Pirfenidone
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2011
- First approval year
- 2011
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Pirfenidone
- Molecular weight
- 185.23
- Structure (SMILES)
- Cc1ccc(=O)n(-c2ccccc2)c1
- esbriet
- Esbriet
- Pirfenidone axunio (previously pirfenidone aet)
- pirfenidone axunio previously pirfenidone aet
- pirfenidone component of esbriet
- Pirfenidone component of esbriet
- pirfenidone viatris
- Pirfenidone viatris
- amr 69
- AMR-69
- egcg 300 mg pirfenidone
- Esbriet 267 MG Oral Capsule
- esbriet component pirfenidone
- ESBRIET component pirfenidone
- nsc 748456
- NSC-748456
- Oral pirfenidone
- pirespa
- Pirespa
- pirfenidona
- Pirfenidona
- pirfenidone
- Pirfenidone
- Pirfenidone [EMA EPAR]
- Pirfenidone [EP MONOGRAPH]
- Pirfenidone [INN]
- Pirfenidone [JAN]
- Pirfenidone [MART.]
- Pirfenidone [MI]
- Pirfenidone [ORANGE BOOK]
- Pirfenidone [USAN]
- Pirfenidone [VANDF]
- Pirfenidone [WHO-DD]
And 23 more, listed on the interactive page.
- ATC classification codes
- L04AX05
Sources for recorded values
- CAS registry numbers
- 53179-13-8
- ChEMBL ID
- CHEMBL1256391
- InChIKey
- ISWRGOKTTBVCFA-UHFFFAOYSA-N
- PubChem compound IDs
- 40632
- RxNorm IDs (RxCUI)
- 1592254
- FDA ingredient codes (UNII)
- D7NLD2JX7U
- Applicant
- LEGACY
- Approval date
- 11 Jan 2017
- Application number
- NDA208780
- Status
- Authorised
- Status date
- 28 Feb 2011
- Authorisation date
- 28 Feb 2011
- Approved indications
- Esbriet is indicated in adults for the treatment of idiopathic pulmonary fibrosis.
- Product number
- EMEA/H/C/002154
- Authorisation holder
- H.A.C. Pharma
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 2
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Idiopathic Pulmonary Fibrosis
- Lung Diseases
- Respiratory Tract Diseases
European medicines record
- Patents
- 35
- Designations
- 6
- Earliest recorded loss of exclusivity
- 28 Mar 2037
- First in class
- Yes
- Fast track
- Yes
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- pirfenidone
- Type
- Synthetic organic
- Drug name stem
- deu-
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Pancreatitis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000278
- Subject identifier
- D010195
- Condition
- Cardiomyopathy, Hypertrophic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000538
- Subject identifier
- D002312
- Condition
- Immune System Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000540
- Subject identifier
- D007154
- Condition
- Respiratory Tract Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000684
- Subject identifier
- D012140
- Condition
- Scleroderma, Systemic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000717
- Subject identifier
- D012595
- Condition
- Leiomyoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000731
- Subject identifier
- D007889
- Condition
- Idiopathic Pulmonary Fibrosis
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000768
- Subject identifier
- D054990
- Condition
- Pneumonia
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003106
- Subject identifier
- D011014
- Condition
- Heart Failure
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003144
- Subject identifier
- D006333
- Condition
- Lung Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003818
- Subject identifier
- D008171
- Condition
- Renal Insufficiency, Chronic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003884
- Subject identifier
- D051436
- Condition
- Keloid
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004212
- Subject identifier
- D007627
- Condition
- Glomerulosclerosis, Focal Segmental
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004236
- Subject identifier
- D005923
- Condition
- Lung Diseases, Interstitial
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004244
- Subject identifier
- D017563
- Condition
- Nephrotic Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004255
- Subject identifier
- D009404
- Condition
- Acute Lung Injury
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004610
- Subject identifier
- D055371
- Condition
- Bronchiolitis Obliterans
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007183
- Subject identifier
- D001989
- Condition
- Pulmonary Fibrosis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0009448
- Subject identifier
- D011658
- Condition
- Burns
- Highest recorded phase
- 2
- Condition identifier
- EFO:0009516
- Subject identifier
- D002056
- Condition
- Respiratory Distress Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:1000637
- Subject identifier
- D012128
- Condition
- Pancreatitis
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000652
- Subject identifier
- D010195
- Condition
- Diabetic Foot
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001459
- Subject identifier
- D017719
- Condition
- Renal Insufficiency
- Highest recorded phase
- 2
- Condition identifier
- EFO:1002048
- Subject identifier
- D051437
- Condition
- Renal Insufficiency
- Highest recorded phase
- 2
- Condition identifier
- HP:0000083
- Subject identifier
- D051437
And 8 more, listed on the interactive page.
- Condition identifier
- EFO_0000181
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000278
- Condition identifier
- EFO_0000538
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000540
- Condition identifier
- EFO_0000658
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000717
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000731
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000768
- Condition identifier
- EFO_0000768
- Highest recorded phase
- 4
- Condition identifier
- EFO_0003106
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003144
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003818
- Condition identifier
- EFO_0003884
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004212
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004244
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004610
- Highest recorded phase
- 2
- Condition identifier
- EFO_0006890
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007153
- Condition identifier
- EFO_0007183
- Condition identifier
- EFO_0008497
- Highest recorded phase
- 2
- Condition identifier
- EFO_0008527
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009448
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009516
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000637
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000652
- Highest recorded phase
- 2
And 50 more, listed on the interactive page.
- Event
- abdominal discomfort
- Reports
- 335
- Reporting signal score
- 420.341
- Event
- abdominal pain upper
- Reports
- 217
- Reporting signal score
- 139.619
- Event
- asthenia
- Reports
- 343
- Reporting signal score
- 142.705
- Event
- carbon monoxide diffusing capacity decreased
- Reports
- 21
- Reporting signal score
- 85.6703
- Event
- constipation
- Reports
- 189
- Reporting signal score
- 78.7593
- Event
- cough
- Reports
- 414
- Reporting signal score
- 334.697
- Event
- decreased appetite
- Reports
- 774
- Reporting signal score
- 1,268
- Event
- diarrhoea
- Reports
- 561
- Reporting signal score
- 201.86
- Event
- dizziness
- Reports
- 419
- Reporting signal score
- 150.222
- Event
- dysgeusia
- Reports
- 100
- Reporting signal score
- 80.7846
- Event
- dyspepsia
- Reports
- 270
- Reporting signal score
- 413.609
- Event
- dyspnoea
- Reports
- 686
- Reporting signal score
- 408.639
- Event
- dyspnoea exertional
- Reports
- 89
- Reporting signal score
- 89.7746
- Event
- fatigue
- Reports
- 831
- Reporting signal score
- 497.782
- Event
- flatulence
- Reports
- 81
- Reporting signal score
- 89.6065
- Event
- forced vital capacity decreased
- Reports
- 48
- Reporting signal score
- 196.477
- Event
- gastric disorder
- Reports
- 113
- Reporting signal score
- 182.468
- Event
- gastrointestinal disorder
- Reports
- 123
- Reporting signal score
- 105.087
- Event
- gastrooesophageal reflux disease
- Reports
- 145
- Reporting signal score
- 149.964
- Event
- idiopathic pulmonary fibrosis
- Reports
- 75
- Reporting signal score
- 255.875
- Event
- lung transplant
- Reports
- 35
- Reporting signal score
- 73.1815
- Event
- nausea
- Reports
- 1,057
- Reporting signal score
- 732.568
- Event
- oxygen saturation decreased
- Reports
- 185
- Reporting signal score
- 250.88
- Event
- photosensitivity reaction
- Reports
- 234
- Reporting signal score
- 598.163
- Event
- pneumonia
- Reports
- 339
- Reporting signal score
- 169.285
And 8 more, listed on the interactive page.
- NCT00001959
- NCT00011076
- NCT00053937
- NCT00754780
- NCT00080223
- NCT00287716
- NCT00287729
- NCT00662038
- NCT01366209
- NCT01504334
- NCT01872689
- NCT01890265
- NCT02136992
- NCT02579603
- NCT02598193
- NCT02606877
- NCT02648048
- NCT02707640
- NCT02951429
- NCT03208933
- NCT03939520
- NCT03981094
- NCT04888715
- NCT05060822
- NCT05321420
And 30 more, listed on the interactive page.
- Dose
- 801 mg
- Route
- Oral
- How often
- Thrice daily
Conditions of use
- Take with food
- Hydrogen bond acceptors
- 2
- Hydrogen bond donors
- 0
- Polar surface area
- 22
- Calculated partition coefficient (ALogP)
- 2.15
- Calculated partition coefficient (XLogP)
- 1.9
- Prodrug
- No
- Chirality
- Achiral
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 1
- Heavy atoms
- 14
- Molecular formula
- C12H11NO
- Monoisotopic mass
- 185.084063974
- Natural product
- Yes
- 0480-3610
- 0480-3611
- 0781-2158
- 0781-8085
- 0781-8086
- 0904-7397
- 0904-7398
- 16729-467
- 16729-468
- 31722-872
- 31722-873
- 33342-461
- 42291-490
- 42291-491
- 42291-492
- 42385-923
- 42385-924
- 42385-925
- 42385-926
- 42571-335
- 42571-336
- 46708-479
- 46708-480
- 50228-441
- 50228-442
And 36 more, listed on the interactive page.
- Recorded assays
- 1,840
- Active assays
- 14
- Confirmatory
- Other
- Screening
- Analgesics
- Anti-Inflammatory Agents, Non-Steroidal
- Antineoplastic Agents
These details could not be displayed.
Related records
Trials (129)
- A Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Participants
- A Phase 3 Study of Efficacy and Safety of AK3280 in Patients With Idiopathic Pulmonary Fibrosis
- A Phase I Evaluation of the Safety and Tolerability of Pirfenidone in Idiopathic Subglottic Stenosis
- A Phase II Study of Pirfenidone Plus PD-1 Inhibitor With or Without Hypofractionated Radiotherapy for Refractory pMMR/MSS Colorectal Cancer
- A Single-arm Clinical Study Evaluating Pirfenidone and Sintilimab in Combination With Standard Neoadjuvant Chemotherapy for Colorectal Cancer Patients With Peritoneal Metastasis.
- A Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.
- A Study Based on Medical Records That Looks at the Characteristics of Idiopathic Pulmonary Fibrosis Patients Grouped by the Type of Medication They Are Taking
- A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood
- A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood
- A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
- A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis
- A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease
- A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy Participants
- A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants
- A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF)
- A Study to Compare the Amount of Nintedanib and Pirfenidone in the Blood When Nintedanib and Pirfenidone Are Given Separately or in Combination
- A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants
- A Study to Evaluate the Efficacy and Safety of Pirfenidone With Novel Coronavirus Infection
- Anti-Inflammatory and Anti-Fibrotic Drugs in Post COVID-19 Pulmonary Fibrosis
- Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Approved for (4)
- Idiopathic pulmonary fibrosis
- Immune system disorder
- Lung disorder
- Respiratory system disorder
In development for (28)
- Acute lung injury Phase 2
- Acute pancreatitis Phase 2
- Acute respiratory distress syndrome Phase 3
- Bronchiolitis obliterans syndrome Phase 2
- Burn Phase 2
- Chronic kidney disease Phase 2
- Colorectal cancer Phase 2
- COVID-19 Phase 3
- Focal segmental glomerulosclerosis Phase 2
- Head and neck squamous cell carcinoma Phase 2
- Heart failure Phase 2
- Hypersensitivity pneumonitis Phase 2
- Hypertrophic cardiomyopathy Phase 2
- Interstitial lung disease Phase 2
- Keloid Phase 3
- Kidney failure Phase 2
- Lung cancer Phase 2
- Multiple sclerosis Phase 1
- Nephrotic syndrome Phase 2
- Neurofibromatosis type 1 Phase 2
Other linked conditions (1)
- Asbestosis