Overview
Pirfenidone is a synthetic pyridone drug. It is an antifibrotic agent with anti-inflammatory and antioxidant properties that is used to treat idiopathic pulmonary fibrosis (IPF), which is a chronic, progressive form of interstitial pneumonia. While its mechanism of action is not yet fully understood, pirfenidone is proposed to primarily regulate tumor necrosis factor (TNF) pathways and modulate cellular oxidation. The FDA first approved pirfenidone alongside nintedanib as one of the first drugs to treat IPF.
Indication
Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). In Canada and Europe, it is approved in adults only.
Associated Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Mild Idiopathic Pulmonary Fibrosis
- Moderate Idiopathic Pulmonary Fibrosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/11 | Phase 1 | Not yet recruiting | |||
2025/04/15 | Phase 3 | Not yet recruiting | Douglas D. Fraser | ||
2025/03/12 | Phase 1 | Recruiting | |||
2024/09/10 | Phase 1 | Completed | |||
2024/09/09 | Phase 1 | Completed | |||
2024/09/05 | Phase 2 | Completed | Materno-Perinatal Hospital of the State of Mexico | ||
2024/08/26 | Phase 1 | Completed | |||
2024/07/03 | N/A | Active, not recruiting | |||
2024/07/03 | Phase 1 | Not yet recruiting | Wuhan Union Hospital, China | ||
2024/02/20 | Phase 2 | Completed | Jorge L Poo |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Alembic Pharmaceuticals Limited | 46708-479 | ORAL | 267 mg in 1 1 | 3/30/2023 | |
| AvKARE | 42291-491 | ORAL | 267 mg in 1 1 | 10/18/2023 | |
| MAJOR PHARMACEUTICALS | 0904-7397 | ORAL | 267 mg in 1 1 | 10/31/2023 | |
| Accord Healthcare Inc. | 16729-467 | ORAL | 267 mg in 1 1 | 12/6/2023 | |
| Laurus Labs Limited | 42385-926 | ORAL | 801 mg in 1 1 | 3/30/2023 | |
| MSN LABORATORIES PRIVATE LIMITED | 69539-120 | ORAL | 801 mg in 1 1 | 4/15/2023 | |
| Sandoz Inc | 0781-8085 | ORAL | 267 mg in 1 1 | 2/16/2022 | |
| AvKARE | 42291-492 | ORAL | 801 mg in 1 1 | 10/18/2023 | |
| Amneal Pharmaceuticals NY LLC | 69238-1642 | ORAL | 267 mg in 1 1 | 8/17/2023 | |
| Genentech, Inc. | 50242-121 | ORAL | 267 mg in 1 1 | 3/8/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/20/2022 | ||
Authorised | 2/27/2011 | ||
Authorised | 1/10/2023 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ESBRIET FILM COATED TABLET 801MG | SIN15601P | TABLET, FILM COATED | 801.000 mg | 12/18/2018 | |
| ESBRIET FILM COATED TABLET 267MG | SIN15600P | TABLET, FILM COATED | 267.000 mg | 12/18/2018 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Pirfenidone Tablets | 国药准字H20193259 | 化学药品 | 片剂 | 7/18/2024 | |
| Pirfenidone Capsules | 国药准字H20163239 | 化学药品 | 胶囊剂 | 8/14/2023 | |
| Pirfenidone Capsules | 国药准字H20133376 | 化学药品 | 胶囊剂 | 8/14/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ESBRIET TABLETS 801MG | N/A | N/A | N/A | 7/2/2021 | |
| ESBRIET TABLETS 267MG | N/A | N/A | N/A | 7/2/2021 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ESBRIET pirfenidone 267 mg hard capsule bottle | 235577 | Medicine | A | 2/29/2016 | |
| PIRFENEX pirfenidone 801 mg tablet blister pack | 405523 | Medicine | A | 12/1/2023 | |
| ESBRIET pirfenidone 267 mg film-coated tablet bottle | 282525 | Medicine | A | 10/25/2017 | |
| ESBRIET pirfenidone 534 mg film-coated tablet bottle | 282526 | Medicine | A | 10/25/2017 | |
| PIRFENIDONE ASTRON pirfenidone 801 mg film-coated tablet bottle | 365250 | Medicine | A | 2/15/2023 | |
| ARX-PIRFENIDONE pirfenidone 801 mg tablet blister pack | 405525 | Medicine | A | 12/1/2023 | |
| PIRFENIDONE CIPLA pirfenidone 267 mg tablet blister pack | 405510 | Medicine | A | 12/1/2023 | |
| PIRFENIDET pirfenidone 801 mg film-coated tablet bottle | 365253 | Medicine | A | 2/15/2023 | |
| PIRFENIDONE AMEDA pirfenidone 801 mg film-coated tablet bottle | 365257 | Medicine | A | 2/15/2023 | |
| PIRFENIDONE ASTRON pirfenidone 267 mg film-coated tablet bottle | 365263 | Medicine | A | 2/15/2023 |
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