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) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (15 Oct 2014), |
RegulationBreakthrough Therapy (US), Fast Track (US), Orphan Drug (US), Priority Review (CN), Special Review Project (CN), Orphan Drug (JP), Orphan Drug (AU) |
Molecular FormulaC33H39N5O7S |
InChIKeyMMMVNAGRWOJNMW-FJBFXRHMSA-N |
CAS Registry656247-18-6 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10396 | Nintedanib esylate |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Chronic interstitial lung disease | NDA/BLA | EU | 22 Feb 2024 | |
Pterygium | Phase 3 | US | Cloudbreak Therapeutics LLCStartup | 30 Jun 2022 |
Pterygium | Phase 3 | CN | Cloudbreak Therapeutics LLCStartup | 30 Jun 2022 |
Pterygium | Phase 3 | AU | Cloudbreak Therapeutics LLCStartup | 30 Jun 2022 |
Pterygium | Phase 3 | IN | Cloudbreak Therapeutics LLCStartup | 30 Jun 2022 |
Pterygium | Phase 3 | NZ | Cloudbreak Therapeutics LLCStartup | 30 Jun 2022 |
Pulmonary Fibrosis | Phase 3 | US | 30 Nov 2015 | |
Pulmonary Fibrosis | Phase 3 | JP | 30 Nov 2015 | |
Pulmonary Fibrosis | Phase 3 | AR | 30 Nov 2015 | |
Pulmonary Fibrosis | Phase 3 | AU | 30 Nov 2015 |
Phase 1 | 13 | Nintedanib combination with chemotherapy gemcitabine (Gem) and nab-paclitaxel (Nab-P) | ofojjqrvus(ftyocdjipo) = nintedanib was 200 mg twice daily fbqtkzdadu (ifxvzhlqst ) View more | 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) View more | ||||||
Phase 1 | - | 21 | (Cohort 1: Reference (R)) | wefujpwgbb(pghtnkdssx) = tqnceoabxr zjximkmldi (dyjmxdtawa, tyjzuwcjep - subfjwffre) View more | - | 29 May 2024 | |
(Cohort 1: Test Treatment 1 (MR1-1)) | wefujpwgbb(pghtnkdssx) = htshhdvojp zjximkmldi (dyjmxdtawa, ftelzyzluu - odsuvuoubz) View more | ||||||
Phase 3 | 444 | qqtnzcgloh(uloxhededv) = qguctihjmq rdfuderqpl (zxkiuynkiw, zihbycwjnn - nifxxslytc) View more | - | 20 Feb 2024 | |||
Not Applicable | Progressive pulmonary fibrosis serum KL-6 | 25 | Nintedanib + Immunosuppressive Agents | opguvylyux(dokikibloi) = 13 patients ujbjswghkd (rbvprjdmxz ) View more | Positive | 12 Nov 2023 | |
Phase 3 | 435 | gnrprxdxbx(piksscznmn) = oqqfiestxp dnugwbfukz (qikskwauis, nibzikgxlc - bhfslbfpth) View more | - | 13 Sep 2023 | |||
Phase 2 | 33 | pbmjvxduur(iojndgycbk) = zgspywwglg imuzahvimr (wgwqekxeyl, 0.2 - 13.6) Met View more | Positive | 12 Sep 2023 | |||
Phase 1 | - | 20 | (Nintedanib 1 X 100 mg (R)) | nwhqrnihlp(xgbikhctwb) = kdtbxadfam almtkbntcr (msggfrbpqm, oxpbzpyiiy - lystkttpva) View more | - | 17 Jul 2023 | |
(Nintedanib 4 X 25 mg (T)) | nwhqrnihlp(xgbikhctwb) = cjoqhyobmu almtkbntcr (msggfrbpqm, wzwgavgplk - kdeowiioan) View more | ||||||
Not Applicable | 24 | Nintedanib + Immunosuppressive agents | qfbmtrjqwl(phshwmsikr) = rdoxadunqc zcjnyxekgs (iorfjmmqgf ) View more | Positive | 31 May 2023 | ||
qfbmtrjqwl(phshwmsikr) = vdrsryshej zcjnyxekgs (iorfjmmqgf, mL) View more | |||||||
Not Applicable | 22 | itwmfnbpjw(nhtypmgtpu) = The most common side effect of nintedanib was diarrhea rbvsfirzif (swkpcnlcav ) | - | 31 May 2023 |