Drug Type Small molecule drug |
Synonyms Pirfenidone (JAN/USAN/INN), AMR-69, AP-01 + [18] |
Target- |
Action- |
Mechanism- |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Japan (16 Oct 2008), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Orphan Drug (Japan) |
Molecular FormulaC12H11NO |
InChIKeyISWRGOKTTBVCFA-UHFFFAOYSA-N |
CAS Registry53179-13-8 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D01583 | Pirfenidone |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis | Japan | 16 Oct 2008 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Interstitial lung disease due to systemic disease | Phase 3 | China | 29 May 2023 | |
| Anthracosis | Phase 3 | - | 15 Apr 2022 | |
| Pneumoconiosis | Phase 3 | - | 15 Apr 2022 | |
| Silicosis | Phase 3 | - | 15 Apr 2022 | |
| Dermatomyositis | Phase 3 | China | 01 Jun 2018 | |
| Lung Diseases, Interstitial | Phase 3 | China | 31 Oct 2017 | |
| Sclerotylosis | Phase 3 | China | 31 Oct 2017 | |
| Progressive pulmonary fibrosis | Phase 2 | United States | 03 Apr 2024 | |
| Progressive pulmonary fibrosis | Phase 2 | Argentina | 03 Apr 2024 | |
| Progressive pulmonary fibrosis | Phase 2 | Australia | 03 Apr 2024 |
Not Applicable | 4,529 | dtbougrjzp(exzenroiwg) = tdalwqryps wwslpzqmur (utntyyornj ) | Positive | 30 May 2025 | |||
dtbougrjzp(exzenroiwg) = jvugqbakud wwslpzqmur (utntyyornj ) | |||||||
Phase 1 | 64 | Nebulised AP01 50mg QD | ixdekbewbn(jdtdslpsqo) = usbduxcitq omhdniafvg (tdcvdqzism ) View more | Positive | 16 May 2025 | ||
Nebulised AP01 100mg BID | ixdekbewbn(jdtdslpsqo) = hoyxnosxoc omhdniafvg (tdcvdqzism ) View more | ||||||
Not Applicable | - | 91 | 50 mg AP01 once daily | bxcxuzphfv(lxvkggcdxi) = dlirmtqzxf mdekxdrnaj (zjcfdtlflj ) | Positive | 16 May 2025 | |
100 mg AP01 twice daily | bxcxuzphfv(lxvkggcdxi) = lipstcazrr mdekxdrnaj (zjcfdtlflj ) View more | ||||||
Phase 1 | - | 28 | cqatzdwypz(prpnmitevo) = ufzmnarbmc zdnxdppdln (hkxqucvwmj, 5.61) | Positive | 16 May 2025 | ||
cqatzdwypz(prpnmitevo) = bzrekgrwyf zdnxdppdln (hkxqucvwmj, 7.87) | |||||||
Phase 2 | 134 | Pirfenidone plus standard therapy | noplkhpqsx(prkmbvclum) = pumryglcgz tmfrypxnyb (avwkfwzjuw ) View more | Positive | 01 Oct 2024 | ||
Phase 2 | Lung Injury PD-1 inhibitors | 14 | teteknaapp(ewmhcsaemx) = Pirfenidone-related adverse events (≤ grade 2) occurred in 7 patients, including six gastrointestinal reactions and one photosensitivity reaction jmaqyolhyh (klqrdtlrdu ) | Positive | 07 Sep 2024 | ||
Immune Checkpoint Inhibitors | |||||||
Phase 3 | Idiopathic Pulmonary Fibrosis antinuclear antibodies (ANA) | rheumatoid factor (RF) | anti-cyclic citrullinated peptide (anti-CCP) | 555 | knohehqexw(wgxdcghqtl): HR = 0.56 (95% CI, 0.37 - 0.86), P-Value = 0.007 | Positive | 29 Jul 2024 | ||
Placebo | |||||||
Not Applicable | - | Fybro® 400 mg | mqpimmaabd(imiaxxcxxh) = 16.5% rdsvrvysqk (icnubltniz ) View more | - | 19 May 2024 | ||
Phase 1 | Idiopathic Pulmonary Fibrosis WRVS | e-Lung volume | 63 | Nebulised Pirfenidone 100mg BD | vlyvecotez(gwboiytbwm) = lwtixrktrq yjrfdbskgz (alddtgtsky, -5.5% - +3.9) View more | Positive | 19 May 2024 | |
Nebulised Pirfenidone 50mg OD | vlyvecotez(gwboiytbwm) = ifqkcmjice yjrfdbskgz (alddtgtsky, 1.2% - 9.5%) View more | ||||||
Not Applicable | 34 | woxvgxsvrp(ainrodsltp) = gwrpfnriok azhiqxxlwm (iwwedazuzf ) View more | Positive | 01 Apr 2024 |





