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AboutPricing
Drug ReportsPirfenidone
Esbriet(pirfenidone)
Esbriet, Pirfenidone (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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Events Timeline
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Clinical
Drug
Target
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Financial
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Events Timeline
5D
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3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Esbriet, Pirfenidone (discontinued: Esbriet, Pirfenidone)
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 Application2025-07-23
pirfenidoneANDA2025-09-22
pirfenidone capsule, 267 mgANDA2025-03-28
pirfenidone pirfenidoneANDA2023-06-03
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
153 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pulmonary fibrosisD011658—J84.1013211052067
Idiopathic pulmonary fibrosisD054990—J84.1121318941861
FibrosisD005355——8211031959
Lung diseasesD008171EFO_0003818J98.4—623112
Interstitial lung diseasesD017563EFO_0004244J84.9—723—12
PneumoniaD011014EFO_0003106J181321—7
Covid-19D000086382—U07.1—33117
Kidney diseasesD007674EFO_0003086N083311—6
Systemic sclerodermaD012595EFO_0000717M34—321—5
Diabetic nephropathiesD003928EFO_0000401—1111—3
Show 13 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Diffuse sclerodermaD045743EFO_0000404——32——4
Extrinsic allergic alveolitisD000542EFO_1001321J67.9—31——3
SclerosisD012598———22——3
PneumoconiosisD011009Orphanet_182098J64—11——2
Bronchiolitis obliteransD001989EFO_0007183J44.81111——2
BronchiolitisD001988——111——2
Bronchiolitis obliterans syndromeD000092122—D89.811111——2
KeloidD007627EFO_0004212L91.0——2——2
Diabetic footD017719EFO_1001459—111——2
UlcerD014456MPATH_579—111——2
Show 9 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Liver diseasesD008107EFO_0001421K70-K77—4———4
Chronic renal insufficiencyD051436—N1822———3
Liver cirrhosisD008103EFO_0001422K74.0—3———3
Radiation pneumonitisD017564EFO_1001411J70.0—2——13
Lung injuryD055370—S27.30—3———3
Neurofibromatosis 1D009456—Q85.0112———3
NeurofibromatosesD017253—Q85.0012———3
NeurofibromaD009455EFO_0000622—12———3
Non-small-cell lung carcinomaD002289——21———2
HypersensitivityD006967EFO_0003785T78.40—2———2
Show 51 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———5————5
NeoplasmsD009369—C803————3
Drug interactionsD004347——2————2
Squamous cell neoplasmsD018307——1————1
Respiratory aspirationD053120EFO_1001839—1————1
Graft vs host diseaseD006086—D89.811————1
Precancerous conditionsD011230——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Radiation fibrosis syndromeD000087525——————11
AsbestosisD001195EFO_0007153J61————11
Cardiovascular diseasesD002318EFO_0000319I98————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 classdeuterated compounds
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1ccc(=O)n(-c2ccccc2)c1
Identifiers
PDB—
CAS-ID53179-13-8
RxCUI—
ChEMBL IDCHEMBL1256391
ChEBI ID32016
PubChem CID40632
DrugBankDB04951
UNII IDD7NLD2JX7U (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Esbriet – Intermune
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Esbriet – Roche
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 10,432 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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38,114 adverse events reported
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