Nintedanib

Generic Name: Nintedanib

Brand Names: Ofev, Vargatef, Nintedanib Accord

Drug Type: Small Molecule

Chemical Formula: C_₃₁H_₃₃N_₅O_₄

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: -

Clinical Trials

Safety and Effectiveness of Nintedanib in Korean Patients

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Nintedanib

First Posted Date: 2020-08-25

Last Posted Date: 2024-03-12

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 70

Registration Number: NCT04525547

Locations: 🇰🇷
Seoul National University Bundang Hospital, Gyeonggi-do, Korea, Republic of
🇰🇷
Inje University Ilsan Paik Hospital, Gyeonggi-do, Korea, Republic of
🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

and more 19 locations

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: Lung Diseases, Interstitial

Interventions: Drug: Nintedanib

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: Lung Diseases, Interstitial

Interventions: Drug: Placebo
Drug: Nintedanib

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

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Nintedanib
Drug: Pirfenidone
Other: Untreated Cohort

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: Lung Diseases, Interstitial

Interventions: Drug: Nintedanib

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

Phase 2

Recruiting

Conditions: Bronchiolitis Obliterans Syndrome (BOS)
Bronchiolitis Obliterans (BO)

Interventions: Drug: Nintedanib

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)

Phase 4

Terminated

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Nintedanib
Other: Pulmonary rehabilitation program

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: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Nintedanib

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: Scleroderma, Systemic

Interventions: Drug: Microgynon
Drug: Nintedanib

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

Phase 2

Terminated

Conditions: Idiopathic Pulmonary Fibrosis
Lung Transplant; Complications

Interventions: Drug: Nintedanib
Drug: Placebo Oral Tablet

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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