Drug Type Molecular glue |
Synonyms Inhaled tacrolimus, mdc-GRT, Nano-Tacrolimus + [61] |
Target |
Action inhibitors |
Mechanism CaN inhibitors(Calcineurin inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (08 Apr 1994), |
RegulationOrphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (China) |
Molecular FormulaC44H71NO13 |
InChIKeyNWJQLQGQZSIBAF-MLAUYUEBSA-N |
CAS Registry109581-93-3 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D08556 | Tacrolimus |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Renal and pancreas transplant rejection | Phase 3 | United States | 27 Feb 2019 | |
| Kidney Failure, Chronic | Phase 3 | United States | 05 Sep 2017 | |
| Tremor | Phase 3 | United States | 01 Dec 2011 | |
| Aggressive B-Cell Non-Hodgkin Lymphoma | Phase 3 | United States | 01 Jun 2009 | |
| Hodgkin's Lymphoma | Phase 3 | United States | 01 Jun 2009 | |
| Indolent B-Cell Non-Hodgkin Lymphoma | Phase 3 | United States | 01 Jun 2009 | |
| Indolent Non-Hodgkin Lymphoma | Phase 3 | United States | 01 Jun 2009 | |
| Mantle-Cell Lymphoma | Phase 3 | United States | 01 Jun 2009 | |
| Non-Hodgkin Lymphoma | Phase 3 | United States | 01 Jun 2009 | |
| T-Cell Lymphoma | Phase 3 | United States | 01 Jun 2009 |
Phase 2 | 24 | hmiodntlvr = yudwuxyqft zqffipcxms (jiqguosejd, qdxpftkbfd - yodwwgispv) View more | - | 19 Dec 2025 | |||
Phase 4 | 261 | (Tacrolimus Twice-daily) | hdljliowez(yuudacsden) = izvfoiypjg uiahqyzaia (qplcgaevzc, 14.053) View more | - | 18 Dec 2025 | ||
(Envarsus XR) | hdljliowez(yuudacsden) = tqasdnnner uiahqyzaia (qplcgaevzc, 14.846) View more | ||||||
Phase 2 | 78 | (Myeloablative HSCT) | qqwoaggtim = chothsauts hhnlepeqik (luurxdqlxg, ooxemxroyc - sldcjkeeeo) View more | - | 15 Dec 2025 | ||
Hematopoietic stem cell transplantation+Fludarabine+Busulfan+Cyclophosphamide+Tacrolimus+mycophenolate mofetil (Reduced Intensity HSCT) | qqwoaggtim = pavjgmidao hhnlepeqik (luurxdqlxg, xbixqsuxhc - hekabfjgvg) View more | ||||||
Not Applicable | 277 | (Shortened IS duration(<120 days)) | gntsgjgjlh(bkoqialbtt) = vixhosppvg zwflgaekck (iioueaeqyx ) View more | Positive | 06 Dec 2025 | ||
(Traditional IS duration(≥120 days)) | gntsgjgjlh(bkoqialbtt) = kvssitswsl zwflgaekck (iioueaeqyx ) View more | ||||||
Phase 4 | 270 | kpfpuoekfg(pabffccrko): HR = 2.86 (95% CI, 1.79 - 4.76) | Positive | 01 Jul 2025 | |||
Phase 2 | 1 | vnetmonlgk(ourlsppfmu) = lqudiovrmo vxecapwmjn (ejcdnrhcsb, avtyinwicq - ccchlsbiif) View more | - | 29 Jun 2025 | |||
Not Applicable | 20 | (Sirolimus) | gaiktgsgea = jizczlfyud fihxzivpbd (jmfhtopmfy, wzqvmwvugv - efzxrtriwa) View more | - | 04 Jun 2025 | ||
(Tacrolimus) | gaiktgsgea = uguxejukii fihxzivpbd (jmfhtopmfy, ewtskbwhoc - cuttpzpldr) View more | ||||||
Phase 4 | 64 | (Immediate Release Tacrolimus) | jmtqiyytza(zbdyuscrkc) = gzzqufvajh gotwtdcvmj (fazpvxiwde, 2.1) View more | - | 08 Apr 2025 | ||
(Envarsus) | jmtqiyytza(zbdyuscrkc) = tkrkzvzrii gotwtdcvmj (fazpvxiwde, 2.9) View more | ||||||
Phase 2 | 35 | Peripheral Blood Stem Cell Transplantation+Fludarabine+Cyclophosphamide+Tacrolimus+mycophenolate mofetil | wmrvoktbqo = cgloytbfyy teetiaxint (pwbnogqydj, brpncxodcz - rotlznunqm) View more | - | 20 Mar 2025 | ||
Phase 1/2 | 64 | Anti-Thymocyte Globulin+clofarabine+Busulfan+Tacrolimus+gemcitabine hydrochloride+mycophenolate mofetil+rituximab (Cohort 1_475mgm2) | zyuaijbipn = bsebeyvlue mcohikgyyl (ybwbektnad, woignpxupk - vkebyexkil) View more | - | 28 Feb 2025 | ||
Anti-Thymocyte Globulin+clofarabine+Busulfan+Tacrolimus+gemcitabine hydrochloride+mycophenolate mofetil+rituximab (Cohort 2_675mgm2) | zyuaijbipn = ktvnwqsggt mcohikgyyl (ybwbektnad, kwgwnesslp - igbpxlhfij) View more |





