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Home › Medications › nintedanib

nintedanib

6 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials of nintedanib

44 trials tracked of nintedanib: 14 in phase 3 or 4 and 12 with published results. The most-cited published study has 296 citations.

44Trials tracked
14Phase 3 & 4
0Recruiting
12With published results
Phase distribution
Phase 4 5 Phase 3 9 Phase 2 9 Phase 1 9 Other / NA 12
  1. Phase 4 Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF Completed · 296 cited
  2. Phase 3 Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function Impairment Completed · 259 cited
  3. Phase 3 Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis Completed · 239 cited
  4. Phase 4 Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF) Completed · 135 cited
  5. Phase 4 Effect of Nintedanib on Biomarkers of Extracellular Matrix Turnover in Patients With Idiopathic Pulmonary Fibrosis and Limited Forced Vital Capacity Impairment Completed · 104 cited
  6. Phase 3 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) Completed · 79 cited
Show 38 more trials
  1. Phase 3 Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF) Completed · 37 cited
  2. Phase 3 A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis Completed · 32 cited
  3. Phase 3 Efficacy and Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Completed · 16 cited
  4. Phase 3 A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis Completed · 12 cited
  5. Phase 3 A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Completed · 8 cited
  6. Phase 4 The Study of the Use of Nintedanib in Slowing Lung Disease in Patients With Fibrotic or Non-Fibrotic Interstitial Lung Disease Related to COVID-19 Completed · 1 cited
  7. Phase 4 A Study to Compare the Amount of Nintedanib and Pirfenidone in the Blood When Nintedanib and Pirfenidone Are Given Separately or in Combination Completed
  8. Phase 3 A Study to Test How Well a Medicine Called Nintedanib Helps People in China With Progressive Lung Fibrosis Completed
  9. Phase 2 Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent Completed
  10. Phase 2 Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174) Completed
  11. Phase 2 Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis Completed
  12. Phase 2 Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer Completed
  13. Phase 2 Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer Completed
  14. Phase 2 Nintedanib in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Up to Two Previous Chemotherapy Regimens Completed
  15. Phase 2 Nintedanib in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors Completed
  16. Phase 2 Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer Completed
  17. Phase 2 Nintedanib in Patients With Advanced Esophagogastric Cancer Completed
  18. Phase 1 Relative Bioavailability of a Single Dose of Nintedanib Given Alone and in Combination With Multiple Doses of Rifampicin Completed
  19. Phase 1 Nintedanib Plus Docetaxel in Japanese Patients With Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy Completed
  20. Phase 1 Influence of Bosentan on the Pharmacokinetics of Nintedanib Completed
  21. Phase 1 Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma Completed
  22. Phase 1 A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD) Completed
  23. Phase 1 Relative Bioavailability of 2 Oral Formulations of Nintedanib Completed
  24. Phase 1 Investigation of Drug-drug Interaction of Nintedanib and Ketoconazole in Healthy Male Volunteers Completed
  25. Phase 1 A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood Completed
  26. Phase 1 Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers Completed
  27. N/A Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib Completed
  28. N/A Safety and Effectiveness of Nintedanib in Korean Patients Completed
  29. N/A Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan Completed
  30. N/A A Study Based on Medical Records in Spain That Looks at Diarrhoea Control in People With Pulmonary Fibrosis Who Are Taking Nintedanib Completed
  31. N/A Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan Completed
  32. N/A All-Case Surveillance of Ofev in Patients With IPF in Japan Completed
  33. N/A Burden of Nintedanib Non-adherence Among Idiopathic Pulmonary Fibrosis (IPF) Patients Completed
  34. N/A 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
  35. N/A Post Marketing Surveillance of Nintedanib in Indian Patients With Idiopathic Pulmonary Fibrosis Completed
  36. N/A Adherence to Nintedanib Among Idiopathic Pulmonary Fibrosis Patients Completed
  37. N/A INREAL - Nintedanib for Changes in Dyspnea and Cough in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease (ILD) With a Progressive Phenotype in Everyday Clinical Practice: a Real-world Evaluation Completed
  38. N/A Dose Reduction and Discontinuation With Anti-Fibrotic Medications Completed

Showing the 44 most-cited and recently-updated of 44 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Pirfenidone reduces lung cancer incidence by 73% in IPF patients with a pooled risk ratio of 0.39
Pulmonology & Critical Care Meta-analysis
Pirfenidone reduces lung cancer incidence by 73% in IPF patients with a pooled risk ratio of 0.39 Antifibrotic drugs may lower lung cancer risk in patients with idiopathic pulmonary fibrosis
This systematic review and meta-analysis evaluated antifibrotic therapies in 15582 patients with idiopathic pulmonary fibrosis. The pooled a…
A large review suggests antifibrotic drugs like pirfenidone might lower lung cancer risk in people with idiopathic pulmonary fibrosis, but m…
Jun 2, 2026
Case Report Details Aumolertinib Rechallenge Following Osimertinib-Induced Interstitial Lung Disease in Lung Adenocarcinoma
Drug Pipeline Guideline
Case Report Details Aumolertinib Rechallenge Following Osimertinib-Induced Interstitial Lung Disease in Lung Adenocarcinoma Can lung cancer drugs be restarted after severe lung injury?
This case report describes a 73-year-old male with stage IV lung adenocarcinoma and EGFR exon 19 deletions who experienced interstitial lung…
Doctors successfully restarted a powerful lung cancer drug after a patient's lungs healed from a dangerous reaction to the first one.
Frontiers Apr 19, 2026
Narrative review outlines clinical framework for managing primary Sjögren's disease with interstitial lung disease
Gastroenterology RCT
Narrative review outlines clinical framework for managing primary Sjögren's disease with interstitial lung disease New Hope for Sjögren's Patients with Lung Scarring
A narrative review synthesizes evidence on managing primary Sjögren's disease with interstitial lung disease, highlighting a pragmatic clini…
Lung scarring in Sjögren's disease can be deadly, but new strategies targeting specific disease patterns offer a path forward for patients.
Frontiers Apr 15, 2026
Phase Ib/II trial of nintedanib plus nivolumab in pretreated NSCLC adenocarcinoma shows 25% 6-month PFS rate
Pulmonology & Critical Care Phase I
Phase Ib/II trial of nintedanib plus nivolumab in pretreated NSCLC adenocarcinoma shows 25% 6-month PFS rate New Drug Combo Helps Some Lung Cancer Patients Live Longer
A single-arm, open-label phase Ib/II trial in 52 patients with pretreated stage IIIB/IV NSCLC adenocarcinoma found a 6-month progression-fre…
A new drug pair safely extends life for some advanced lung cancer patients who previously tried immunotherapy or have high PD-L1 markers.
Apr 13, 2026
FDA Approves Nintedanib Capsules (nintedanib esylate) for Idiopathic Pulmonary Fibrosis and Progressive Fibrosing ILDs
Pulmonology & Critical Care FDA Approval
FDA Approves Nintedanib Capsules (nintedanib esylate) for Idiopathic Pulmonary Fibrosis and Progressive Fibrosing ILDs FDA approves a new drug to treat two types of progressive, scarring lung diseases
The FDA has approved nintedanib capsules for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and for adults with chronic fi…
FDA approves new drug to treat two types of progressive, scarring lung diseases that make lungs stiff and hard to breathe.
FDA Apr 7, 2026
FDA Approves Nintedanib Capsules (nintedanib esylate) for Idiopathic Pulmonary Fibrosis and Progressive Fibrosing ILDs
Pulmonology & Critical Care FDA Approval
FDA Approves Nintedanib Capsules (nintedanib esylate) for Idiopathic Pulmonary Fibrosis and Progressive Fibrosing ILDs FDA approves a new drug to treat two serious, scarring lung diseases in adults
The FDA has approved nintedanib capsules for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and for adults with chronic fi…
FDA approves new drug nintedanib to treat two serious, scarring lung diseases in adults with progressive conditions.
FDA Apr 7, 2026