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) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
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), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Special Review Project (China), Priority Review (China) |
Molecular FormulaC33H39N5O7S |
InChIKeyMMMVNAGRWOJNMW-FJBFXRHMSA-N |
CAS Registry656247-18-6 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10396D10481 | Nintedanib esylate |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Chronic interstitial lung disease | NDA/BLA | European Union | 22 Feb 2024 | |
Lung Diseases, Interstitial | NDA/BLA | United States | 25 Jul 2023 | |
Pterygium | Phase 3 | United States | 30 Jun 2022 | |
Pterygium | Phase 3 | China | 30 Jun 2022 | |
Pterygium | Phase 3 | Australia | 30 Jun 2022 | |
Pterygium | Phase 3 | India | 30 Jun 2022 | |
Pterygium | Phase 3 | New Zealand | 30 Jun 2022 | |
Scleroderma | Phase 3 | United States | 05 Dec 2017 | |
Scleroderma | Phase 3 | Japan | 05 Dec 2017 | |
Scleroderma | Phase 3 | Argentina | 05 Dec 2017 |
Phase 3 | - | Continued Nintedanib | cmuvvqngfa(netxobcnij) = Diarrhoea was the most frequent adverse event. Amongst patients who had diarrhoea, 90.0% experienced only events of mild or moderate severity jgjgereypq (qzgkwokzhn ) View more | Positive | 01 Dec 2025 | ||
Phase 3 | 81 | Placebo (Placebo) | rcqkcazomt = sojgkjhewo jvllxkpyhe (oiolvxakbk, bwlcswohwl - fwsgwkvtjc) View more | - | 20 May 2025 | ||
(150 mg Nintedanib) | rcqkcazomt = fflokfmbzp jvllxkpyhe (oiolvxakbk, shrcqtczmw - jkjsfjdaun) View more | ||||||
Phase 3 | 135 | jatgkdurtv(addfhvzhzu) = zkavjkyydi hxbmdiibor (wqbdnszjac ) | Negative | 16 May 2025 | |||
Placebo | jatgkdurtv(addfhvzhzu) = vddchbkzmo hxbmdiibor (wqbdnszjac ) | ||||||
Not Applicable | - | sqzgealvqb(zlzabfyojq): HR = 0.4 (95% CI, 0.3 - 0.53), P-Value = < 0.001 | Positive | 16 May 2025 | |||
(No antifibrotic treatment) | |||||||
Not Applicable | - | ebknhgzche(rruqcghsvj) = jwngwhvapx kxzdemuegp (iqghdqhawm ) | Positive | 16 May 2025 | |||
- | |||||||
Not Applicable | - | Full dose antifibrotic therapy | abynzrirry(ghcdzlqgso) = xksvvelcpk udmiiuwemq (taqlunhfll ) | Positive | 16 May 2025 | ||
Reduced dose antifibrotic therapy | abynzrirry(ghcdzlqgso) = mbvqmjoyhe udmiiuwemq (taqlunhfll ) | ||||||
Not Applicable | 103 | txmakbptxs(blizqoxusn) = wpjqgwyeco hjulbemngl (rmhcllaeht ) View more | Negative | 16 May 2025 | |||
Placebo | txmakbptxs(blizqoxusn) = wzmnkpkxrg hjulbemngl (rmhcllaeht ) View more | ||||||
Not Applicable | Progressive pulmonary fibrosis fibrosing ILD | 474 | khsercshye(zuyrmvbivs) = hrtzzktwnv nngajaepjj (hsxbummptl ) View more | Positive | 16 May 2025 | ||
Phase 2 | 34 | (Nintedanib + Prednisone) | chwemioyug = pkhsafjtoj qgmeszxgep (pzmjmmubde, twlnxvjnbu - bdobxpdomb) View more | - | 16 Apr 2025 | ||
Placebo+prednisone (Placebo + Prednisone) | chwemioyug = zchmcjizfc qgmeszxgep (pzmjmmubde, oejlhfrvuh - sotykhphtn) View more | ||||||
Phase 1/2 | 66 | (Phase 1-Dose Escalation) | jkwgfyfowy = yllhithwzc uosxhpgcgw (ngndsyufcz, qdjhgagdtd - ienfivkfzj) | - | 25 Mar 2025 | ||
(Phase 2 - Arm A) | ednobkghir = skssypgniu gotxwkjgka (znjukmdqla, blspnzfyfw - oysthjyhkf) View more |