Tacrolimus clinical trials
Also written Prograf, FK506, Advagraf and Fujimycin.
How each study uses Tacrolimus is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
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Approvals
The first approval found in each region, with its record
- United States
- 8 Apr 1994 · PROGRAF · NDA 050708 (FDA, Drugs@FDA)
- European Union
- 27 Feb 2002 · Protopic · EMEA/H/C/000374 (EMA)
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
588 studies that test it; most in 2004 (35)
| Year | Studies |
|---|---|
| 1998 | 2 |
| 1999 | 4 |
| 2000 | 8 |
| 2001 | 7 |
| 2002 | 23 |
| 2003 | 22 |
| 2004 | 35 |
| 2005 | 25 |
| 2006 | 29 |
| 2007 | 25 |
| 2008 | 31 |
| 2009 | 23 |
| 2010 | 32 |
| 2011 | 32 |
| 2012 | 24 |
| 2013 | 25 |
| 2014 | 20 |
| 2015 | 28 |
| 2016 | 23 |
| 2017 | 26 |
| 2018 | 24 |
| 2019 | 23 |
| 2020 | 23 |
| 2021 | 9 |
| 2022 | 14 |
| 2023 | 11 |
| 2024 | 13 |
| 2025 | 11 |
| 2026 | 16 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 175 · Other 425
Astellas Pharma Inc (83) · Fred Hutchinson Cancer Center (18) · Veloxis Pharmaceuticals (11) · National Institute of Allergy and Infectious Diseases (NIAID) (10) · M.D. Anderson Cancer Center (10) · Astellas Pharma Korea, Inc. (10) · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (9) · National Cancer Institute (NCI) (8)
Often tested with
Tested in the same studies.
Mycophenolic Acid (114) · Fludarabine (74) · Cyclophosphamide (73) · Sirolimus (52) · Methotrexate (42) · Cyclosporine (38) · Fludarabine phosphate (36) · Busulfan (30)
Related medicines
As reviewed, each with the page that says it.
- One of Calcineurin inhibitors source
- One of Immunosuppressive Agents source
- One of Calcineurin Inhibitor source
Coming up
From the study records. Dates are the sponsors’ own estimates and often move.
Tested against it · 9 phase 3 studies under way
Tacrolimus is the comparator. A study of two new drugs counts under both.
- 2Crisaborole · Cairo University · next primary completion Nov 2026
- 1Obinutuzumab · Hoffmann-La Roche
- 1Zanubrutinib · BeOne Medicines · next primary completion Oct 2027
- 1Tegoprubart · Eledon Pharmaceuticals · next primary completion Mar 2029
- 1Povetacicept · Vertex Pharmaceuticals Incorporated · next primary completion Dec 2028
- 1Frexalimab · Sanofi · next primary completion Aug 2029
- 1Inebilizumab · Amgen · next primary completion Sep 2031
Reaching primary completion within a year · 25, 3 in phase 3
Studies that test Tacrolimus, phase 3 first.
- Dec 2026Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP PancreatitisPhase 3 · Johns Hopkins University
- Jan 2027Crisaborole 2% Versus Tacrolimus 0.1% in Children With Mild to Moderate Atopic DermatitisPhase 3 · Shalamar Institute of Health Sciences
- Mar 2027Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic ProfilePhase 2/3 · Roberto Gedaly
- Nov 2026Early Human Leukocyte Antigen (HLA) Matched Sibling Hematopoietic Stem Cell TransplantationPhase 2 · Emory University
- Nov 2026A Randomized Controlled Trial Comparing the Effectiveness and Safety of Topical Tacrolimus 0.03% Versus Crisaborole 2% in Patients With Mild to Moderate Atopic Dermatitis Over 8 WeeksNot applicable · Foundation University Islamabad
- Dec 2026Tacrolimus Ophthalmic Solution for the Treatment of Non-infectious Anterior UveitisPhase 2 · Novaliq GmbH
- Dec 2026Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney TransplantsPhase 4 · Roy D. Bloom, MD
- Dec 2026Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis CongenitaPhase 2 · Boston Children's Hospital
- Dec 2026BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI)Phase 2 · University of Illinois at Chicago
- Dec 2026Use of Tacrolimus and MTOR Inhibitors With Anticipatory Therapy vs. Tacrolimus and Mycophenolic Acid With Universal Prophylaxis in Renal Recipients at High Risk of Posttransplant Cytomegalovirus.Phase 4 · Hospital Universitario La Paz
Studies
Open first, then newest update. How each study uses Tacrolimus is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 600
- Stem Cell Transplantation for Participants With Germline RUNX1 Associated Blood CancersNot yet recruitingPhase 2National Cancer Institute (NCI)NCT07524530Written as Tacrolimus
- Tacrolimus as Prophylaxis of Post-ERCP PancreatitisRecruitingPhase 4Amsterdam UMC, location VUmcNCT07781722Written as Tacrolimus
- Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versus-Host Disease After Donor Reduced-Intensity Hematopoietic Cell TransplantRecruitingPhase 1City of Hope Medical CenterNCT06996119Written as Tacrolimus
- Efficacy of Fractional Co2 Laser With Topical Tacrolimus 0.1 in the Treatment of Nail PsoriasisNot yet recruitingNot applicableCairo UniversityNCT07919873Written as Topical tacrolimus 0.1% ointment
- CIRTEN-Simultaneous Pancreas-Kidney Transplant RecipientsRecruitingPhase 2/3University of Wisconsin, MadisonNCT03769298Written as Envarsus XR
- Advancing Transplantation Outcomes in ChildrenRecruitingPhase 2National Institute of Allergy and Infectious Diseases (NIAID)NCT06055608Written as Tacrolimus (Group1)
- Allogeneic Hematopoietic Stem Cell Transplant for GATA2 MutationsRecruitingPhase 2National Cancer Institute (NCI)NCT01861106Written as Tacrolimus
- Ruxolitinib With Tacrolimus and Methotrexate for the Prevention of Graft Versus Host Disease in Pediatric and Young Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic SyndromeRecruitingPhase 2City of Hope Medical CenterNCT06128070Written as Tacrolimus
- Early Use of Tacrolimus in HLA-Mismatched Haploidentical Allogeneic Hematopoietic Transplantation With Post-Transplant CyclophosphamideRecruitingPhase 2Northside Hospital, Inc.NCT06828796Written as Tacrolimus
- Automated Total Marrow and Lymphoid Irradiation for Allogeneic Hematopoietic Cell TransplantNot yet recruitingPhase 2Stanford UniversityNCT07634536Written as Tacrolimus
- Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)Not yet recruitingPhase 2Case Comprehensive Cancer CenterNCT06084780Written as Tacrolimus
- 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 TransplantationRecruitingPhase 2Hannah Choe, MDNCT07249346Written as Tacrolimus
- TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCTRecruitingPhase 1Stanford UniversityNCT07302776Written as Tacrolimus
- Uterus Transplantation to Treat InfertilityRecruitingPhase 2/3Johns Hopkins UniversityNCT05646992Written as Tacrolimus
- Human Penile AllotransplantationRecruitingPhase 2/3Johns Hopkins UniversityNCT02395497Written as Tacrolimus
- Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder ArthroplastyRecruitingPhase 2NYU Langone HealthNCT07138898Written as Tacrolimus
- Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation After Reduced Intensity ConditioningRecruitingPhase 2City of Hope Medical CenterNCT06815003Written as Tacrolimus
- Allo HSCT for High Risk HemoglobinopathiesRecruitingPhase 2Masonic Cancer Center, University of MinnesotaNCT06872333Written as Tacrolimus
- Utilization of a Microdevice for Psoriasis and Atopic DermatitisNot yet recruitingPhase 4University of California, San FranciscoNCT07352566Written as Tacrolimus
- Tacrolimus Minimization in Kidney Transplant Recipients Selected According to the AGORA Algorithm for Their Low Immunological Risk and Medium-term Graft FailureRecruitingPhase 3Nantes University HospitalNCT06235892Written as TACROLIMUS
See all 600 studies that test Tacrolimus →
Given beside what is tested · 262 — Tacrolimus is usual care or a partner of the new treatment
- A Multicenter Phase 1 Study of Orca-Q in Primary Progressive Multiple SclerosisNot yet recruitingPhase 1Orca Biosystems, Inc.NCT06900192Written as Tacrolimus
- Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of ImmunityRecruitingPhase 2National Cancer Institute (NCI)NCT04339777Written as Tacrolimus (Tacro)
- A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)RecruitingPhase 3BiogenNCT06962800Written as Tacrolimus
- Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant RecipientsNot yet recruitingEarly Phase 1Virginia Commonwealth UniversityNCT07806136Written as Tacrolimus (Kidney transplant maintenance immunosuppression)
- Expanding Liver Transplant Immunosuppression Minimization Via EverolimusRecruitingPhase 2National Institute of Allergy and Infectious Diseases (NIAID)NCT06280950Written as Tacrolimus (continued reduction)
- 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 SyndromeRecruitingPhase 1City of Hope Medical CenterNCT06287944Written as Tacrolimus
- A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)RecruitingPhase 3Incyte CorporationNCT06615050Written as Tacrolimus (Tac)
- Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)RecruitingPhase 2Fred Hutchinson Cancer CenterNCT03970096Written as Tacrolimus
- Ruxolitinib Before, During and After Hematopoietic Cell Transplant in Older Patients With Myelofibrosis and Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap SyndromesRecruitingPhase 2Fred Hutchinson Cancer CenterNCT07228624Written as Tacrolimus
- A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplant for Subjects With VEXAS (Vacuoles, E1 Enzyme, X-linked, Autoinflammatory, Somatic) SyndromeRecruitingPhase 2National Cancer Institute (NCI)NCT05027945Written as Tacrolimus
- Belatacept in Heart TransplantationRecruitingPhase 2National Institute of Allergy and Infectious Diseases (NIAID)NCT06478017Written as Tacrolimus
- Total Marrow and Lymphoid Irradiation in Combination With Fludarabine and Melphalan as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplant in Older Patients With Refractory and Relapsed Acute Myeloid Leukemia and High-risk Myelodysplastic SyndromeRecruitingPhase 2City of Hope Medical CenterNCT07582172Written as Tacrolimus
- Ruxolitinib With Azacitidine Maintenance for the Treatment of Patients With Acute Myeloid Leukemia Undergoing Reduced Intensity Allogeneic Stem Cell TransplantationRecruitingPhase 1OHSU Knight Cancer InstituteNCT07548983Written as Tacrolimus
- High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With SplenomegalyRecruitingPhase 2M.D. Anderson Cancer CenterNCT06345495Written as Tacrolimus
- 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 sAMLRecruitingPhase 1/2Heinrich-Heine University, DuesseldorfNCT05807932Written as Tacrolimus
- CSF-1R Inhibitor, Axatilimab, for Prevention of Acute and Chronic GVHD After HLA-Matched Related and Unrelated Donor Allogeneic Stem Cell TransplantationNot yet recruitingPhase 2Medical College of WisconsinNCT07808112Written as Tacrolimus
- A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular DegenerationRecruitingPhase 1Astellas Institute for Regenerative MedicineNCT03178149Written as tacrolimus
- A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive MedicationsRecruitingPhase 3Bristol-Myers SquibbNCT04877288Written as Tacrolimus
- Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary MyelofibrosisRecruitingPhase 2Fred Hutchinson Cancer CenterNCT04370301Written as Tacrolimus
- CC-101 (f/k/a NR1) Neural Stem Cell Transplantation for Adults With Chronic Ischemic StrokeNot yet recruitingPhase 2Clarion Cells, Inc.NCT07709845Written as Tacrolimus
Showing 20 of 262.
As the comparator · 77 — what is tested is compared with Tacrolimus
- Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)RecruitingPhase 2/3Vertex Pharmaceuticals IncorporatedNCT07204275Written as Tacrolimus
- Evaluation of Crisaborole 2% Versus Tacrolimus 0.1% Each Combined With Excimer Light in the Treatment of Stable Non-segmental Facial Vitiligo: a Prospective Randomized Controlled Study.RecruitingPhase 3Cairo UniversityNCT07904910Written as tacrolimus 0.1%
- Efficacy of Crisaborole 2% Ointment Versus Tacrolimus 0.1% Ointment in the Treatment of Intertriginous and/or Anogenital Psoriasis.Not yet recruitingPhase 3Cairo UniversityNCT07892339Written as tacrolimus ointment 0.1%
- A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney TransplantationRecruitingPhase 2/3SanofiNCT07412470Written as Tacrolimus
- A Phase 3 Study of Inebilizumab in Participants With Primary Membranous NephropathyRecruitingPhase 3AmgenNCT07851220Written as Tacrolimus
- Study of Tegoprubart Efficacy and Safety Compared With Tacrolimus in Kidney TransplantationNot yet recruitingPhase 3Eledon PharmaceuticalsNCT07835581Written as Tacrolimus
- Extended-Release Tacrolimus Following Liver TransplantationRecruitingPhase 4University of AlbertaNCT05242315Written as Prograf (SOC)
- VEL-101 to Prevent Rejection After Kidney TransplantationRecruitingPhase 2Veloxis PharmaceuticalsNCT07290777Written as Tacrolimus (TAC)
- Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant RecipientsEnrolling by invitationPhase 2Eledon PharmaceuticalsNCT06126380Written as Tacrolimus
- Evaluation of the Efficacy of 0.08% Tacrolimus Nanoencapsulated Aqueous Solution Spray Vs. 0.1% Free Tacrolimus Commercial Ointment in the Treatment of Oral Lichen PlanusRecruitingPhase 1/2Hospital de Clinicas de Porto AlegreNCT06591884Written as tacrolimus ointment 0.1%
- A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous NephropathyActive, not recruitingPhase 3Hoffmann-La RocheNCT04629248Written as Tacrolimus
- Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal TransplantationTerminatedPhase 2National Institute of Allergy and Infectious Diseases (NIAID)NCT01436305Written as Short-term Tac
- A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous NephropathyActive, not recruitingPhase 2/3BeOne MedicinesNCT05707377Written as Tacrolimus
- Belatacept Early Steroid Withdrawal TrialCompletedPhase 4University of CincinnatiNCT01729494Written as Tacrolimus
- Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney TransplantationCompletedPhase 2Eledon PharmaceuticalsNCT05983770Written as Tacrolimus
- A Study of TCD601 in de Novo Renal Transplant RecipientsCompletedPhase 2ITB-Med LLCNCT05669001Written as TAC
- Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant RecipientsCompletedPhase 2Novartis PharmaceuticalsNCT03663335Written as Tacrolimus
- TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant RecipientsCompletedPhase 3Hospices Civils de LyonNCT00133887Written as tacrolimus
- Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell TransplantationCompletedPhase 2Dimitrios Tzachanis, MD PhDNCT03680092Written as Tacrolimus
- Rituximab and Targeted Nursing for Pediatric Nephrotic SyndromeCompletedNot applicableWuhan Children's HospitalNCT07049172Written as Tacrolimus
Showing 20 of 77.
What changed recently
From the registry's own updates since Oct 15, 2026.
Started recruiting1
- Tacrolimus as Prophylaxis of Post-ERCP PancreatitisNov 12, 2026NCT07781722
Newly registered1
Codes
What other systems call Tacrolimus · ClinicalTrials.gg INT008530
- MeSH (NLM) D016559TacrolimusConfirmed ClinicalTrials.gov, NLM, Wikidata
- UNII (FDA) WM0HAQ4WNMTACROLIMUSConfirmed FDA, NLM, Wikidata
- RxNorm 484288Confirmed FDA, Wikidata
- Wikidata Q27130595tacrolimus hydrateConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C1311TacrolimusConfirmed FDA, Wikidata
- DrugBank DBSALT000167One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | D016559 | Tacrolimus | Confirmed ClinicalTrials.gov, NLM, Wikidata |
| UNII (FDA) | WM0HAQ4WNM | TACROLIMUS | Confirmed FDA, NLM, Wikidata |
| RxNorm | 484288 | — | Confirmed FDA, Wikidata |
| Wikidata | Q27130595 | tacrolimus hydrate | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C1311 | Tacrolimus | Confirmed FDA, Wikidata |
| DrugBank | DBSALT000167 | — | One source Wikidata |
Also registered as tacrolimus anhydrous (UNII Y5L2157C4J · RxNorm 235991).
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.