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
-

Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan

Active, not recruiting
Conditions
Interventions
First Posted Date
2020-03-27
Last Posted Date
2024-11-21
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
586
Registration Number
NCT04325217
Locations
🇯🇵

Nippon Boehringer Ingelheim Co., Ltd., Tokyo, Japan

A Study to Find Out How Nintedanib is Taken up in the Body and How Well it is Tolerated in Children and Adolescents With Interstitial Lung Disease (ILD)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2019-09-17
Last Posted Date
2024-07-09
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
39
Registration Number
NCT04093024
Locations
🇺🇸

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

🇬🇷

General Hospital of Thessaloniki "Ippokrateio", Thessaloniki, Greece

🇧🇷

Serviços Medicos Respirar Sul Fluminense, Barra Mansa, Brazil

and more 40 locations

A Study Based on Medical Records That Looks at the Characteristics of Idiopathic Pulmonary Fibrosis Patients Grouped by the Type of Medication They Are Taking

First Posted Date
2019-05-21
Last Posted Date
2021-11-15
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
13264
Registration Number
NCT03958071
Locations
🇺🇸

Plymouth Meeting, Plymouth, Pennsylvania, United States

A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2019-01-29
Last Posted Date
2023-09-13
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
435
Registration Number
NCT03820726
Locations
🇯🇵

National Hospital Organization Himeji Medical Center, Hyogo, Himeji, Japan

🇫🇷

HOP Civil, Strasbourg, France

🇷🇺

1stPavlov St.Med.Univ.St.-Petersburg Res.Inst., St. Petersburg, Russian Federation

and more 118 locations

Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation

First Posted Date
2019-01-15
Last Posted Date
2024-02-01
Lead Sponsor
University Hospital, Basel, Switzerland
Target Recruit Count
20
Registration Number
NCT03805477
Locations
🇸🇦

King Faisal Specialist Hospital & Research Centre, Riyadh, Saudi Arabia

🇨🇭

Clinic of Hematology, University Hospital Basel, Basel, Switzerland

🇨🇭

Clinic of Respiratory Medicine, University Hospital Basel, Basel, Switzerland

Study of Pulmonary Rehabilitation in Patients With Idiopathic Pulmonary Fibrosis (IPF)

First Posted Date
2018-10-23
Last Posted Date
2021-06-09
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
19
Registration Number
NCT03717012
Locations
🇺🇸

The LaPorte County Institute for Clinical Research, Michigan City, Indiana, United States

🇺🇸

Temple University Hospital, Oaks, Pennsylvania, United States

🇺🇸

Metroplex Pul and Sleep Ctr, McKinney, Texas, United States

and more 16 locations

Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib

Completed
Conditions
Interventions
First Posted Date
2018-10-18
Last Posted Date
2024-07-31
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
180
Registration Number
NCT03710824
Locations
🇬🇷

University Hospital of Heraklion, University Pulmonology Cl, Heraklion, Greece

🇬🇷

Univ. Gen. Hosp. of Ioannina, Ioannina, Greece

🇬🇷

Gen. Hosp. of Chest Diseases "Sotiria", Univ. Resp. Med., Athens, Greece

and more 7 locations

A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

Phase 1
Completed
Conditions
Interventions
First Posted Date
2018-09-18
Last Posted Date
2020-11-09
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
17
Registration Number
NCT03675581
Locations
🇪🇸

Hospital Santa Creu i Sant Pau, Barcelona, Spain

🇪🇸

Hospital Vall d'Hebron, Barcelona, Spain

🇳🇱

Radboud Universitair Medisch Centrum, Nijmegen, Netherlands

and more 7 locations

Continuation of Nintedanib After Single Lung Transplantation in IPF Subjects

First Posted Date
2018-06-19
Last Posted Date
2023-04-07
Lead Sponsor
Temple University
Target Recruit Count
1
Registration Number
NCT03562416
Locations
🇺🇸

Temple University Hospital, Philadelphia, Pennsylvania, United States

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