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tacrolimus + steroid
tacrolimus + steroid is a immunosuppressant Small molecule drug developed by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan. It is currently in Phase 3 development for Prophylaxis of organ rejection in patients receiving allogeneic organ transplants.
Tacrolimus is an immunosuppressant that inhibits calcineurin, a protein phosphatase involved in the activation of T-lymphocytes, while steroids reduce inflammation and suppress the immune system.
Tacrolimus is a small molecule inhibitor of the FK506-binding protein 1A, which is involved in the mechanism of action. It is often used in combination with steroids for the prevention of acute allograft rejection in simultaneous kidney/pancreas transplant recipients.
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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 + steroid |
|---|---|
| Sponsor | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan |
| Drug class | immunosuppressant |
| Target | calcineurin |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Tacrolimus works by binding to the immunophilin FKBP-12, which inhibits calcineurin and prevents the transcription of IL-2 and other cytokines. Steroids, such as prednisone, have anti-inflammatory properties and can suppress the immune system by reducing the production of cytokines and other inflammatory mediators.
Approved indications
- Prophylaxis of organ rejection in patients receiving allogeneic organ transplants
Common side effects
- Diarrhea
- Nausea
- Headache
- Tremor
- Hypertension
- Hyperkalemia
- Anemia
- Leukopenia
- Thrombocytopenia
- Infection
Key clinical trials
- Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia (PHASE2)
- A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation (PHASE2, PHASE3)
- A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR) (PHASE2)
- Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation (PHASE2)
- A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (PHASE2)
- Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib (PHASE2)
- Treatment of Antibody-Mediated Rejection (ABMR) With CarBel (PHASE2)
- A Study of Immune Suppression Treatment for People With Sickle Cell Disease or β-Thalassemia Who Are Going to Receive an Allogeneic Hematopoietic Cell Transplantation (HCT) (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 + steroid CI brief — competitive landscape report
- tacrolimus + steroid updates RSS · CI watch RSS
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan portfolio CI
Frequently asked questions about tacrolimus + steroid
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Related
- Drug class: All immunosuppressant drugs
- Target: All drugs targeting calcineurin
- Manufacturer: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Prophylaxis of organ rejection in patients receiving allogeneic organ transplants
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing