Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate BIBF 1120 (nintedanib) across conditions such as idiopathic pulmonary fibrosis, interstitial lung diseases, systemic sclerosis, non-small cell lung cancer, renal cell carcinoma, and colorectal adenocarcinoma. Encompassing recruiting, active, completed, and withdrawn statuses, these studies investigate safety, combination regimens, and drug pharmacokinetics. Investigations are sponsored by major pharmaceutical companies, including Boehringer Ingelheim, alongside academic centers, university hospitals, and medical research institutes.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06643091 NOT_YET_RECRUITING
Castleman Disease
Assistance Publique - Hôpitaux de Paris
 2024-11-01 PHASE2
NCT07485920 NOT_YET_RECRUITING
Limited-stage Small Cell Lung Cancer (LS-SCLC)
The Affiliated Hospital of Qingdao University
 2026-05-01 PHASE4
NCT07335562 NOT_YET_RECRUITING
Systemic Sclerosis
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
 2026-08-29 PHASE3
NCT07679893 RECRUITING
Idiopathic Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis (IPF)
Mannkind Corporation
 2026-06-30 PHASE2
NCT06297096 RECRUITING
Systemic Sclerosis; Interstitial Lung Disease
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
 2025-07-01 PHASE3
NCT07583589 NOT_YET_RECRUITING
Idiopathic Pulmonary Fibrosis (IPF)
First Affiliated Hospital of Wenzhou Medical University
 2026-05-12 PHASE2
NCT03805477 RECRUITING
Bronchiolitis Obliterans Syndrome (BOS); Bronchiolitis Obliterans (BO)
University Hospital, Basel, Switzerland
 2019-03-20 PHASE2
NCT04976036 RECRUITING
Telangiectasia, Hereditary Hemorrhagic
Dr. Romain Lazor
 2022-05-05 PHASE2
NCT07194382 RECRUITING
Idiopathic Pulmonary Fibrosis (IPF)
Avalyn Pharma Inc.
 2026-03-10 PHASE2
NCT07454291 RECRUITING
Idiopathic Pulmonary Fibrosis
Endeavor Biomedicines, Inc.
 2026-04-28 PHASE1
NCT06071013 RECRUITING
Non-small Cell Lung Cancer; EGFR Gene Mutation; EGFR-TKI Resistant Mutation
China Medical University Hospital
 2024-02-23 PHASE1; PHASE2
NCT07162961 NOT_YET_RECRUITING
Adenomyosis of Uterus
Sun Yat-sen University
 2025-09-01 PHASE3
NCT07344558 COMPLETED
Idiopathic Pulmonary Fibrosis (IPF)
Mannkind Corporation
 2025-12-22 PHASE1
NCT07229716 RECRUITING
Pulmonary Fibrosis
Guangdong Hengrui Pharmaceutical Co., Ltd
 2026-04-04 PHASE1
NCT05195918 COMPLETED
Idiopathic Pulmonary Fibrosis
Hal Chapman
 2023-08-24 PHASE1
NCT03939520 COMPLETED
Progressive Idiopathic Pulmonary Fibrosis
Hospices Civils de Lyon
 2020-06-11 PHASE4
NCT06479603 RECRUITING
Sarcoidosis, Pulmonary
Post Graduate Institute of Medical Education and Research, Chandigarh
 2024-06-30 PHASE4
NCT07015398 COMPLETED
Healthy Participants
Trevi Therapeutics
 2025-06-30 PHASE1
NCT05285982 COMPLETED
Lung Diseases, Interstitial
Boehringer Ingelheim
 2022-04-06 PHASE3
NCT02551068 COMPLETED
Idiopathic Pulmonary Fibrosis
University of British Columbia
 2015-12
NCT03283007 COMPLETED
Lung-transplant Recipients
Assistance Publique - Hôpitaux de Paris
 2019-10-30 PHASE3
NCT05799755 COMPLETED
Myositis Associated Interstitial Lund Disease (MA-ILD)
Rohit Aggarwal, MD
 2023-08-01 PHASE4
NCT06568458 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2024-09-19 PHASE1
NCT06717100 COMPLETED
Drug Interactions
PureTech
 2024-12-17 PHASE1
NCT02856425 COMPLETED
Patients With Any Advanced Solid Tumors
Gustave Roussy, Cancer Campus, Grand Paris
 2016-11-10 PHASE1
NCT05335278 TERMINATED
Interstitial Lung Disease; Myopathy, Inflammatory
McGill University Health Centre/Research Institute of the McGill University Health Centre
 2021-06-01
NCT04161014 UNKNOWN
Pneumoconiosis Coal; Asbestosis; Silicosis
Holdsworth House Medical Practice
 2020-10-09 PHASE2
NCT06625489 COMPLETED
Idiopathic Pulmonary Fibrosis
GlaxoSmithKline
 2024-10-07 PHASE1
NCT06532942 UNKNOWN
Healthy Volunteers
Mannkind Corporation
 2024-05-28 PHASE1
NCT05635071 UNKNOWN
Uterine Adhesions
Sixth Affiliated Hospital, Sun Yat-sen University
 2023-12-01 PHASE2; PHASE3
NCT05067517 WITHDRAWN
Progressive Fibrosing Interstitial Lung Disease
West Virginia University
 2021-11 PHASE3
NCT02225405 COMPLETED
Stage IB Non-Small Cell Lung Carcinoma AJCC v7; Stage II Non-Small Cell Lung Cancer AJCC v7; Stage IIA Non-Small Cell Lung Carcinoma AJCC v7; Stage IIB Non-Small Cell Lung Carcinoma AJCC v7; Stage IIIA Non-Small Cell Lung Cancer AJCC v7
M.D. Anderson Cancer Center
 2015-04-03 PHASE1
NCT05065190 COMPLETED
Lung Diseases, Interstitial
Boehringer Ingelheim
 2021-11-25 PHASE3
NCT02496585 COMPLETED
Lung Cancer; Lung Metastases
Memorial Sloan Kettering Cancer Center
 2015-07-08 PHASE2
NCT06200714 Recruiting
Idiopathic Pulmonary Fibrosis|Diarrhoea
Boehringer Ingelheim
 2024-04-30 --
NCT05755308 UNKNOWN
Idiopathic Pulmonary Fibrosis
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
 2023-10
NCT04619680 COMPLETED
Pulmonary Fibrosis; Interstitial Lung Disease; Respiratory Disease
Icahn School of Medicine at Mount Sinai
 2020-11-18 PHASE4
NCT05373914 UNKNOWN
Idiopathic Pulmonary Fibrosis
Blade Therapeutics
 2022-05-31 PHASE2
NCT06070610 COMPLETED
Healthy
Boehringer Ingelheim
 2023-11-08 PHASE1
NCT03513484 ACTIVE_NOT_RECRUITING
Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A; Fibroblast Growth Factor Basic Form Measurement; FLT3 Internal Tandem Duplication; Recurrent Adult Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia
Northwestern University
 2018-11-14 PHASE1
NCT05676112 Withdrawn
Pulmonary Fibrosis
Boehringer Ingelheim|China-Japan Friendship Hospital
 2023-12-29 --
NCT03377023 ACTIVE_NOT_RECRUITING
Non Small Cell Lung Cancer; Lung Cancer, Nonsmall Cell; Non Small Cell Lung Cancer Metastatic
H. Lee Moffitt Cancer Center and Research Institute
 2018-02-02 PHASE1; PHASE2
NCT06070610 Completed
Healthy
Boehringer Ingelheim
 2023-11-08 Phase 1
NCT02863055 TERMINATED
Malignant Pleural Mesothelioma
European Organisation for Research and Treatment of Cancer - EORTC
 2018-02-04 PHASE2
NCT04541680 UNKNOWN
SARS-Cov-2 Induced Pulmonary Fibrosis
Assistance Publique - Hôpitaux de Paris
 2020-10-29 PHASE3
NCT05755308 Not yet recruiting
Idiopathic Pulmonary Fibrosis
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
 2023-10 Not Applicable
NCT06071013 Not yet recruiting
Non-small Cell Lung Cancer|EGFR Gene Mutation|EGFR-TKI Resistant Mutation
China Medical University Hospital
 2023-09-28 Phase 1|Phase 2
NCT05644600 TERMINATED
Healthy Subjects
AstraZeneca
 2023-05-26 PHASE1
NCT03361319 WITHDRAWN
NSCLC, Recurrent; Adenocarcinoma of Lung
Royal Marsden NHS Foundation Trust
 2020-07 PHASE1; PHASE2
NCT05817240 COMPLETED
Idiopathic Pulmonary Fibrosis
Endeavor Biomedicines, Inc.
 2023-05-03 PHASE1
NCT04046614 COMPLETED
Adenocarcinoma of the Lung
AIO-Studien-gGmbH
 2018-05-25 PHASE1; PHASE2
NCT03954782 COMPLETED
Telangiectasia, Hereditary Hemorrhagic; Rendu Osler Disease
Hospices Civils de Lyon
 2020-06-22 PHASE2
NCT03313180 COMPLETED
Lung Diseases, Interstitial
Boehringer Ingelheim
 2017-11-27 PHASE3
NCT05262751 COMPLETED
Healthy
Boehringer Ingelheim
 2022-03-28 PHASE1
NCT04856111 UNKNOWN
Novel Coronavirus-induced Lung Fibrosis
Post Graduate Institute of Medical Education and Research, Chandigarh
 2021-03-17 PHASE4
NCT03820726 COMPLETED
Lung Diseases, Interstitial
Boehringer Ingelheim
 2019-04-16 PHASE3
NCT04093024 COMPLETED
Lung Diseases, Interstitial
Boehringer Ingelheim
 2019-12-03 PHASE3
NCT04971746 COMPLETED
Healthy
Lakefront Biotherapeutics NV
 2021-07-19 PHASE1
NCT03562416 TERMINATED
Idiopathic Pulmonary Fibrosis; Lung Transplant; Complications
Temple University
 2019-07-05 PHASE2
NCT04939467 COMPLETED
Drug Drug Interaction
Blade Therapeutics
 2021-10-15 PHASE1
NCT03062943 COMPLETED
Lymphangioleiomyomatosis
IRCCS Multimedica
 2016-12-06 PHASE2
NCT07588646 COMPLETED
Idiopathic Pulmonary Fibrosis
Sunshine Lake Pharma Co., Ltd.
 2021-06-29 PHASE1
NCT05383131 COMPLETED
Idiopathic Pulmonary Fibrosis
Sunshine Lake Pharma Co., Ltd.
 2021-06-23 PHASE1
NCT02902484 TERMINATED
Cancer of Pancreas
University of Texas Southwestern Medical Center
 2017-09-07 PHASE1; PHASE2
NCT02730416 COMPLETED
Endometrial Cancer
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
 2016-12-12 PHASE2
NCT04938453 COMPLETED
Healthy
Boehringer Ingelheim
 2021-07-14 PHASE1
NCT04888715 COMPLETED
Idiopathic Pulmonary Fibrosis
Daewoong Pharmaceutical Co. LTD.
 2021-07-23 PHASE1
NCT02665143 COMPLETED
Relapsed/Refractory Acute Myeloid Leukemia
Yale University
 2016-07-21 PHASE2
NCT02009579 COMPLETED
Uterine Cervical Neoplasms
Belgian Gynaecological Oncology Group
 2014-03 PHASE2
NCT02808247 TERMINATED
Sarcoma, Soft Tissue
European Organisation for Research and Treatment of Cancer - EORTC
 2017-07-07 PHASE2
NCT02531737 COMPLETED
Lung Neoplasms
University Hospital, Limoges
 2015-09 PHASE2
NCT04338802 UNKNOWN
COVID-19; Nintedanib; Safety; Effect of Drugs
Huilan Zhang
 2020-04-02 PHASE2
NCT02234596 COMPLETED
Esophagogastric Adenocarcinoma
Memorial Sloan Kettering Cancer Center
 2014-09-04 PHASE2
NCT03717012 TERMINATED
Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim
 2018-11-15 PHASE4
NCT03292250 COMPLETED
HNSCC; Head and Neck Neoplasms
Seoul National University Hospital
 2017-09-10 PHASE2
NCT02866370 UNKNOWN
Ovarian Clear Cell Carcinoma; Endometrial Clear Cell Carcinoma
NHS Greater Glasgow and Clyde
 2015-04 PHASE2
NCT02299141 COMPLETED
Carcinoma, Non-Small-Cell Lung; Non-Small Cell Lung Cancer; Nonsmall Cell Lung Cancer
Washington University School of Medicine
 2015-05-07 PHASE2
NCT02668393 COMPLETED
Carcinoma, Non-Small-Cell Lung
Boehringer Ingelheim
 2016-03-07 PHASE1
NCT02308553 COMPLETED
Cutaneous Malignant Melanoma
Prof. Dr. med. Dirk Schadendorf
 2015-03-17 PHASE1; PHASE2
NCT03675581 COMPLETED
Scleroderma, Systemic
Boehringer Ingelheim
 2018-11-08 PHASE1
NCT03287947 TERMINATED
Appendix Cancer
Wake Forest University Health Sciences
 2017-11-10 PHASE2
NCT02399215 COMPLETED
Carcinoid Tumor; Metastatic Carcinoid Tumor; Neuroendocrine Neoplasm
Roswell Park Cancer Institute
 2015-05-15 PHASE2
NCT01788982 COMPLETED
Medullary Thyroid Cancer (MTC); Differentiated Thyroid Cancer (DTC)
European Organisation for Research and Treatment of Cancer - EORTC
 2014-05 PHASE2
NCT02452463 TERMINATED
Lung Non-Squamous Non-Small Cell Carcinoma; Radiation-Induced Pneumonitis; Stage II Lung Non-Small Cell Cancer AJCC v7; Stage IIA Lung Non-Small Cell Carcinoma AJCC v7; Stage IIB Lung Non-Small Cell Carcinoma AJCC v7; Stage III Lung Non-Small Cell Cancer AJCC v7; Stage IIIA Lung Non-Small Cell Cancer AJCC v7; Stage IIIB Lung Non-Small Cell Cancer AJCC v7; Stage IV Lung Non-Small Cell Cancer AJCC v7
Roswell Park Cancer Institute
 2015-06-29 PHASE2
NCT02856867 WITHDRAWN
Esophagogastric Adenocarcinoma; Metastatic Disease; No Previous Chemotherapy for Metastatic Esophagogastric Cancer
European Organisation for Research and Treatment of Cancer - EORTC
 2016-12 PHASE2
NCT02999178 COMPLETED
Lung Diseases, Interstitial
Boehringer Ingelheim
 2017-01-17 PHASE3
NCT02597933 COMPLETED
Scleroderma, Systemic
Boehringer Ingelheim
 2015-11-12 PHASE3
NCT03363815 COMPLETED
Heathy Volunteer
Celgene
 2017-12-04 PHASE1
NCT02389764 TERMINATED
Breast Cancer
M.D. Anderson Cancer Center
 2015-06-22 PHASE2
NCT02835833 COMPLETED
Renal Cell Carcinoma; Colorectal Adenocarcinoma; Non-squamous Non-small Cell Lung Cancer; Platinum-refractory Ovarian Carcinoma; Cervical Carcinoma
University of Alabama at Birmingham
 2016-06-09 PHASE1
NCT01907100 TERMINATED
Mesothelioma
Boehringer Ingelheim
 2013-09-19 PHASE2; PHASE3
NCT01610869 COMPLETED
Ovarian Cancer; Fallopian Tube Cancer
University College, London
 2014-08 PHASE2
NCT02802345 COMPLETED
Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim
 2016-06-30 PHASE3
NCT02751385 TERMINATED
Carcinoma, Non-Small-Cell Lung
Boehringer Ingelheim
 2016-05-20 PHASE1
NCT01890265 COMPLETED
Idiopathic Pulmonary Fibrosis
Kyntra Bio
 2013-07-30 PHASE2
NCT02393755 COMPLETED
Colon Adenocarcinoma; Rectal Adenocarcinoma; Recurrent Colon Carcinoma; Recurrent Rectal Carcinoma; Stage IVA Colon Cancer; Stage IVA Rectal Cancer; Stage IVB Colon Cancer; Stage IVB Rectal Cancer
Roswell Park Cancer Institute
 2015-05-08 PHASE1; PHASE2
NCT02619162 COMPLETED
Breast Cancer
Centro Nacional de Investigaciones Oncologicas CARLOS III
 2015-07 PHASE1
NCT02788474 COMPLETED
Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim
 2016-06-09 PHASE4
NCT01619085 COMPLETED
Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim
 2012-06-06 PHASE3
NCT02598193 COMPLETED
Idiopathic Pulmonary Fibrosis
Hoffmann-La Roche
 2016-01-14 PHASE4
NCT02606877 COMPLETED
Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim
 2016-04-19 PHASE4
NCT02579603 COMPLETED
Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim
 2015-10-16 PHASE4
NCT02568449 COMPLETED
Recurrent Pleural Malignant Mesothelioma; Stage IV Pleural Mesothelioma
Barbara Ann Karmanos Cancer Institute
 2016-03-15 PHASE2
NCT01658462 COMPLETED
Breast Cancer
Centre Oscar Lambret
 2013-05 PHASE2
NCT01979952 COMPLETED
Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim
 2013-11-26 PHASE3
NCT02780700 TERMINATED
Colorectal Neoplasms
Boehringer Ingelheim
 2016-07-05 PHASE2
NCT01948141 COMPLETED
Recurrent Non-small Cell Lung Cancer; Squamous Cell Lung Cancer; Stage III Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
Roswell Park Cancer Institute
 2014-01-30 PHASE2
NCT02558387 UNKNOWN
Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck
Samsung Medical Center
 2014-11 PHASE2
NCT02149108 COMPLETED
Colorectal Neoplasms
Boehringer Ingelheim
 2014-09-25 PHASE3
NCT02667704 COMPLETED
Healthy
Boehringer Ingelheim
 2016-02 PHASE1
NCT02300298 COMPLETED
Carcinoma, Non-Small-Cell Lung
Boehringer Ingelheim
 2014-12-24 PHASE1
NCT01225887 COMPLETED
Endometrial Adenocarcinoma; Endometrial Clear Cell Adenocarcinoma; Endometrial Mucinous Adenocarcinoma; Endometrial Serous Adenocarcinoma; Endometrial Squamous Cell Carcinoma; Endometrial Transitional Cell Carcinoma; Endometrial Undifferentiated Carcinoma; Malignant Uterine Corpus Mixed Epithelial and Mesenchymal Neoplasm; Recurrent Uterine Corpus Carcinoma
Gynecologic Oncology Group
 2011-10 PHASE2
NCT02231164 TERMINATED
Carcinoma, Non-Small-Cell Lung
Boehringer Ingelheim
 2014-10-14 PHASE3
NCT02572752 COMPLETED
Healthy
Boehringer Ingelheim
 2015-08 PHASE1
NCT01417156 COMPLETED
Pulmonary Fibrosis
Boehringer Ingelheim
 2011-09 PHASE2
NCT01583322 COMPLETED
Ovarian Cancer
ARCAGY/ GINECO GROUP
 2012-06 PHASE2
NCT02191865 COMPLETED
Hepatic Insufficiency
Boehringer Ingelheim
 2014-07 PHASE1
NCT01594125 COMPLETED
Carcinoma, Hepatocellular
Boehringer Ingelheim
 2012-05 PHASE1
NCT01770392 COMPLETED
Healthy
Boehringer Ingelheim
 2013-01 PHASE1
NCT01679613 COMPLETED
Healthy
Boehringer Ingelheim
 2012-09 PHASE1
NCT00806819 COMPLETED
Carcinoma, Non-Small-Cell Lung
Boehringer Ingelheim
 2008-12 PHASE3

(data from https://clinicaltrials.gov, updated on 2024-10-15)

Check the BIBF 1120 (Nintedanib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BIBF 1120 (Nintedanib) potently binds to the intracellular kinase domains of VEGFR1/2/3, FGFR1/2/3, and PDGFRα/β, blocking receptor autophosphorylation and downstream MAPK and Akt signaling pathways. This biochemical inhibition suppresses cell proliferation and induces apoptosis in endothelial cells, pericytes, and smooth muscle cells, thereby preventing tumor angiogenesis and fibrotic tissue remodeling in conditions like idiopathic pulmonary fibrosis and non-small cell lung cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.