Esbriet
(Pirfenidone)ApprovedSmall molecule
Pirfenidone is used to treat a serious lung disease called idiopathic pulmonary fibrosis (IPF), which causes scarring of the lungs and makes it harder to breathe. It works by slowing down the progression of this disease.[2] Esbriet is currently approved and in use across 28 indications[4].[1]
Esbriet is one of 526 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.
28
Indications
115
Total Trials
15
Active Trials
525
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
20
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 28 indications
Competition
Competitive Landscape
254 competitors in Colorectal Cancer
#DrugCompanyPhaseTrials
1Esbriet
LLegacy Health System
Approved
Stivarga
BayerPhase 3
Wellcovorin
EEastern Cooperative Oncology Group
Phase 3
Acetylsalicylic Acid
BayerPhase 3
XL092
RochePhase 3
Huaier Granule
QQidong Gaitianli Medicines Co., Ltd
Phase 3
PD-1 Monoclonal Antibody
SSichuan Baili Pharmaceutical Co., Ltd.
Phase 3
Adjuvant Chemotherapy
NNizhny Novgorod Regional Clinical Oncology Center
Phase 3
SHR-A1811
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Phase 3
IBI363
Innovent Biologics (Suzhou) Co. Ltd.Phase 3
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Idiopathic Pulmonary Fibrosis20 trials
Show 17 more trials
Interstitial Lung Disease5 trials
Fibrosis5 trials
Pirfenidone and Advanced Liver Fibrosis.
Completed·GGrupo Mexicano para el Estudios de las Enfermedades Hepaticas·Phase 2·NCT04099407·122 enrolled
Show 2 more trials
IPF4 trials
Pulmonary Fibrosis4 trials
58 more indications
Interaction4 trials
Hypersensitivity Pneumonitis3 trials
Drug Interactions3 trials
TED3 trials
Chronic Kidney Disease3 trials
Fed3 trials
COVID-193 trials
Pirfenidone in Adult Hospitalized Patients With COVID-19
Completed·—·Phase 3·NCT05713292·168 enrolled
Injury2 trials
Efficacy and Safety2 trials
Treatment2 trials
Idiopathic Pulmonary Fibrosis (IPF)2 trials
Acute Kidney Injury1 trial
Adult1 trial
Diabetic Nephropathy1 trial
Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy
Completed·IInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·Phase 3·NCT02689778·62 enrolled
Silicosis1 trial
Pirfenidone for the Reduction of Metabolic, Inflammatory and Fibrogenic Activity in Complicated Silicosis
Unknown status·IInstituto de investigación e innovación biomédica de Cádiz·Phase 2·NCT05118256·18 enrolled
Heart Failure1 trial
Corona Virus Infection1 trial
Hermansky-Pudlak syndrome1 trial
Oral Pirfenidone for the Pulmonary Fibrosis of Hermansky-Pudlak Syndrome
Completed·—·Phase 2·NCT00001596·35 enrolled
Asbestosis1 trial
Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis
Unknown status·—·N/A·NCT05133453·40 enrolled
Lung Disease1 trial
Pirfenidone vs. Nintedanib for Fibrotic Lung Disease After Coronavirus Disease-19 Pneumonia
Unknown status·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 4·NCT04856111·48 enrolled
Chemotherapy1 trial
Plexiform Neurofibroma1 trial
Cardiovascular Disease1 trial
Uterine leiomyoma1 trial
Development of a Non-Invasive Treatment for Uterine Leiomyoma (Fibroids)
Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 2·NCT00332033·32 enrolled
ILD1 trial
Phase ll Study of Pirfenidone in Patients With RAILD (TRAIL1)
Completed·—·Phase 2·NCT02808871·123 enrolled
Keloid1 trial
Acute Myocardial Infarction1 trial
Oral Submucous Fibrosis1 trial
Neurofibromatosis Type 11 trial
Diabetic Ulcer1 trial
Effect of Topic Pirfenidone in Diabetic Ulcers
Completed·IInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·Phase 3·NCT02222376·36 enrolled
Kidney Disease1 trial
Pirfenidone: A New Drug to Treat Kidney Disease in Patients With Diabetes
Completed·—·Phase 1/2·NCT00063583·77 enrolled
Focal Segmental Glomerulosclerosis1 trial
Pirfenidone to Treat Kidney Disease (Focal Segmental Glomerulosclerosis)
Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT00001959·21 enrolled
Head and Neck Squamous Cell Carcinoma1 trial
Acute Lung Injury1 trial
Multiple Sclerosis1 trial
Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)
Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT03109288·250 enrolled
Peritoneal (Metastatic) Cancer1 trial
Pancreatitis, Acute1 trial
Lung Cancer1 trial
To Evaluate the Efficacy of Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Colorectal Carcinoma1 trial
A Randomized Phase 2 Clinical Trial Evaluating Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Patients With Standard Treatment Failure of Advanced or Metastatic pMMR/MSS Colorectal Carcinoma
Recruiting·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 2·NCT06484153·25 enrolled
Recurrent Acute Pancreatitis1 trial
Unspecified1 trial
Regulatory
FDA Approval Timeline[5]
Oct 15, 2014
ESBRIET
NDA NDA022535
Jan 11, 2017
ESBRIET
NDA NDA208780
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Esbriet drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Pirfenidone. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]
Details
Drug Info
Quick Facts
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- LLegacy Health System