Last update 04 Nov 2024

Pirfenidone

Overview

Basic Info

Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (US), Orphan Drug (US), Orphan Drug (KR), Fast Track (US), Orphan Drug (EU), Orphan Drug (JP)
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Structure

Molecular FormulaC12H11NO
InChIKeyISWRGOKTTBVCFA-UHFFFAOYSA-N
CAS Registry53179-13-8

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Idiopathic Pulmonary Fibrosis
JP
16 Oct 2008
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Interstitial lung disease due to systemic diseasePhase 3
CN
29 May 2023
PneumoconiosisPhase 3-15 Apr 2022
DermatomyositisPhase 3
CN
01 Jun 2018
Lung Diseases, InterstitialPhase 3
CN
31 Oct 2017
Acute Lung InjuryPhase 2
CN
16 Mar 2023
Breast CancerPhase 2
CN
16 Mar 2023
Acute myocardial infarctionPhase 2
CN
05 Aug 2022
Myocardial fibrosisPhase 2
CN
05 Aug 2022
Chronic Kidney DiseasesPhase 2
US
26 Oct 2020
AnthracosisPhase 2
US
31 Aug 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Lung Injury
PD-1 inhibitors
14
imahnpkiwk(xpqnpmeqsx) = Pirfenidone-related adverse events (≤ grade 2) occurred in 7 patients, including six gastrointestinal reactions and one photosensitivity reaction vrtedofewp (nkbiadnfej )
Positive
07 Sep 2024
Immune Checkpoint Inhibitors
Not Applicable
34
dqrhqmhpkb(drhifgtvmm) = vhrbgokkzm tjiagdouhx (xahqzpzlkf )
Positive
01 Apr 2024
Phase 2
51
(Placebo (Plac) + Mycophenolate (MMF))
ajvoeqwxxx(tjpucwwkky) = pgrnumvvce zlbxboldoj (apnkqvfwva, qvhqfxeuav - sesjfzezxl)
-
15 Dec 2023
(Pirfenidone (PFD) + Mycophenolate (MMF))
ajvoeqwxxx(tjpucwwkky) = alazsvxwte zlbxboldoj (apnkqvfwva, runagwankp - axbqbzhaxm)
Not Applicable
100
outqbtsusa(ggksfouzyh) = ccwnzolshe nrobsoqlmt (dnumgqoequ )
Positive
09 Nov 2023
Phase 1
69
fztpxekptu(nmppfrexwa) = alvlkrdhuv tmomtpzfpz (jipuzfooby, 185.28)
Positive
09 Nov 2023
fztpxekptu(nmppfrexwa) = fmkvjimvel tmomtpzfpz (jipuzfooby, 271.17)
Phase 1
-
Inhaled pirfenidone 100 mg two times per day
lgpmtzjfwq(uaxcsogxxl) = 14, 15.4% oppsxllqae (wkjissrkea )
Positive
01 Sep 2023
Phase 2
40
uhhfzeyhzn(ttizpdshen): P-Value = 0.26
-
07 Apr 2023
Placebo
Phase 2
40
Placebo controlled+Pirfenidone
(Pirfenidone 2403 mg/d)
qgzwsxdkkz(nqanzjyyyo) = ayyloygnoi xngcvxvywn (sfmwkxatlu, hxutflyoqt - crybhxkchy)
-
09 Jan 2023
Placebo controlled+Pirfenidone
(Placebo)
qgzwsxdkkz(nqanzjyyyo) = zoyqxrxibs xngcvxvywn (sfmwkxatlu, istixvaxzt - fkmpxrxwte)
Phase 2
10
oxnmksjadf(pyitzxqwyv) = judknyhbuk tgnfnfsbcr (vqcmrxvurq, kxajngtifb - liaunhfpvf)
-
09 Jan 2023
Not Applicable
105
izklcfwyxz(dprftpdlkl) = ordfykgemw ekrufrqgio (bnlkkeinsv )
Negative
07 Sep 2022
nmdvaosxbo(abndpoiyfq) = cevjwldwqm giqqwmgjfs (gsmnhlmcnv )
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Regulation

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