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)

Clinical Trials

Study to Determine Potential for Drug-drug Interactions When Co-administering Deupirfenidone (LYT-100) and Nintedanib

Phase 1

Not yet recruiting

Conditions: Drug Interactions

Interventions: Drug: Nintedanib 150 MG [Ofev]

First Posted Date: 2024-12-04

Last Posted Date: 2024-12-04

Lead Sponsor: PureTech

Target Recruit Count: 30

Registration Number: NCT06717100

Nintedanib Treatment in Unicentric Castleman Disease

Phase 2

Not yet recruiting

Conditions: Castleman Disease

Interventions: Drug: Nintedanib

First Posted Date: 2024-10-15

Last Posted Date: 2024-10-15

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 13

Registration Number: NCT06643091

A Study to Evaluate the Safety, Tolerability and Blood Levels of GSK3915393 Administered to Healthy Participants of Chinese, Japanese and European Ancestry and to Assess Effects of GSK3915393 on Nintedanib

Phase 1

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Nintedanib
Drug: GSK3915393

First Posted Date: 2024-10-03

Last Posted Date: 2025-02-18

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 50

Registration Number: NCT06625489

Locations: 🇺🇸
GSK Investigational Site, Las Vegas, Nevada, United States

Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC

Recruiting

Conditions: Radiation Pneumonitis
NSCLC
Nintedanib

First Posted Date: 2024-08-26

Last Posted Date: 2024-08-26

Lead Sponsor: Second Hospital of Shanxi Medical University

Target Recruit Count: 40

Registration Number: NCT06570317

Locations: 🇨🇳
Jinzhong third people's hospital, Jinzhong, Shanxi, China
🇨🇳
Jincheng General Hospital, Jincheng, Shanxi, China
🇨🇳
Frist Hospital of Shanxi Medical University, Taiyuan, Shanxi, China

and more 4 locations