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.
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- 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
- -
Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer
- Conditions
- Interventions
- First Posted Date
- 2017-12-19
- Last Posted Date
- 2024-06-26
- Target Recruit Count
- 68
- Registration Number
- NCT03377023
- Locations
- 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
A Study to Evaluate the Effect of Multiple Doses of CC-90001 on the Pharmacokinetics of Omeprazole, Midazolam, Warfarin, Rosuvastatin, Metformin, Digoxin, and Nintedanib in Healthy Adult Subjects
- First Posted Date
- 2017-12-06
- Last Posted Date
- 2019-01-25
- Lead Sponsor
- Celgene
- Target Recruit Count
- 56
- Registration Number
- NCT03363815
- Locations
- 🇺🇸
Covance Clinical Research Unit, Daytona Beach, Florida, United States
A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis
- First Posted Date
- 2017-10-18
- Last Posted Date
- 2024-02-20
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 444
- Registration Number
- NCT03313180
- Locations
- 🇫🇷
HOP Pasteur, Nice, France
🇦🇷Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich, Buenos Aires, Argentina
🇦🇷CEMER-Centro Medico De Enfermedades Respiratorias, Florida, Argentina
Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)]
- Conditions
- Interventions
- First Posted Date
- 2017-09-25
- Last Posted Date
- 2022-03-29
- Lead Sponsor
- Seoul National University Hospital
- Target Recruit Count
- 180
- Registration Number
- NCT03292250
- Locations
- 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of
LCI-GI-APX-NIN-001: Nintedanib in Metastatic Appendiceal Carcinoma
- First Posted Date
- 2017-09-19
- Last Posted Date
- 2022-08-09
- Lead Sponsor
- Wake Forest University Health Sciences
- Target Recruit Count
- 5
- Registration Number
- NCT03287947
- Locations
- 🇺🇸
Levine Cancer Institute, Charlotte, North Carolina, United States
Nintedanib in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome Grade 0p-1-2
- First Posted Date
- 2017-09-14
- Last Posted Date
- 2024-05-31
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Target Recruit Count
- 80
- Registration Number
- NCT03283007
- Locations
- 🇫🇷
Foch Hospital, Suresnes, France
Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan
- First Posted Date
- 2017-08-08
- Last Posted Date
- 2021-04-13
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 101
- Registration Number
- NCT03242759
- Locations
- 🇨🇳
Chang-Hua Christian Hospital, Changhua, Taiwan
🇨🇳Chang Gung Memorial Hospital(Linkou), Tao-Yuan, Taiwan
🇨🇳Taichung Veterans General Hospital, Taichung, Taiwan
A Study of Nintedanib for LymphAngioleioMyomatosis (LAM)
- First Posted Date
- 2017-02-24
- Last Posted Date
- 2022-09-28
- Lead Sponsor
- IRCCS Multimedica
- Target Recruit Count
- 30
- Registration Number
- NCT03062943
- Locations
- 🇮🇹
Pneumology unit, Milan, Italy
Post Marketing Surveillance of Nintedanib in Indian Patients With Idiopathic Pulmonary Fibrosis
- First Posted Date
- 2017-02-08
- Last Posted Date
- 2024-08-22
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 21
- Registration Number
- NCT03047031
- Locations
- 🇮🇳
P.D. Hinduja National Hospital, Mumbai, India
🇮🇳Asthma Bhawan, Jaipur, India
🇮🇳CK Birla Hospitals, The Calcutta Medical Research Institute, Kolkata, India
Efficacy and Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
- First Posted Date
- 2016-12-21
- Last Posted Date
- 2020-05-05
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 663
- Registration Number
- NCT02999178
- Locations
- 🇺🇸
The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
🇺🇸Baylor University Medical Center, Dallas, Texas, United States
🇧🇪ULB Hopital Erasme, Bruxelles, Belgium
Drug Development Updates
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