Nintedanib

Generic Name
Nintedanib
Brand Names
Ofev, Vargatef, Nintedanib Accord
Drug Type
Small Molecule
Chemical Formula
C31H33N5O4
CAS Number
656247-17-5
Unique Ingredient Identifier
G6HRD2P839
Background

Nintedanib is a small molecule kinase inhibitor used in the treatment of pulmonary fibrosis, systemic sclerosis-associated interstitial lung disease, and non-small cell lung cancer (NSCLC). It was first approved for use in the United States in 2014. Within the spectrum of idiopathic pulmonary fibrosis treatment options, nintedanib is currently one of only tw...

Indication

Nintedanib is indicated for the treatment of idiopathic pulmonary fibrosis (IPF) and to slow declining pulmonary function in patients with systemic sclerosis-associated interstitial lung disease. It is also indicated for the treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype.
...

Associated Conditions
Idiopathic Pulmonary Fibrosis (IPF), Respiratory Function Impaired, Chronic Progressive Fibrosing Interstitial Lung Disease, Locally advanced Non-Small Cell Lung Carcinoma (NSCLC), Locally recurrent Non-Small Cell Lung Carcinoma (NSCLC), Metastatic Non-Small Cell Lung Carcinoma (NSCLC)
Associated Therapies
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Investigation of Drug-drug Interaction of Nintedanib and Ketoconazole in Healthy Male Volunteers

Phase 1
Completed
Conditions
Interventions
First Posted Date
2012-09-06
Last Posted Date
2014-11-27
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
34
Registration Number
NCT01679613
Locations
🇩🇪

1199.161.1 Boehringer Ingelheim Investigational Site, Biberach, Germany

Phase II Study of Docetaxel +/- Nintedanib in Breast Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2012-08-07
Last Posted Date
2019-05-31
Lead Sponsor
Centre Oscar Lambret
Target Recruit Count
51
Registration Number
NCT01658462
Locations
🇫🇷

Centre Alexis Vautrin, Vandoeuvre Les Nancy, France

🇫🇷

Centre Léonard de Vinci, Dechy, France

🇫🇷

Institut Jean Godinot, Reims, France

and more 9 locations

Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2012-06-14
Last Posted Date
2022-03-25
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
752
Registration Number
NCT01619085
Locations
🇧🇪

Yvoir - UNIV UCL de Mont-Godinne, Yvoir, Belgium

🇨🇱

Instituto Nacional del Tórax, Santiago de Chile, Chile

🇨🇳

Peking University People's Hospital, Beijing, China

and more 167 locations

Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174)

Phase 2
Completed
Conditions
Interventions
First Posted Date
2011-08-16
Last Posted Date
2017-03-06
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
20
Registration Number
NCT01417156
Locations
🇯🇵

Boehringer Ingelheim Investigational Site, Yokohama, Kanagawa, Japan

Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer

First Posted Date
2010-10-21
Last Posted Date
2017-10-09
Lead Sponsor
Gynecologic Oncology Group
Target Recruit Count
37
Registration Number
NCT01225887
Locations
🇺🇸

MedStar Franklin Square Medical Center/Weinberg Cancer Institute, Baltimore, Maryland, United States

🇺🇸

Riverside Methodist Hospital, Columbus, Ohio, United States

🇺🇸

Bay Area Medical Center, Marinette, Wisconsin, United States

and more 56 locations
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