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Nintedanib - Boehringer Ingelheim

Drug Profile

Nintedanib - Boehringer Ingelheim

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

Latest Information Update: 01 Jan 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; University of Texas Southwestern Medical Center
  • Class Acetamides; Antifibrotics; Antineoplastics; Esters; Indoles; Piperazines; 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 3 antagonists; Vascular endothelial growth factor receptor-1 antagonists; Vascular endothelial growth factor receptor-2 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

Highest Development Phases

  • 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; Pancreatic cancer
  • No development reported Multiple myeloma; Salivary gland cancer; Solid tumours
  • Discontinued Prostate cancer

Most Recent Events

  • 10 Nov 2023 Updated efficacy data from the phase III SENSCIS-ON trial in Systemic scleroderma presented at the ACR Convergence 2023 (ACR-ARP-2023)
  • 09 Sep 2023 Updated efficacy data from a phase III INBUILD trial in Interstitial lung diseases presented at the 33rd Annual Congress of the European Respiratory Society (ERS-2023)
  • 25 Jul 2023 US FDA accepts supplemental new drug application for nintedanib for fibrosing Interstitial lung disease (ILD) (In adolescents, In children) for review
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