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Prograf-XL
Prograf-XL is a Calcineurin inhibitor Small molecule drug developed by Astellas Pharma Inc. It is currently in Phase 3 development for Prevention of organ rejection in kidney transplant patients. Also known as: tacrolimus extended release, FK506E, MR4, FK506XL.
Prograf-XL is an immunosuppressant that inhibits calcineurin.
Prograf-XL is an immunosuppressant that inhibits calcineurin. Used for Prevention of organ rejection in kidney transplant patients.
At a glance
| Generic name | Prograf-XL |
|---|---|
| Also known as | tacrolimus extended release, FK506E, MR4, FK506XL |
| Sponsor | Astellas Pharma Inc |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Prograf-XL works by inhibiting calcineurin, a protein phosphatase involved in the activation of T-lymphocytes. This action prevents the activation of T-lymphocytes and subsequent immune response. As a result, Prograf-XL reduces the risk of organ rejection in transplant patients.
Approved indications
- Prevention of organ rejection in kidney transplant patients
Common side effects
- Diarrhea
- Nausea
- Vomiting
- Headache
- Tremor
Key clinical trials
- De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis (PHASE2)
- Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf® (PHASE2)
- Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation (PHASE2)
- To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients (PHASE4)
- Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant (PHASE3)
- Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts (PHASE3)
- A Study to Compare How the Body Absorbs and Processes Two Different Formulations of the Anti-rejection Medication Tacrolimus (Advagraf® or Prograf®) in Children Receiving an Organ Transplant, and How Safe and Effective They Are Over a Longer Period of Time (PHASE2)
- Global, Multicentre, Non Interventional Advagraf Conversion Registry in Kidney Transplant Patients
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Prograf-XL CI brief — competitive landscape report
- Prograf-XL updates RSS · CI watch RSS
- Astellas Pharma Inc portfolio CI
Frequently asked questions about Prograf-XL
What is Prograf-XL?
How does Prograf-XL work?
What is Prograf-XL used for?
Who makes Prograf-XL?
Is Prograf-XL also known as anything else?
What drug class is Prograf-XL in?
What development phase is Prograf-XL in?
What are the side effects of Prograf-XL?
What does Prograf-XL target?
Related
- Drug class: All Calcineurin inhibitor drugs
- Target: All drugs targeting Calcineurin
- Manufacturer: Astellas Pharma Inc — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Prevention of organ rejection in kidney transplant patients
- Also known as: tacrolimus extended release, FK506E, MR4, FK506XL
- Compare: Prograf-XL vs similar drugs
- Pricing: Prograf-XL cost, discount & access