Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cyclosporin or tacrolimus · 1 trial · 3 indications
| Name | Type | Description |
|---|---|---|
| Cyclosporin or tacrolimus | DRUG | - |
Inclusion Criteria: * Age over 18 * Treatment with a calcineurin inhibitor * Patients with mild to moderate renal insufficiency Exclusion Criteria: * Patients with acute rejection * Patients who received a transplant more than 10 years ago
Cyclosporin or tacrolimus is used in graft rejection, specifically in kidney transplant recipients. The Phase 3 study NCT00273871 evaluated conversion from calcineurin inhibitors to Rapamune versus standard therapy in established renal allograft recipients, a population that also included kidney failure and kidney transplantation. Both agents are small molecule immunosuppressants.
Cyclosporin or tacrolimus targets PPIA, also known as cyclophilin A. PPIA is a peptidyl-prolyl cis-trans isomerase, and the drug acts as a modulator of this target. This target interaction underlies the immunosuppressive activity relevant to preventing graft rejection in transplant recipients.
Pfizer, Inc. is the developer associated with cyclosporin or tacrolimus. Pfizer trades on the New York Stock Exchange under the ticker PFE. The company is listed as the sponsor of the Phase 3 clinical development program for this asset in graft rejection.
Cyclosporin or tacrolimus is in Phase 3 development. It is an investigational small molecule and is not described as approved. The Phase 3 trial NCT00273871 has been completed, and no active trials are currently listed for this asset.
Cyclosporin or tacrolimus has been studied in one Phase 3 trial, NCT00273871, titled Study Comparing Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients. The trial enrolled 190 participants, was randomized, used an uncontrolled design, and is now completed.
No. Cyclosporin or tacrolimus and Rapamune are different agents. In trial NCT00273871, participants were converted from calcineurin inhibitors, which include cyclosporin and tacrolimus, to Rapamune, also known as sirolimus, or continued standard therapy. The study compared these two treatment approaches in renal allograft recipients.