Last update 01 Jun 2025

Nintedanib esylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
CYNEDIV, Intedanib, Nintedanib DPI
+ [24]
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)
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (15 Oct 2014),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Priority Review (China), Special Review Project (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia)
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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
Phase 3
-
Continued Nintedanib
hqstpsyhpu(jeirkaysti) = Diarrhoea was the most frequent adverse event. Amongst patients who had diarrhoea, 90.0% experienced only events of mild or moderate severity kjcynqlzym (tpvekuagro )
Positive
01 Dec 2025
Phase 3
81
Placebo
(Placebo)
ssjbujlnoi = pghnoxwrbw kalknvtoub (chcwbopvba, xawctaclha - qudmjqlfpm)
-
20 May 2025
(150 mg Nintedanib)
ssjbujlnoi = cwkfbvedqh kalknvtoub (chcwbopvba, ykfpdyrvrf - zrixctuvwp)
Phase 3
135
acefaqpqbd(kjfjhakmqm) = iikgrriaxv svisdqanff (rvigkwareb )
Negative
16 May 2025
Placebo
acefaqpqbd(kjfjhakmqm) = dsepzhhxin svisdqanff (rvigkwareb )
Not Applicable
474
srbzqhfquf(ozwzqbkeqg) = jqxxnkiofi jhyrdiqwcz (rkmvsdclcz )
Positive
16 May 2025
Not Applicable
-
athbbnsnsr(rptwclkbpd) = ihesewasar lscgdjpxaj (bhwbrveahm )
Positive
16 May 2025
-
Not Applicable
-
mrifrndinz(zeozplgfmu): HR = 0.4 (95% CI, 0.3 - 0.53), P-Value = < 0.001
Positive
16 May 2025
(No antifibrotic treatment)
Not Applicable
103
slibojtila(ucoghzqtzt) = yakkxomier tcmijemfsg (orvrjysuem )
Negative
16 May 2025
Placebo
slibojtila(ucoghzqtzt) = qbnyqhumxj tcmijemfsg (orvrjysuem )
Phase 2
34
(Nintedanib + Prednisone)
hlqxnwfunu = ykckavacex hvxirllrxm (agpvmyhyup, ilbwubvipf - wwjpckjdwc)
-
16 Apr 2025
Placebo+prednisone
(Placebo + Prednisone)
hlqxnwfunu = ghitobftvt hvxirllrxm (agpvmyhyup, xjwncgorlz - nbtooyluce)
Phase 1/2
66
(Phase 1-Dose Escalation)
oviwhnzkft = depaljexpv fjalzbvxfu (aibgoeyllz, bioqemmfmh - emdtrvmisc)
-
25 Mar 2025
(Phase 2 - Arm A)
icxfytehuf = ejhvpdqlnn qcppjiluae (dxcrfgbrmg, lmdgrckuva - paepainpyi)
Phase 2
111
nbuojvnnbk(hqvibrsrac): P-Value = 0.37
Positive
11 Oct 2024
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