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Esbriet(pirfenidone)
Esbriet (pirfenidone) is a small molecule pharmaceutical. Pirfenidone was first approved as Esbriet on 2011-02-27. It is used to treat pulmonary fibrosis in the USA. It has been approved in Europe to treat idiopathic pulmonary fibrosis, lung diseases, and respiratory tract diseases.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Esbriet (generic drugs available since 2022-01-03)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pirfenidone
Tradename
Company
Number
Date
Products
ESBRIETGenentechN-022535 RX2014-10-15
1 products, RLD, RS
ESBRIETGenentechN-208780 RX2017-01-11
2 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
esbrietNew Drug Application2020-12-11
pirfenidone pirfenidone ANDA2023-06-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
pulmonary fibrosis—D011658J84.10
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Pirfenidone, Esbriet, Genentech Inc
101886372037-03-28DP
87789472033-08-30U-1613, U-2044, U-2045
78163832030-01-08U-1603, U-2042, U-2050
79106102030-01-08U-1604, U-2048, U-2049
80130022030-01-08U-1603, U-2047, U-2082
80844752030-01-08U-1605, U-2052, U-2054, U-2268
83187802030-01-08U-1606, U-2046, U-2081
86480982030-01-08U-1611, U-2051, U-2052
87541092030-01-08U-1612, U-2053
75667292029-04-22U-1600, U-2077, U-2078, U-2269, U-2270
76357072029-04-22U-1609, U-2072, U-2073, U-2074, U-2075, U-2076, U-2083
85924622029-04-22U-1609, U-2055, U-2056, U-2057, U-2058, U-2059, U-2060, U-2061, U-2062, U-2063
86097012029-04-22U-1610, U-2064, U-2065, U-2066, U-2067, U-2068, U-2069, U-2070
83831502028-05-10DPU-2361
76962362027-12-18U-1601
77677002027-12-18U-1601, U-2080
84206742027-12-18DPU-1608, U-2079
77672252026-09-22DPU-1602
79889942026-09-22DPU-1602
87536792026-09-22DPU-1602
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AX: Other immunosuppressants in atc
— L04AX05: Pirfenidone
HCPCS
No data
Clinical
Clinical Trials
98 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Idiopathic pulmonary fibrosisD054990J84.1126954529
Interstitial lung diseasesD017563EFO_0004244J84.89—523—10
Connective tissue diseasesD003240EFO_1001986M35———2—2
Pulmonary sarcoidosisD017565DOID_13406D86.0———1—1
DermatomyositisD003882EFO_0000398M33———1—1
SepsisD018805A41.9———1—1
Acute kidney injuryD058186HP_0001919N17———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pulmonary fibrosisD011658J84.10—41—26
Systemic sclerodermaD012595EFO_0000717M34—31——3
PneumoniaD011014EFO_0003106J181—2——3
Diabetic nephropathiesD003928EFO_0000401111——2
Extrinsic allergic alveolitisD000542EFO_1001321J67.9—21——2
PneumoconiosisD011009Orphanet_182098J64—11——2
Bronchiolitis obliteransD001989EFO_0007183111——2
Diabetic footD017719EFO_1001459111——2
AlbuminuriaD000419EFO_0004285R80.9——1——1
KeloidD007627EFO_0004212L91.0——1——1
Show 1 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FibrosisD00535514———4
Covid-19D000086382U07.1—1——23
Chronic renal insufficiencyD051436N1812———2
Renal insufficiencyD051437HP_0000083N1911———2
Liver cirrhosisD008103EFO_0001422K74.0—2———2
Liver diseasesD008107EFO_0001421K70-K77—2———2
Radiation pneumonitisD017564EFO_1001411J70.0—1——12
Chronic hepatitis cD019698EFO_0004220B18.2—2———2
Neurofibromatosis 1D009456Q85.0111———2
Multiple sclerosisD009103EFO_0003885G3511———1
Show 18 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—2————2
NeoplasmsD009369C801————1
Non-small-cell lung carcinomaD0022891————1
Lung neoplasmsD008175C34.901————1
Squamous cell neoplasmsD0183071————1
Graft vs host diseaseD006086D89.811————1
Precancerous conditionsD0112301————1
Drug interactionsD0043471————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AsbestosisD001195EFO_0007153J61————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePIRFENIDONE
INNpirfenidone
Description
Pirfenidone is a pyridone that is 2-pyridone substituted at positions 1 and 5 by phenyl and methyl groups respectively. An anti-inflammatory drug used for the treatment of idiopathic pulmonary fibrosis. It has a role as a non-narcotic analgesic, a non-steroidal anti-inflammatory drug and an antipyretic.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Cc1ccc(=O)n(-c2ccccc2)c1
Identifiers
PDB—
CAS-ID53179-13-8
RxCUI1592254
ChEMBL IDCHEMBL1256391
ChEBI ID32016
PubChem CID40632
DrugBankDB04951
UNII IDD7NLD2JX7U (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Esbriet - Intermune
$
€
£
₣
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Esbriet - Roche
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,887 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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13,209 adverse events reported
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