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.
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- 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
- -
Expanded Access Program of Nintedanib in Patients With Idiopathic Pulmonary Fibrosis
- Conditions
- First Posted Date
- 2014-09-03
- Last Posted Date
- 2019-02-08
- Lead Sponsor
- Boehringer Ingelheim
- Registration Number
- NCT02230982
- Locations
- 🇧🇷
UNIFESP Departamento de Medicina de Pneumologia, Sao Paulo - SP, Brazil
🇧🇷Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Brazil
🇧🇷Hospital das Clínicas de Sao Paulo - INCOR, Sao Paulo, Brazil
Cisplatin, Docetaxel, and Nintedanib Before Surgery in Treating Patients With Previously Untreated Stage IB-IIIA Non-small Cell Lung Cancer
- Conditions
- Interventions
- First Posted Date
- 2014-08-26
- Last Posted Date
- 2024-05-08
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 26
- Registration Number
- NCT02225405
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers
- First Posted Date
- 2014-07-16
- Last Posted Date
- 2016-02-01
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 33
- Registration Number
- NCT02191865
- Locations
- 🇩🇪
1199.200.49001 Boehringer Ingelheim Investigational Site, Kiel, Germany
Expanded Access Program of Nintedanib in Patients With Idiopathic Pulmonary Fibrosis (EAP)
- Conditions
- First Posted Date
- 2014-06-24
- Last Posted Date
- 2017-05-08
- Lead Sponsor
- Boehringer Ingelheim
- Registration Number
- NCT02171156
- Locations
- 🇺🇸
1199.177.1003 Boehringer Ingelheim Investigational Site, Winter Park, Florida, United States
🇺🇸1199.177.1022 Boehringer Ingelheim Investigational Site, Spartanburg, South Carolina, United States
🇺🇸1199.177.1067 Boehringer Ingelheim Investigational Site, Houston, Texas, United States
ENGOT-cx1/BGOG-cx1: 3 Weekly Carboplatin/Paclitaxel With or Without Nintedanib in Cervix Cancer
- First Posted Date
- 2013-12-12
- Last Posted Date
- 2024-08-07
- Lead Sponsor
- Belgian Gynaecological Oncology Group
- Target Recruit Count
- 120
- Registration Number
- NCT02009579
- Locations
- 🇧🇪
Institut Jules Bordet, Bruxelles, Belgium
🇧🇪AZ Groeninge, Kortrijk, Belgium
🇧🇪UZ Leuven, Leuven, Belgium
Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)
- Conditions
- Interventions
- First Posted Date
- 2013-11-08
- Last Posted Date
- 2018-04-17
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 113
- Registration Number
- NCT01979952
- Locations
- 🇨🇦
St. Paul's Hospital, Vancouver, British Columbia, Canada
🇨🇦QEII Health Sciences Centre (Dalhousie University), Halifax, Nova Scotia, Canada
🇺🇸Lowcountry Lung and Crit Care, Charleston, South Carolina, United States
Nintedanib in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Up to Two Previous Chemotherapy Regimens
- Conditions
- Interventions
- First Posted Date
- 2013-09-23
- Last Posted Date
- 2017-06-08
- Lead Sponsor
- Roswell Park Cancer Institute
- Target Recruit Count
- 6
- Registration Number
- NCT01948141
- Locations
- 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States
🇺🇸University Hospitals Case Medical Center, Cleveland, Ohio, United States
Nintedanib (BIBF 1120) in Mesothelioma
- Conditions
- Interventions
- First Posted Date
- 2013-07-24
- Last Posted Date
- 2019-03-18
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 545
- Registration Number
- NCT01907100
- Locations
- 🇦🇺
Northern Cancer Institute, St Leonards, New South Wales, Australia
🇺🇸Texas Oncology - McAllen, McAllen, Texas, United States
🇺🇸Cancer Care Northwest Centers, PS, Spokane Valley, Washington, United States
Nintedanib(BIBF1120) in Thyroid Cancer
- Conditions
- Interventions
- First Posted Date
- 2013-02-11
- Last Posted Date
- 2020-07-31
- Target Recruit Count
- 100
- Registration Number
- NCT01788982
- Locations
- 🇧🇪
Cliniques Universitaires Saint-Luc, Brussels, Belgium
🇧🇪U.Z. Leuven - Campus Gasthuisberg, Leuven, Belgium
🇮🇹Azienda Ospedaliera Universitaria "Federico II", Napoli, Italy
Relative Bioavailability of a Single Dose of Nintedanib Given Alone and in Combination With Multiple Doses of Rifampicin
- First Posted Date
- 2013-01-17
- Last Posted Date
- 2014-11-27
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 26
- Registration Number
- NCT01770392
- Locations
- 🇩🇪
1199.162.1 Boehringer Ingelheim Investigational Site, Biberach, Germany
Drug Development Updates
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