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Last Updated: December 6, 2019

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CLINICAL TRIALS PROFILE FOR TACROLIMUS

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505(b)(2) Clinical Trials for Tacrolimus

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00374803 Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal Completed Novartis Phase 4 2006-04-01 To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.
New Formulation NCT00374803 Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal Completed University of Cincinnati Phase 4 2006-04-01 To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.
New Formulation NCT00717470 A Study in Kidney Transplant Subjects to Investigate the Optimal Suppression of Immunity to Help Prevent Kidney Rejection Completed Astellas Pharma Inc Phase 4 2008-05-01 To compare how well the new formulation of Tacrolimus® used once daily, in combination with other drugs helps prevent the rejection of a new kidney after transplantation compared to the twice daily dose of Tacrolimus
New Combination NCT01265537 A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf Recruiting Astellas Pharma Canada, Inc. N/A 2012-03-01 While the incidence of acute rejection and early graft loss have improved dramatically with the advent of newer immunosuppressant medications, improvements in long-term patient and allograft survival after kidney transplantation have not been achieved. The specific drug combination that provides the best outcomes with the least amount of side effects is not known. Each kidney transplant center uses the combination of drugs that they believe is optimal. This study is about identifying whether drugs that are currently approved for use in kidney transplantation can be used in a new combination safely and with potentially fewer side effects than the drug combinations that are currently used at St. Paul's Hospital and other transplant centres.
New Combination NCT01265537 A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf Recruiting University of British Columbia N/A 2012-03-01 While the incidence of acute rejection and early graft loss have improved dramatically with the advent of newer immunosuppressant medications, improvements in long-term patient and allograft survival after kidney transplantation have not been achieved. The specific drug combination that provides the best outcomes with the least amount of side effects is not known. Each kidney transplant center uses the combination of drugs that they believe is optimal. This study is about identifying whether drugs that are currently approved for use in kidney transplantation can be used in a new combination safely and with potentially fewer side effects than the drug combinations that are currently used at St. Paul's Hospital and other transplant centres.
New Combination NCT01643668 Busulfan/Clofarabine + Allogeneic Stem Cell Transplantation Completed Massachusetts General Hospital Phase 2 2012-07-01 This research is a phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational intervention to learn whether it works in treating a specific cancer. "Investigational" means that the study intervention is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not yet approved this study intervention for your type of cancer. All participants on this study are treated in an identical manner. The investigators are doing this study because there continues to be a significant risk of relapse of disease after reduced intensity transplantation. In studies which have compared transplants using high-doses of chemotherapy and/or radiation versus reduced intensity transplants, patients undergoing reduced intensity transplants appear to have higher rates of relapse, but lower rates of toxicity and complication. This study attempts to utilize clofarabine, a newer chemotherapy agent shown to be quite active in AML, ALL, and MDS, to increase the anti-tumor effects of the conditioning regimen without accumulating unacceptable toxicity. The reduced intensity allogeneic stem cell transplantation procedure involves giving you chemotherapy in relatively less intense doses to suppress your immune system. This is followed by an infusion of healthy blood stem cells from a matched related donor or a matched unrelated volunteer donor. It is hoped that these donor cells can eventually then attack any cancer cells which remain. In this research study, the investigators are looking to see how well this new combination of busulfan and clofarabine works in reduced intensity allogeneic stem cell transplantation. By "works" the investigators mean to analyze safety, ability of donor cells to engraft (take hold), as well as measures of complications including toxicity, infections, graft-vs-host disease (GVHD), and relapse.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Tacrolimus

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002792 Combination Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorders Completed National Cancer Institute (NCI) Phase 2 1996-06-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bone marrow or peripheral stem cell transplantation with chemotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus either bone marrow or peripheral stem cell transplantation in treating patients with myeloproliferative disorders.
NCT00002792 Combination Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorders Completed Fred Hutchinson Cancer Research Center Phase 2 1996-06-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bone marrow or peripheral stem cell transplantation with chemotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus either bone marrow or peripheral stem cell transplantation in treating patients with myeloproliferative disorders.
NCT00002809 Bone Marrow Transplant Plus Cyclophosphamide and Total-Body Irradiation in Treating Patients With Hematologic Cancer Completed Temple University Phase 2 1996-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy and radiation therapy together with bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bone marrow transplant from an unrelated donor together with cyclophosphamide and total-body irradiation works in treating patients with hematologic cancer.
NCT00002831 Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous or Acute Leukemia Completed National Cancer Institute (NCI) Phase 1/Phase 2 1994-07-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of high-dose chemotherapy plus peripheral stem cell transplantation in treating patients with chronic myelogenous or acute leukemia.
NCT00002831 Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous or Acute Leukemia Completed M.D. Anderson Cancer Center Phase 1/Phase 2 1994-07-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of high-dose chemotherapy plus peripheral stem cell transplantation in treating patients with chronic myelogenous or acute leukemia.
NCT00003572 Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers Completed National Cancer Institute (NCI) Phase 2 1998-08-01 RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Bone marrow transplantation may be able to replace immune cells that have been destroyed by radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Mycophenolate mofetil and tacrolimus may be an effective treatment for graft-versus-host disease caused by bone marrow transplantation. PURPOSE: Phase II trial to study the effectiveness of total-body irradiation, tacrolimus, and mycophenolate mofetil plus bone marrow transplantation in treating patients with hematologic cancers.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tacrolimus

Condition Name

Condition Name for Tacrolimus
Intervention Trials
Kidney Transplantation 122
Leukemia 88
Lymphoma 73
Myelodysplastic Syndromes 57
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Condition MeSH

Condition MeSH for Tacrolimus
Intervention Trials
Leukemia 164
Myelodysplastic Syndromes 121
Preleukemia 120
Graft vs Host Disease 100
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Clinical Trial Locations for Tacrolimus

Trials by Country

Trials by Country for Tacrolimus
Location Trials
Canada 160
France 111
Spain 106
Germany 96
Italy 79
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Trials by US State

Trials by US State for Tacrolimus
Location Trials
Texas 142
California 127
Ohio 98
New York 98
Florida 86
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Clinical Trial Progress for Tacrolimus

Clinical Trial Phase

Clinical Trial Phase for Tacrolimus
Clinical Trial Phase Trials
Phase 4 299
Phase 3 142
Phase 2/Phase 3 29
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Clinical Trial Status

Clinical Trial Status for Tacrolimus
Clinical Trial Phase Trials
Completed 452
Recruiting 211
Terminated 92
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Clinical Trial Sponsors for Tacrolimus

Sponsor Name

Sponsor Name for Tacrolimus
Sponsor Trials
National Cancer Institute (NCI) 127
Astellas Pharma Inc 104
M.D. Anderson Cancer Center 63
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Sponsor Type

Sponsor Type for Tacrolimus
Sponsor Trials
Other 1067
Industry 489
NIH 184
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