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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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Clinical
Drug
Target
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Financial
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Safety
Events Timeline
5D
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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
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 Application2024-07-08
pirfenidoneANDA2024-11-04
pirfenidone pirfenidoneANDA2023-06-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
pulmonary fibrosis—D011658—
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
144 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——1325952171
FibrosisD005355——828932066
Idiopathic pulmonary fibrosisD054990—J84.1121318841860
Lung diseasesD008171HP_0002088J98.4—624113
Interstitial lung diseasesD017563HP_0006530J84.89—623—11
PneumoniaD011014EFO_0003106—1431—8
Covid-19D000086382———32127
Kidney diseasesD007674EFO_0003086N083311—6
Diabetic nephropathiesD003928EFO_0000401—1111—3
Wounds and injuriesD014947—T14.8—2—1—3
Show 10 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SclerosisD012598——132——4
Systemic sclerodermaD012595EFO_0000717M34.0—32——4
Diffuse sclerodermaD045743EFO_0000404——32——4
HypersensitivityD006967HP_0012393T78.40—31——3
Extrinsic allergic alveolitisD000542EFO_1001321J67.9—31——3
PneumoconiosisD011009Orphanet_182098J64—11——2
Bronchiolitis obliteransD001989EFO_0007183—111——2
BronchiolitisD001988HP_0011950—111——2
Bronchiolitis obliterans syndromeD000092122——111——2
Diabetic footD017719EFO_1001459—111——2
Show 7 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Liver diseasesD008107HP_0002910K70-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
Lung neoplasmsD008175HP_0100526C34.9011———2
Show 50 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———4————4
NeoplasmsD009369—C803————3
Squamous cell neoplasmsD018307——1————1
Respiratory aspirationD053120EFO_1001839—1————1
Graft vs host diseaseD006086—D89.811————1
Precancerous conditionsD011230——1————1
Drug interactionsD004347——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
Post-acute covid-19 syndromeD000094024——————11
Cardiovascular diseasesD002318HP_0001626—————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)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
DrugBank—
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 8,724 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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36,096 adverse events reported
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