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 two disease-modifying therapies available and indicated for the condition (the other being Pirfenidone) and as such is used as a first-line treatment following diagnosis to slow down the progressive loss of lung function. As a chemotherapeutic agent for NSCLC, nintedanib, in combination with Docetaxel, is reserved for patients who have tried and failed first-line chemotherapeutic options.

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.

In the EU, under the brand name Vargatef, nintedanib is indicated in combination with docetaxel for the treatment of adult patients with metastatic, locally advanced, or locally recurrent non-small cell lung cancer of adenocarcinoma histology who have already tried first-line therapy.

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

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

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

and more 1 locations

Influence of Bosentan on the Pharmacokinetics of Nintedanib

Phase 1
Completed
Conditions
Interventions
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

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-12-02
Last Posted Date
2019-07-23
Lead Sponsor
Centro Nacional de Investigaciones Oncologicas CARLOS III
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

Completed
Conditions
Interventions
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

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

and more 6 locations

A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis

Phase 3
Completed
Conditions
Interventions
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

and more 191 locations

Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)

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

and more 35 locations

Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF

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

and more 20 locations

Relative Bioavailability of 2 Oral Formulations of Nintedanib

Phase 1
Completed
Conditions
Interventions
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

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