Drug Profile

Nintedanib - Boehringer Ingelheim

Alternative Names: BIBF-1120; CYNEDIV; Intedanib; OFEV; Ofev; Vargatef

Latest Information Update: 10 Dec 2024

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At a glance

Originator Boehringer Ingelheim
Developer Atrium Health; Boehringer Ingelheim; Duke University; European Organisation for Research and Treatment of Cancer; Lurie Cancer Center; M. D. Anderson Cancer Center; National Cancer Institute (USA); Northwestern University; Roswell Park Cancer Institute; University College London; University of Alabama at Birmingham; University of Duisburg-Essen
Class Acetamides; Antifibrotics; Antineoplastics; Esters; Indoles; Piperazines; Skin disorder therapies; Small molecules
Mechanism of Action Fms-like tyrosine kinase 3 inhibitors; Lymphocyte specific protein tyrosine kinase p56(lck) inhibitors; Lyn protein-tyrosine kinase inhibitors; Platelet-derived growth factor alpha receptor antagonists; Platelet-derived growth factor beta receptor antagonists; Src-family kinase inhibitors; Type 1 fibroblast growth factor receptor antagonists; Type 3 fibroblast growth factor receptor antagonists; Type-2 fibroblast growth factor receptor antagonists; Vascular endothelial growth factor receptor-1 antagonists; Vascular endothelial growth factor receptor-2 antagonists; Vascular endothelial growth factor receptor-3 antagonists

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Interstitial lung diseases; Systemic scleroderma; Idiopathic pulmonary fibrosis; Mesothelioma
New Molecular Entity Yes

Marketed Idiopathic pulmonary fibrosis; Interstitial lung diseases; Non-small cell lung cancer; Systemic scleroderma
Phase III Colorectal cancer; Malignant-mesothelioma; Ovarian cancer; Pulmonary fibrosis
Phase II Bladder cancer; Breast cancer; Endometrial cancer; Fallopian tube cancer; Gastrointestinal cancer; Inflammatory breast cancer; Liver cancer; Peritoneal cancer; Renal cell carcinoma; Soft tissue sarcoma
Phase I/II Malignant melanoma
No development reported Multiple myeloma; Salivary gland cancer; Solid tumours
Discontinued Prostate cancer

10 Dec 2024 No development reported - Phase-III for Interstitial lung diseases (In children, In adolescents) in Poland, Ukraine, Hungary, France, Italy, Australia, Russia, Denmark (PO) (NCT04093024) ( EudraCT2018-004530-14)
02 Dec 2024 Nintedanib is still in phase-III trial in Systemic scleroderma in Thailand (PO) (NCT03313180)
02 Dec 2024 No development reported - Phase-III for Interstitial lung diseases (In children, In adolescents) in Portugal, Germany, Greece, United Kingdom, Belgium, Spain, Finland, Czech Republic, Norway (PO) (NCT04093024) ( EudraCT2018-004530-14)

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