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Drug ReportsTacrolimus
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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Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
immune system diseasesD007154
therapeuticsD013812
operative surgical proceduresD013514
immune system phenomenaD055633
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 XLAstellas PharmaN-204096 RX2013-07-19
3 products, RLD, RS
PROGRAFAstellas PharmaN-050708 RX1994-04-08
3 products, RLD, RS
PROGRAFAstellas PharmaN-050709 RX1994-04-08
1 products, RLD, RS
PROGRAFAstellas PharmaN-210115 RX2018-05-24
2 products, RLD, RS
PROTOPICLEO PharmaN-050777 RX2000-12-08
2 products, RLD, RS
ENVARSUS XRVeloxis PharmaceuticalsN-206406 RX2015-07-10
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
astagraf xlNew Drug Application2023-08-25
envarsusNew Drug Application2025-02-26
hyaluronic acid sodium salt 1% / niacinamide 4% / tacrolimus 0.1%unapproved drug other2019-04-24
hyaluronic acid sodium salt 1% / tacrolimus 0.1% / urea 20%unapproved drug other2019-05-16
niacinamide 4% / tacrolimus 0.03%unapproved drug other2019-05-16
niacinamide 4% / tacrolimus 0.1%unapproved drug other2019-04-24
prografNew Drug Application2023-08-25
protopicNew Drug Application2010-05-24
tacrolimusANDA2025-09-22
tacrolimus 0.1%unapproved drug other2019-05-09
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
atopic dermatitisEFO_0000274D003876L20
graft vs host disease—D006086D89.81
Agency Specific
FDA
EMA
Expiration
Code
TACROLIMUS, PROGRAF, ASTELLAS
2028-07-16ODE-360
2025-05-24ODE-269, ODE-294
TACROLIMUS, ASTAGRAF XL, ASTELLAS
2025-05-24ODE*
Patent Expiration
Patent
Expires
Flag
FDA Information
Tacrolimus, Envarsus Xr, Veloxis Pharms Inc
86642392028-08-30U-1752, U-2677, U-2678
86859982028-08-30DPU-1752, U-2677, U-2678
95499182028-05-30DP
101661902028-05-30DP
108641992028-05-30U-2677, U-2678
111100812028-05-30U-2678
111233312028-05-30U-2677
114198232028-05-30DP
79942142024-08-30DP
84869932024-08-30DPU-1752
85860842024-08-30U-1752
85919462024-08-30DP
86175992024-08-30DP
86234102024-08-30DP
86234112024-08-30U-1752
88891852024-08-30U-1752
88891862024-08-30U-1752
91619072024-08-30DPU-1752
97573622024-08-30DP
97639202024-08-30DP
105488802024-08-30U-2677, U-2678
110770962024-08-30DP
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
HCPCS
Code
Description
J7503
Tacrolimus, extended release, (envarsus xr), oral, 0.25 mg
J7507
Tacrolimus, immediate release, oral, 1 mg
J7508
Tacrolimus, extended release, (astagraf xl), oral, 0.1 mg
J7525
Tacrolimus, parenteral, 5 mg
Clinical
Clinical Trials
1556 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Medication adherenceD055118EFO_0006344———1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTacrolimus
INNtacrolimus
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 classimmunosuppressives
Image (chem structure or protein)Loading
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-ID109581-93-3
RxCUI—
ChEMBL IDCHEMBL3989887
ChEBI ID—
PubChem CID445643
DrugBankDB00864
UNII IDY5L2157C4J (ChemIDplus, GSRS)
Target
Agency Approved
FKBP1A
FKBP1A
Organism
Homo sapiens
Gene name
FKBP1A
Gene synonyms
FKBP1, FKBP12
NCBI Gene ID
2280
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
Q9H566
Mouse ortholog
Fkbp1a (14225)
peptidyl-prolyl cis-trans isomerase FKBP1A (Q545E9)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
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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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 78,476 documents
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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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125,672 adverse events reported
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