CLINICAL TRIALS PROFILE FOR TACROLIMUS

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	2008-05-14	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	Completed	Astellas Pharma Canada, Inc.	N/A	2011-06-24	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	Completed	University of British Columbia	N/A	2011-06-24	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.

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	1995-08-01	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	1995-08-01	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.

Clinical Trial Conditions for Tacrolimus

Condition Name

Condition Name for Tacrolimus
Intervention	Trials
Kidney Transplantation	140
Leukemia	93
Lymphoma	80
Myelodysplastic Syndromes	66

Condition MeSH

Condition MeSH for Tacrolimus
Intervention	Trials
Leukemia	202
Myelodysplastic Syndromes	156
Preleukemia	148
Graft vs Host Disease	118

Clinical Trial Locations for Tacrolimus

Trials by Country

Trials by Country for Tacrolimus
Location	Trials
Italy	88
Korea, Republic of	79
United Kingdom	65
Belgium	65
Australia	63

Trials by US State

Trials by US State for Tacrolimus
Location	Trials
California	168
Texas	168
New York	138
Ohio	121
Pennsylvania	114

Clinical Trial Progress for Tacrolimus

Clinical Trial Phase

Clinical Trial Phase for Tacrolimus
Clinical Trial Phase	Trials
Phase 4	351
Phase 3	175
Phase 2/Phase 3	37

Clinical Trial Status

Clinical Trial Status for Tacrolimus
Clinical Trial Phase	Trials
Completed	687
Recruiting	171
Terminated	144

Clinical Trial Sponsors for Tacrolimus

Sponsor Name

Sponsor Name for Tacrolimus
Sponsor	Trials
National Cancer Institute (NCI)	163
Astellas Pharma Inc	114
M.D. Anderson Cancer Center	66

Sponsor Type

Sponsor Type for Tacrolimus
Sponsor	Trials
Other	1445
Industry	611
NIH	247

Tacrolimus: Clinical Trials, Market Analysis, and Projections

Introduction to Tacrolimus

Tacrolimus is a potent immunosuppressive drug widely used to prevent the rejection of transplanted organs, particularly in kidney, liver, and heart transplant patients. Its efficacy and relatively fewer side effects compared to traditional immunosuppressants have made it a cornerstone in transplantation medicine.

Current Clinical Trials and Developments

Tegoprubart and Tacrolimus Comparison

A significant clinical trial currently underway is the Phase 2 BESTOW trial conducted by Eledon Pharmaceuticals. This trial evaluates the safety and efficacy of tegoprubart (AT-1501) compared to tacrolimus in patients undergoing kidney transplantation. The study, which has completed enrollment ahead of schedule, involves 120 participants and aims to assess whether tegoprubart can offer a superior or equivalent immunosuppressive profile to tacrolimus[1][4].

Trial Design and Objectives

The BESTOW trial is a randomized, multicenter, open-label, active control study. Participants receive rabbit antithymocyte globulin (rATG) induction with corticosteroids and mycophenolate as maintenance therapy and are randomized to receive either tegoprubart or tacrolimus. The primary objectives are to evaluate the safety and efficacy of tegoprubart in preventing organ rejection in kidney transplant patients[4].

Market Analysis of Tacrolimus

Current Market Size and Growth

The tacrolimus market has experienced strong growth in recent years, driven by advancements in transplantation medicine, increased organ transplant procedures, and expanded applications in dermatology and autoimmune diseases. As of 2023, the market size was valued at $6.2 billion and is expected to grow to $6.59 billion in 2024 at a compound annual growth rate (CAGR) of 6.3%[3].

Forecasted Growth and Trends

The tacrolimus market is projected to continue its growth trajectory, reaching $8.47 billion by 2028 with a CAGR of 6.5%. Key drivers include expanded therapeutic applications, regulatory approvals for new indications, increased investment in research and development, and growing awareness and acceptance of immunosuppressant therapies. Other trends include the adoption of personalized medicine approaches, advancements in drug delivery systems, and the integration of pharmacogenomics for optimized dosing regimens[3].

Regional and Segment Analysis

The market is segmented by product type (injections, tablets and capsules, others), application, end-use, and region. North America, Europe, and the Asia Pacific are significant regions contributing to the market growth. The increasing availability and accessibility of tacrolimus, along with efforts to simplify transplantation procedures and educate the public on organ donation, have also contributed to the market's favorable growth[5].

Market Projections and Future Outlook

Increasing Demand and Healthcare Infrastructure

The demand for tacrolimus is expected to rise due to the growing number of transplant surgeries and the wider acceptance of transplantation as an effective treatment for various medical conditions. The expanding healthcare infrastructure in emerging markets and the growing emphasis on bioequivalence studies are additional factors driving market growth[5].

Impact of Demographic Changes

The growing geriatric population is another significant factor contributing to the increased demand for tacrolimus. Older adults often require organ transplants or face immune-related disorders, leading healthcare systems to adapt and meet the evolving healthcare needs of this demographic[5].

Advancements in Medical Research and Pharmaceuticals

Continuous advancements in medical research and pharmaceuticals have significantly improved patient outcomes post-transplantation. These developments include more targeted and personalized approaches to immunosuppression, enhanced drug delivery technologies, and the development of novel formulations[3].

Key Takeaways

• Clinical Trials: The BESTOW trial compares tegoprubart with tacrolimus in kidney transplant patients, focusing on safety and efficacy.
• Market Size: The tacrolimus market was valued at $6.2 billion in 2023 and is expected to grow to $8.47 billion by 2028.
• Growth Drivers: Advancements in transplantation medicine, increased organ transplant procedures, and expanded therapeutic applications.
• Regional Growth: Significant contributions from North America, Europe, and the Asia Pacific.
• Future Outlook: Increasing demand due to growing transplant surgeries, expanding healthcare infrastructure, and demographic changes.

FAQs

What is the primary use of tacrolimus in medical treatment?

Tacrolimus is primarily used as an immunosuppressive drug to prevent the rejection of transplanted organs, such as kidneys, livers, and hearts.

What is the current market size of the tacrolimus market?

As of 2023, the tacrolimus market size was valued at $6.2 billion.

What are the key drivers of the tacrolimus market growth?

Key drivers include advancements in transplantation medicine, increased organ transplant procedures, expanded therapeutic applications, and growing awareness and acceptance of immunosuppressant therapies.

What is the projected growth rate of the tacrolimus market?

The market is expected to grow at a CAGR of 6.5% from 2024 to 2028.

How does the growing geriatric population impact the tacrolimus market?

The growing geriatric population increases the demand for tacrolimus as older adults often require organ transplants or face immune-related disorders.

Sources

1. Eledon Pharmaceuticals. Eledon Announces Completion of Enrollment in Phase 2 BESTOW Clinical Trial Assessing Tegoprubart for Prevention of Organ Rejection in Kidney Transplant Patients. Retrieved from https://ir.eledon.com/news-releases/news-release-details/eledon-announces-completion-enrollment-phase-2-bestow-clinical
2. PharmiWeb. Global Tacrolimus Market Business Growth, Development Factors and Growth Analysis 2020-2025. Retrieved from https://www.pharmiweb.com/press-release/2020-09-15/global-tacrolimus-market-business-growth-development-factors-and-growth-analysis-2020-2025
3. The Business Research Company. Tacrolimus Market Share, Future Analysis Report 2024 To 2033. Retrieved from https://www.thebusinessresearchcompany.com/report/tacrolimus-global-market-report
4. ClinicalTrials.gov. Tegoprubart in Patients Undergoing Kidney Transplantation. Retrieved from https://clinicaltrials.ucsf.edu/trial/NCT05983770
5. Polaris Market Research. Tacrolimus Market Size USD 9,683.26 Million By 2032 | CAGR: 4.5%. Retrieved from https://www.polarismarketresearch.com/press-releases/tacrolimus-market