Prograf, Protopic(tacrolimus)
Advagraf, Astagraf, Envarsus, Modigraf, Prograf, Protopic, Tacforius, Tacrolimus (tacrolimus) is a small molecule pharmaceutical. Tacrolimus was first approved as Prograf on 1994-04-08. It is used to treat atopic dermatitis and graft vs host disease in the USA. It has been approved in Europe to treat atopic dermatitis, graft rejection, kidney transplantation, and liver transplantation. The pharmaceutical is active against peptidyl-prolyl cis-trans isomerase FKBP1A.
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Commercial
Trade Name
FDA
EMA
Astagraf, Envarsus, Prograf, Protopic, Tacrolimus (discontinued: Tacrolimus)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tacrolimus
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ASTAGRAF XL | Astellas Pharma | N-204096 RX | 2013-07-19 | 3 products, RLD, RS |
| PROGRAF | Astellas Pharma | N-050708 RX | 1994-04-08 | 3 products, RLD, RS |
| PROGRAF | Astellas Pharma | N-050709 RX | 1994-04-08 | 1 products, RLD, RS |
| PROGRAF | Astellas Pharma | N-210115 RX | 2018-05-24 | 2 products, RLD, RS |
| PROTOPIC | LEO Pharma | N-050777 RX | 2000-12-08 | 2 products, RLD, RS |
| ENVARSUS XR | Veloxis Pharmaceuticals | N-206406 RX | 2015-07-10 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| astagraf xl | New Drug Application | 2023-08-25 |
| envarsus | New Drug Application | 2025-02-26 |
| hyaluronic acid sodium salt 1% / niacinamide 4% / tacrolimus 0.1% | unapproved drug other | 2019-04-24 |
| hyaluronic acid sodium salt 1% / tacrolimus 0.1% / urea 20% | unapproved drug other | 2019-05-16 |
| niacinamide 4% / tacrolimus 0.03% | unapproved drug other | 2019-05-16 |
| niacinamide 4% / tacrolimus 0.1% | unapproved drug other | 2019-04-24 |
| prograf | New Drug Application | 2023-08-25 |
| protopic | New Drug Application | 2010-05-24 |
| tacrolimus | ANDA | 2025-04-17 |
| tacrolimus 0.1% | unapproved drug other | 2019-05-09 |
Show 2 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| atopic dermatitis | EFO_0000274 | D003876 | L20 |
| graft vs host disease | — | D006086 | D89.81 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TACROLIMUS, PROGRAF, ASTELLAS | |||
| 2028-07-16 | ODE-360 | ||
| 2025-05-24 | ODE-269, ODE-294 | ||
TACROLIMUS, ASTAGRAF XL, ASTELLAS | |||
| 2025-05-24 | ODE* | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Tacrolimus, Envarsus Xr, Veloxis Pharms Inc | |||
| 8664239 | 2028-08-30 | U-1752, U-2677, U-2678 | |
| 8685998 | 2028-08-30 | DP | U-1752, U-2677, U-2678 |
| 9549918 | 2028-05-30 | DP | |
| 10166190 | 2028-05-30 | DP | |
| 10864199 | 2028-05-30 | U-2677, U-2678 | |
| 11110081 | 2028-05-30 | U-2678 | |
| 11123331 | 2028-05-30 | U-2677 | |
| 11419823 | 2028-05-30 | DP | |
| 7994214 | 2024-08-30 | DP | |
| 8486993 | 2024-08-30 | DP | U-1752 |
| 8586084 | 2024-08-30 | U-1752 | |
| 8591946 | 2024-08-30 | DP | |
| 8617599 | 2024-08-30 | DP | |
| 8623410 | 2024-08-30 | DP | |
| 8623411 | 2024-08-30 | U-1752 | |
| 8889185 | 2024-08-30 | U-1752 | |
| 8889186 | 2024-08-30 | U-1752 | |
| 9161907 | 2024-08-30 | DP | U-1752 |
| 9757362 | 2024-08-30 | DP | |
| 9763920 | 2024-08-30 | DP | |
| 10548880 | 2024-08-30 | U-2677, U-2678 | |
| 11077096 | 2024-08-30 | DP | |
ATC Codes
D: Dermatologicals
— D11: Other dermatological preparations in atc
— D11A: Other dermatological preparations in atc
— D11AH: Agents for dermatitis, excluding corticosteroids
— D11AH01: Tacrolimus
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AD: Calcineurin inhibitors
— L04AD02: Tacrolimus
Clinical
Clinical Trials
1542 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney transplantation | D016030 | — | — | 20 | 62 | 38 | 140 | 61 | 305 |
| Syndrome | D013577 | — | — | 29 | 74 | 12 | 6 | 11 | 117 |
| Graft vs host disease | D006086 | — | D89.81 | 30 | 77 | 17 | 4 | 7 | 116 |
| Liver transplantation | D016031 | EFO_0010682 | — | 6 | 24 | 23 | 35 | 23 | 107 |
| Renal insufficiency | D051437 | — | N19 | 11 | 13 | 17 | 26 | 13 | 74 |
| Graft rejection | D006084 | — | — | 4 | 16 | 7 | 18 | 18 | 59 |
| Immunosuppression therapy | D007165 | — | — | 4 | 4 | 3 | 20 | 29 | 58 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 11 | 12 | 8 | 23 | 10 | 55 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 8 | 10 | 12 | 15 | 15 | 54 |
| Dermatitis | D003872 | — | L30.9 | 2 | 6 | 16 | 20 | 5 | 49 |
Show 119 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 58 | 156 | 19 | — | 11 | 213 |
| Myelodysplastic syndromes | D009190 | — | D46 | 41 | 115 | 14 | — | 8 | 160 |
| Lymphoma | D008223 | — | C85.9 | 32 | 98 | 5 | — | 8 | 127 |
| Preleukemia | D011289 | — | — | 31 | 81 | 9 | — | 7 | 116 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 24 | 73 | 14 | — | 4 | 104 |
| Myeloid leukemia | D007951 | — | C92 | 23 | 72 | 11 | — | 3 | 98 |
| Multiple myeloma | D009101 | — | C90.0 | 26 | 64 | 1 | — | 6 | 86 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 17 | 60 | 11 | — | 3 | 85 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 17 | 61 | 4 | — | 4 | 81 |
| Hematologic neoplasms | D019337 | — | — | 28 | 56 | 2 | — | 3 | 75 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 19 | 43 | — | — | 3 | 57 |
| Plasmacytoma | D010954 | — | C90.3 | 8 | 28 | — | — | 4 | 38 |
| Aplastic anemia | D000741 | — | D61.9 | 2 | 19 | — | — | 2 | 23 |
| Anemia | D000740 | EFO_0004272 | D64.9 | 3 | 18 | — | — | — | 20 |
| Myeloid leukemia chronic-phase | D015466 | — | — | 4 | 16 | — | — | — | 18 |
| Myeloid leukemia accelerated phase | D015465 | — | — | 3 | 17 | — | — | — | 18 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 3 | 16 | — | — | — | 17 |
| B-cell lymphoma | D016393 | — | — | 2 | 16 | — | — | — | 16 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 5 | 11 | — | — | — | 14 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 1 | 13 | — | — | — | 14 |
Show 183 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Immune tolerance | D007108 | — | — | 1 | — | — | — | 2 | 3 |
| Islets of langerhans transplantation | D016381 | — | — | 1 | — | — | — | 2 | 3 |
| Hepacivirus | D016174 | — | — | 1 | — | — | — | 1 | 2 |
| Alopecia | D000505 | — | L64 | 2 | — | — | — | — | 2 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | 1 | — | — | — | — | 1 |
| Thromboembolism | D013923 | — | — | 1 | — | — | — | — | 1 |
| Peripheral blood stem cell transplantation | D036102 | — | — | 1 | — | — | — | — | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | — | 1 | — | — | — | — | 1 |
| Medulloblastoma | D008527 | — | — | 1 | — | — | — | — | 1 |
Show 23 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bone diseases | D001847 | — | M89.9 | — | — | — | — | 2 | 2 |
| Corneal diseases | D003316 | — | H18.9 | — | — | — | — | 2 | 2 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | — | — | 2 | 2 |
| Acute kidney injury | D058186 | — | N17 | — | — | — | — | 2 | 2 |
| Heart disease risk factors | D000082742 | — | — | — | — | — | — | 1 | 1 |
| Antibody formation | D000917 | — | — | — | — | — | — | 1 | 1 |
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | — | — | — | — | 1 | 1 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 1 | 1 |
| Torsades de pointes | D016171 | EFO_0005307 | I47.21 | — | — | — | — | 1 | 1 |
| Postoperative complications | D011183 | — | — | — | — | — | — | 1 | 1 |
Show 36 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tacrolimus |
| INN | tacrolimus |
| Description | Tacrolimus (anhydrous) is a macrolide lactam containing a 23-membered lactone ring, originally isolated from the fermentation broth of a Japanese soil sample that contained the bacteria Streptomyces tsukubaensis. It has a role as an immunosuppressive agent and a bacterial metabolite. |
| Classification | Small molecule |
| Drug class | immunosuppressives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C=CC[C@@H]1/C=C(\C)C[C@H](C)C[C@H](OC)[C@H]2O[C@@](O)(C(=O)C(=O)N3CCCC[C@H]3C(=O)O[C@H](/C(C)=C/[C@@H]3CC[C@@H](O)[C@H](OC)C3)[C@H](C)[C@@H](O)CC1=O)[C@H](C)C[C@@H]2OC.O |
Identifiers
| PDB | — |
| CAS-ID | 109581-93-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3989887 |
| ChEBI ID | — |
| PubChem CID | 445643 |
| DrugBank | DB00864 |
| UNII ID | Y5L2157C4J (ChemIDplus, GSRS) |
Target
Agency Approved
FKBP1A
FKBP1A
Organism
Homo sapiens
Gene name
FKBP1A
Gene synonyms
FKBP1, FKBP12
NCBI Gene ID
Protein name
peptidyl-prolyl cis-trans isomerase FKBP1A
Protein synonyms
12 kDa FK506-binding protein, 12 kDa FKBP, Calstabin-1, FK506 binding protein 1A, 12kDa, FK506 binding protein12, FK506-binding protein 1, FK506-binding protein 12, FK506-binding protein 1A, FK506-binding protein, T-cell, 12-kD, FKBP-12, FKBP-1A, FKBP12-Exip3, Immunophilin FKBP12, PPIase FKBP1A, protein kinase C inhibitor 2, Rotamase
Uniprot ID
Mouse ortholog
Fkbp1a (14225)
peptidyl-prolyl cis-trans isomerase FKBP1A (Q545E9)
Alternate
No data
Variants
No data
Financial
Revenue by drug
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Estimated US medical usage
Tacrolimus
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Astagraf xl, Envarsus, Prograf, Protopic, Tacrolimus
Adverse Events
Top Adverse Reactions
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115,584 adverse events reported
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