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 93 indications[4].[1]

Prograf is one of 1271 small molecule programs targeting Acute Myeloid Leukemia. It is currently in Approved.

Indications

773

Total Trials

Active Trials

1,270

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Acute Myeloid LeukemiaCompleted

Severe Aplastic AnemiaCompleted

Renal TransplantationCompleted

MalignanciesCompleted

Allogeneic Hematopoietic Stem Cell TransplantationNot yet recruiting

Chronic Graft Versus Host DiseaseCompleted

Hematopoietic and Lymphoid Cell NeoplasmActive, not recruiting

Allogeneic Stem Cell TransplantationRecruiting

Renal Transplant RecipientsCompleted

Kidney TransplantCompleted

Acute Myeloid LeukemiaPhase 3

Completed

Severe Aplastic AnemiaPhase 2

Completed

Renal TransplantationApproved

Completed

MalignanciesPhase 2

Completed

Allogeneic Hematopoietic Stem Cell TransplantationPhase 2

Not yet recruiting

Chronic Graft Versus Host DiseasePhase 2

Completed

Hematopoietic and Lymphoid Cell NeoplasmPhase 2

Active, not recruiting

Allogeneic Stem Cell TransplantationPhase 2

Recruiting

Renal Transplant RecipientsApproved

Completed

Kidney TransplantApproved

Completed

Showing 10 of 93 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Prograf

VVeloxis Pharmaceuticals

Approved

2 2

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 3

Tianeptine

Pfizer

Preclinical

1 4

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

1 5

Naltrexone/bupropion

Novo Nordisk

Preclinical

1 6

Sertraline ODT

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 7

Perflutren Lipid Microsphere

IImaRx Therapeutics

Preclinical

1 8

QBX258

Novartis

Preclinical

1 9

Ibrance

Pfizer

Preclinical

1 10

Fluorothymidine F-18

MM.D. Anderson Cancer Center

Preclinical

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

Timeline

Expected Milestones

Q4 2028

Phase 1Recruiting

Stem Cell Transplant

NCT02333162

Phase 2Recruiting

Bone Marrow Failure

NCT04232085

Q1 2032

Phase 2Recruiting

Malignancies

NCT07214688

Q2 2036

Phase 2Recruiting

Severe Aplastic Anemia

NCT06412497

Clinical

Trials by Indication[1]

Kidney Transplant27 trials

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

Trial to Evaluate Safety and Tolerability of Tacrolimus Extended-Release (Astagraf XL) in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients

Completed·—·Phase 4·NCT03194321·20 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 24 more 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 Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation After Kidney Transplant

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00790439

Mycophenolate Mofetil (MMF) Discontinuation From a Tacrolimus/MMF/Steroid Triple Regimen After Kidney Transplantation

Completed· Astellas logo

Astellas·Phase 3·NCT00693381·152 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

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

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

Anti-Viral Effects of Voclosporin in COVID-19 Positive Kidney Transplant Recipients

Completed·LLeiden University Medical Center·Phase 2·NCT04701528·20 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

A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01820572·446 enrolled

Efficacy and Safety of Induction Strategies Combined With Low Tacrolimus Exposure in Kidney Transplant Recipients Receiving Everolimus or Sodium Mycophenolate

Completed·HHospital do Rim e Hipertensão·Phase 4·NCT01354301·300 enrolled

Induction Therapy Study in Live Donor Kidney Transplant Recipients With a Positive Crossmatch

Completed·JJohns Hopkins University·Phase 3·NCT00275509·56 enrolled

The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients

Completed·MMayo Clinic·Phase 4·NCT00275535·165 enrolled

Efficacy of Achieving Early Target Trough Levels of Tacrolimus Using CYP3A5 Guided Dosing Versus Weight-based Dosing in a Multi-ethnic Population of Kidney Transplant Recipients in Singapore

Completed·SSingapore General Hospital·N/A·NCT04825262·74 enrolled

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

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

Validation of Population Pharmacokinetic Model Derived From Healthy Volunteer in Kidney Transplant Recipients

Unknown status·SSeoul National University Hospital··NCT02808065·40 enrolled

Global, Multicentre, Non Interventional Advagraf Conversion Registry in Kidney Transplant Patients

Completed· Astellas logo

Astellas··NCT02555787·4,430 enrolled

Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient

Completed· Pfizer logo

Pfizer·Phase 2·NCT00263328·46 enrolled

MicroRNA Expression in Everolimus-based Versus Tacrolimus-based Regimens in Kidney Transplantation

Unknown status·—·N/A·NCT02091973·50 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

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

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

Iguratimod in Kidney Transplant Recipients

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

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

Completed· Novartis logo

Novartis·Phase 3·NCT01843348·612 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

Liver Transplant14 trials

Everolimus Monotherapy as Immunosuppression After Liver Transplant

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

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

Completed· Novartis logo

Novartis·Phase 3·NCT02115113·78 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

Show 11 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

Belatacept in Liver Transplant Recipients

Terminated· Bristol-Myers Squibb logo

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

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

Safety and Efficacy of Basiliximab, Delayed Dose Tacrolimus Plus ECMPA (Enteric Coated Mycophenolic Acid) Following Liver Transplantation

Completed·UUniversity of California, Los Angeles·Phase 4·NCT02123108·59 enrolled

Evaluation of the Impact of Tacrolimus-based Immunosuppression on Heidelberg Liver Transplant Cohort (HDTACRO): Study Protocol for an Investigator Initiated, Non-interventional Prospective Study

Unknown status·UUniversity Hospital Heidelberg··NCT04444817·100 enrolled

Sirolimus-based Immunosuppression Treatment Regimen for Liver Transplantation

Unknown status·SSouthern Medical University, China·Phase 2/3·NCT03500848·130 enrolled

Steroid Free Immunosuppression in Liver Transplantation

Completed·TThomas Jefferson University·Phase 4·NCT00296244·40 enrolled

Prospective Tacrolimus Pharmacokinetics Study in Pediatric Living Donor Liver Transplantation

Unknown status·CCliniques universitaires Saint-Luc- Université Catholique de Louvain·Phase 4·NCT02064777·60 enrolled

A Study of Thymoglobulin and Tacrolimus in Liver Transplant

Unknown status·UUniversity of Nebraska·Phase 4·NCT00564538·100 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

Stem Cell Transplant13 trials

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

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

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

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

Busulfan and Fludarabine Before Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer

Withdrawn·UUniversity of California, San Francisco·Phase 2·NCT00301912

Show 10 more trials

Cyclophosphamide and/or Mycophenolate Mofetil With or Without Tacrolimus in Treating Patients Who Are Undergoing a Donor Bone Marrow or Peripheral Stem Cell Transplant for Hematologic Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT00255710·60 enrolled

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

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

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

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

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

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

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

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

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

Total-Body Irradiation and Cyclophosphamide in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer and Other Diseases

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00317785·50 enrolled

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

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

Tacrolimus11 trials

Treatment of Dry Eye Using 0.03% Tacrolimus Eye Drops

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

Extended Release Tacrolimus vs. Twice-Daily Tacrolimus

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

Show 8 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

Therapeutic Effect of Tacrolimus in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome

Completed·SSeoul National University Hospital·Phase 2/3·NCT01084980·20 enrolled

Pharmacokinetics of Tacrolimus in Children

Completed·SShandong University·Phase 4·NCT03347357·28 enrolled

Ocular Penetration of Topical Tacrolimus Eye Drops

Unknown status·TThe Eye Center and The Eye Foundation for Research in Ophthalmology·N/A·NCT02794610·10 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

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

Graft Versus Host Disease6 trials

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

TAC/MTX vs. TAC/MMF/PTCY for Prevention of Graft-versus-Host Disease and Microbiome and Immune Reconstitution Study (BMT CTN 1703/1801)

Completed·MMedical College of Wisconsin·Phase 3·NCT03959241·431 enrolled

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

Show 3 more trials

Tacrolimus and Mycophenolate Mofetil in Preventing Graft-Versus-Host Disease in Patients Who Have Undergone Total-Body Irradiation With or Without Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant for Hematologic Cancer

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00089011·150 enrolled

Bortezomib Plus Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease (GVHD) After Mismatched Allogeneic Non-Myeloablative Blood Stem Cell Transplantation

Completed·—·Phase 1/2·NCT00369226·45 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

86 more indications

Interaction6 trials

Drug Interaction Study of Apixaban With Cyclosporine and Tacrolimus

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

Drug-Drug Interaction (DDI) Study of ALXN2050 in Healthy Adult Participants

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT05202145·61 enrolled

Drug Interaction Between Colchicine and Calcineurin Inhibitors in Renal Graft Recipients

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 1·NCT01160276·17 enrolled

Show 3 more trials

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

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 Recipients5 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

A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With Basiliximab, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients

Completed· Novartis logo

Novartis·Phase 4·NCT00369161·228 enrolled

Show 2 more trials

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

Selective CD28 Blockade in Renal Transplant Recipients

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

Stem Cell Transplantation4 trials

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

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

Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Related Stem Cell Transplantation

Completed·—·Phase 2·NCT00144703·55 enrolled

Stem Cell Transplantation in Treating Patients With Hematologic Cancer

Completed·NNorthwestern University·Phase 1·NCT00004904

Show 1 more trial

Stem Cell Transplantation in Patients With High-Risk and Recurrent Pediatric Sarcomas

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00043979·60 enrolled

Atopic Dermatitis4 trials

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

Completed·TTechnische Universität Dresden·N/A·NCT00148746

Tacrolimus Versus Hydrocortisone in Atopic Dermatitis

Completed·—·Phase 4·NCT05324618·200 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

Lupus Nephritis4 trials

Tacrolimus Versus Cyclophosphamide as Treatment for Lupus Nephritis

Completed·ZZhejiang University·Phase 1·NCT01207297·40 enrolled

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

Multicenter Registry of Pediatric Lupus Nephritis in China

Unknown status·XXiqiang Dang··NCT03791827·1,200 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

Bone Marrow Transplantation4 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

Bone Marrow Transplantation vs Standard of Care in Patients With Severe Sickle Cell Disease (BMT CTN 1503)

Completed·MMedical College of Wisconsin·Phase 2·NCT02766465·138 enrolled

Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Advanced Hematologic Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00014469

Show 1 more trial

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

Hematologic Malignancies4 trials

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

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 2·NCT01341301·25 enrolled

Myeloablative Haploidentical BMT With Post-transplant Cyclophosphamide for Pediatric Patients With Hematologic Malignancies

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT02120157·35 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

Show 1 more trial

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

Chronic Graft Versus Host Disease3 trials

Rapamycin for Prevention of Chronic Graft-Versus-Host Disease

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

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

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

Renal Allograft Recipients3 trials

Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

Completed· Pfizer logo

Pfizer·Phase 4·NCT00261820·160 enrolled

Evaluate Efficacy Study of Combination Therapy of Everolimus and Low Dose Tacrolimus in Renal Allograft Recipients

Unknown status·SSeoul St. Mary's Hospital·Phase 4·NCT02036554·234 enrolled

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

Completed· Pfizer logo

Pfizer·Phase 2·NCT00518271·120 enrolled

Acute Graft Versus Host Disease3 trials

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

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

Transplantation3 trials

Completed·MMassachusetts General Hospital·Phase 2·NCT00133367·32 enrolled

Allogeneic Transplantation Using Timed Sequential Busulfan and Fludarabine Conditioning

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01572662·201 enrolled

Maraviroc-Based GVHD Prophylaxis in HLA-Unrelated and HLA-Mismatched Related Transplantation

Unknown status·—·Phase 2·NCT02799888·40 enrolled

Rheumatoid Arthritis2 trials

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

Special Drug Use-Results Survey of Prograf Capsule in Rheumatoid Arthritis Patients

Completed· Astellas logo

Astellas··NCT01870908·664 enrolled

Myelodysplastic Syndrome2 trials

Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01168219·68 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

Kidney Cancer2 trials

Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Recurrent Kidney Cancer

Withdrawn·FFox Chase Cancer Center·Phase 2·NCT00025519

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

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

Cognitive Function2 trials

Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Immediate Release Tacrolimus to Slow Release Envarsus

Completed·UUniversity of Kansas Medical Center··NCT03703154·30 enrolled

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

Allogeneic Hematopoietic Stem Cell Transplantation2 trials

Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed or Refractory High-Risk NBL.

Withdrawn·NNationwide Children's Hospital·Phase 2·NCT00874315

A Multi-Institutional Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Malignant Neuro-Epithelial and Other Solid Tumors

Terminated·MMontefiore Medical Center·Phase 1·NCT02653196·1 enrolled

Concentration2 trials

A Study to Compare the Finger Prick Whole Blood MITRA Assay Method With the Established Venepuncture Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients

Completed· Astellas logo

Astellas·Phase 4·NCT03465969·80 enrolled

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

Terminated· Astellas logo

Astellas··NCT02377609·108 enrolled

Hematopoietic Stem Cell Transplant2 trials

Tacrolimus in Allogeneic Hematopoietic Stem Cell Transplant (HCT)

Completed·UUNC Lineberger Comprehensive Cancer Center··NCT04645667·38 enrolled

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

Lymphoid Malignancies2 trials

CMC-544 and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT01664910·27 enrolled

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

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

Renal Transplant2 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

Insulin Secretion1 trial

Insulin Secretion and Advagraf

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

Lymphoma1 trial

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

De Novo Renal Transplantation1 trial

A Dose Escalation Study in de Novo Renal Transplantation

Completed·IITB-Med LLC·Phase 2·NCT04311632·13 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

AIN1 trial

Autologous Transplant Targeted Against Crohn's

Withdrawn·NNorthwestern University·Phase 2·NCT04154735

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

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

Nephrotic Syndrome1 trial

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

Brain Cancer1 trial

Chemotherapy and Donor Stem Transplant for the Treatment of Patients With High Grade Brain Cancer

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT04521946

Membranous Nephropathy1 trial

Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy

Completed·NNanjing University School of Medicine·N/A·NCT00302523·16 enrolled

Combination Therapy1 trial

Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UC

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

Efficacy and Safety1 trial

A Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus

Unknown status·HHospital de Clinicas de Porto Alegre·Phase 4·NCT01608412·120 enrolled

Methotrexate1 trial

Phase I/II Study of Pentostatin Combined With Tacrolimus and Mini-Methotrexate for GVHD Prevention After MUD BMT

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT00506922·150 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

Thrombocytopenia1 trial

Tacrolimus for Thrombocytopenia in SS

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

Idiopathic Membranous Glomerulonephritis1 trial

Mycophenolate Mofetil and Tacrolimus Versus Tacrolimus for the Treatment of Idiopathic Membranous Glomerulonephritis

Completed·IImperial College Healthcare NHS Trust·Phase 4·NCT00843856·40 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

Acute Lymphoblastic Leukemia1 trial

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

Hematopoietic Cell Transplantation1 trial

Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation

Completed·SStanford University·Phase 2·NCT03734601·22 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

Mantle Cell Lymphoma1 trial

Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00006747·4 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

Chronic Hepatitis1 trial

Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection

Completed·—·Phase 4·NCT00163657·312 enrolled

Hematologic Cancer1 trial

Low-Dose Fludarabine, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer

Completed·UUniversity of California, San Francisco·Phase 1·NCT00301951·7 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

Pilot Study1 trial

A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf

Completed·UUniversity of British Columbia·N/A·NCT01265537·30 enrolled

Irritation1 trial

Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Skin Irritation

Unknown status·OOdense University Hospital·Phase 4·NCT00779792·36 enrolled

Asthma1 trial

Inhaled Tacrolimus, Add-on to Inhaled Corticosteroids & Long Acting B2 Agonists in Moderate to Severe Persistent Asthma

Completed· Astellas logo

Astellas·Phase 2·NCT00189722·160 enrolled

Multiple Myeloma1 trial

Melphalan and Busulfan Followed By Donor Peripheral Stem Cell Transplant, Tacrolimus, and Methotrexate in Treating Patients With Multiple Myeloma

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00313625·20 enrolled

Prevention1 trial

Aerosol Cyclosporine for Prevention of Lung Rejection

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00268515

Graft Rejection1 trial

Effectiveness and Safety of Campath in Combination With Tacrolimus Monotherapy to Prevent Kidney Graft Rejection

Completed·—·Phase 3·NCT00147381·197 enrolled

COVID-191 trial

Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With COVID-19 Lung Injury

Unknown status·HHospital Universitari de Bellvitge·Phase 3·NCT04341038·84 enrolled

Systemic Sclerosis1 trial

Low-Dose Conditioning Followed by Donor Stem Cell Transplant in Treating Patients With Severe Systemic Sclerosis

Withdrawn·FFred Hutchinson Cancer Research Center/University of Washington Cancer Consortium·Phase 2·NCT01047072

Nephropathy1 trial

Using mTOR Inhibitors in the Prevention of BK Nephropathy

Completed·—·N/A·NCT01649609·40 enrolled

Crohn's Disease1 trial

Topical Tacrolimus 0.1% Ointment For Treatment Of Cutaneous Crohn's Disease

Completed·UUniversity of Aberdeen·Phase 2·NCT01233570·20 enrolled

Trial1 trial

Advagraf/Prograf Conversion Trial

Completed·NNorman Muirhead·Phase 4·NCT01410162·53 enrolled

Acute Myeloid Leukemia1 trial

Peginterferon Alfa-2a to Enhance Anti-leukemic Responses After Allogeneic Transplantation in Acute Myeloid Leukemia

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 1/2·NCT02328755·37 enrolled

Type 1 Diabetes1 trial

Islet Transplantation for Type 1 Diabetes

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00014911·36 enrolled

Allogeneic Stem Cell Transplantation1 trial

Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT)

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT01518153·16 enrolled

Myelofibrosis1 trial

Ruxolitinib Phosphate and Chemotherapy Given Before and After Reduced Intensity Donor Stem Cell Transplant in Treating Patients With Myelofibrosis

Completed·—·Phase 1·NCT02917096·18 enrolled

Induction Therapy1 trial

A Study To Compare Sirolimus Versus Tacrolimus In De Novo Simultaneous Pancreas- Kidney Allograft Recipients Receiving An Induction Therapy With Antithymocyte Globulin Plus Mycophenolate Mofetil Plus Corticosteroids

Unknown status·NNantes University Hospital·Phase 4·NCT00693446·118 enrolled

Peripheral Nerve Injury1 trial

Enhancement of Functional Recovery After Peripheral Nerve Injury With Tacrolimus

Withdrawn·WWashington University School of Medicine·Phase 1/2·NCT00950391

Cardiac Transplant1 trial

The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients

Enrolling by invitation·—·Phase 2·NCT03292861·60 enrolled

Myeloid Leukemia1 trial

Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia

Withdrawn·JJonsson Comprehensive Cancer Center·Phase 2·NCT00004878

Severe Aplastic Anemia1 trial

MT2023-20: Hematopoietic Cell Transplant With Reduced Intensity Conditioning and Post-transplant Cyclophosphamide for Severe Aplastic Anemia and Other Forms of Acquired Bone Marrow Failure.

Recruiting·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT06412497·60 enrolled

Aplastic Anemia1 trial

Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer, Metastatic Kidney Cancer, or Aplastic Anemia

Unknown status·UUniversity of California, San Francisco·N/A·NCT00295997·35 enrolled

Drug Monitoring1 trial

Therapeutic Drug Monitoring of Tacrolimus Biliary Concentrations for Liver-transplanted Patients (STABILE)

Completed·RRennes University Hospital··NCT02820259·42 enrolled

Systemic Lupus Erythematosus1 trial

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

Function1 trial

Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function

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

Thalassemia1 trial

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

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

Malignancies1 trial

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

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

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

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 Transplant1 trial

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

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

Peripheral Blood Stem Cell Transplantation1 trial

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

Completed·—·Phase 2·NCT00282282·31 enrolled

Treatment1 trial

Prognostic Model of TAC in the Treatment of MN

Unknown status·QQianfoshan Hospital··NCT05667922·50 enrolled

Hemoglobinopathies1 trial

HSCT For Patients With High Risk Hemoglobinopathies Using Reduced Intensity

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

Unspecified1 trial

Protocol Calcineurin Inhibitor (CNI) Weaning

Terminated·NNantes University Hospital·Phase 3·NCT01292525·16 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 8, 1994

PROGRAF

NDA NDA050709

Apr 8, 1994

PROGRAF

NDA NDA050708

Apr 8, 1994

PROGRAF

NDA NDA050709

Jun 22, 1995

PROGRAF

NDA NDA050709

Jun 22, 1995

PROGRAF

NDA NDA050708

Jun 22, 1995

PROGRAF

NDA NDA050708

Jun 22, 1995

PROGRAF

NDA NDA050708

Apr 25, 1996

PROGRAF

NDA NDA050709

Apr 25, 1996

PROGRAF

NDA NDA050708

Apr 22, 1997

PROGRAF

NDA NDA050708

Apr 22, 1997

PROGRAF

NDA NDA050709

Apr 22, 1997

PROGRAF

NDA NDA050709

Apr 22, 1997

PROGRAF

NDA NDA050708

Apr 20, 1998

PROGRAF

NDA NDA050709

Apr 20, 1998

PROGRAF

NDA NDA050708

Aug 24, 1998

PROGRAF

NDA NDA050708

Aug 24, 1998

PROGRAF

NDA NDA050708

Aug 24, 1998

PROGRAF

NDA NDA050708

Dec 1, 2000

PROGRAF

NDA NDA050709

Dec 1, 2000

PROGRAF

NDA NDA050708

Dec 8, 2000

PROTOPIC

NDA NDA050777

May 8, 2001

PROGRAF

NDA NDA050708

Jul 25, 2001

PROGRAF

NDA NDA050708

Jul 25, 2001

PROGRAF

NDA NDA050708

Jul 25, 2001

PROGRAF

NDA NDA050709

Oct 24, 2002

PROGRAF

NDA NDA050708

Jun 16, 2004

PROGRAF

NDA NDA050709

Jun 16, 2004

PROGRAF

NDA NDA050708

Dec 13, 2005

PROGRAF

NDA NDA050709

Dec 13, 2005

PROGRAF

NDA NDA050708

Mar 29, 2006

PROGRAF

NDA NDA050708

Mar 29, 2006

PROGRAF

NDA NDA050709

Apr 27, 2006

PROGRAF

NDA NDA050708

Apr 27, 2006

PROGRAF

NDA NDA050709

Feb 13, 2009

PROGRAF

NDA NDA050709

Feb 13, 2009

PROGRAF

NDA NDA050708

May 19, 2009

PROGRAF

NDA NDA050708

May 19, 2009

PROGRAF

NDA NDA050709

Jul 14, 2011

PROGRAF

NDA NDA050708

Jul 14, 2011

PROGRAF

NDA NDA050709

Jul 14, 2011

PROGRAF

NDA NDA050709

Jul 14, 2011

PROGRAF

NDA NDA050708

Feb 6, 2012

PROGRAF

NDA NDA050709

Feb 6, 2012

PROGRAF

NDA NDA050708

Jul 5, 2012

PROGRAF

NDA NDA050709

Jul 5, 2012

PROGRAF

NDA NDA050708

Aug 14, 2012

PROGRAF

NDA NDA050709

Aug 14, 2012

PROGRAF

NDA NDA050708

Jan 28, 2013

PROGRAF

NDA NDA050708

Jul 19, 2013

ASTAGRAF XL

NDA NDA204096

Aug 16, 2013

PROGRAF

NDA NDA050709

Sep 4, 2013

PROGRAF

NDA NDA050708

Sep 4, 2013

PROGRAF

NDA NDA050709

Mar 19, 2014

PROGRAF

NDA NDA050708

May 19, 2015

PROGRAF

NDA NDA050708

May 19, 2015

PROGRAF

NDA NDA050709

Jul 1, 2015

PROGRAF

NDA NDA050709

Jul 10, 2015

ENVARSUS XR

NDA NDA206406

May 24, 2018

PROGRAF

NDA NDA050708

May 24, 2018

PROGRAF

NDA NDA050709

May 24, 2018

PROGRAF

NDA NDA210115

Dec 2, 2018

PROGRAF

NDA NDA210115

Dec 2, 2018

PROGRAF

NDA NDA050708

Dec 2, 2018

PROGRAF

NDA NDA050709

Jun 11, 2019

PROGRAF

NDA NDA050709

Jun 11, 2019

PROGRAF

NDA NDA210115

Jun 11, 2019

PROGRAF

NDA NDA050708

Dec 30, 2020

PROGRAF

NDA NDA050708

Dec 30, 2020

PROGRAF

NDA NDA210115

Dec 30, 2020

PROGRAF

NDA NDA050709

Jul 16, 2021

PROGRAF

NDA NDA210115

Jul 16, 2021

PROGRAF

NDA NDA050709

Jul 16, 2021

PROGRAF

NDA NDA050708

Nov 22, 2022

PROGRAF

NDA NDA050708

Nov 22, 2022

PROGRAF

NDA NDA210115

Nov 22, 2022

PROGRAF

NDA NDA050709

Sep 14, 2023

PROGRAF

NDA NDA050708

Sep 14, 2023

PROGRAF

NDA NDA210115

Sources

References

[1]
ClinicalTrials.gov — 773 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 NDA050708). 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

11123331May 30, 2028

11110081May 30, 2028

5 more patents

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