Prograf
(Tacrolimus)ApprovedSmall molecule
Tacrolimus is used to prevent the body's immune system from rejecting transplanted organs like kidneys, heart, or liver. It's also used to treat severe skin inflammation (eczema) and eye inflammation.[2] Prograf is currently approved and in use across 104 indications[4].[1]
Prograf is one of 1354 small molecule programs targeting Kidney Transplant. It is currently in Approved.
104
Indications
769
Total Trials
17
Active Trials
1,353
Competitors
6
FDA Applications
NDA/BLA/ANDA regulatory filings
10
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 104 indications
Competition
Competitive Landscape
744 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Prograf
VVeloxis Pharmaceuticals
Approved
Lexiscan
AstellasPreclinical
Voltaren
NovartisPreclinical
Zolymbus
AbbViePreclinical
Blenoxane
Bristol-Myers SquibbPreclinical
Methylthioninium Chloride
PProvepharm SAS
Preclinical
MS Contin
HHikma Pharmaceuticals LLC
Preclinical
Duragesic-100
CCephalon
Preclinical
MS Contin
HHikma Pharmaceuticals LLC
Preclinical
Spravato
WWim Janssens
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Kidney Transplant22 trials
Show 19 more trials
Comparison of Tacrolimus Extended-Release (Envarsus XR) to Tacrolimus Immediate-Release in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients
Completed·—·Phase 4·NCT04225988·20 enrolled
Optimization of NULOJIX® Usage Towards Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation
Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT01790594·46 enrolled
A Study to Compare Treatment With Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant
Terminated·—·Phase 3·NCT00005113·102 enrolled
Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00240994·35 enrolled
Liver Transplant17 trials
Show 14 more trials
Immune System Suppression With Alemtuzumab and Tacrolimus in Liver Transplantation Patients
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00105235·27 enrolled
Early Conversion of Prolonged-release Tacrolimus in Liver Transplantation.
Not yet recruiting·—·Phase 4·NCT06147648·352 enrolled
Tacrolimus12 trials
Show 9 more trials
Atopic Dermatitis11 trials
Show 8 more trials
Nephrotic Syndrome6 trials
Show 3 more trials
87 more indications
Graft Versus Host Disease6 trials
Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Blood Stem Cell Transplantation
Completed·—·Phase 2·NCT00146614·105 enrolled
Show 3 more trials
Lupus Nephritis6 trials
Show 3 more trials
Vitiligo6 trials
The Effect of Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or NB-UVB in Stable Generalized Vitiligo
Unknown status·—·Phase 1·NCT03234673·30 enrolled
Show 3 more trials
Hematologic Malignancies5 trials
Reduced Intensity, Partially HLA Mismatched BMT to Treat Hematologic Malignancies
Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1/2·NCT01203722·87 enrolled
Show 2 more trials
Targeted Marrow Irradiation, Fludarabine Phosphate, and Busulfan Before Donor Progenitor Cell Transplant in Treating Patients With Hematologic Malignancies
Completed·—·Phase 1·NCT02129582·14 enrolled
Renal Transplant Recipients4 trials
Bone Marrow Transplantation3 trials
Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor
Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 2·NCT01350245·28 enrolled
A Research Study of Bone Marrow Transplantation From Unrelated or Partially Matched Related Donors
Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 2·NCT01349101·78 enrolled
Stem Cell Transplantation3 trials
Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Un-Related Stem Cell Transplantation
Completed·—·Phase 2·NCT00144677·30 enrolled
Multiple Myeloma3 trials
Renal Transplantation3 trials
Research Study of ATG and Rituximab in Renal Transplantation
Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT01318915·10 enrolled
TACrolimus in Renal Transplantation: Individualization by Pharmacogenetic
Completed·—·Phase 4·NCT00552201·280 enrolled
Stem Cell Transplant3 trials
De Novo Renal Transplantation3 trials
Immunosuppression2 trials
Safety and Efficacy2 trials
Hematological Malignancies2 trials
Bone Marrow Transplant2 trials
Acute Graft Versus Host Disease2 trials
Lung Transplantation2 trials
Psoriasis2 trials
Graft Vs Host Disease2 trials
Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation
Active, not recruiting·UUniversity of Michigan Rogel Cancer Center·Phase 1/2·NCT03842696·43 enrolled
Fasting Conditions2 trials
Bioavailability Study of Tacrolimus Capsules, 5 mg of Dr. Reddy's Under Fasting Conditions
Completed·—·Phase 1·NCT01131988·40 enrolled
Bioavailability Study of Tacrolimus Capsules, 5 mg of Dr. Reddys's Laboratories Limited Under Non-Fasting Conditions
Completed·—·Phase 1·NCT01132027·40 enrolled
Chronic Lymphocytic Leukemia1 trial
Renal Transplant Rejection1 trial
Ulcerative Colitis1 trial
Immunodeficiency1 trial
Hematologic Cancer1 trial
Renal Allograft Recipients1 trial
Recurrent or Refractory1 trial
Graft-versus-host-disease (GVHD)1 trial
Research Study to Determine if an Experimental Agent, LLME Can Decrease the Incidence and Severity of Graft-Versus-Host-Disease (GVHD) Following Blood (Hematopoietic) Stem Cell Transplantation
Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 1/2·NCT00429416·14 enrolled
Interstitial Lung Disease1 trial
Survival1 trial
Strategies to Improve Islet Survival
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00464555·5 enrolled
Immune Thrombocytopenia1 trial
T-cell non-Hodgkin lymphoma1 trial
Islet Transplantation1 trial
Stem Cell1 trial
Membranous Nephropathy1 trial
Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN)
Unknown status·XXinhua Hospital, Shanghai Jiao Tong University School of Medicine·N/A·NCT03549663·108 enrolled
Flushing1 trial
Acute Lymphoblastic Leukemia1 trial
Heart Transplant1 trial
Behcet Disease1 trial
Uses of Tacrolimus in Behcet Disease
Completed·—·N/A·NCT05032248·40 enrolled
Photobiomodulation1 trial
Gut Microbiome1 trial
Clinical Trial1 trial
Keratoconjunctivitis1 trial
Topical Tacrolimus in Vernal Keratoconjunctivitis
Unknown status·TThe Eye Center and The Eye Foundation for Research in Ophthalmology·Phase 4·NCT02456025·20 enrolled
Allergic Contact Dermatitis1 trial
Pancreatitis1 trial
Oral Lichen Planus1 trial
Vulvar Lichen Sclerosus1 trial
Focal Segmental Glomerulosclerosis1 trial
Myasthenia Gravis1 trial
Malignancy1 trial
Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy
Active, not recruiting·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT03674411·22 enrolled
Cutaneous Lupus Erythematosus1 trial
Hereditary Hemorrhagic Telangiectasia1 trial
Hematopoietic Cell Transplantation1 trial
Cardiovascular1 trial
Psoriasis Vulgaris1 trial
Botox Versus Tacrolimus in Psoriasis Vulgaris
Not yet recruiting·—·Phase 4·NCT06203470·60 enrolled
Kidney Cancer1 trial
Malignancies1 trial
Shorter Course Tacro After NMA, Related Donor PBSCT With High-dose Posttransplant Cy for Hard-to-Engraft Malignancies
Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT02556931·117 enrolled
Lymphoma1 trial
Leukemia1 trial
Myelodysplastic Syndrome1 trial
Myositis1 trial
Rheumatoid Arthritis1 trial
Type 1 Diabetes1 trial
Peritransplant Deoxyspergualin in Islet Transplantation in Type 1 Diabetes
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00434850·14 enrolled
Acute Myeloid Leukemia1 trial
Total Body Irradiation1 trial
Severe Aplastic Anemia1 trial
Prevention1 trial
Myelodysplastic Syndromes1 trial
Sickle Cell Disease1 trial
Unspecified3 trials
Regulatory
FDA Approval Timeline[5]
Apr 8, 1994
PROGRAF
NDA NDA050709
Aug 24, 1998
PROGRAF
NDA NDA050708
Dec 8, 2000
PROTOPIC
NDA NDA050777
Jul 19, 2013
ASTAGRAF XL
NDA NDA204096
Jul 10, 2015
ENVARSUS XR
NDA NDA206406
May 24, 2018
PROGRAF
NDA NDA210115
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Prograf drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Tacrolimus. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- FK506-Binding Protein 1a Inhibitor[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- VVeloxis Pharmaceuticals