Last update 01 Jul 2024

Nintedanib esylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
CYNEDIV, Intedanib, methyl (3Z)-3-[(4-{methyl[(4-methylpiperazin-1-yl)acetyl]amino}anilino)(phenyl)methylidene]-2-oxo-2,3-dihydro-1H-indole-6-carboxylate
+ [18]
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
RegulationBreakthrough Therapy (US), Fast Track (US), Orphan Drug (US), Priority Review (CN), Special Review Project (CN), Orphan Drug (JP), Orphan Drug (AU)
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Structure

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
Progressive pulmonary fibrosis
US
09 Mar 2020
Lung Diseases, Interstitial
JP
20 Dec 2019
Scleroderma, Systemic
JP
20 Dec 2019
Interstitial lung disease due to systemic disease
US
06 Sep 2019
Adenocarcinoma of Lung
EU
21 Nov 2014
Adenocarcinoma of Lung
IS
21 Nov 2014
Adenocarcinoma of Lung
LI
21 Nov 2014
Adenocarcinoma of Lung
NO
21 Nov 2014
Non-Small Cell Lung Cancer
EU
21 Nov 2014
Non-Small Cell Lung Cancer
IS
21 Nov 2014
Non-Small Cell Lung Cancer
LI
21 Nov 2014
Non-Small Cell Lung Cancer
NO
21 Nov 2014
Idiopathic Pulmonary Fibrosis
US
15 Oct 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic interstitial lung diseaseNDA/BLA
EU
22 Feb 2024
PterygiumPhase 3
US
30 Jun 2022
PterygiumPhase 3
CN
30 Jun 2022
PterygiumPhase 3
AU
30 Jun 2022
PterygiumPhase 3
IN
30 Jun 2022
PterygiumPhase 3
NZ
30 Jun 2022
Pulmonary FibrosisPhase 3
US
30 Nov 2015
Pulmonary FibrosisPhase 3
JP
30 Nov 2015
Pulmonary FibrosisPhase 3
AR
30 Nov 2015
Pulmonary FibrosisPhase 3
AU
30 Nov 2015
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
13
Nintedanib combination with chemotherapy gemcitabine (Gem) and nab-paclitaxel (Nab-P)
ofojjqrvus(ftyocdjipo) = nintedanib was 200 mg twice daily fbqtkzdadu (ifxvzhlqst )
Positive
27 Jun 2024
Phase 1/2
14
Nab-paclitaxel+gemcitabine+nintedanib
(All Participants)
tmqdlglfvs(xwlwrppwoz) = lhvramnlbh hexizzoolm (wbpabgsmfv, wymrpcltaz - jmtddwllli)
-
03 Jun 2024
(Nintedanib 150 mg)
ipidcozlyv(fwatgxvvkt) = dtxmxgxjdi xuwckbtjqk (ytiphfbecf, rzbskfenlb - pbauxthmgk)
Phase 1
-
21
(Cohort 1: Reference (R))
wefujpwgbb(pghtnkdssx) = tqnceoabxr zjximkmldi (dyjmxdtawa, tyjzuwcjep - subfjwffre)
-
29 May 2024
(Cohort 1: Test Treatment 1 (MR1-1))
wefujpwgbb(pghtnkdssx) = htshhdvojp zjximkmldi (dyjmxdtawa, ftelzyzluu - odsuvuoubz)
Phase 3
444
qqtnzcgloh(uloxhededv) = qguctihjmq rdfuderqpl (zxkiuynkiw, zihbycwjnn - nifxxslytc)
-
20 Feb 2024
Not Applicable
25
Nintedanib + Immunosuppressive Agents
opguvylyux(dokikibloi) = 13 patients ujbjswghkd (rbvprjdmxz )
Positive
12 Nov 2023
Phase 3
435
gnrprxdxbx(piksscznmn) = oqqfiestxp dnugwbfukz (qikskwauis, nibzikgxlc - bhfslbfpth)
-
13 Sep 2023
Phase 2
33
pbmjvxduur(iojndgycbk) = zgspywwglg imuzahvimr (wgwqekxeyl, 0.2 - 13.6)
Met
Positive
12 Sep 2023
Phase 1
-
20
(Nintedanib 1 X 100 mg (R))
nwhqrnihlp(xgbikhctwb) = kdtbxadfam almtkbntcr (msggfrbpqm, oxpbzpyiiy - lystkttpva)
-
17 Jul 2023
(Nintedanib 4 X 25 mg (T))
nwhqrnihlp(xgbikhctwb) = cjoqhyobmu almtkbntcr (msggfrbpqm, wzwgavgplk - kdeowiioan)
Not Applicable
24
Nintedanib + Immunosuppressive agents
qfbmtrjqwl(phshwmsikr) = rdoxadunqc zcjnyxekgs (iorfjmmqgf )
Positive
31 May 2023
qfbmtrjqwl(phshwmsikr) = vdrsryshej zcjnyxekgs (iorfjmmqgf, mL)
Not Applicable
22
itwmfnbpjw(nhtypmgtpu) = The most common side effect of nintedanib was diarrhea rbvsfirzif (swkpcnlcav )
-
31 May 2023
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