Last reviewed · How we verify
Tacrolimus (Arm A)
Tacrolimus (Arm A) is a Calcineurin inhibitor Small molecule drug developed by Weill Medical College of Cornell University. It is currently FDA-approved for Organ transplant rejection prophylaxis (kidney, heart, liver, pancreas), Atopic dermatitis, Autoimmune uveitis. Also known as: Prograf.
Tacrolimus inhibits calcineurin phosphatase, blocking T-cell activation and proliferation by preventing transcription of IL-2 and other cytokine genes.
Tacrolimus is a small molecule inhibitor of the FK506-binding protein 1A, which is involved in the regulation of the immune system. It is used to treat conditions such as Graft vs Host Disease, Malignancy, Immunosuppression, Kidney Transplantation, and Liver Transplantation.
At a glance
| Generic name | Tacrolimus (Arm A) |
|---|---|
| Also known as | Prograf |
| Sponsor | Weill Medical College of Cornell University |
| 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 interleukin-2 and other T-cell activation genes, resulting in potent immunosuppression. This mechanism makes it effective for preventing organ rejection and treating autoimmune conditions.
Approved indications
- Organ transplant rejection prophylaxis (kidney, heart, liver, pancreas)
- Atopic dermatitis
- Autoimmune uveitis
- Autoimmune hepatitis
Common side effects
- Nephrotoxicity
- Hypertension
- Hyperglycemia
- Tremor
- Headache
- Infection
- Hyperkalemia
- Neurotoxicity (encephalopathy)
Key clinical trials
- 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)
- Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients (PHASE2)
- 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)
- 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)
- Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS) (PHASE2)
- Allo HSCT for High Risk Hemoglobinopathies (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 (Arm A) CI brief — competitive landscape report
- Tacrolimus (Arm A) updates RSS · CI watch RSS
- Weill Medical College of Cornell University portfolio CI
Frequently asked questions about Tacrolimus (Arm A)
What is Tacrolimus (Arm A)?
How does Tacrolimus (Arm A) work?
What is Tacrolimus (Arm A) used for?
Who makes Tacrolimus (Arm A)?
Is Tacrolimus (Arm A) also known as anything else?
What drug class is Tacrolimus (Arm A) in?
What development phase is Tacrolimus (Arm A) in?
What are the side effects of Tacrolimus (Arm A)?
What does Tacrolimus (Arm A) target?
Related
- Drug class: All Calcineurin inhibitor drugs
- Target: All drugs targeting Calcineurin (via FKBP12 binding)
- Manufacturer: Weill Medical College of Cornell University — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Organ transplant rejection prophylaxis (kidney, heart, liver, pancreas)
- Indication: Drugs for Atopic dermatitis
- Indication: Drugs for Autoimmune uveitis
- Also known as: Prograf
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing