Last update 04 Aug 2026

Tacrolimus

Overview

Basic Info

Drug Type
Molecular glue
Synonyms
Inhaled tacrolimus, mdc-GRT, Nano-Tacrolimus
+ [62]
Target
Action
inhibitors
Mechanism
CaN inhibitors(Calcineurin inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (08 Apr 1994),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (China)
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Structure/Sequence

Molecular FormulaC44H71NO13
InChIKeyNWJQLQGQZSIBAF-MLAUYUEBSA-N
CAS Registry109581-93-3

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Vernal Keratoconjunctivitis
South Korea
11 Jul 2019
Lung Diseases, Interstitial
Japan
14 Jun 2013
Small intestine transplantation rejection
Japan
26 Jul 2011
Colitis, Ulcerative
Japan
07 Jul 2009
Mucositis
Japan
25 Jan 2008
Allograft Rejection
European Union
23 Apr 2007
Allograft Rejection
Iceland
23 Apr 2007
Allograft Rejection
Liechtenstein
23 Apr 2007
Allograft Rejection
Norway
23 Apr 2007
Liver transplant rejection
European Union
23 Apr 2007
Liver transplant rejection
Iceland
23 Apr 2007
Liver transplant rejection
Liechtenstein
23 Apr 2007
Liver transplant rejection
Norway
23 Apr 2007
Lupus Nephritis
Japan
26 Jan 2007
Rejection of pancreas transplant
Japan
19 Jan 2005
Lung transplant rejection
Japan
31 Jan 2003
Cardiac transplant rejection
Japan
20 Jun 2001
Myasthenia Gravis
Japan
20 Sep 2000
Dermatitis, Atopic
Japan
16 Jun 1999
Bone marrow transplant rejection
Japan
30 Apr 1999
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pulmonary Arterial HypertensionPhase 3-29 May 2026
Renal and pancreas transplant rejectionPhase 3
United States
27 Feb 2019
Kidney Failure, ChronicPhase 3
United States
05 Sep 2017
TremorPhase 3
United States
01 Dec 2011
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
United States
01 Jun 2009
Hodgkin's LymphomaPhase 3
United States
01 Jun 2009
Indolent B-Cell Non-Hodgkin LymphomaPhase 3
United States
01 Jun 2009
Indolent Non-Hodgkin LymphomaPhase 3
United States
01 Jun 2009
Mantle-Cell LymphomaPhase 3
United States
01 Jun 2009
Non-Hodgkin LymphomaPhase 3
United States
01 Jun 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
211
(Everolimus/Low-Dose Tacrolimus)
peqcuudumy(lecrosyatt) = mpauqylivy cbehxvrtex (rtcygsifuu, 2.2)
-
31 Jul 2026
(Tacrolimus/Mycophenolate Mofetil)
peqcuudumy(lecrosyatt) = qmiqqijoww cbehxvrtex (rtcygsifuu, 2.5)
Phase 2
10
Allogeneic Hematopoietic Stem Cell Transplantation+Cyclophosphamide+Tacrolimus+mycophenolate mofetil
jqhvkiqznv = zawxzegqyj hbjrzmsvrv (xvfkiskqdp, uqzmmlkkxv - secjwkgvmr)
-
23 Jul 2026
Phase 2
84
(Arm A (MRD / High Intensity Conditioning))
bkmlncxozx = srrvrijxmj vcxeatvrxm (zgbtqtabtk, eiybxajceu - qgyfuqqshq)
-
01 Jun 2026
(Arm B (MRD / Low Intensity Conditioning))
bkmlncxozx = kjwjehqjdm vcxeatvrxm (zgbtqtabtk, ajdneuloob - tkrkrmiawx)
Not Applicable
16
tnvgziviaf(llzqgtorhb) = vifandxxto wuanldtkhb (tsirbbdbtz, 0.3 - 31.4)
Positive
29 May 2026
Phase 2
13
(Arm A -Briquilimab, Fludarabine, 200 Centigray (cGy) Total Body Irradiation)
uwizduybeu = virsaevcsn bitblqfxlr (mqksfimwnc, xysdflbjdw - ovcbofhtkz)
-
29 May 2026
(Arm B - Briquilimab, Fludarabine, Cyclophosphamide, 200 Centigray (cGy) Total Body Irradiation)
uwizduybeu = feteilwueg bitblqfxlr (mqksfimwnc, mxxzryprjk - jmzkltjjxt)
Phase 4
-
56
bexuwfivht(yvezgqmqdq) = rwcmbzygir ofgseqhjfk (vzpgdxkqro, egxthqvsxy - brodkipoet)
-
29 Apr 2026
Phase 2
48
COVID-19 Vaccine
(Additional mRNA COVID-19 Vaccine Without ISR)
kyiqmdmasa(dghsnofubn) = prwdikmsyl wbfjpxketx (duseudctrp, khubkuebbl - cjokjmazpt)
-
23 Apr 2026
COVID-19 Vaccine
(Additional mRNA COVID-19 Vaccine With ISR)
kyiqmdmasa(dghsnofubn) = oycynmdoux wbfjpxketx (duseudctrp, mrgbnnbqqw - uyjprwbniw)
Phase 2
15
(Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab))
huzfmbiqbq = tgnqbskggy jcxhhnyepy (quwziaufpw, yjcmwmnycj - hsfvqmschn)
-
15 Apr 2026
(Cohort 2: FM (Fludarabine/Melphalan))
huzfmbiqbq = pdujicyrmy jcxhhnyepy (quwziaufpw, seownpbwse - ceibpawclc)
Phase 2
40
Allogeneic hematopoietic stem cell transplantation+Fludarabine+Busulfan+Cyclophosphamide (CY)+Tacrolimus+mycophenolate mofetil
tlaglzswec = wjufgvttzd kccjqqumxx (ymnouqmqlh, wwqjdsrjts - smpzqtsndn)
-
15 Apr 2026
Not Applicable
445
tbzwpsjpvs(jiyeefwqxz) = jbaywpftnh jqjywjlbxf (ufmigpabso )
Positive
22 Mar 2026
tbzwpsjpvs(jiyeefwqxz) = vjghiwnfub jqjywjlbxf (ufmigpabso )
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Clinical Trial

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Approval

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Regulation

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