Last reviewed · How we verify
Tacrolimus immediate release
Tacrolimus immediate release, marketed by Astellas Pharma Global Development, Inc., is a well-established immunosuppressive agent with a strong presence in the transplant market. The drug's key strength lies in its proven efficacy and safety profile, supported by extensive clinical use. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | Tacrolimus immediate release |
|---|---|
| Also known as | FK506, Prograf, generic immediate release tacrolimus |
| Sponsor | Astellas Pharma Global Development, Inc. |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients (PHASE4)
- VEL-101 to Prevent Rejection After Kidney Transplantation (PHASE2)
- Envarsus XR Compared to Immediate Release Tacrolimus (PHASE4)
- PK Assessment of Tacrolimus Exposure Before and After a Switch From Twice Daily Immediate-release (Prograf®) to Once-daily Prolonged Release Tacrolimus (Envarsus®) (PHASE4)
- Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR (PHASE4)
- Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants (PHASE4)
- CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients (PHASE2, PHASE3)
- Extended Release Versus Immediate Release Tacrolimus Following Renal Allograft Failure to Reduce Allosensitisation (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |