Product Description
Tacrolimus (FK 506) is a macrolide immunosuppressant which possesses similar but more potent immunosuppressant properties compared with cyclosporin, inhibiting cell-mediated and humoral immune responses. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/7506654/)
Mechanisms of Action: Calcineurin Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral,Topical,Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Heart Transplant | Kidney Transplant | Liver Transplant | Lung Transplant | Transplantation Unspecified | Kidney Transplant | Transplantation Unspecified | Kidney Transplant | Transplantation Unspecified
Known Adverse Events: Pericardial Effusion | Hypertension | Abdominal Pain | Headache | Pain Unspecified | Paresthesia | Tremor | Insomnia | Anemia | Leukopenia | General Diabetes | Hyperglycemia | Hyperkalemia | Hypertension, Renal | Bronchitis | Constipation | Diarrhea | Edema | Kidney Transplant
Company: Astellas Pharma
Company Location: NEW YORK NY 10005
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, China, Czech Republic, France, Germany, India, Japan, Netherlands, United States
Active Clinical Trial Count: 17
Highest Development Phases
Phase 3: Dermatitis, Atopic|Graft vs Host Disease|Kidney Failure, Chronic|Kidney Transplant|Lung Transplant|Pancreas Transplant
Phase 2: Allogeneic Stem Cell Transplant|Epistaxis|Gastrointestinal Hemorrhage|Geographic Atrophy|Healthy Volunteers|Heart Transplant|Liver Transplant|Macular Degeneration|Respiratory Aspiration|Retinal Degeneration|Telangiectasia, Hereditary Hemorrhagic|Telangiectasis|Transplantation Unspecified
Phase 1: Corneal Transplant
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| INCB18424-370 | P3 |
Not yet recruiting |
Graft vs Host Disease |
2030-10-20 |
|
| VEL-IIS-2020-085 | P1 |
Enrolling by invitation |
Lung Transplant |
2026-06-30 |
|
| PMR-EC-1206 | P2 |
Unknown Status |
Liver Transplant|Kidney Transplant|Transplantation Unspecified|Heart Transplant|Lung Transplant |
2026-05-31 |
|
| CIRTEN SPK | P3 |
Recruiting |
Kidney Transplant|Pancreas Transplant |
2025-12-01 |