Pirfenidone - PharmaKB

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

Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

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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 diseases	D012140
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Esbriet (generic drugs available since 2022-01-03)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Pirfenidone

Tradename	Company	Number	Date	Products
ESBRIET	Genentech	N-022535 RX	2014-10-15	1 products, RLD, RS
ESBRIET	Genentech	N-208780 RX	2017-01-11	2 products, RLD, RS

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Labels

FDA

EMA

No data

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
pulmonary fibrosis	—	D011658	J84.10

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Pirfenidone, Esbriet, Genentech Inc
10188637	2037-03-28	DP
8778947	2033-08-30		U-1613, U-2044, U-2045
7816383	2030-01-08		U-1603, U-2042, U-2050
7910610	2030-01-08		U-1604, U-2048, U-2049
8013002	2030-01-08		U-1603, U-2047, U-2082
8084475	2030-01-08		U-1605, U-2052, U-2054, U-2268
8318780	2030-01-08		U-1606, U-2046, U-2081
8648098	2030-01-08		U-1611, U-2051, U-2052
8754109	2030-01-08		U-1612, U-2053
7566729	2029-04-22		U-1600, U-2077, U-2078, U-2269, U-2270
7635707	2029-04-22		U-1609, U-2072, U-2073, U-2074, U-2075, U-2076, U-2083
8592462	2029-04-22		U-1609, U-2055, U-2056, U-2057, U-2058, U-2059, U-2060, U-2061, U-2062, U-2063
8609701	2029-04-22		U-1610, U-2064, U-2065, U-2066, U-2067, U-2068, U-2069, U-2070
8383150	2028-05-10	DP	U-2361
7696236	2027-12-18		U-1601
7767700	2027-12-18		U-1601, U-2080
8420674	2027-12-18	DP	U-1608, U-2079
7767225	2026-09-22	DP	U-1602
7988994	2026-09-22	DP	U-1602
8753679	2026-09-22	DP	U-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

136 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 fibrosis	D054990	—	J84.112	11	17	8	4	15	54
Interstitial lung diseases	D017563	HP_0006530	J84.89	—	5	2	3	—	10
Diabetic nephropathies	D003928	EFO_0000401	—	1	1	1	1	—	3
Connective tissue diseases	D003240	EFO_1001986	M35	—	—	—	2	—	2
Pulmonary sarcoidosis	D017565	DOID_13406	D86.0	—	—	—	1	—	1
Dermatomyositis	D003882	EFO_0000398	M33	—	—	—	1	—	1
Sepsis	D018805	HP_0100806	A41.9	—	—	—	1	—	1
Acute kidney injury	D058186	HP_0001919	N17	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pulmonary fibrosis	D011658	—	J84.10	—	5	1	—	3	8
Systemic scleroderma	D012595	EFO_0000717	M34	—	3	1	—	—	3
Pneumonia	D011014	EFO_0003106	—	1	—	2	—	—	3
Extrinsic allergic alveolitis	D000542	EFO_1001321	J67.9	—	2	1	—	—	2
Pneumoconiosis	D011009	Orphanet_182098	J64	—	1	1	—	—	2
Bronchiolitis obliterans	D001989	EFO_0007183	—	1	1	1	—	—	2
Diabetic foot	D017719	EFO_1001459	—	1	1	1	—	—	2
Albuminuria	D000419	EFO_0004285	R80.9	—	—	1	—	—	1
Keloid	D007627	EFO_0004212	L91.0	—	—	1	—	—	1
Respiratory distress syndrome	D012128	EFO_1000637	J80	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Covid-19	D000086382	—	U07.1	—	2	—	—	2	4
Fibrosis	D005355	—	—	1	4	—	—	—	4
Non-small-cell lung carcinoma	D002289	—	—	2	1	—	—	—	2
Chronic renal insufficiency	D051436	—	N18	1	2	—	—	—	2
Renal insufficiency	D051437	HP_0000083	N19	1	1	—	—	—	2
Liver cirrhosis	D008103	EFO_0001422	K74.0	—	2	—	—	—	2
Liver diseases	D008107	HP_0002910	K70-K77	—	2	—	—	—	2
Radiation pneumonitis	D017564	EFO_1001411	J70.0	—	1	—	—	1	2
Chronic hepatitis c	D019698	EFO_0004220	B18.2	—	2	—	—	—	2
Neurofibromatosis 1	D009456	—	Q85.01	1	1	—	—	—	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	3	—	—	—	—	3
Neoplasms	D009369	—	C80	2	—	—	—	—	2
Lung neoplasms	D008175	HP_0100526	C34.90	1	—	—	—	—	1
Squamous cell neoplasms	D018307	—	—	1	—	—	—	—	1
Graft vs host disease	D006086	—	D89.81	1	—	—	—	—	1
Precancerous conditions	D011230	—	—	1	—	—	—	—	1
Drug interactions	D004347	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lung diseases	D008171	HP_0002088	J98.4	—	—	—	—	1	1
Asbestosis	D001195	EFO_0007153	J61	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Pirfenidone
INN	pirfenidone
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