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 115 indications[4].[1]

Prograf is one of 1866 small molecule programs targeting Peripheral Nerve Injury. It is currently in Approved.

115

Indications

764

Total Trials

Active Trials

1,865

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Peripheral Nerve InjuryActive, not recruiting

Systemic Lupus ErythematosusActive, not recruiting

Cirrhosis of LiverActive, not recruiting

Left Ventricular HypertrophyActive, not recruiting

Oral Lichen PlanusActive, not recruiting

Ischemia Reperfusion InjuryActive, not recruiting

Corneal DiseaseActive, not recruiting

Aplastic AnemiaActive, not recruiting

Erectile DysfunctionActive, not recruiting

Liver TransplantActive, not recruiting

Peripheral Nerve InjuryPhase 1/Phase 2

Active, not recruiting

Systemic Lupus ErythematosusApproved

Active, not recruiting

Cirrhosis of LiverPreclinical

Active, not recruiting

Left Ventricular HypertrophyApproved

Active, not recruiting

Oral Lichen PlanusPhase 1

Active, not recruiting

Ischemia Reperfusion InjuryPhase 2/Phase 3

Active, not recruiting

Corneal DiseasePreclinical

Active, not recruiting

Aplastic AnemiaPhase 2

Active, not recruiting

Erectile DysfunctionApproved

Active, not recruiting

Liver TransplantApproved

Active, not recruiting

Showing 10 of 115 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Prograf

VVeloxis Pharmaceuticals

Approved

2 2

Tykerb

GSK

Preclinical

80 3

Avastin

BBio-Thera Solutions

Preclinical

153 4

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 5

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 6

Voltaren

Novartis

Preclinical

1 7

Lupron

EEastern Cooperative Oncology Group

Preclinical

5 8

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 9

Spravato

WWim Janssens

Preclinical

2 10

Chirocaine

PPurdue Pharma LP

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Post-ApprovalRecruiting

Systemic Lupus Erythematosus

NCT05916781

Phase 2Recruiting

Heart Transplantation

NCT04477629

Phase 1Active, not recruiting

Kidney Transplant

NCT03816332

Q4 2026

Post-ApprovalRecruiting

Effectiveness

NCT06701825

Phase 2Not yet recruiting

Transplantation

NCT06084780

Q1 2027

Phase 2Active, not recruiting

Acute Lymphoblastic Leukemia

NCT00792948

Clinical

Trials by Indication[1]

Kidney Transplant23 trials

Prospective Pilot Feasibility Study Comparing Envarsus Once-a-day to Tacrolimus Twice-a-day Immunosuppressive Regimen on Drug Bioavailability in Hispanic First Time Kidney Transplant Recipients

Unknown status·—·Phase 1·NCT03438773·50 enrolled

Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

Completed·EEledon Pharmaceuticals·Phase 2·NCT05983770·127 enrolled

Once-daily Regimen With Envarsus® to Optimize Immunosuppression Management and Outcomes in Kidney Transplant Recipients

Completed·MMedical University of South Carolina·N/A·NCT02954198·40 enrolled

Show 20 more trials

To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients

Completed· Astellas logo

Astellas·Phase 4·NCT02723591·599 enrolled

Pharmacokinetics of Tacrolimus in Kidney Transplant Recipients: Once Daily Versus Twice Daily Dosing

Completed·NNational Center for Research Resources (NCRR)·N/A·NCT00028171

Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT03816332·12 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

Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients

Completed·AAssociação Médico Espírita de Botucatu·Phase 4·NCT02683291·48 enrolled

Comparison of NODAT in Kidney Transplant Patients Receiving Belatacept Versus Standard Immunosuppression

Unknown status·UUniversity of Arizona·Phase 4·NCT01875224·32 enrolled

A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00402168·173 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

Evaluating Safety and Efficacy of TOL101 Induction Versus Anti-Thymocyte Globulin to Prevent Kidney Transplant Rejection

Unknown status·TTolera Therapeutics, Inc·Phase 1/2·NCT01154387·85 enrolled

Comparison of the Two Immunosuppressive Regimens Based on Tacrolimus and Cyclosporine Following Kidney Transplantation

Unknown status·UUniwersytet Mikolaja Kopernika w Toruniu·Phase 4·NCT00204191·300 enrolled

Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation

Completed·—·Phase 4·NCT03511560·50 enrolled

Pre-transplant Assessment of Tacrolimus Blood Level Concentration, as a Predictor of Tacrolimus Dose Requirements After Kidney Transplantation

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT00297310·89 enrolled

12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients

Completed· Novartis logo

Novartis·Phase 3·NCT01843348·612 enrolled

Iguratimod in Kidney Transplant Recipients

Unknown status·TThe First Affiliated Hospital with Nanjing Medical University·N/A·NCT02839941·60 enrolled

A Study to Compare Early Steroid Withdrawal and Long-Term Steroid Maintenance Therapy in Kidney Transplant Patients

Completed· Astellas logo

Astellas·Phase 4·NCT00650468·397 enrolled

Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients

Unknown status·MMaastricht University Medical Center·Phase 1·NCT00987103·18 enrolled

A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant

Completed· Astellas logo

Astellas··NCT02057484·2,300 enrolled

Enteric-coated Mycophenolate Sodium (EC-MPS) With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus in Stable Kidney Transplant Recipients

Completed· Novartis logo

Novartis·Phase 3·NCT00284934·94 enrolled

Combination Drug Therapy Followed by Single Drug Steroid Free Therapy to Prevent Organ Rejection in Kidney Transplantation

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT00076570·31 enrolled

Liver Transplant13 trials

A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year

Completed· Astellas logo

Astellas··NCT02143479·398 enrolled

Reduction in the Risk of Rejection by Mycophenolate Mofetil Dose Adjustment in Liver Transplant Patients With Side Effects Caused by the Calcineurine Inhibitors

Completed·UUniversity Hospital, Limoges·Phase 4·NCT00456235·92 enrolled

A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients

Completed· Astellas logo

Astellas·Phase 2·NCT00282243·70 enrolled

Show 10 more trials

Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant

Completed· Roche logo

Roche·Phase 4·NCT00118742·293 enrolled

A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients

Completed· Astellas logo

Astellas·Phase 2·NCT00282256·19 enrolled

Comparing Efficacy & Safety of Tacrolimus With/Without MMF or Monoclonal Anti-IL2R Antibody in Liver Transplantation.

Completed· Astellas logo

Astellas·Phase 3·NCT00295594·627 enrolled

Belatacept in Liver Transplant Recipients

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00555321·260 enrolled

Randomized Controlled Trial in Liver Transplant Recipients Treated in Steroid Sparing Regimen

Completed·—·Phase 1·NCT00286871·40 enrolled

Everolimus Plus Mycophenolic Acid for Kidney Preservation in Liver Transplant Recipients With Impaired Kidney Function

Terminated·IIndiana University·Phase 3·NCT04258423·4 enrolled

Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT02188719·15 enrolled

Pharmacokinetic of Tacrolimus in Paediatric Liver Transplant Patients

Unknown status·AAssistance Publique - Hôpitaux de Paris·N/A·NCT02337036·80 enrolled

REnal Function in Liver Transplantation: Everolimus With Calcineurin Inhibitor (CNI)-Sparing sTrategy

Completed· Novartis logo

Novartis·Phase 3·NCT02115113·78 enrolled

Everolimus Monotherapy as Immunosuppression After Liver Transplant

Terminated·IIndiana University·Phase 3·NCT04063865·14 enrolled

Stem Cell Transplant12 trials

Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders

Active, not recruiting·—·Phase 2·NCT00544115·260 enrolled

Early Administration of ATG Followed by Cyclophosphamide, Busulfan and Fludarabine Before a Donor Stem Cell Transplant in Patients With Hematological Cancer

Completed·NNorthside Hospital, Inc.·Phase 2·NCT00787761·24 enrolled

Busulfan, Cyclophosphamide, & Antithymocyte Globulin Followed by Stem Cell Transplant in Treating Hematologic Cancer

Completed·UUniversity of Nebraska·Phase 2·NCT00611351·5 enrolled

Show 9 more trials

Intensity Modulated Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients With Relapsed Hematologic Cancers Undergoing a Second Donor Stem Cell Transplant

Recruiting·UUniversity of Chicago·Phase 1·NCT02333162·30 enrolled

Pre-transplant Immunosuppression and Donor Stem Cell Transplant for the Treatment of Severe Hemoglobinopathies

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT04776850

Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00857389·60 enrolled

Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease

No longer available·BBarbara Ann Karmanos Cancer Institute··NCT00423826

Fludarabine Phosphate, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Peripheral Blood Stem Cell Transplant, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Malignancies

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT01056614·23 enrolled

CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant

Active, not recruiting·DDiane George·Phase 1/2·NCT02061800·14 enrolled

Fludarabine and Busulfan Followed by Donor Peripheral Stem Cell Transplant and Antithymocyte Globulin, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Cancer

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00346359·40 enrolled

Clofarabine, Melphalan, and Thiotepa Followed By a Donor Stem Cell Transplant in Treating Patients With High-Risk and/or Advanced Hematologic Cancer or Other Disease

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT00423514·38 enrolled

Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Cancer

Terminated·NNorthside Hospital, Inc.·Phase 2·NCT00818961·36 enrolled

Tacrolimus10 trials

Tacrolimus Toothpaste for Management of Oral Chronic Graft vs. Host Disease (cGVHD)

Completed·—·Phase 1·NCT06638879·7 enrolled

Treatment of Dry Eye Using 0.03% Tacrolimus Eye Drops

Completed·UUniversity of Sao Paulo General Hospital·Phase 4·NCT01850979·24 enrolled

Diabetogenicity of Cyclosporine and Tacrolimus

Completed·UUniversity of Aarhus·Phase 4·NCT00766909·18 enrolled

Show 7 more trials

The New LC-MS/MS Method for Determination of Unbound Tacrolimus in Plasma

Unknown status·NNational Science Centre, Poland··NCT04657562·380 enrolled

Pharmacokinetic Studies of Tacrolimus in Transplant Patients

Completed·UUniversity of Cincinnati·Phase 4·NCT01889758·78 enrolled

Determining Equivalence Dose for Oral Versus Sublingual Administration of Tacrolimus in Hepatic Receptors

Completed·PPontificia Universidad Catolica de Chile·N/A·NCT02608606·20 enrolled

A Study to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus in Healthy Adults

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 1·NCT01038167·20 enrolled

Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys

Completed· Astellas logo

Astellas·Phase 3·NCT00321113·142 enrolled

A Study to Compare How the Body Absorbs and Processes Two Different Formulations of the Anti-rejection Medication Tacrolimus (Advagraf® or Prograf®) in Children Receiving an Organ Transplant, and How Safe and Effective They Are Over a Longer Period of Time

Completed· Astellas logo

Astellas·Phase 2·NCT01614665·44 enrolled

Extended Release Tacrolimus vs. Twice-Daily Tacrolimus

Completed·LLorenzo Gallon·Phase 3·NCT03289650·29 enrolled

Atopic Dermatitis4 trials

Standardized Time- and Score-oriented Treatment of Moderate and Severe Atopic Dermatitis

Completed·TTechnische Universität Dresden·N/A·NCT00148746

An Efficacy and Safety Study of Tacrolimus Ointment in Pediatric Participants With Atopic Dermatitis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT01782729·30 enrolled

An Efficacy and Safety Study of Tacrolimus Ointment in Adult Participants With Atopic Dermatitis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT01828879·74 enrolled

Show 1 more trial

Evaluation to Assess the Long Term Safety of Tacrolimus Ointment for Atopic Dermatitis

Withdrawn·UUniversity of California, Davis·Phase 4·NCT00368719

88 more indications

Interaction4 trials

Drug Interaction Study of Apixaban With Cyclosporine and Tacrolimus

Completed·TThomas Jefferson University·Phase 1·NCT03083782·12 enrolled

Interaction Between Rimonabant and Cyclosporine and Tacrolimus

Completed·UUniversity of Oslo School of Pharmacy·Phase 4·NCT00525681·18 enrolled

Drug-Drug Interaction Study Between EDP-938, Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects

Completed·EEnanta Pharmaceuticals, Inc·Phase 1·NCT04498741·89 enrolled

Show 1 more trial

Identification of Drug-drug Interaction Between Tacrolimus and Mycophenolate Mofetil in Healthy Adults

Completed·SSeoul National University Hospital·Phase 1·NCT02743247·18 enrolled

Renal Transplant Recipients4 trials

Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients

Completed·SSeoul National University Hospital·Phase 2/3·NCT01476488

Validation of Pharmacogenetics Plus Drug Combination Guided Initial Tacrolimus Dosage in Renal Transplant Recipients

Unknown status·SSun Yat-sen University·N/A·NCT01068067·60 enrolled

24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients

Completed· Novartis logo

Novartis·Phase 4·NCT01169701·71 enrolled

Show 1 more trial

Selective CD28 Blockade in Renal Transplant Recipients

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04903054

Acute Lymphoblastic Leukemia4 trials

225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome

Recruiting·—·Phase 1·NCT06287944·15 enrolled

Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation and Donor Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or High-Risk Myelodysplastic Syndrome

Terminated·FFred Hutchinson Cancer Center·Phase 1·NCT00589316·26 enrolled

Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT00792948·97 enrolled

Show 1 more trial

Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome

Recruiting·—·Phase 1·NCT06195891·33 enrolled

Stem Cell Transplantation4 trials

Stem Cell Transplantation in Treating Patients With Hematologic Cancer

Completed·NNorthwestern University·Phase 1·NCT00004904

Mycophenolate Mofetil, Tacrolimus, Daclizumab, and Donor Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

Completed·UUniversity of Maryland, Baltimore·Phase 2·NCT00006350

Venetoclax in Addition to Sequential Conditioning With Fludarabine / Amsacrine / Ara-C (FLAMSA) + Treosulfan for Allogeneic Blood Stem Cell Transplantation in Patients With MDS, CMML or sAML

Recruiting·HHeinrich-Heine University, Duesseldorf·Phase 1/2·NCT05807932·38 enrolled

Show 1 more trial

Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation

Completed·—·Phase 2·NCT03680092·43 enrolled

Hematologic Malignancies4 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

Reduced Intensity Chemotherapy and Radiation Therapy Before Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 2·NCT02566304·35 enrolled

Single or Double Donor Umbilical Cord Blood Transplant in Treating Patients With High-Risk Hematologic Malignancies

Withdrawn·UUniversity of Medicine and Dentistry of New Jersey·Phase 2·NCT01652014

Show 1 more trial

Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in With High-Risk Hematologic Malignancies

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 2·NCT01760655·62 enrolled

Acute Graft Versus Host Disease4 trials

A Study Using Tacrolimus, Sirolimus and Bortezomib as Acute Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation

Completed·—·Phase 1·NCT00670423·27 enrolled

Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft Versus Host Disease (GVHD) Following Myeloablative Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-005)

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT04095858·11 enrolled

Safety & Efficacy of Atorvastatin for Prophylaxis of Acute Graft Versus Host Disease in Patients With Hematological Malignancies HLA- Donor Hematopoietic Stem Cell Transplantation

Completed·OOhio State University Comprehensive Cancer Center·Phase 2·NCT01491958·40 enrolled

Show 1 more trial

Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00105001·210 enrolled

Lupus Nephritis4 trials

A Study to Evaluate the Safety and Efficacy of Tacrolimus for Lupus Nephritis Under Actual Use Situations

Completed· Astellas logo

Astellas··NCT01410747·1,484 enrolled

A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis

Unknown status·SSeoul National University Hospital·Phase 2·NCT00569101·9 enrolled

Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis

Completed·TThe University of Hong Kong·Phase 3·NCT02630628·130 enrolled

Show 1 more trial

Comparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis

Completed·TTuen Mun Hospital·Phase 4·NCT00371319·150 enrolled

Graft Versus Host Disease4 trials

Calcineurin Inhibitor-Free Interventions BMT CTN 1301 for Prevention of Graft-versus-Host Disease (BMT CTN 1301)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT02345850·346 enrolled

Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer

Completed·—·Phase 2·NCT00589563·32 enrolled

Axatilimab Plus Standard of Care Therapy for the Prevention of Graft Versus Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Hematologic Cancer, ABRAXAS Trial

Not yet recruiting·MMayo Clinic·Phase 2·NCT07349771·72 enrolled

Show 1 more trial

Itacitinib for the Prevention of Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplantation

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT04127721

Nephrotic Syndrome3 trials

Population Pharmacokinetics of Tacrolimus in Nephrotic Syndrome

Unknown status·TThe Third Xiangya Hospital of Central South University··NCT04045171·200 enrolled

A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome

Completed· Astellas logo

Astellas·Phase 4·NCT01763580·144 enrolled

Study of Tacrolimus vs Mycophenolate Mofetil in Pediatric Patients With Nephrotic Syndrome

Completed·TThe Children's Hospital of Zhejiang University School of Medicine·Phase 4·NCT04048161·270 enrolled

Transplantation3 trials

Mismatched Transplantation Using High-dose Post-transplant Cyclophosphamide

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01010217·176 enrolled

Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)

Not yet recruiting·—·Phase 2·NCT06084780·20 enrolled

Human Penile Tissue Allotransplantation for Devastating Penile and Concomitant Genital Trauma

Withdrawn·WWake Forest University Health Sciences·Phase 1·NCT03240822

Lymphoma3 trials

Reduced Intensity Conditioning Before Partially Matched Donor Stem Cell Transplant in Treating Patients With Advanced Cutaneous T Cell Lymphoma

Withdrawn·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 1·NCT02548468

S0501 Fludarabine, Melphalan, and Donor Stem Cell Transplant Followed By Tacrolimus and Methotrexate in Treating Patients for Relapsed Lymphoma

Terminated·SSWOG Cancer Research Network·Phase 2·NCT00121186·1 enrolled

Tacrolimus/Sirolimus/Methotrexate vs Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil for GVHD Prophylaxis After Reduced Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoma

Completed·—·Phase 3·NCT00928018·139 enrolled

Chronic Graft Versus Host Disease3 trials

Hydroxychloroquine in Treating Patients With Newly Diagnosed Chronic Graft-Versus-Host Disease

Completed·CChildren's Oncology Group·Phase 3·NCT00031824·82 enrolled

Ixazomib in the Prophylaxis of Chronic Graft-versus-host Disease.

Active, not recruiting·FFundación Pública Andaluza para la gestión de la Investigación en Sevilla·Phase 1/2·NCT03225417·142 enrolled

Rapamycin for Prevention of Chronic Graft-Versus-Host Disease

Terminated·YYale University·Phase 1/2·NCT00623012·2 enrolled

Renal Transplant3 trials

A Study of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®)

Completed· Astellas logo

Astellas··NCT02147938·578 enrolled

Polymorphism of the Cytochrome P450-system in Renal Transplants

Completed·UUniversity Hospital Schleswig-Holstein··NCT00223054·200 enrolled

Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients

Completed·NNational Taiwan University Hospital·Phase 4·NCT02077556·14 enrolled

Peripheral Blood Stem Cell Transplantation2 trials

Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis in Myeloablative Allogeneic Peripheral Blood Stem Cell Transplantation

Recruiting·HHannah Choe, MD·Phase 2·NCT07249346·124 enrolled

Tacrolimus and Sirolimus as Prophylaxis After Allogenic Non-myeloablative Peripheral Blood Stem Cell Transplantation

Completed·—·Phase 2·NCT00282282·31 enrolled

Thalassemia2 trials

Hematopoietic Stem Cell Transplantation for Patients With Thalassemia Major: A Multicenter, Prospective Clinical Study

Completed·FFirst Affiliated Hospital of Guangxi Medical University·Phase 4·NCT04009525·823 enrolled

Efficacy of Basiliximab in the Prevention of Acute Graft-versus-host Disease in Unrelated Allogeneic Hematopoietic Stem Cell Transplantation Therapy for Thalassemia Major

Completed·ZZhongming Zhang·Phase 4·NCT02342145·205 enrolled

Bone Marrow Transplantation2 trials

Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00003572·20 enrolled

Treatment of Bone Marrow to Prevent Graft-Versus-Host Disease in Patients With Acute or Chronic Leukemia Undergoing Bone Marrow Transplantation

Completed·UUnknown Sponsor·Phase 2/3·NCT00004255

Kidney Cancer2 trials

Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00027573·36 enrolled

Donor Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Relapsed or Refractory Metastatic Kidney Cancer

Completed·UUniversity of Rochester·Phase 2·NCT00262886·35 enrolled

Renal Allograft Recipients2 trials

Study Comparing Standard Dose and Reduced Dose Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients

Completed· Pfizer logo

Pfizer·Phase 2·NCT00518271·120 enrolled

Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

Completed· Pfizer logo

Pfizer·Phase 4·NCT00261820·160 enrolled

Malignancies2 trials

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

Fludarabine and Intermediate-dose TBI Followed by PTCy in Patients Undergoing Allo Transplant for Heme Malignancies

Recruiting·HHackensack Meridian Health·Phase 2·NCT07214688·209 enrolled

Delayed Graft Function2 trials

Calcineurin Inhibitor in NEuRoloGically Deceased Donors to Decrease Kidney delaYed Graft Function (CINERGY)

Active, not recruiting·UUniversité de Sherbrooke·Phase 2·NCT05148715·414 enrolled

Envarsus in Delayed Graft Function (E-DGF)

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT03864926·100 enrolled

Myelofibrosis2 trials

Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary Myelofibrosis

Recruiting·FFred Hutchinson Cancer Center·Phase 2·NCT04370301·20 enrolled

Combination Chemotherapy, Total Body Irradiation, and Donor Blood Stem Cell Transplant in Treating Patients With Secondary Myelofibrosis

Active, not recruiting·—·Phase 1·NCT03118492·22 enrolled

Bone Marrow Transplant2 trials

Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00134004·210 enrolled

Bone Marrow Transplant Plus Cyclophosphamide and Total-Body Irradiation in Treating Patients With Hematologic Cancer

Completed·TTemple University·Phase 2·NCT00002809·10 enrolled

Myelodysplastic Syndrome2 trials

Alloreactive NK Cells for Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT00402558·15 enrolled

Cyclophosphamide and Busulfan Followed by Donor Stem Cell Transplant in Treating Patients With Myelofibrosis, Acute Myeloid Leukemia, or Myelodysplastic Syndrome

Completed·FFred Hutchinson Cancer Center·N/A·NCT00445744·52 enrolled

Hemoglobinopathies2 trials

Allo HSCT for High Risk Hemoglobinopathies

Recruiting·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT06872333·62 enrolled

HSCT For Patients With High Risk Hemoglobinopathies Using Reduced Intensity

Completed·NNorthwell Health·Phase 1/2·NCT02435901·29 enrolled

Systemic Lupus Erythematosus2 trials

Effectiveness of Mycophenolate Mofetil Combined With Tacrolimus for Steroid Tapering in Systemic Lupus Erythematosus

Recruiting·CChinese SLE Treatment And Research Group·Phase 4·NCT05916781·220 enrolled

Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis

Completed·—·Phase 4·NCT00125307·20 enrolled

Immunosuppression2 trials

Renal Allograft Function and Histology Following Switching From A Tacrolimus to Sirolimus (SRL)-Based Immunosuppression-

Terminated·TThe Cleveland Clinic·Phase 3·NCT01166724·12 enrolled

Thymoglobulin Induction Therapy With Minimal Immunosuppression and Evaluation of Allograft Status

Terminated·WWeill Medical College of Cornell University·Phase 4·NCT00731874·34 enrolled

Hematopoietic Stem Cell Transplant2 trials

A Study of Tacrolimus/Methotrexate and Tocilizumab to Prevent Acute Graft-Versus-Host Disease (AGVD) After Allogeneic Hematopoietic Stem Cell Transplant

Completed·—·Phase 2·NCT02206035·45 enrolled

Standard of Care vs. Bortezomib in Graft-Versus Host Disease After Hematopoietic Stem Cell Transplant

Completed·—·Phase 2·NCT01754389·138 enrolled

Treatment2 trials

Prognostic Model of TAC in the Treatment of MN

Unknown status·QQianfoshan Hospital··NCT05667922·50 enrolled

Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

Completed· Astellas logo

Astellas·Phase 4·NCT00885820·240 enrolled

Acute Myeloid Leukemia2 trials

Total Marrow and Lymphoid Irradiation Before Donor Transplant and Cyclophosphamide in Treating Patients With Acute Myeloid Leukemia

Suspended·—·Phase 1·NCT03467386·56 enrolled

Allogeneic Hematopoietic Stem Cell Transplantation (AlloSCT) Initial Salvage Therapy for Induction Failure Acute Myeloid Leukemia (AML)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02441803·11 enrolled

Effectiveness1 trial

Effectiveness and Cost-effectiveness of a Pre-emptive Genotyping Strategy in Patients Receiving Tacrolimus

Recruiting·IInstituto de Investigación Hospital Universitario La Paz·Phase 4·NCT06701825·114 enrolled

AIN1 trial

Autologous Transplant Targeted Against Crohn's

Withdrawn·NNorthwestern University·Phase 2·NCT04154735

Heart Transplantation1 trial

Belatacept in De Novo Heart Transplantation

Recruiting·NNYU Langone Health·Phase 2·NCT04477629·12 enrolled

Allogeneic Hematopoietic Cell Transplant1 trial

NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders

Completed·RRoswell Park Cancer Institute·Phase 2·NCT00053989·41 enrolled

Breast Cancer1 trial

Topical Tacrolimus for Breast Cancer-related Lymphedema

Enrolling by invitation·OOdense University Hospital·Phase 2/3·NCT06306274·80 enrolled

Monoclonal1 trial

Sequential Therapy (FK506 + Monoclonal Anti-IL2R Antibodies + MMF) Versus FK506 With Steroids in Liver TX

Completed· Astellas logo

Astellas·Phase 2·NCT00693524·94 enrolled

Combination Therapy1 trial

Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UC

Terminated·MMedical College of Wisconsin·Phase 3·NCT02954159·4 enrolled

Immune Suppression1 trial

A Phase I/II GVHD Prevention Trial Combining Pacritinib With Sirolimus-Based Immune Suppression

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1/2·NCT02891603·40 enrolled

Hepatitis B1 trial

Viral Immunity in Solid Organ Transplant Recipients: Monitoring Of The Response To Hepatitis B Booster Vaccination

Unknown status·UUniversity Hospital, Grenoble··NCT06307808·66 enrolled

Medication1 trial

Study to Evaluate the Amount of Medications That May be Removed From the Body During Plasmapheresis

Withdrawn·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University··NCT00203281

Sickle Cell Disease1 trial

Abatacept for GVHD Prophylaxis After Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease

Completed·MMonica Bhatia·Phase 1·NCT02867800·24 enrolled

Survival1 trial

Strategies to Improve Islet Survival

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00464555·5 enrolled

Amyotrophic Lateral Sclerosis1 trial

Immunosuppression in Amyotrophic Lateral Sclerosis (ALS)

Completed·EEmory University·Phase 2·NCT01884571·31 enrolled

Rheumatoid Arthritis1 trial

The Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months and Long-term Treatment

Completed·QQiang Shu·Phase 4·NCT02837978·150 enrolled

Asthma1 trial

Dose Response of Inhaled Tacrolimus in Patients With Moderate Persistent Asthma

Completed· Astellas logo

Astellas·Phase 2·NCT00189787·370 enrolled

Thrombocytopenia1 trial

Tacrolimus for Thrombocytopenia in SS

Unknown status·PPeking Union Medical College Hospital·Phase 2/3·NCT05678335·54 enrolled

Leukemia1 trial

Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT03856216·15 enrolled

Mesenchymal Stem Cells1 trial

Cord Blood Expansion on Mesenchymal Stem Cells

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT00498316·98 enrolled

Left Ventricular Hypertrophy1 trial

Everolimus and Tacrolimus Combination for Regression of Left Ventricular Hypertrophy in Renal Transplants

Completed·EEdoardo Melilli·Phase 4·NCT03415750·20 enrolled

Multiple Myeloma1 trial

Reduce Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed Multiple Myeloma

Terminated·SSrinivas Devarakonda·Phase 2·NCT04205240·1 enrolled

Cognitive Function1 trial

Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Calcineurin Inhibitors (CNIs) to Everolimus

Completed·UUniversity of Kansas Medical Center··NCT03413722·30 enrolled

Vasculitis1 trial

Hematopoietic Stem Cell Support in Vasculitis

Terminated·NNorthwestern University·Phase 1·NCT00278512·7 enrolled

Renal Transplantation1 trial

TACrolimus in Renal Transplantation: Individualization by Pharmacogenetic

Completed·—·Phase 4·NCT00552201·280 enrolled

Nephropathy1 trial

Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy

Completed·UUniversity of Oxford·Phase 2/3·NCT01120028·852 enrolled

aGVHD Prophylaxis1 trial

ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis

Recruiting·LLeland Metheny·Phase 2·NCT06680661·20 enrolled

Hematological Malignancies1 trial

2-Step Approach to Stem Cell Transplant in Treating Participants With Hematological Malignancies

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 2·NCT03712878·10 enrolled

Hematopoietic Cell Transplantation1 trial

Sirolimus, Tacrolimus, Thymoglobulin and Rituximab as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Haploidentical and HLA Partially Matched Donor Hematopoietic Cell Transplantation

Terminated·BBarbara Ann Karmanos Cancer Institute·Phase 2·NCT01116232·4 enrolled

Myositis1 trial

Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus

Completed·TTokyo Medical and Dental University·Phase 2/3·NCT00504348·25 enrolled

Efficacy1 trial

Efficacy Study of FK-506 and Cyclosporine in Vernal Keratoconjunctivits (VKC)

Completed·SSiriraj Hospital·Phase 2/3·NCT01068054·24 enrolled

Myeloproliferative Disorder1 trial

Combination Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorders

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00002792·20 enrolled

Membranous Nephropathy1 trial

A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)

Recruiting· Biogen logo

Biogen·Phase 3·NCT06962800·180 enrolled

Function1 trial

Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function

Completed·PPoitiers University Hospital·Phase 3·NCT02334488·329 enrolled

Minimal Change Disease1 trial

Tacrolimus Versus Prednisolone for the Treatment of Minimal Change Disease

Completed·IImperial College Healthcare NHS Trust·Phase 4·NCT00982072·52 enrolled

Lymphoid Malignancies1 trial

Bortezomib and Chemotherapy in Treating Participants With Lymphoid Malignancies Undergoing Stem Cell Transplant

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00439556·40 enrolled

Acute Leukemia1 trial

Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous or Acute Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT00002831·24 enrolled

Hermansky-Pudlak syndrome1 trial

Medical Treatment of Colitis in Patients With Hermansky-Pudlak Syndrome

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00514982

Hematological Diseases1 trial

Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases

Completed·WWake Forest University Health Sciences·Phase 2·NCT02248597·27 enrolled

Bone Marrow Failure1 trial

Regenerative Medicine to Restore Hematopoiesis and Immune Function in Immunodeficiencies and Inherited Bone Marrow Failures

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT04232085·27 enrolled

Transplant Recipient1 trial

Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients

Completed·NNewark Beth Israel Medical Center·Phase 4·NCT00299221·150 enrolled

Methylprednisolone1 trial

Campath-1H + FK506 and Methylprednisolone for GVHD

Completed·—·Phase 2·NCT00109993·34 enrolled

Concentration1 trial

To Validate an Analytical Method to Measure Concentration of Tacrolimus in Blood Taken From Finger Pricks

Terminated· Astellas logo

Astellas··NCT02377609·108 enrolled

Insulin Secretion1 trial

Insulin Secretion and Advagraf

Completed·UUniversity of Oslo School of Pharmacy·Phase 4·NCT01092806·20 enrolled

Toxicity1 trial

Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients

Terminated·EEmory University·Phase 2·NCT02877082·5 enrolled

Withdrawal1 trial

Belatacept Early Steroid Withdrawal Trial

Completed·UUniversity of Cincinnati·Phase 4·NCT01729494·316 enrolled

Chronic Hepatitis1 trial

A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver Transplantation

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01938625·35 enrolled

Aplastic Anemia1 trial

Optimizing Haploidentical Aplastic Anemia Transplantation (BMT CTN 1502)

Completed·MMedical College of Wisconsin·Phase 2·NCT02918292·32 enrolled

Seborrheic Dermatitis1 trial

Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis

Completed·PPusan National University Hospital·Phase 4·NCT01591070·104 enrolled

Hepatitis C1 trial

Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus

Terminated· Novartis logo

Novartis·Phase 4·NCT00260208·361 enrolled

Clinical Trial1 trial

Clinical Trial of 0.0003% Calcitriol, 0.1% Tacrolimus, and Petrolatum for the Treatment of Pityriasis Alba

Completed·UUniversidad Autonoma de San Luis Potosí·Phase 4·NCT01388517·39 enrolled

Phase 21 trial

Open-Label Phase 2 Trial of a Steroid-Free, CNI-Free, Belatacept-Based Immunosuppressive Regimen

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT01856257·71 enrolled

B-cell NHL1 trial

A Phase II Study of Allo-HCT for B-Cell NHL Using Zevalin, Fludarabine and Melphalan

Completed·—·Phase 2·NCT00577278·41 enrolled

Allogeneic Stem Cell Transplantation1 trial

Sirolimus, Tacrolimus and Short Course Methotrexate for Prevention of Acute GVHD in Recipients of Mismatched Unrelated Donor Allogeneic Stem Cell Transplantation

Completed·YYale University·Phase 1·NCT00612274·26 enrolled

Juvenile Myelomonocytic Leukemia1 trial

Busulfan, Cyclophosphamide, and Melphalan or Busulfan and Fludarabine Phosphate Before Donor Hematopoietic Cell Transplant in Treating Younger Patients With Juvenile Myelomonocytic Leukemia

Completed·CChildren's Oncology Group·Phase 2·NCT01824693·30 enrolled

Drug Interactions1 trial

Investigation of Potential Drug-drug Interactions Between Faldaprevir and the Immunosuppressant Drugs Cyclosporine or Tacrolimus

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02016625·32 enrolled

Ischemia Reperfusion Injury1 trial

TOP-Study (Tacrolimus Organ Perfusion): Treatment of Ischemia Reperfusion Injury in Marginal Organs With an ex Vivo Tacrolimus Perfusion

Terminated·LLudwig-Maximilians - University of Munich·Phase 2/3·NCT01564095·25 enrolled

Suicide1 trial

Donor Lymphocyte Infusion (DLI) of T-cells Genetically Modified With iCasp9 Suicide Gene

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT01875237·3 enrolled

Type 1 Diabetes1 trial

Islet Transplantation in Type 1 Diabetes

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00434811·48 enrolled

CML1 trial

Imatinib Mesylate, Busulfan, Fludarabine, and Antithymocyte Globulin for CML Patients

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT00499889·42 enrolled

Unspecified1 trial

Prograf-Advagraf Cross Over Conversion Study

Completed·UUniversity Health Network, Toronto·Phase 3·NCT01797341·13 enrolled

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]
ClinicalTrials.gov — 764 trial records for Tacrolimus. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Prograf drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Tacrolimus compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Tacrolimus. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA210115). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Prograf. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Veloxis Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

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

Patent Landscape[6]

Patent Cliff

May 30, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12403095May 30, 2028

11419823May 30, 2028

9549918May 30, 2028

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