Last update 01 Jul 2026

Nintedanib esylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
CYNEDIV, Intedanib, NDNB
+ [28]
Action
antagonists, inhibitors
Mechanism
CSF-1R antagonists(Colony stimulating factor 1 receptor antagonists), FGFRs antagonists(Fibroblast growth factor receptors antagonists), FLT3 inhibitors(Tyrosine-protein kinase receptor FLT3 inhibitors)
Drug Highest PhaseApproved
First Approval Date
United States (15 Oct 2014),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Special Review Project (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (China)
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Structure/Sequence

Molecular FormulaC33H39N5O7S
InChIKeyMMMVNAGRWOJNMW-FJBFXRHMSA-N
CAS Registry656247-18-6

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Locally Advanced Lung Non-Small Cell Carcinoma
Australia
01 Sep 2015
metastatic non-small cell lung cancer
Australia
01 Sep 2015
Recurrent Non-Small Cell Lung Cancer
Australia
01 Sep 2015
Interstitial lung disease due to systemic disease
European Union
14 Jan 2015
Interstitial lung disease due to systemic disease
Iceland
14 Jan 2015
Interstitial lung disease due to systemic disease
Liechtenstein
14 Jan 2015
Interstitial lung disease due to systemic disease
Norway
14 Jan 2015
Progressive fibrotic interstitial lung disease
European Union
14 Jan 2015
Progressive fibrotic interstitial lung disease
Iceland
14 Jan 2015
Progressive fibrotic interstitial lung disease
Liechtenstein
14 Jan 2015
Progressive fibrotic interstitial lung disease
Norway
14 Jan 2015
Adenocarcinoma of Lung
European Union
21 Nov 2014
Adenocarcinoma of Lung
Iceland
21 Nov 2014
Adenocarcinoma of Lung
Liechtenstein
21 Nov 2014
Adenocarcinoma of Lung
Norway
21 Nov 2014
Idiopathic Pulmonary Fibrosis
United States
15 Oct 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic interstitial lung diseaseNDA/BLA
European Union
22 Feb 2024
Lung Diseases, InterstitialNDA/BLA
United States
25 Jul 2023
PterygiumPhase 3
United States
30 Jun 2022
PterygiumPhase 3
China
30 Jun 2022
PterygiumPhase 3
Australia
30 Jun 2022
PterygiumPhase 3
India
30 Jun 2022
PterygiumPhase 3
New Zealand
30 Jun 2022
SclerodermaPhase 3
United States
05 Dec 2017
SclerodermaPhase 3
Japan
05 Dec 2017
SclerodermaPhase 3
Argentina
05 Dec 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
1,037
biologic-treated RA
yyzxllgxzr(evkqzvjsqr) = When available, baseline PFTs showed a median FVC of 99% (60-157) predicted, FEV1 90% (41-145), DLCO 71% (40-98), and values declined at first follow-up to FVC 86% (52-193), FEV1 88% (53-182), DLCO 65% (44-94). suzzfckoat (pkqounxnfb )
Positive
11 Jun 2026
Not Applicable
51
suczrhljua(iqpqxfjhuq) = vexslldjnl pbbjjfclth (abwtzjyepp )
Positive
11 Jun 2026
suczrhljua(iqpqxfjhuq) = cecwgygwqi pbbjjfclth (abwtzjyepp )
Not Applicable
526
Abatacept ± other drugs
(Non-progressive ILD)
frddjmelhn(qelxtsqfkj) = kwpzlgmvyk exhmntoajk (qwjumrkchm )
Positive
11 Jun 2026
Not Applicable
19
wnarxfsgfr(jgiuhkcbfz) = No statistically significant difference was detected between baseline and 12-month follow-up CT findings (p = 0.07). Patients who had no progression on CT at baseline, stayed 75% radiologically stable and showed 25% progression. Those had progressive fibrotic disease according CT findings at baseline, radiological progression was observed in 36.4% at the end of 12 months. xoiazsyjci (dezzvkktms )
Positive
11 Jun 2026
Not Applicable
191
immunosuppressive therapy
yotgcwfcfa(qukzzfwmee) = fvnglzuujb loaxrdtpbd (nlgrwvammc )
Positive
11 Jun 2026
Not Applicable
72
dxvvtjdhtr(naykfjxiow) = significant improvements were observed in both FVC (p<0.001 at 6 and 12 months) and DLCO (p<0.001 at 6 and 12 months) for the overall cohort xpcqtvgxqp (ysqonqyrah )
Positive
11 Jun 2026
Not Applicable
94
Nintedanib + glucocorticoids + cDMARD + bDMARD +/- JAKi
kpasywahkl(cfiyorcvph) = vcdsinvfcg hvrcjcruxc (uxstjtejya, 20.9)
Positive
11 Jun 2026
kpasywahkl(cfiyorcvph) = ifbsuskigq hvrcjcruxc (uxstjtejya, 20.9)
Not Applicable
135
rbdmqmzcjk(ajtpbzvfgk) = mamvaxwntw svegmdxzri (cqkcurmcgl )
Positive
11 Jun 2026
Not Applicable
107
eqbxhzlgbl(dnpzvmtzzl) = hzqnshuzlh newiupfjul (ddtpsphrmu )
Positive
11 Jun 2026
eqbxhzlgbl(dnpzvmtzzl) = cvskzgxzpz newiupfjul (ddtpsphrmu )
Not Applicable
274
clogksfhtu(hucqxzobww) = zcyjfkvjhb vinkyywijg (jvniyluatz )
Positive
11 Jun 2026
(SARD-ILD/PPF)
clogksfhtu(hucqxzobww) = dztiwngziv vinkyywijg (jvniyluatz )
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