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
- -
Investigation of the Effect of Nintedanib on the Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Patients With Non-small Cell Lung Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-04-26
- Last Posted Date
- 2019-03-14
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 2
- Registration Number
- NCT02751385
- Locations
- 🇩🇪
Klinikum Chemnitz gGmbH, Chemnitz, Germany
Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma
- Conditions
- Interventions
- First Posted Date
- 2016-01-29
- Last Posted Date
- 2021-01-29
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 14
- Registration Number
- NCT02668393
- Locations
- 🇫🇷
HOP d'Angers, Angers, France
🇫🇷HOP Jean Minjoz, Besançon, France
🇩🇪Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH, Großhansdorf, Germany
Influence of Bosentan on the Pharmacokinetics of Nintedanib
- First Posted Date
- 2016-01-29
- Last Posted Date
- 2017-04-13
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 13
- Registration Number
- NCT02667704
- Locations
- 🇩🇪
Boehringer Ingelheim Investigational Site, Biberach, Germany
Nintedanib+Letrozole in Postmenopausal Women With Breast Cancer: Clinical Trial Safety and Pharmacodynamics
- First Posted Date
- 2015-12-02
- Last Posted Date
- 2019-07-23
- Target Recruit Count
- 25
- Registration Number
- NCT02619162
- Locations
- 🇪🇸
Hospital de La Princesa, Madrid, Spain
🇪🇸Clínica Quirón, Madrid, Spain
🇪🇸Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain
All-Case Surveillance of Ofev in Patients With IPF in Japan
- First Posted Date
- 2015-11-18
- Last Posted Date
- 2024-10-11
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 10117
- Registration Number
- NCT02607722
A Study to Compare the Amount of Nintedanib and Pirfenidone in the Blood When Nintedanib and Pirfenidone Are Given Separately or in Combination
- Conditions
- Interventions
- First Posted Date
- 2015-11-17
- Last Posted Date
- 2019-03-04
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 37
- Registration Number
- NCT02606877
- Locations
- 🇬🇧
Papworth Hospital, Cambridge, United Kingdom
🇬🇧Glenfield Hospital, Leicester, United Kingdom
🇬🇧Southmead Hospital, Bristol, United Kingdom
A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis
- First Posted Date
- 2015-11-05
- Last Posted Date
- 2019-12-13
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 580
- Registration Number
- NCT02597933
- Locations
- 🇺🇸
University of Texas Southwestern Medical Center, Dallas, Texas, United States
🇦🇺St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia
🇧🇪ULB Hopital Erasme, Bruxelles, Belgium
Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)
- Conditions
- Interventions
- First Posted Date
- 2015-11-05
- Last Posted Date
- 2018-06-13
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 89
- Registration Number
- NCT02598193
- Locations
- 🇺🇸
Stanford University School of Medicine ; Pulmonary/Critical Care Medicine, Stanford, California, United States
🇺🇸Mount Sinai School of Medicine, New York, New York, United States
🇺🇸Inova Health Care Services; Advanced Lung Disease Transplant Program, Falls Church, Virginia, United States
Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF
- Conditions
- Interventions
- First Posted Date
- 2015-10-19
- Last Posted Date
- 2018-02-13
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 105
- Registration Number
- NCT02579603
- Locations
- 🇺🇸
Western CT Medical Group, P.C., Danbury, Connecticut, United States
🇫🇷HOP Avicenne, Bobigny, France
🇫🇷HOP de la Cavale Blanche, Brest, France
Relative Bioavailability of 2 Oral Formulations of Nintedanib
- First Posted Date
- 2015-10-09
- Last Posted Date
- 2017-01-05
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 70
- Registration Number
- NCT02572752
- Locations
- 🇩🇪
Boehringer Ingelheim Investigational Site, Biberach, Germany
Drug Development Updates
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