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Tacrolimus prolonged release
Tacrolimus prolonged release is a Small molecule drug developed by Astellas Pharma Europe Ltd.. It is currently in Phase 2 development. Also known as: FK506E, MR4, Advagraf, tacrolimus modified release.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Tacrolimus prolonged release |
|---|---|
| Also known as | FK506E, MR4, Advagraf, tacrolimus modified release, Astagraf XL |
| Sponsor | Astellas Pharma Europe Ltd. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf® (PHASE2)
- PK Assessment of Tacrolimus Exposure Before and After a Switch From Twice Daily Immediate-release (Prograf®) to Once-daily Prolonged Release Tacrolimus (Envarsus®) (PHASE4)
- Bioavailability and Practicability of Envarsus Versus Advagraf in Liver Transplant Recipients (PHASE4)
- Evaluation of Anti-rejection Drug, Tacrolimus, in African-Americans With Kidney Transplant (PHASE4)
- Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients (NA)
- P-glypoprotein Inhibition Effect on the Pharmacokinetics of Two Tacrolimus Formulations: Prolonged and Extended-release (PHASE2)
- 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)
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:
- Tacrolimus prolonged release CI brief — competitive landscape report
- Tacrolimus prolonged release updates RSS · CI watch RSS
- Astellas Pharma Europe Ltd. portfolio CI
Frequently asked questions about Tacrolimus prolonged release
What is Tacrolimus prolonged release?
Who makes Tacrolimus prolonged release?
Is Tacrolimus prolonged release also known as anything else?
What development phase is Tacrolimus prolonged release in?
Related
- Manufacturer: Astellas Pharma Europe Ltd. — full pipeline
- Also known as: FK506E, MR4, Advagraf, tacrolimus modified release, Astagraf XL
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing