. * Recipients of a kidney from a donor 10 - 65 years old. Ex...
Sotrastaurin was studied for use in renal transplantation, specifically to prevent organ rejection in kidney transplant recipients. It was evaluated in combination with tacrolimus and standard of care medications. The drug is an investigational small molecule and has not been approved for any indication.
Sotrastaurin targets protein kinase C (PKC) isoforms, specifically PRKD3, PRKCI, PRKCA, PRKCG, PRKCD, and PRKCB. It acts as an inhibitor of these kinases. This mechanism is intended to suppress immune responses involved in transplant rejection.
Sotrastaurin is being developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the clinical trial evaluating the drug in renal transplantation.
Sotrastaurin is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any regulatory agency. The Phase 2 trial has been completed.
Sotrastaurin was evaluated in a single Phase 2 clinical trial, NCT01064791, titled "Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients." The trial enrolled 298 participants and is completed.