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
-

Myositis Interstitial Lung Disease Nintedanib Trial

First Posted Date
2023-04-05
Last Posted Date
2024-12-13
Lead Sponsor
Rohit Aggarwal, MD
Target Recruit Count
70
Registration Number
NCT05799755
Locations
🇺🇸

University of Alabama, Birmingham, Alabama, United States

🇺🇸

Mayo Clinic Arizona, Scottsdale, Arizona, United States

🇺🇸

University of South Florida, Tampa, Florida, United States

and more 8 locations

Dose Reduction and Discontinuation With Anti-Fibrotic Medications

First Posted Date
2023-03-22
Last Posted Date
2023-09-11
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
2778
Registration Number
NCT05779007
Locations
🇺🇸

Boehringer Ingelheim, Ridgefield, Connecticut, United States

Safety of Nintedanib in Real World in China

First Posted Date
2023-01-09
Last Posted Date
2024-12-10
Lead Sponsor
Boehringer Ingelheim
Registration Number
NCT05676112

A Study to Assess the Effect of AZD5055 on the Pharmacokinetics (PK) of Nintedanib in Healthy Participants.

Phase 1
Terminated
Conditions
Interventions
First Posted Date
2022-12-09
Last Posted Date
2024-02-08
Lead Sponsor
AstraZeneca
Target Recruit Count
18
Registration Number
NCT05644600
Locations
🇬🇧

Research Site, Glendale, United Kingdom

Correlation Between Changes in Lung Function and Changes in Cough and Dyspnoea in Nintedanib-treated Connective Tissue Disease Interstitial Lung Disease (CTD-ILD) Patients

Recruiting
Conditions
Interventions
First Posted Date
2022-08-16
Last Posted Date
2024-11-26
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
120
Registration Number
NCT05503030
Locations
🇬🇷

"ATTIKON" University General Hospital, Athens, Greece

🇬🇷

University General Hospital of Heraklion, Heraklion, Greece

🇬🇷

University General Hospital of Patra, Patra, Greece

and more 8 locations

To Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy Volunteers

First Posted Date
2022-05-19
Last Posted Date
2022-05-19
Lead Sponsor
Sunshine Lake Pharma Co., Ltd.
Target Recruit Count
33
Registration Number
NCT05383131
Locations
🇨🇳

Shanghai Xuhui Central Hospital, Shanghai, China

INCHANGE - Nintedanib for Changes in Cough and Dyspnea in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease With a Progressive Phenotype in Everyday Clinical Practice: a Real-world Evaluation

Active, not recruiting
Conditions
Interventions
First Posted Date
2021-12-09
Last Posted Date
2024-07-19
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
160
Registration Number
NCT05151640
Locations
🇧🇬

Acibadem CityClinic UMBAL Tokuda Hospital, Sofia, Bulgaria

🇧🇬

UMBAL Alexandrovska, Sofia, Bulgaria

🇧🇬

MBAL VMA Military Medical Academy, Sofia, Bulgaria

and more 30 locations

Efficacy & Safety of Nintedanib in Patients With Progressive Fibrosing Coal Mine Dust-Induced Interstitial Lung Disease

First Posted Date
2021-10-05
Last Posted Date
2021-10-05
Lead Sponsor
West Virginia University
Target Recruit Count
160
Registration Number
NCT05067517
Locations
🇺🇸

West Virginia University Hospital, Morgantown, West Virginia, United States

A Study to Test How Well a Medicine Called Nintedanib Helps People in China With Progressive Lung Fibrosis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2021-10-01
Last Posted Date
2024-06-12
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
81
Registration Number
NCT05065190
Locations
🇨🇳

China-Japan Friendship Hospital, Beijing, China

🇨🇳

The Second Hospital of Jilin University, Changchun, China

🇨🇳

First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China

and more 13 locations
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