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Drug

Tacrolimus

Approved · FDA / EMA
ClassFK506-binding protein 1A inhibitorEmerging researchLate-stage developmentRising momentum
Also known as Astagraf, Envarsus, Envarsus XR, Hecoria+5 more

Astagraf, Envarsus, Envarsus XR, Hecoria, Prograf, Protopic, Tacro, Tacrolimus, Topical, fujimycin.

RxNorm42316ChEMBLCHEMBL3989887ATCL04AD02ATCD11AH01UNIIWM0HAQ4WNM
7
Research papers
25
Active clinical trials
FKBP1A
Primary target
7
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Human Penile Allotransplantation

Clinical trial2026-07-14Results expected Q2 2034 · ClinicalTrials.gov

A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplant for Subjects With VEXAS (Vacuoles, E1 Enzyme, X-linked, Autoinflammatory, Somatic) Syndrome

Clinical trial2026-07-10Results expected Q3 2031 · ClinicalTrials.gov

Allogeneic Hematopoietic Stem Cell Transplant for Patients With Mutations in GATA2 or the MonoMAC Syndrome

Clinical trial2026-07-08Results expected Q4 2027 · ClinicalTrials.gov

Randomized Pilot Study of Ruxolitinib for Switch-Maintenance Prophylaxis of Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation After Intermediate-Dose Post-Transplant Cyclophosphamide (Rux Switch-Maintenance in Intermediate PTCY: RuSMa-PTCY) in Comparison to Full-Dose PTCY

Clinical trial2026-07-07Results expected Q1 2029 · ClinicalTrials.gov

Label change: TACROLIMUS (ANDA090402)

Regulatory2025-05-07FDA

Gut microbiome modulates tacrolimus pharmacokinetics through the transcriptional regulation of ABCB1.

Research2023-07-06Microbiome

ETFAD/EADV Eczema task force 2020 position paper on diagnosis and treatment of atopic dermatitis in adults and children.

Research2020-11-17Journal of the European Academy of Dermatology and Venereology : JEADV

Impact of adding tacrolimus to initial treatment of interstitial pneumonitis in polymyositis/dermatomyositis: a single-arm clinical trial.

Research2020-05-01Rheumatology (Oxford, England)

Mycophenolate mofetil and tacrolimus versus tacrolimus alone for the treatment of idiopathic membranous glomerulonephritis: a randomised controlled trial.

Research2019-09-06BMC nephrology

Approval: Tacforius (EMA)

Regulatory2017-12-08EMA

Approval: Envarsus (EMA)

Regulatory2014-07-18EMA

Approval: TACROLIMUS (ANDA090402)

Regulatory2010-07-01FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Tacrolimus
Aliases & brands
AstagrafEnvarsusEnvarsus XRHecoriaPrografProtopicTacroTacrolimus, Topicalfujimycin
RxNorm CUI
42316
ChEMBL ID
CHEMBL3989887
ATC codes
L04AD02D11AH01
UNII
WM0HAQ4WNM
Primary mechanism
FK506-binding protein 1A inhibitor
Regulatory jurisdictions
fdaema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Peptidyl-prolyl cis-trans isomerase FKBP1A
FKBP1A · P62942
INHIBITORFK506-binding protein 1A inhibitor

Regulatory timeline

7 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2009-05-15 → 2010-07-01)
Earliest approval
2002-02-27
Latest approval
2017-12-08
Authorities
FDA · EMA
Total events
7
fdaU.S. Food and Drug Administration· 2 events
2025-05-07Label change
Label change: TACROLIMUS (ANDA090402)
Evidence ↗
2010-07-01ApprovalMulti-authority
Approval: TACROLIMUS (ANDA090402)
Evidence ↗
emaEuropean Medicines Agency· 5 events
2017-12-08Approval
Approval: Tacforius (EMA)
Indication: Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal… Show full indication

Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.

Evidence ↗
2014-07-18Approval
Approval: Envarsus (EMA)
Indication: Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal… Show full indication

Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.

Evidence ↗
2009-05-15ApprovalMulti-authority
Approval: Modigraf (EMA)
Indication: Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other… Show full indication

Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

189 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
189
registered trials across all phases
LATEST COMPLETION 2025
25
Active studies
21
Recruiting
85
Late-stage (III+)
121
Completed
43
Discontinued
PHASE DISTRIBUTIONn = 189
Early Phase 12Phase 118Phase 1 / 27Phase 277Phase 2 / 39Phase 324Phase 439Phase N / A13

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Feasibility, Efficacy And Safety Of De Novo Extended-Release Tacrolimus Following Liver Transplantation

RecruitingPH IVUniversity of Albertan=942034

Efficacy and Safety of Mesobotox as a Potential New Therapeutic Modality of Psoriasis Vulgaris in Comparison/Combination With Topical Calcineurin Inhibitor

Not yet recruitingPH IVAssiut Universityn=602026

Evaluation Dose Adjustments in Kidney Transplant Patients on Immediate Release and Extended Release Tacrolimus

CompletedPH IVSentara Norfolk General Hospitaln=462023

Study of Pharmacogenomic-Guided Tacrolimus Dosing and Monitoring in Kidney Transplant Recipients

CompletedPH IVUniversity of North Carolina, Chapel Hilln=972022

Prospective Study Comparing Brand and Generic Immunosuppression on Transplant Outcomes, Adherence, & Immune Response

CompletedPH IVUniversity of California, Los Angelesn=1762021

Recent completions

Trials that read out recently, adding to the completed evidence base.

Phase IIa Study of Addition of Itacitinib With Tacrolimus/Sirolimus Regimen for GVHD Prophylaxis in Fludarabine and Melphalan Non-Myeloablative Conditioning Hematopoietic Cell Transplantation for Acute Leukemias, MDS or MF

CompletedPH IICity of Hope Medical Centern=592025

A Phase I/II Clinical Trial of "Off-the-shelf" NK Cell Administration in Combination With Allogeneic SCT to Decrease Disease Relapse in Patients With High-risk Myeloid Malignancies Undergoing Matched Related, Matched Unrelated, One Antigen Mismatched Unrelated, or Haploidentical Stem-cell Transplantation

CompletedPH IIM.D. Anderson Cancer Centern=242025

A Phase II Study Evaluating Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors for Prevention of GVHD

CompletedPH IIFred Hutchinson Cancer Centern=842025

A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV±V Lupus Nephritis

CompletedPH IIIThe University of Hong Kongn=1302024

Tacrolimus Trial for Hereditary Hemorrhagic Telangiectasia (HHT)

CompletedPH IIUnity Health Toronton=102024

Benadamustine, Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation (FluBuBe)

CompletedPH IISt. Petersburg State Pavlov Medical Universityn=502024

Research activity

7 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20072023
Most influential

ETFAD/EADV Eczema task force 2020 position paper on diagnosis and treatment of atopic dermatitis in adults and children.

Journal of the European Academy of Dermatology and Venereology : JEADV · 2020 · 258 cites

A prospective, randomized trial of single-drug versus dual-drug immunosuppression in heart transplantation: the tacrolimus in combination, tacrolimus alone compared (TICTAC) trial.

Circulation. Heart failure · 2011 · 47 cites

Gut microbiome modulates tacrolimus pharmacokinetics through the transcriptional regulation of ABCB1.

Microbiome · 2023 · 42 cites

A randomized clinical trial of age and genotype-guided tacrolimus dosing after pediatric solid organ transplantation.

Pediatric transplantation · 2018 · 34 cites

Impact of adding tacrolimus to initial treatment of interstitial pneumonitis in polymyositis/dermatomyositis: a single-arm clinical trial.

Rheumatology (Oxford, England) · 2020 · 33 cites

Randomized trial of tacrolimus monotherapy: tacrolimus in combination, tacrolimus alone compared (the TICTAC trial).

The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation · 2007 · 19 cites
Recent papers

Gut microbiome modulates tacrolimus pharmacokinetics through the transcriptional regulation of ABCB1.

Microbiome · 2023 · 42 cites

ETFAD/EADV Eczema task force 2020 position paper on diagnosis and treatment of atopic dermatitis in adults and children.

Journal of the European Academy of Dermatology and Venereology : JEADV · 2020 · 258 cites

Impact of adding tacrolimus to initial treatment of interstitial pneumonitis in polymyositis/dermatomyositis: a single-arm clinical trial.

Rheumatology (Oxford, England) · 2020 · 33 cites

Mycophenolate mofetil and tacrolimus versus tacrolimus alone for the treatment of idiopathic membranous glomerulonephritis: a randomised controlled trial.

BMC nephrology · 2019 · 6 cites

A randomized clinical trial of age and genotype-guided tacrolimus dosing after pediatric solid organ transplantation.

Pediatric transplantation · 2018 · 34 cites

A prospective, randomized trial of single-drug versus dual-drug immunosuppression in heart transplantation: the tacrolimus in combination, tacrolimus alone compared (TICTAC) trial.

Circulation. Heart failure · 2011 · 47 cites
Major research themes6
Heart Transplantation2Dermatitis, Atopic1Eczema1Gastrointestinal Microbiome1Organ Transplantation1Tacrolimus1
Journals, researchers & institutions
Top journals
  • BMC nephrology1
  • Circulation. Heart failure1
  • Journal of the European Academy of Dermatology and Venereology : JEADV1
  • Microbiome1
  • Pediatric transplantation1
  • Rheumatology (Oxford, England)1
Leading researchers
  • Arroyo LH2
  • Baran DA2
  • Camacho M2
  • Carr C2
  • Cohen M2
  • Gass AL2
  • Zucker MJ2
  • Adams L1
Leading institutions
free-text, unnormalised
  • Newark Beth Israel Medical Center2
  • Aarhus University Hospital1
  • Bern University Hospital1
  • Cardiovascular Data Management Centre (CVDMC) Hospital for Sick Children1
  • Centre for Inflammatory Disease1
  • Centre Hospitalier Universitaire Vaudois1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.