Drug · Small Molecule

Nintedanib

CI-DRUG-00000408Explore in graph →NCIt C62765 CHEMBL502835 CIViC Approved

Regulatory

Approvals (17)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory4 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	—	Nintedanib Viatris is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Viatris is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Nintedanib Viatris is indicated in children and adolescents from 6 to 17 years old for the treatment of clinically significant, progressive fibrosing interstitial lung diseases (ILDs). Nintedanib Viatris is indicated in adults, adolescents and children aged 6 years and older for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).	approved

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 10 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	2	5	71	17	CA, EU, US	Oct 15, 2014	2002-11
Malignant Lung Neoplasm	Approved	Phase 3	1	2	20	1	EU	Nov 21, 2014	2005-06
Malignant Mesothelioma	Phase3	Phase 3	0	1	3	0	—	—	Sep 19, 2013
Malignant Breast Neoplasm	Phase2	Phase 2	0	0	3	0	—

Curated evidence

Clinical evidence (1)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–1 of 1 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
RET Fusion1
Nintedanib	Lung Non-Small Cell Carcinoma

Clinical trials

Trials with this intervention (71)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 71 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT01658462	Phase II Study of Docetaxel +/- Nintedanib in Breast Cancer(VAROCE)	completed	Phase 2	51	Centre Oscar LambretOTHER	1	Sep 17, 2026	clinicaltrials
NCT03377023	Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer	active not recruiting

Molecule

Record

Kind: Small Molecule
Mechanism: Platelet-derived growth factor receptor inhibitor; Vascular endothelial growth factor receptor inhibitor; Fibroblast growth factor receptor inhibitor
Targets: 9 genes
UNII: 42F62RTZ4G
Aliases: AURO-NINTEDANIB, BIBF 1120, BIBF1120, EUGIA-NINTEDANIB, GLN-NINTEDANIB, Intedanib, JAMP NINTEDANIB, Methyl (3Z)-3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino)(phenyl)methylidene)-2-oxo-2,3-dihydro-1H-indole-6-carboxylate, Multitargeted Tyrosine Kinase Inhibitor BIBF 1120, Nintedanib, Nintedanib Accord, NINTEDANIB CAPSULES, 100 MG AND 150 MG, Nintedanib component of ofev, Nintedanib Esilate, Nintedanib Viatris, OFEV, Tyrosine Kinase Inhibitor BIBF 1120, Vargatef

Data updated 13 hours agoSource updated unknown

Identifiers

Codes (25)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EX09	NINTEDANIB
DIN (Health Canada)	02443066