Drugs / Nintedanib
Nintedanib
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | NINTEDANIB ESYLATE | — | 2026-07-09 | fda.gov ↗ |
| Approved | EU (EMA) | Vargatef | — | 2014-11-21 | europa.eu ↗ |
Trials 155 · started per year
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EU approved 2014
US approved 2026
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 156 trials | ||||||
| Phase 1 | NCT07454291 | Apr → Oct 2026 expected | idiopathic pulmonary fibrosis | Endeavor Biomedicines, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT07229716 | Apr → May 2026 overdue | pulmonary fibrosis | Guangdong Hengrui Pharmaceutical Co., Ltd | Recruiting | No outcome recorded |
| Phase 1 | NCT07344558 | Dec 2025 → Jun 2026 overdue | idiopathic pulmonary fibrosis | Mannkind Corporation | Recruiting | No outcome recorded |
| Phase 1 | NCT07015398 | Jun → Sep 2025 | — | Trevi Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT06717100 | Dec 2024 → Feb 2025 | — | PureTech | Completed | No outcome recorded |
| Phase 1 | NCT06625489 | Oct → Nov 2024 | idiopathic pulmonary fibrosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT06568458 | Sep 2024 → Feb 2025 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT06070610 | Nov → Dec 2023 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT05644600 | May → Jul 2023 | — | AstraZeneca | Terminated | No outcome recorded |
| Phase 1 | NCT05817240 | May → Jun 2023 | idiopathic pulmonary fibrosis | Endeavor Biomedicines, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05830799 | Mar → May 2023 | — | Vicore Pharma AB | Completed | No outcome recorded |
| Phase 1 | NCT05262751 | Mar → Nov 2022 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT04939467 | Oct → Dec 2021 | — | Blade Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04888715 | Jul → Aug 2021 | idiopathic pulmonary fibrosis | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT04971746 | Jul 2021 → May 2022 | — | Lakefront Biotherapeutics NV | Completed | No outcome recorded |
| Phase 1 | NCT04938453 | Jul → Aug 2021 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT07588646 | Jun → Nov 2021 | idiopathic pulmonary fibrosis | Sunshine Lake Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05383131 | Jun → Nov 2021 | idiopathic pulmonary fibrosis | Sunshine Lake Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03513484 | Nov 2018 → Dec 2023 overdue | acute myeloid leukemia, FLT3 internal tandem duplication | Northwestern University | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03675581 | Nov 2018 → Oct 2019 | systemic sclerosis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT03363815 | Dec 2017 → Jul 2018 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02856425 | Nov 2016 → Jan 2025 | — | Gustave Roussy, Cancer Campus, Grand Paris | Completed | No outcome recorded |
| Phase 1 | NCT02835833 | Jun 2016 → Apr 2018 | cervical carcinoma, colorectal adenocarcinoma, non-small cell lung carcinoma, ovarian carcinoma +1 | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 1 | NCT02751385 | May 2016 → Nov 2017 | non-small cell lung carcinoma | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 1 | NCT02668393 | Mar 2016 → Nov 2019 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02667704 | Feb → Mar 2016 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02572752 | Aug → Nov 2015 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02619162 | Jul 2015 → Nov 2017 | breast cancer | Spanish National Cancer Research Centre | Completed | No outcome recorded |
| Phase 1 | NCT02225405 | Apr 2015 → May 2024 | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02300298 | Dec 2014 → Jan 2016 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02191865 | Jul → Dec 2014 | liver disorder | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01684111 | Jun 2013 → Jan 2016 | non-small cell lung carcinoma | Aktion Bronchialkarzinom e.V. | Completed | No outcome recorded |
| Phase 1 | NCT01683682 | Apr 2013 → Jan 2015 | non-small cell lung carcinoma | Aktion Bronchialkarzinom e.V. | Completed | No outcome recorded |
| Phase 1 | NCT01679613 | Sep → Nov 2012 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01349296 | Jul 2012 → Oct 2014 | cancer | University of Cologne | Completed | No outcome recorded |
| Phase 1 | NCT01594125 | May 2012 → Nov 2014 | hepatocellular carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01485874 | Nov 2011 → Dec 2015 | ovarian cancer | Hoosier Cancer Research Network | Terminated | No outcome recorded |
| Phase 1 | NCT01346540 | Apr 2011 → Apr 2013 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01329549 | Apr 2011 → Oct 2012 | ovarian neoplasm | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 1 | NCT01314105 | Mar 2011 → Jul 2013 | ovarian cancer, peritoneum cancer | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00979576 | Oct 2009 → Feb 2015 | non-small cell lung carcinoma | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 1 | NCT00998296 | Oct 2009 → Dec 2012 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00876460 | Mar 2009 → Sep 2012 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00730821 | Jan 2007 → Aug 2009 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182193 | Sep → Nov 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182128 | Jun 2006 → Jun 2009 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182219 | Nov 2005 → Apr 2007 | prostate neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182245 | Oct 2005 → Jan 2007 | female reproductive system neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182076 | Oct → Nov 2005 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182154 | Oct → Nov 2005 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182102 | Sep 2005 → May 2010 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182232 | Jun 2005 → May 2007 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00715403 | Oct 2004 → Sep 2009 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182206 | Jun 2003 → Jun 2005 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182141 | Apr 2003 → Mar 2005 | plasma cell myeloma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01951846 | Nov 2002 → Nov 2004 | cancer | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1/210 trials | ||||||
| Phase 1/2 | NCT06071013 | Feb 2024 → Aug 2026 overdue | non-small cell lung carcinoma | China Medical University Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03361319 | Jul 2020 → Jul 2023 | lung adenocarcinoma | Royal Marsden NHS Foundation Trust | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT04046614 | May 2018 → May 2023 | lung adenocarcinoma | AIO-Studien-gGmbH | Completed | No outcome recorded |
| Phase 1/2 | NCT03377023 | Feb 2018 → Nov 2023 overdue | non-small cell lung carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02902484 | Sep 2017 → Oct 2021 | malignant pancreatic neoplasm | University of Texas Southwestern Medical Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT02393755 | May 2015 → Nov 2017 | colon adenocarcinoma, rectum adenocarcinoma | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT02308553 | Mar 2015 → Oct 2019 | cutaneous melanoma | Prof. Dr. med. Dirk Schadendorf | Completed | No outcome recorded |
| Phase 1/2 | NCT01666600 | Aug 2012 → Mar 2017 | glioblastoma | Prof. Dr. Wolfgang Wick | Terminated | No outcome recorded |
| Phase 1/2 | NCT01488344 | Mar 2012 → Nov 2014 | acute myeloid leukemia | University Hospital Muenster | Unknown | No outcome recorded |
| Phase 1/2 | NCT01484080 | Oct 2011 → Nov 2013 | breast cancer | Spanish National Cancer Research Centre | Completed | No outcome recorded |
| Phase 252 trials | ||||||
| Phase 2 | NCT07679893 | Jun 2026 → Jan 2028 expected | idiopathic pulmonary fibrosis | Mannkind Corporation | Recruiting | No outcome recorded |
| Phase 2 | NCT06742502 | Nov 2024 → Dec 2027 expected | primary mediastinal large B-cell lymphoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06643091 | Nov 2024 → May 2030 expected | localized Castleman disease | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04976036 | May 2022 → Dec 2026 expected | hereditary hemorrhagic telangiectasia | Dr. Romain Lazor | Recruiting | No outcome recorded |
| Phase 2 | NCT04161014 | Oct 2020 → Dec 2024 | anthracosis, asbestosis, silicosis | Holdsworth House Medical Practice | Unknown | No outcome recorded |
| Phase 2 | NCT03954782 | Jun 2020 → Feb 2023 | hereditary hemorrhagic telangiectasia | Hospices Civils de Lyon | Completed | No outcome recorded |
| Phase 2 | NCT04338802 | Apr → May 2020 | COVID-19 | Huilan Zhang | Unknown | No outcome recorded |
| Phase 2 | NCT03562416 | Jul 2019 → Dec 2021 | bronchiolitis obliterans syndrome, idiopathic pulmonary fibrosis | Temple University | Terminated | No outcome recorded |
| Phase 2 | NCT03805477 | Mar 2019 → Dec 2026 expected | transplant-related bronchiolitis obliterans | University Hospital, Basel, Switzerland | Recruiting | No outcome recorded |
| Phase 2 | NCT02863055 | Feb 2018 → Oct 2023 | malignant pleural mesothelioma | European Organisation for Research and Treatment of Cancer - EORTC | Terminated | No outcome recorded |
| Phase 2 | NCT03287947 | Nov 2017 → Sep 2019 | appendix cancer | Wake Forest University Health Sciences | Terminated | No outcome recorded |
| Phase 2 | NCT03292250 | Sep 2017 → Mar 2020 | head and neck squamous cell carcinoma | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02808247 | Jul 2017 → Nov 2020 | soft tissue sarcoma | European Organisation for Research and Treatment of Cancer - EORTC | Terminated | No outcome recorded |
| Phase 2 | NCT02730416 | Dec 2016 → Oct 2021 | endometrial cancer | Nordic Society of Gynaecological Oncology - Clinical Trials Unit | Completed | No outcome recorded |
| Phase 2 | NCT03062943 | Dec 2016 → Dec 2021 | lymphangioleiomyomatosis | IRCCS Multimedica | Completed | No outcome recorded |
| Phase 2 | NCT02665143 | Jul 2016 → Mar 2021 | acute myeloid leukemia | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT02780700 | Jul → Sep 2016 | colorectal neoplasm | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 2 | NCT02568449 | Mar 2016 → Jan 2017 | malignant pleural mesothelioma | Barbara Ann Karmanos Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT02531737 | Sep 2015 → Sep 2020 | lung neoplasm | University Hospital, Limoges | Completed | No outcome recorded |
| Phase 2 | NCT02496585 | Jul 2015 → Apr 2024 | lung cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02452463 | Jun 2015 → Jun 2019 | non-small cell lung carcinoma, radiation pneumonitis | Roswell Park Cancer Institute | Terminated | No outcome recorded |
| Phase 2 | NCT02389764 | Jun 2015 → Jun 2018 | breast cancer | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT02399215 | May 2015 → Sep 2019 | carcinoid tumor | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT02299141 | May 2015 → Jan 2020 | non-small cell lung carcinoma | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT02866370 | Apr 2015 → Mar 2020 | endometrial clear cell adenocarcinoma, ovarian clear cell cancer | NHS Greater Glasgow and Clyde | Unknown | No outcome recorded |
| Phase 2 | NCT02558387 | Nov 2014 → Jul 2016 | salivary gland cancer | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT02278978 | Oct 2014 → Dec 2015 | urothelial carcinoma | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02234596 | Sep 2014 → Apr 2020 | gastroesophageal adenocarcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01610869 | Aug 2014 → Jan 2018 | fallopian tube cancer, ovarian cancer | University College, London | Completed | No outcome recorded |
| Phase 2 | NCT02152059 | Jul 2014 → Jul 2016 | small cell lung carcinoma | AHS Cancer Control Alberta | Withdrawn | No outcome recorded |
| Phase 2 | NCT01788982 | May 2014 → Aug 2019 | medullary thyroid gland carcinoma | European Organisation for Research and Treatment of Cancer - EORTC | Completed | No outcome recorded |
| Phase 2 | NCT01948141 | Jan 2014 → Aug 2016 | non-small cell lung carcinoma, squamous cell lung carcinoma | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT01658462 | May 2013 → Dec 2016 | breast cancer | Centre Oscar Lambret | Completed | No outcome recorded |
| Phase 2 | NCT01669798 | Feb 2013 → Sep 2017 | fallopian tube cancer, ovarian cancer, peritoneum cancer | AA Secord | Completed | No outcome recorded |
| Phase 2 | NCT01583322 | Jun 2012 → May 2015 | ovarian cancer | ARCAGY/ GINECO GROUP | Completed | No outcome recorded |
| Phase 2 | NCT01380782 | May 2012 → Jul 2013 | anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma, gliosarcoma | Patrick Y. Wen, MD | Completed | No outcome recorded |
| Phase 2 | NCT01441297 | Dec 2011 → Oct 2015 | small cell lung carcinoma | Ji-youn Han | Completed | No outcome recorded |
| Phase 2 | NCT01225887 | Oct 2011 → Jan 2016 | endometrial clear cell adenocarcinoma, endometrial mucinous adenocarcinoma, endometrial serous adenocarcinoma, endometrial squamous cell carcinoma +3 | Gynecologic Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT01417156 | Sep 2011 → Oct 2015 | pulmonary fibrosis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01362361 | Jun 2011 → Jun 2016 | colorectal cancer | Martin-Luther-University Halle-Wittenberg | Completed | No outcome recorded |
| Phase 2 | NCT01251484 | Jan 2011 → Aug 2012 | glioblastoma | Ulrik Lassen | Completed | No outcome recorded |
| Phase 2 | NCT01170065 | Jun 2010 → Sep 2016 | pulmonary fibrosis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01136174 | May 2010 → Mar 2011 | idiopathic pulmonary fibrosis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01024920 | Dec 2009 → Nov 2011 | renal cell carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01004003 | Oct 2009 → Jul 2014 | hepatocellular carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00987935 | Oct 2009 → Jul 2014 | hepatocellular carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00514683 | Aug 2007 → Jun 2010 | pulmonary fibrosis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00801294 | Jul 2006 → Nov 2007 | colorectal neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00710762 | Mar 2006 → Sep 2008 | ovarian neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00706628 | Mar 2006 → Dec 2008 | prostate neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT02182063 | Nov 2005 → Jan 2007 | prostate neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT02182050 | Aug 2005 → Jan 2007 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05635071 | Dec 2023 → Jul 2024 | adhesions of uterus | Sixth Affiliated Hospital, Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2/3 | NCT01907100 | Sep 2013 → Mar 2018 | mesothelioma | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 322 trials | ||||||
| Phase 3 | NCT07335562 | Aug 2026 → Nov 2028 expected | systemic sclerosis | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Recruiting | No outcome recorded |
| Phase 3 | NCT07162961 | Sep 2025 → Jun 2026 overdue | adenomyosis | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06297096 | Jul 2025 → Dec 2027 expected | interstitial lung disease, systemic sclerosis | National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland | Recruiting | No outcome recorded |
| Phase 3 | NCT05285982 | Apr 2022 → Aug 2025 | interstitial lung disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT05065190 | Nov 2021 → Apr 2024 | interstitial lung disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT04541680 | Oct 2020 → Oct 2023 | postinflammatory pulmonary fibrosis | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| Phase 3 | NCT04093024 | Dec 2019 → May 2022 | interstitial lung disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT03283007 | Oct 2019 → Mar 2025 | bronchiolitis obliterans syndrome | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT03820726 | Apr 2019 → Aug 2022 | interstitial lung disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT03313180 | Nov 2017 → Jan 2023 | interstitial lung disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT02999178 | Jan 2017 → Apr 2019 | interstitial lung disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT02802345 | Jun 2016 → Dec 2017 | idiopathic pulmonary fibrosis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT02597933 | Nov 2015 → Oct 2018 | systemic sclerosis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT02231164 | Oct 2014 → Dec 2015 | non-small cell lung carcinoma | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 3 | NCT02149108 | Sep 2014 → May 2016 | colorectal neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01979952 | Nov 2013 → Oct 2016 | idiopathic pulmonary fibrosis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01619085 | Jun 2012 → Jul 2017 | idiopathic pulmonary fibrosis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01335477 | May 2011 → Oct 2013 | pulmonary fibrosis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01335464 | Apr 2011 → Oct 2013 | pulmonary fibrosis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01015118 | Nov 2009 → Apr 2013 | ovarian neoplasm, peritoneal neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00805194 | Dec 2008 → Nov 2010 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00806819 | Dec 2008 → Jun 2011 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT07485920 | May 2026 → Dec 2028 expected | small cell lung carcinoma | The Affiliated Hospital of Qingdao University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04619680 | Nov 2020 → Feb 2024 | pulmonary fibrosis | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 4 | NCT03939520 | Jun 2020 → Jan 2026 | idiopathic pulmonary fibrosis | Hospices Civils de Lyon | Completed | No outcome recorded |
| Phase 4 | NCT02788474 | Jun 2016 → Aug 2017 | idiopathic pulmonary fibrosis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 4 | NCT02606877 | Apr 2016 → Mar 2017 | idiopathic pulmonary fibrosis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 4 | NCT02598193 | Jan 2016 → May 2017 | idiopathic pulmonary fibrosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT02579603 | Oct 2015 → Jan 2017 | idiopathic pulmonary fibrosis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05335278 | Jun 2021 → Dec 2024 | interstitial lung disease, myositis disease | McGill University Health Centre/Research Institute of the McGill University Health Centre | Terminated | No outcome recorded |
| Phase not stated5 trials | ||||||
| — | NCT02230982 | — | idiopathic pulmonary fibrosis | Boehringer Ingelheim | No longer available | No outcome recorded |
| — | NCT03843892 | — | interstitial lung disease | Boehringer Ingelheim | Approved for marketing | No outcome recorded |
| — | NCT02171156 | — | idiopathic pulmonary fibrosis | Boehringer Ingelheim | Approved for marketing | No outcome recorded |
| — | NCT04739150 | — | interstitial lung disease | Boehringer Ingelheim | No longer available | No outcome recorded |
| — | NCT05624281 | — | interstitial lung disease specific to childhood | Boehringer Ingelheim | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 19 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06482190 Background | Jul → Dec 2024 | idiopathic pulmonary fibrosis, pulmonary fibrosis | Shenzhen Resproly Biopharmaceutical Co., Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT05195918 Background | Aug 2023 → Mar 2026 | idiopathic pulmonary fibrosis | Hal Chapman | Completed | No outcome recorded |
| Phase 1 | NCT01770392 Comparator | Jan → Mar 2013 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01022853 Background | Dec 2009 → Feb 2013 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182258 Comparator | Jun → Aug 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT07583589 Background | May 2026 → Mar 2027 expected | idiopathic pulmonary fibrosis | First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07194382 Comparator | Mar → Dec 2026 expected | idiopathic pulmonary fibrosis | Avalyn Pharma Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT05497284 Background | Nov 2022 → Aug 2024 | idiopathic pulmonary fibrosis | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT03287414 Background | Dec 2017 → Nov 2020 | idiopathic pulmonary fibrosis | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT02856867 Comparator | Dec 2016 → Jun 2019 | gastroesophageal adenocarcinoma, metastatic neoplasm | European Organisation for Research and Treatment of Cancer - EORTC | Withdrawn | No outcome recorded |
| Phase 2 | NCT02009579 Comparator | Mar 2014 → Jan 2021 | uterine cervix neoplasm | Belgian Gynaecological Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT01890265 Comparator | Jul 2013 → Nov 2017 | idiopathic pulmonary fibrosis | Kyntra Bio | Completed | No outcome recorded |
| Phase 2 | NCT00904839 Comparator | May 2009 → Jan 2012 | colorectal neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07299695 Comparator | Jan 2026 → Jun 2028 expected | idiopathic pulmonary fibrosis | Argyrios Tzouvelekis | Recruiting | No outcome recorded |
| Phase 3 | NCT05067517 Comparator | Nov 2021 → Jul 2024 | interstitial lung disease | West Virginia University | Withdrawn | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT06479603 Comparator | Jun 2024 → Dec 2025 overdue | pulmonary sarcoidosis | Post Graduate Institute of Medical Education and Research, Chandigarh | Recruiting | No outcome recorded |
| Phase 4 | NCT05799755 Comparator | Aug 2023 → Mar 2025 | interstitial lung disease | Rohit Aggarwal, MD | Completed | No outcome recorded |
| Phase 4 | NCT04856111 Comparator | Mar 2021 → Nov 2022 | postinflammatory pulmonary fibrosis | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| Phase 4 | NCT03717012 Background | Nov 2018 → Mar 2020 | idiopathic pulmonary fibrosis | Boehringer Ingelheim | Terminated | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 178 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nintedanib | “This study will evaluate the impact Nintedanib Solution for Inhalation (AP02) has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary...” NCT07194382 ↗126“Nintedanib (BIBF 1120), a potent multikinase inhibitor of VEGFR-1/-2/-3, FGFR-1/-2/-3 and PDGFR-α/-β, exerts growth inhibitory and pro-apoptotic effects in myeloid leukemic...” PMID 27716819 ↗ Oct 2016 “Nintedanib, an oral triple angiokinase inhibitor of VEGF receptor, platelet-derived growth factor receptor, and fibroblast growth factor receptor, has shown activity in phase 2...” PMID 26590673 ↗ Nov 2015 “Effect of small angiokinase inhibitor nintedanib (BIBF 1120) on QT interval in patients with previously untreated, advanced renal cell cancer in an open-label, phase II study.” PMID 23625328 ↗ Apr 2013 “Nintedanib plus mFOLFOX6 as second-line treatment of metastatic, chemorefractory colorectal cancer: The randomised, placebo-controlled, phase II TRICC-C study (AIO-KRK-0111).” PMID 32930387 ↗ Oct 2020 “Antifibrotics (nintedanib, pirfenidone, or nerandomilast) will be continued during hospitalization if already prescribed and not contraindicated.” NCT07299695 ↗ “Phase I study of nintedanib incorporating dynamic contrast-enhanced magnetic resonance imaging in patients with advanced solid tumors.” PMID 25795637 ↗ Mar 2015 “Nintedanib (formerly known as BIBF 1120) is an intracellular inhibitor that targets multiple tyrosine kinases.” PMID 24836310 ↗ May 2014 “Phase II trial of triple tyrosine kinase receptor inhibitor nintedanib in recurrent high-grade gliomas.” PMID 25338318 ↗ Oct 2014 “Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant setting.” NCT01583322 ↗ “Background standard-of-care treatment for IPF: nintedanib, pirfenidone, or no background therapy” NCT03287414 ↗ “will receive 6 cycles of maintenance treatment with nintedanib if CR/CMR/PR is achieved” NCT06742502 ↗ “Expanded Access Use of OFEV (Nintedanib) in Non-IPF Interstitial Lung Disease” NCT03843892 ↗ “Cohort 2 will also receive single dose of nintedanib oral soft capsule.” NCT06482190 ↗ “oral tyrosine kinase inhibitor, nintedanib (BIBF 1120)” PMID 33077258 ↗ Oct 2020 “nintedanib, pirfenidone, or neither” NCT05497284 ↗ “Nintedanib (BIBF 1120)” NCT00987935 ↗ “Nintedanib, Ofev” NCT05830799 ↗ |
| Known as | AP02 | “This study will evaluate the impact Nintedanib Solution for Inhalation (AP02) has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary...” NCT07194382 ↗ |
| Known as | BIBF 1120 | “This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by...” NCT01907100 ↗59“Nintedanib (BIBF 1120), a potent multikinase inhibitor of VEGFR-1/-2/-3, FGFR-1/-2/-3 and PDGFR-α/-β, exerts growth inhibitory and pro-apoptotic effects in myeloid leukemic...” PMID 27716819 ↗ Oct 2016 “In a 12-month, phase 2 trial, we assessed the efficacy and safety of four different oral doses of the tyrosine kinase inhibitor BIBF 1120 as compared with placebo in patients...” PMID 21992121 ↗ Sep 2011 “Effect of small angiokinase inhibitor nintedanib (BIBF 1120) on QT interval in patients with previously untreated, advanced renal cell cancer in an open-label, phase II study.” PMID 23625328 ↗ Apr 2013 “Oral BIBF 1120 will be administered during 2 weeks at the dose determined during the phase-I part that can be combined safely with weekly paclitaxel” NCT01484080 ↗ “LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer” NCT01015118 ↗ “The tyrosine kinase inhibitor nintedanib (BIBF 1120) is in clinical development for the treatment of idiopathic pulmonary fibrosis.” PMID 24556663 ↗ Feb 2014 “Nintedanib (formerly known as BIBF 1120) is an intracellular inhibitor that targets multiple tyrosine kinases.” PMID 24836310 ↗ May 2014 “Dose Escalation Study of Nintedanib (BIBF 1120) in Japanese Patients With Hepatocellular Carcinoma” NCT01594125 ↗ “Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1)” NCT02149108 ↗ “Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy” NCT00710762 ↗ “BIBF1120 twice daily along with standard therapy of PLD + carboplatin” NCT01314105 ↗ “nintedanib (BIBF1120) along with standard therapy of pemetrexed” NCT00806819 ↗ “Nintedanib (BIBF 1120, Ofev)” NCT03562416 ↗ “Nintedanib (BIBF 1120)” NCT02496585 ↗ |
| Known as | MNKD-201 | “MNKD-201 is a dry powder nintedanib formulation for oral inhalation.” NCT07344558 ↗ |
| Known as | Nintedanib, Ofev | “Nintedanib, Ofev” NCT05830799 ↗ |
| Known as | Ofev | “Expanded Access Use of OFEV (Nintedanib) in Non-IPF Interstitial Lung Disease” NCT03843892 ↗5“Nintedanib 150 milligrams [Ofev]” NCT05335278 ↗ “Nintedanib (BIBF 1120, Ofev)” NCT03562416 ↗ “Nintedanib 150 MG [Ofev]” NCT04541680 ↗ “Nintedanib 100 MG [Ofev]” NCT05635071 ↗ “Nintedanib 150 MG [Ofev]” NCT04161014 ↗ |
| Known as | Vargatef | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01583322 ↗ |
| Action | Inhibit | “VEGF inhibitor” NCT00998296 ↗ |
| Modality | Small molecule | “small angiokinase inhibitor nintedanib” PMID 23625328 ↗ Apr 2013 |
| Route | Oral | “BIBF 1120 Administered at Oral Doses” NCT00514683 ↗ |