THERAPY DOSSIER · th-b0eb3b3e5bef

BIBF1120 (nintedanib)

Drug · Triple angiokinase inhibitor: PDGFR, VEGFR and FGFR (1, 2 and 3) inhibitor (INHIBITOR, direct interaction)

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Evidence & regulatory context

Mechanism: Triple angiokinase inhibitor: PDGFR, VEGFR and FGFR (1, 2 and 3) inhibitor (INHIBITOR, direct interaction)
Target: CHEMBL2095189; CHEMBL2095227; CHEMBL2095217
Injury models: Chemical/toxin
Reported indication: Not recorded
First approval: 2014
Development stage: Not recorded
ChEMBL record: CHEMBL502835 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: BIBF 1120; BIBF-1120; Ofev; Vargatef; Intedanib; nintedanib esylate
Note: Not recorded

Clinical trials 7

0 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT02999178 ↗PHASE3completed

Nintedanib over 52 weeks in progressive fibrosing ILD (INBUILD)

Lung Diseases, Interstitial

Enrolment: 663 · Results not recorded

NCT02866370 ↗PHASE2unknown

Nintedanib vs chemotherapy in recurrent clear cell carcinoma of ovary/endometrium

Ovarian Clear Cell Carcinoma · Endometrial Clear Cell Carcinoma

Enrolment: 120 · Results not recorded

NCT03062943 ↗PHASE2completed

Pilot study of nintedanib for lymphangioleiomyomatosis (LAM)

Lymphangioleiomyomatosis

Enrolment: 30 · Results not recorded

NCT02308553 ↗PHASE1/PHASE2completed

Nintedanib/Vargatef with paclitaxel in BRAF wild-type metastatic melanoma

Cutaneous Malignant Melanoma

Enrolment: 33 · Results not recorded

NCT02182258 ↗PHASE1completed

Single rising IV doses of BIBF 1120 and absolute bioavailability

Healthy

Enrolment: 30 · Results not recorded

NCT04325217 ↗NAcompleted

Post-marketing surveillance of Ofev in SSc-associated ILD (Japan)

Lung Diseases, Interstitial

Enrolment: 586 · Results not recorded

NCT04614441 ↗NAcompleted

Non-interventional evidence collection for ILD (OFEV, Taiwan)

Idiopathic Pulmonary Fibrosis

Enrolment: 214 · Results not recorded

Preclinical evidence 1

1 studies reported at therapy level; 1 evidence entries itemised.

PMID 28291245 ↗2017Reported benefit

Tyrosine kinase inhibitor BIBF1120 ameliorates inflammation, angiogenesis and fibrosis in CCl4-induced liver fibrogenesis mouse model.

MouseChemical/toxinC57BL/6malen = n = 5 per groupintraperitoneal5 mg/kg in 1 per cent DMSO and 5 per cent beta-hydroxycyclo…post-disease, on day 2 and day 3 after carbon tetrachloride given at day 1

Model: Single intraperitoneal injection of carbon tetrachloride 1 mL/kg in olive oil at day 1

Post-disease BIBF1120 at 5 mg/kg reduced collagen I, desmin, alpha-smooth muscle actin, extracellular matrix and adhesion proteins, TIMP1, angiogenic markers and pro-inflammatory cytokines with a shift toward M2 macrophages, although alanine aminotransferase levels were unchanged.

Extraction: extract · Supplied extraction confidence: 0.92. Machine-extracted fields require source verification.

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