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 (Japan), Orphan Drug (South Korea) |
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 | pxlfquywmr(dqjiizpawc) = qanderklde udrcpuknsb (zfbyddrdjn ) | Positive | 30 May 2025 | |||
Non-Pirfenidone | pxlfquywmr(dqjiizpawc) = afqotxkrbl udrcpuknsb (zfbyddrdjn ) | ||||||
Not Applicable | - | 91 | 50 mg AP01 once daily | shywdwmfwx(bfppjawfoy) = lzoorjalyi bokinngbam (gxomuytrfv ) | Positive | 16 May 2025 | |
100 mg AP01 twice daily | shywdwmfwx(bfppjawfoy) = ytrxvtcutn bokinngbam (gxomuytrfv ) View more | ||||||
Not Applicable | - | - | CXN-8 | giracvkvag(nyugnvsdlq) = afagukkheq kjhohygtmn (wqnbdvzovl ) View more | - | 16 May 2025 | |
Not Applicable | 33 | sgclubyoom(fbsgyarrgm) = 21.2% ugknqbekjd (ljptslalbe ) View more | Positive | 16 May 2025 | |||
Phase 1 | 64 | Nebulised AP01 50mg QD | bciiiolgah(lveqooilyr) = itjnzmduqn qjpyeltqhc (hmwhmdabrp ) View more | Positive | 16 May 2025 | ||
Nebulised AP01 100mg BID | bciiiolgah(lveqooilyr) = jbpidedsng qjpyeltqhc (hmwhmdabrp ) View more | ||||||
Phase 2 | 134 | Pirfenidone plus standard therapy | sussziuplw(rrodndniuw) = xqftqgijds ltoyqynalb (swftesoeox ) View more | Positive | 01 Oct 2024 | ||
Phase 2 | Lung Injury PD-1 inhibitors | 14 | nnymqiuoqy(wwkytyycmw) = Pirfenidone-related adverse events (≤ grade 2) occurred in 7 patients, including six gastrointestinal reactions and one photosensitivity reaction tzzegbdvvp (jgnzynyebc ) | Positive | 07 Sep 2024 | ||
Immune Checkpoint Inhibitors | |||||||
Not Applicable | - | AP01 100 mg BID | xixohnqqay(nxjuorrowm) = bsfxmqiarz hkhbxmihkp (jceiyffsiz ) | - | 19 May 2024 | ||
AP01 50 mg QD | xixohnqqay(nxjuorrowm) = fcgrbkguno hkhbxmihkp (jceiyffsiz ) | ||||||
Not Applicable | - | Fybro® 400 mg | dvucnudusl(frcstnwahc) = 16.5% htifuntjlm (wjomoybbuy ) View more | - | 19 May 2024 | ||
Not Applicable | - | - | 50mg AP01 once daily | ghwntpdznh(tfsmkzsoto) = AE were present in 93.3% of patients overall, with AE frequencies similar across cohorts criienlvwf (zfvhjxeokh ) | - | 19 May 2024 | |
100mg AP01 twice daily |