Last reviewed · How we verify
Advagraf QD
Advagraf QD is a Calcineurin inhibitor Small molecule drug developed by Rabin Medical Center. It is currently in Phase 3 development for Prevention of organ rejection in adult kidney transplant recipients, Prevention of organ rejection in adult liver transplant recipients. Also known as: Advagraf.
Advagraf QD is a once-daily extended-release formulation of tacrolimus that suppresses T-cell activation by inhibiting calcineurin phosphatase.
Advagraf QD is a once-daily extended-release formulation of tacrolimus that suppresses T-cell activation by inhibiting calcineurin phosphatase. Used for Prevention of organ rejection in adult kidney transplant recipients, Prevention of organ rejection in adult liver transplant recipients.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Advagraf QD |
|---|---|
| Also known as | Advagraf |
| Sponsor | Rabin Medical Center |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin (via FKBP12 binding) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Transplantation |
| Phase | Phase 3 |
Mechanism of action
Tacrolimus binds to the immunophilin FKBP12 and inhibits calcineurin, a phosphatase required for T-cell receptor signaling and IL-2 production. The extended-release QD formulation allows for once-daily dosing compared to twice-daily immediate-release tacrolimus, improving medication adherence in transplant recipients while maintaining immunosuppressive efficacy.
Approved indications
- Prevention of organ rejection in adult kidney transplant recipients
- Prevention of organ rejection in adult liver transplant recipients
Common side effects
- Tremor
- Headache
- Hypertension
- Nephrotoxicity
- Hyperglycemia
- Infections
Key clinical trials
- Twice-daily Tacrolimus and Everolimus Convert to Once-daily Tacrolimus and Everolimus in Liver Transplant Recipient (PHASE4)
- A Study of Patient Adherence and Convenience to Immunosuppressive Agents in Newly Liver Transplant (PHASE4)
- Influence of CYP3A5 Polymorphism on Liver Function Abnormality and the Trough Level Change After Conversion (PHASE4)
- Incidence of Non Adherence to Treatment With Once-daily Formulation of Tacrolimus (PHASE3)
- Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients (PHASE4)
- Insulin Secretion and Advagraf (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Advagraf QD CI brief — competitive landscape report
- Advagraf QD updates RSS · CI watch RSS
- Rabin Medical Center portfolio CI
Frequently asked questions about Advagraf QD
What is Advagraf QD?
How does Advagraf QD work?
What is Advagraf QD used for?
Who makes Advagraf QD?
Is Advagraf QD also known as anything else?
What drug class is Advagraf QD in?
What development phase is Advagraf QD in?
What are the side effects of Advagraf QD?
What does Advagraf QD target?
Related
- Drug class: All Calcineurin inhibitor drugs
- Target: All drugs targeting Calcineurin (via FKBP12 binding)
- Manufacturer: Rabin Medical Center — full pipeline
- Therapeutic area: All drugs in Immunology / Transplantation
- Indication: Drugs for Prevention of organ rejection in adult kidney transplant recipients
- Indication: Drugs for Prevention of organ rejection in adult liver transplant recipients
- Also known as: Advagraf
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing