Active Ingredient History
Tacrolimus, previously known as FK506, is the active ingredient in Prograf. Tacrolimus is a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It reduces peptidyl-prolyl isomerase activity by binding to the immunophilin FKBP-12 (FK506 binding protein) creating a new complex. This FKBP12-FK506 complex interacts with and inhibits calcineurin thus inhibiting both T-lymphocyte signal transduction and IL-2 transcription. Tacrolimus inhibits T-lymphocyte activation, although the exact mechanism of action is not known. Experimental evidence suggests that tacrolimus binds to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin inhibited. This effect may prevent the dephosphorylation and translocation of nuclear factor of activated T-cells (NF-AT), a nuclear component thought to initiate gene transcription for the formation of lymphokines (such as interleukin-2, gamma interferon). The net result is the inhibition of T-lymphocyte activation (i.e., immunosuppression). Prograf is indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver transplants, kidney transplants, heart transplants. It has also been used in a topical preparation in the treatment of severe atopic dermatitis. NCATS
Drug Pricing (per unit)
Note: This drug pricing data is preliminary, incomplete, and may contain errors.
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Kidney Transplantation (approved 1994)
Abdominal Wall (Early Phase 1)
Allergy and Immunology (Phase 4)
Allografts (Phase 4)
Alopecia (Phase 1)
Alzheimer Disease (Phase 2)
Amputation (Phase 2/Phase 3)
Amputation, Traumatic (Phase 2/Phase 3)
Amyotrophic Lateral Sclerosis (Phase 2)
Anaplasia (Phase 3)
Anemia (Phase 2)
Anemia, Aplastic (Phase 2)
Anemia, Diamond-Blackfan (Phase 2)
Anemia, Hemolytic, Autoimmune (Phase 4)
Anemia, Refractory (Phase 2)
Anemia, Sickle Cell (Phase 2)
Angiofibroma (Phase 1)
Antigens, CD (Phase 1)
Arthritis, Rheumatoid (Phase 4)
Aspergillosis (Phase 1)
Asthma (Phase 2)
Atherosclerosis (Phase 3)
Autoimmune Diseases (Phase 3)
beta-Thalassemia (Phase 4)
Bone Marrow Cells (Phase 2)
Bone Marrow Failure Disorders (Phase 2)
Bone Marrow Transplantation (Phase 4)
Brain Death (Phase 2)
Brain Neoplasms (Phase 1)
Breast Cancer Lymphedema (Phase 1/Phase 2)
Breast Neoplasms (Phase 3)
Bronchiolitis Obliterans (Phase 3)
Burkitt Lymphoma (Phase 2)
Carcinoma (Phase 1)
Carcinoma, Acinar Cell (Phase 1)
Carcinoma, Adenoid Cystic (Phase 1)
Carcinoma, Basal Cell (Phase 1)
Carcinoma, Hepatocellular (Phase 4)
Carcinoma, Merkel Cell (Phase 1)
Carcinoma, Mucoepidermoid (Phase 1)
Carcinoma, Squamous Cell (Phase 1)
Cardiovascular Diseases (Phase 4)
Chemical and Drug Induced Liver Injury (Phase 2)
Choroid Plexus Neoplasms (Phase 1)
Chromosome Aberrations (Phase 2)
Cognitive Dysfunction (Phase 2)
Colitis (Phase 2)
Colitis, Ulcerative (Phase 4)
Colorectal Neoplasms (Phase 4)
Common Variable Immunodeficiency (Phase 2)
Congenital Bone Marrow Failure Syndromes (Phase 1)
Conjunctivitis (Phase 3)
Conjunctivitis, Allergic (Phase 4)
Corneal Diseases (Phase 2/Phase 3)
COVID-19 (Phase 3)
Crohn Disease (Phase 2)
Cytokines (Phase 2)
Cytomegalovirus (Phase 4)
Cytomegalovirus Infections (Phase 4)
Delayed Graft Function (Phase 4)
Dermatitis (Phase 4)
Dermatitis, Atopic (Phase 4)
Dermatitis, Contact (Phase 4)
Dermatitis, Occupational (Phase 4)
Dermatitis, Seborrheic (Phase 4)
Dermatomyositis (Phase 2/Phase 3)
Desmoplastic Small Round Cell Tumor (Phase 2)
Diabetes Mellitus (Phase 4)
Diabetes Mellitus, Type 1 (Phase 3)
Diabetes Mellitus, Type 2 (Phase 4)
Diabetic Nephropathies (Phase 4)
DiGeorge Syndrome (Phase 1/Phase 2)
Diploidy (Phase 2)
Drug Evaluation (Phase 2)
Drug Interactions (Phase 4)
Drugs, Investigational (Phase 4)
Dry Eye Syndromes (Phase 4)
Edema (Phase 2/Phase 3)
Encephalitis (Phase 2/Phase 3)
End Stage Liver Disease (Phase 4)
Ependymoma (Phase 1)
Epidermolysis Bullosa (Phase 2)
Epistaxis (Phase 2)
Epstein-Barr Virus Infections (Phase 1)
Erectile Dysfunction (Phase 4)
Fanconi Anemia (Phase 2)
General Surgery (Phase 2/Phase 3)
Genetic Diseases, Inborn (Phase 2)
Genital Diseases, Male (Phase 1)
Genital Neoplasms, Male (Phase 1)
Geriatrics (Phase 4)
Gestational Trophoblastic Disease (Phase 2)
Glioma (Phase 1)
Glomerulonephritis, IGA (Phase 2)
Glomerulonephritis, Membranous (Phase 4)
Graft Rejection (Phase 4)
Graft Survival (Phase 2)
Graft vs Host Disease (Phase 4)
Healthy Volunteers (Phase 1)
Heart Diseases (Phase 3)
Heart Failure (Phase 4)
Heart Transplantation (Phase 4)
Hematologic Diseases (Phase 2)
Hematologic Neoplasms (Phase 2)
Hematopoietic Stem Cell Transplantation (Phase 4)
Hemoglobinopathies (Phase 2)
Hemoglobin SC Disease (Phase 2)
Hemoglobinuria, Paroxysmal (Phase 2)
Hemorrhage (Phase 2)
Hepacivirus (Phase 1)
Hepatitis (Phase 4)
Hepatitis, Autoimmune (Phase 2)
Hepatitis B (Phase 4)
Hepatitis C (Phase 4)
Hepatitis C, Chronic (Phase 4)
Hermanski-Pudlak Syndrome (Phase 2)
Herpesvirus 4, Human (Phase 4)
Histiocytosis, Langerhans-Cell (Phase 2)
Hodgkin Disease (Phase 3)
Host vs Graft Reaction (Phase 3)
Hypercholesterolemia (Phase 1)
Hyperkalemia (Phase 1)
Hypertrophy, Left Ventricular (Phase 4)
Hypoglycemia (Phase 2)
Immune System Diseases (Phase 4)
Immunoproliferative Disorders (Phase 1)
Immunosuppression Therapy (Phase 4)
Infections (Phase 4)
Infertility, Female (Phase 3)
Inosine Triphosphate (Phase 2)
Intestinal Neoplasms (Phase 2)
Intestines (Phase 2)
Intraocular Lymphoma (Phase 2)
Islets of Langerhans Transplantation (Phase 3)
Keratoconjunctivitis (Phase 3)
Keratoplasty, Penetrating (Phase 2/Phase 3)
Kidney (Phase 4)
Kidney Diseases (Phase 4)
Kidney Failure, Chronic (Phase 4)
Kidney Neoplasms (Phase 2)
Kidney Transplantation (Phase 4)
Kidney Tubular Necrosis, Acute (Phase 1/Phase 2)
Leukemia (Phase 3)
Leukemia, Biphenotypic, Acute (Phase 3)
Leukemia, Eosinophilic, Acute (Phase 2)
Leukemia, Hairy Cell (Phase 2)
Leukemia, Large Granular Lymphocytic (Phase 2)
Leukemia, Lymphocytic, Chronic, B-Cell (Phase 3)
Leukemia, Lymphoid (Phase 2)
Leukemia-Lymphoma, Adult T-Cell (Phase 2)
Leukemia, Megakaryoblastic, Acute (Phase 1/Phase 2)
Leukemia, Monocytic, Acute (Phase 2)
Leukemia, Myeloid (Phase 2)
Leukemia, Myeloid, Accelerated Phase (Phase 2)
Leukemia, Myeloid, Acute (Phase 3)
Leukemia, Myeloid, Chronic-Phase (Phase 3)
Leukemia, Myelomonocytic, Acute (Phase 2)
Leukemia, Myelomonocytic, Chronic (Phase 2)
Leukemia, Myelomonocytic, Juvenile (Phase 2)
Leukemia, Neutrophilic, Chronic (Phase 2)
Leukemia, Plasma Cell (Phase 2)
Leukemia, Prolymphocytic (Phase 2)
Leukemia, Prolymphocytic, B-Cell (Phase 2)
Leukemia, Prolymphocytic, T-Cell (Phase 2)
Lichen Planus, Oral (Phase 2)
Livedoid Vasculopathy (Phase 3)
Liver Cirrhosis (Phase 4)
Liver Diseases (Phase 4)
Liver Failure (Phase 4)
Liver Transplantation (Phase 4)
Living Donors (Phase 4)
Lung Diseases (Phase 2)
Lung Diseases, Interstitial (Phase 3)
Lung Injury (Phase 3)
Lung Transplantation (Phase 4)
Lupus Erythematosus, Cutaneous (Phase 2)
Lupus Erythematosus, Systemic (Phase 4)
Lupus Nephritis (Phase 4)
Lymphatic Diseases (Phase 1)
Lymphedema (Phase 1/Phase 2)
Lymphocytes (Phase 2)
Lymphohistiocytosis, Hemophagocytic (Phase 1)
Lymphoma (Phase 3)
Lymphoma, B-Cell (Phase 2)
Lymphoma, B-Cell, Marginal Zone (Phase 2)
Lymphoma, Follicular (Phase 2)
Lymphoma, Large B-Cell, Diffuse (Phase 2)
Lymphoma, Large-Cell, Anaplastic (Phase 2)
Lymphoma, Large-Cell, Immunoblastic (Phase 2)
Lymphoma, Mantle-Cell (Phase 2)
Lymphoma, Non-Hodgkin (Phase 3)
Lymphoma, T-Cell (Phase 2)
Lymphoma, T-Cell, Peripheral (Phase 2)
Lymphomatoid Granulomatosis (Phase 2)
Lymphoproliferative Disorders (Phase 2)
Macular Degeneration (Phase 2)
Maintenance (Phase 3)
Mastocytosis (Phase 2)
Medication Adherence (Phase 3)
Medulloblastoma (Phase 1)
Melanoma (Phase 1)
Metabolic Diseases (Phase 2)
Mucopolysaccharidoses (Phase 2/Phase 3)
Multiple Myeloma (Phase 3)
Multiple Sclerosis (Phase 2)
Myasthenia Gravis (Phase 3)
Myeloablative Agonists (Phase 2)
Myelodysplastic Syndromes (Phase 3)
Myeloproliferative Disorders (Phase 3)
Neoplasm Metastasis (Phase 1)
Neoplasm, Residual (Phase 2)
Neoplasms (Phase 2)
Neoplasms by Histologic Type (Phase 1)
Neoplasms by Site (Phase 1)
Neoplasms, Germ Cell and Embryonal (Phase 1)
Neoplasms, Neuroepithelial (Early Phase 1)
Neoplasms, Plasma Cell (Phase 2)
Nephrosis, Lipoid (Phase 4)
Nephrotic Syndrome (Phase 4)
Nerve Sheath Neoplasms (Phase 2)
Neuroblastoma (Phase 2)
Neuroectodermal Tumors (Phase 1)
Neuroectodermal Tumors, Primitive (Phase 1)
Neurofibroma (Phase 1)
Neurofibromatoses (Phase 1)
Neutropenia (Phase 2)
Organ Transplantation (Phase 4)
Osteopetrosis (Phase 1/Phase 2)
Osteosarcoma (Phase 1)
Ovarian Neoplasms (Phase 2)
Pancreas Transplantation (Phase 4)
Pancreatic Neoplasms (Phase 1)
Paraproteinemias (Phase 2)
Patient Compliance (Phase 2)
Pediatrics (Phase 2/Phase 3)
Penis (Phase 2/Phase 3)
Peripheral Nerve Injuries (Phase 1/Phase 2)
Pharmacokinetics (Phase 4)
Pigmentation Disorders (Phase 2/Phase 3)
Pityriasis (Phase 4)
Plasma (Phase 3)
Plasmacytoma (Phase 2)
Plasmapheresis (Phase 4)
Polycythemia Vera (Phase 2)
Polymyositis (Phase 2/Phase 3)
Polyomavirus Infections (Phase 4)
Precancerous Conditions (Phase 2)
Primary Immunodeficiency Diseases (Phase 2)
Primary Myelofibrosis (Phase 3)
Prostatic Diseases (Phase 1)
Prostatic Neoplasms (Phase 4)
Psoriasis (Phase 3)
Pulmonary Arterial Hypertension (Phase 2)
Purpura (Phase 4)
Purpura, Thrombocytopenic, Idiopathic (Phase 2)
Recurrence (Phase 1/Phase 2)
Red-Cell Aplasia, Pure (Phase 4)
Renal Dialysis (Phase 4)
Renal Insufficiency (Phase 4)
Renal Insufficiency, Chronic (Phase 4)
Renal Replacement Therapy (Phase 4)
Reperfusion Injury (Phase 4)
Reproductive Health (Phase 3)
Respiratory Syncytial Virus Infections (Phase 1)
Rhabdoid Tumor (Phase 1)
Rhabdomyosarcoma (Phase 2)
Salivary Gland Neoplasms (Phase 1)
Sarcoma (Phase 2)
Sarcoma, Ewing (Phase 2)
Sarcoma, Kaposi (Phase 4)
Sarcoma, Myeloid (Phase 2)
Scleroderma, Systemic (Phase 2)
Sclerosis (Phase 2)
Severe Combined Immunodeficiency (Phase 2)
Sezary Syndrome (Phase 2)
Shwachman-Diamond Syndrome (Phase 2)
Sjogren's Syndrome (Phase 4)
Skin Neoplasms (Phase 4)
Stem Cell Transplantation (Phase 2)
Survival (Phase 3)
Tacrolimus (Phase 4)
Telangiectasia, Hereditary Hemorrhagic (Phase 2)
Testicular Neoplasms (Phase 2)
Thalassemia (Phase 2)
Therapeutic Equivalency (Phase 4)
Thrombocythemia, Essential (Phase 2)
Thrombocytopenia (Phase 2)
Tissue Donors (Phase 2)
Translocation, Genetic (Phase 2)
Transplantation (Phase 4)
Transplantation, Homologous (Phase 1)
Transplantation Immunology (Phase 3)
Tremor (Phase 4)
Tuberous Sclerosis (Phase 1)
Urogenital Neoplasms (Phase 1)
Urological Manifestations (Phase 1)
Urologic Surgical Procedures, Male (Phase 2/Phase 3)
Uterus (Phase 3)
Uveitis (Phase 3)
Vascular Grafting (Phase 2/Phase 3)
Vasculitis (Phase 1)
Virus Diseases (Phase 4)
Vitiligo (Phase 4)
Vulvar Lichen Sclerosus (Phase 2)
Waldenstrom Macroglobulinemia (Phase 2)
Wiskott-Aldrich Syndrome (Phase 2)
Wounds and Injuries (Phase 2/Phase 3)
| Trial | Phase | Start Date | Organizations | Indications |
|---|
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