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tacrolimus + mycophenolate mofetil
tacrolimus + mycophenolate mofetil is a Immunosuppressant combination Small molecule drug developed by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan. It is currently in Phase 3 development for Organ transplant rejection prevention (likely kidney, heart, or liver transplantation).
This combination suppresses T-cell activation and proliferation through calcineurin inhibition (tacrolimus) and inosine monophosphate dehydrogenase inhibition (mycophenolate mofetil) to prevent organ rejection.
Tacrolimus and mycophenolate mofetil are used as maintenance immunosuppressive treatments in various conditions, including Type 1 Diabetes, Islet Transplantation, and renal transplant in end-stage renal failure. Mycophenolate mofetil is a small molecule inhibitor of inosine-5'-monophosphate dehydrogenase.
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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 | tacrolimus + mycophenolate mofetil |
|---|---|
| Sponsor | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan |
| Drug class | Immunosuppressant combination |
| Target | Calcineurin (tacrolimus); Inosine monophosphate dehydrogenase (mycophenolate mofetil) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Transplantation |
| Phase | Phase 3 |
Mechanism of action
Tacrolimus binds to FK-binding protein and inhibits calcineurin, blocking T-cell receptor signaling and IL-2 production. Mycophenolate mofetil selectively inhibits inosine monophosphate dehydrogenase, depleting guanosine nucleotides required for T and B cell proliferation. Together, they provide synergistic immunosuppression for transplant rejection prevention.
Approved indications
- Organ transplant rejection prevention (likely kidney, heart, or liver transplantation)
Common side effects
- Nephrotoxicity
- Neurotoxicity (tremor, headache)
- Gastrointestinal disturbances (diarrhea, nausea)
- Infection
- Hyperglycemia
- Hypertension
Key clinical trials
- Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita (PHASE2)
- Tocilizumab in Lung Transplantation (PHASE2)
- A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation (PHASE2, PHASE3)
- MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases (PHASE2)
- Allogeneic Hematopoietic Stem Cell Transplant for GATA2 Mutations (PHASE2)
- Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation (PHASE2)
- A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy (PHASE3)
- Fludarabine and Intermediate-dose TBI Followed by PTCy in Patients Undergoing Allo Transplant for Heme Malignancies (PHASE2)
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 + mycophenolate mofetil CI brief — competitive landscape report
- tacrolimus + mycophenolate mofetil updates RSS · CI watch RSS
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan portfolio CI
Frequently asked questions about tacrolimus + mycophenolate mofetil
What is tacrolimus + mycophenolate mofetil?
How does tacrolimus + mycophenolate mofetil work?
What is tacrolimus + mycophenolate mofetil used for?
Who makes tacrolimus + mycophenolate mofetil?
What drug class is tacrolimus + mycophenolate mofetil in?
What development phase is tacrolimus + mycophenolate mofetil in?
What are the side effects of tacrolimus + mycophenolate mofetil?
What does tacrolimus + mycophenolate mofetil target?
Related
- Drug class: All Immunosuppressant combination drugs
- Target: All drugs targeting Calcineurin (tacrolimus); Inosine monophosphate dehydrogenase (mycophenolate mofetil)
- Manufacturer: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan — full pipeline
- Therapeutic area: All drugs in Immunology / Transplantation
- Indication: Drugs for Organ transplant rejection prevention (likely kidney, heart, or liver transplantation)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing