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Tacrolimus, Accord
Tacrolimus, Accord is a Calcineurin inhibitor Small molecule drug developed by University of Cincinnati. It is currently FDA-approved for Organ transplant rejection prophylaxis (kidney, heart, liver), Atopic dermatitis, Autoimmune conditions (off-label use in various settings). Also known as: Accord Healthcare tacrolimus.
Tacrolimus inhibits calcineurin phosphatase, blocking T-cell activation and proliferation by preventing IL-2 transcription.
Tacrolimus is a small molecule inhibitor of the FK506-binding protein 1A, used in immunosuppressive regimens to prevent rejection in patients with end-stage renal failure who have undergone kidney transplantation. It is typically administered in combination with other immunosuppressants, such as mycophenolate mofetil or everolimus, as part of a reduced-dose regimen.
At a glance
| Generic name | Tacrolimus, Accord |
|---|---|
| Also known as | Accord Healthcare tacrolimus |
| Sponsor | University of Cincinnati |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin (via FKBP12 binding) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Tacrolimus binds to the immunophilin FKBP12, and this complex inhibits calcineurin, a serine/threonine phosphatase essential for dephosphorylating NFAT (nuclear factor of activated T cells). By preventing NFAT nuclear translocation, tacrolimus suppresses the transcription of IL-2 and other cytokines required for T-cell proliferation and immune response. This potent immunosuppressive effect makes it valuable in transplantation and autoimmune conditions.
Approved indications
- Organ transplant rejection prophylaxis (kidney, heart, liver)
- Atopic dermatitis
- Autoimmune conditions (off-label use in various settings)
Common side effects
- Nephrotoxicity
- Hypertension
- Hyperglycemia/new-onset diabetes
- Neurotoxicity (tremor, headache)
- Infection
- Hyperkalemia
- Gastrointestinal disturbances
Key clinical trials
- Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients (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)
- 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)
- Tocilizumab in Cardiac Transplantation (PHASE2)
- Reduced Intensity, Partially HLA Mismatched BMT to Treat Hematologic Malignancies (PHASE1, PHASE2)
- A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplant for Subjects With VEXAS (Vacuoles, E1 Enzyme, X-linked, Autoinflammatory, Somatic) Syndrome (PHASE2)
- Total Marrow and Lymphoid Irradiation Before Donor Transplant and Cyclophosphamide in Treating Patients With Acute Myeloid Leukemia (PHASE1)
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, Accord CI brief — competitive landscape report
- Tacrolimus, Accord updates RSS · CI watch RSS
- University of Cincinnati portfolio CI
Frequently asked questions about Tacrolimus, Accord
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Related
- Drug class: All Calcineurin inhibitor drugs
- Target: All drugs targeting Calcineurin (via FKBP12 binding)
- Manufacturer: University of Cincinnati — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Organ transplant rejection prophylaxis (kidney, heart, liver)
- Indication: Drugs for Atopic dermatitis
- Indication: Drugs for Autoimmune conditions (off-label use in various settings)
- Also known as: Accord Healthcare tacrolimus
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing