Drugs / Nintedanib
Nintedanib
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed idiopathic pulmonary fibrosis 1 milestone | |||||
| Filed | US (FDA) | Ofev | idiopathic pulmonary fibrosis | 2014-07-02 | “Ofev® (nintedanib), which is currently under FDA review for the treatment of people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.” prnewswire.com ↗ “the New Drug Application (NDA) for its investigational compound nintedanib has been accepted for filing by the U.S. Food & Drug Administration (FDA)” prnewswire.com ↗ |
| Filed pulmonary systemic sclerosis 2 milestones | |||||
| Filed | EU (EMA) | — | pulmonary systemic sclerosis | 2019-03-18 | “Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA and EMA.” prnewswire.com ↗ |
| Filed | US (FDA) | — | pulmonary systemic sclerosis | 2019-03-18 | “Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA and EMA.” prnewswire.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | US (FDA) | NINTEDANIB ESYLATE | — | 2026-07-09 | fda.gov ↗ |
| Approved | EU (EMA) | Vargatef | — | 2014-11-21 | europa.eu ↗ |
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US approved 2026
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 156 trials · 1 met primary · 1 missed | ||||||
| Phase 1 | NCT07454291 | Apr → Oct 2026 expected | idiopathic pulmonary fibrosis | Endeavor Biomedicines, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT07229716 | Apr → Jun 2026 | pulmonary fibrosis | Guangdong Hengrui Pharmaceutical Co., Ltd | Completed | 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 Stop: Enrollment |
| 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 | Met primary |
| 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 | Missed primary |
| 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 Stop: Business |
| 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 | NCT02182154 | Oct → Nov 2005 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182076 | 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 · 1 met primary · 1 missed | ||||||
| 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 Stop: Business |
| 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 Stop: Business |
| Phase 1/2 | NCT02393755 | May 2015 → Nov 2017 | colon adenocarcinoma, rectum adenocarcinoma | Roswell Park Cancer Institute | Completed | Met primary |
| 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 | Missed primary |
| Phase 1/2 | NCT01484080 | Oct 2011 → Nov 2013 | breast cancer | Spanish National Cancer Research Centre | Completed | No outcome recorded |
| Phase 252 trials · 12 missed | ||||||
| Phase 2 | NCT07679893 | May 2026 → Dec 2027 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 | Missed primary |
| 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| Phase 2 | NCT03287947 | Nov 2017 → Sep 2019 | appendix cancer | Wake Forest University Health Sciences | Terminated | No outcome recorded Stop: Enrollment |
| 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 | Missed primary |
| Phase 2 | NCT02730416 | Dec 2016 → Oct 2021 | endometrial cancer | Nordic Society of Gynaecological Oncology - Clinical Trials Unit | Completed | Missed primary |
| 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 Stop: Enrollment |
| Phase 2 | NCT02389764 | Jun 2015 → Jun 2018 | breast cancer | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| 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 | Missed primary |
| 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 | Missed primary |
| Phase 2 | NCT01380782 | May 2012 → Jul 2013 | anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma, gliosarcoma | Patrick Y. Wen, MD | Completed | Missed primary |
| Phase 2 | NCT01441297 | Dec 2011 → Oct 2015 | small cell lung carcinoma | Ji-youn Han | Completed | Missed primary |
| 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 | Missed primary |
| 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 | Missed primary |
| 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 | Missed primary |
| Phase 2 | NCT00514683 | Aug 2007 → Jun 2010 | pulmonary fibrosis | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2 | NCT00801294 | Jul 2006 → Nov 2007 | colorectal neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00706628 | Mar 2006 → Dec 2008 | prostate neoplasm | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2 | NCT00710762 | Mar 2006 → Sep 2008 | ovarian 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 · 7 met primary · 3 missed | ||||||
| Phase 3 | NCT07335562 | Feb 2027 → Nov 2028 expected | systemic sclerosis | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Not yet 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 | Missed primary |
| 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 | Met primary |
| Phase 3 | NCT02802345 | Jun 2016 → Dec 2017 | idiopathic pulmonary fibrosis | Boehringer Ingelheim | Completed | Missed primary |
| Phase 3 | NCT02597933 | Nov 2015 → Oct 2018 | systemic sclerosis | Boehringer Ingelheim | Completed | Met primary |
| 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 | Mixed |
| Phase 3 | NCT01979952 | Nov 2013 → Oct 2016 | idiopathic pulmonary fibrosis | Boehringer Ingelheim | Completed | Missed primary |
| 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 | Met primary |
| Phase 3 | NCT01335464 | Apr 2011 → Oct 2013 | pulmonary fibrosis | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT01015118 | Nov 2009 → Apr 2013 | ovarian neoplasm, peritoneal neoplasm | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00805194 | Dec 2008 → Nov 2010 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00806819 | Dec 2008 → Jun 2011 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | Met primary |
| Phase 47 trials · 1 missed | ||||||
| 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 | Missed primary |
| 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 Stop: Enrollment |
| Phase not stated5 trials | ||||||
| — | NCT02171156 | — | idiopathic pulmonary fibrosis | Boehringer Ingelheim | Approved for marketing | No outcome recorded |
| — | NCT02230982 | — | idiopathic pulmonary fibrosis | Boehringer Ingelheim | No longer available | No outcome recorded |
| — | NCT05624281 | — | interstitial lung disease specific to childhood | Boehringer Ingelheim | No longer available | No outcome recorded |
| — | NCT04739150 | — | interstitial lung disease | Boehringer Ingelheim | No longer available | No outcome recorded |
| — | NCT03843892 | — | interstitial lung disease | Boehringer Ingelheim | Approved for marketing | No outcome recorded |
| Comparator or background therapy19 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 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 | Missed primary Stop: Business |
| Phase 2 | NCT03287414 Background | Dec 2017 → Nov 2020 | idiopathic pulmonary fibrosis | Novartis Pharmaceuticals | Terminated | Missed primary Stop: Business |
| 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 | Met primary |
| Phase 2 | NCT00904839 Comparator | May 2009 → Jan 2012 | colorectal neoplasm | Boehringer Ingelheim | Completed | Missed primary |
| 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 Stop: Enrollment |
| 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 Stop: Enrollment |
News releases announcing trial results or a regulatory action · 52
| Date | Issuer | Release |
|---|---|---|
| 2026-09-21 | Avalyn Pharma Inc. | Results Avalyn Publishes Phase 1 Data Highlighting AP02’s Lung-Targeted Delivery and Encouraging Safety Profile avalynpharma.com ↗ |
| 2026-08-25 | PureTech | Results PureTech Founded Entity Celea Therapeutics to Deliver Two Presentations at the Upcoming European Respiratory Society (ERS) Congress puretechhealth.com ↗
Phase 1 drug-drug interaction study demonstrates that clinically relevant drug-drug interactions with deupirfenidone and nintedanib co-administration are unlik |
| 2026-07-29 | Mannkind Corporation | Results MannKind Reports Positive Phase 1b INFLO-1 Results, Demonstrating Safety and Tolerability of Nintedanib DPI and Clinical Validation of Its DPI Technology in IPF mannkindcorp.com ↗
MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company focused on developing innovative, patient-centric therapies for chronic diseases, today announced positive topline results from INFLO-1, its Phase 1b randomized, double-blind, placebo-controlled study evaluating nintedanib dry powder inhalation (DPI) in patients with idiopathic pulmonary fibrosis (IPF). |
| 2026-04-13 | Avalyn Pharma Inc. | Results Avalyn Showcases Clinical Data Across Multiple Pulmonary Fibrosis Programs at ATS 2025 avalynpharma.com ↗
Results from the Phase 1 single-ascending dose (SAD) and multiple-ascending dose (MAD) clinical trials of AP02 in healthy adult volunteers and patients with idiopathic pulmonary fibrosis (IPF) demonstrated favorable safety and tolerability at all dose levels evaluated. |
| 2026-04-13 | Avalyn Pharma Inc. | Results Avalyn Completes Successful Phase 1 Clinical Trials of AP02, its Novel Inhaled Formulation of Nintedanib, Preparing for Phase 2 Development in Idiopathic Pulmonary Fibrosis avalynpharma.com ↗
today announced that AP02 (inhaled nintedanib) was safe and well tolerated in multiple single-ascending dose (SAD) and multiple-ascending dose (MAD) Phase 1 clinical trials in healthy adult volunteers and patients with idiopathic pulmonary fibrosis (IPF). |
| 2024-11-04 | Mannkind Corporation | Results MannKind Successfully Completes Phase 1 Trial of Nintedanib DPI for Pulmonary Fibrotic Diseases mannkindcorp.com ↗
Nintedanib DPI was shown to be safe and well tolerated in healthy volunteers with the tested doses and study duration |
| 2023-12-18 | Starpharma Pty Ltd | Results Positive DEP docetaxel Phase 2 results starpharma.com ↗
In advanced, metastatic non-small cell lung cancer (NSCLC) patients, DEP ® docetaxel administered in combination with nintedanib (Vargatef®) achieved a DCR of 80.0%, with disease control for up to 24 weeks. |
| 2023-07-25 | Boehringer Ingelheim | Regulatory U.S. FDA accepts supplemental New Drug Application for OFEV® (nintedanib) for children and adolescents aged 6-17 years old with fibrosing interstitial lung disease prnewswire.com ↗ |
| 2022-09-05 | Boehringer Ingelheim | Results New data from Boehringer Ingelheim support the potential use of nintedanib in children and adolescents with fibrosing interstitial lung disease prnewswire.com ↗
The trial showed encouraging data for both primary endpoints and results were published in the European Respiratory Journal (ERJ) and presented at the European Respiratory Society (ERS) International Congress in Barcelona, Spain . |
| 2021-05-14 | Boehringer Ingelheim | Results Study analysis available during ATS 2021 supports long-term treatment with Ofev® in patients with systemic sclerosis-associated interstitial lung disease prnewswire.com ↗ |
| 2020-11-05 | Boehringer Ingelheim | Results New analysis supports long-term treatment with Ofev® in SSc-ILD patients prnewswire.com ↗
Boehringer Ingelheim today announced results from an interim analysis of the SENSCIS®-ON trial evaluating Ofev® (nintedanib) in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). |
| 2020-08-05 | Boehringer Ingelheim | Results New Analyses of Ofev® data in patients with chronic fibrosing ILDs available during American Thoracic Society Congress prnewswire.com ↗
Ofev reduced the percent of patients experiencing an absolute decline in FVC >5% predicted, 43.4% compared to 55% for placebo, at 52 weeks. |
| 2020-07-09 | Boehringer Ingelheim | Regulatory ANVISA aprova novo tratamento para doença rara pulmonar prnewswire.com ↗
O medicamento nintedanibe, da farmacêutica Boehringer Ingelheim, recebeu aprovação da Agência Nacional de Vigilância Sanitária (ANVISA)[2] para doenças pulmonares intersticiais (DPIs) fibrosantes com fenótipo progressivo, uma condição crônica, na qual a fibrose pulmonar continua a piorar. |
| 2020-03-09 | Boehringer Ingelheim | Regulatory FDA approves Ofev® as first treatment for chronic fibrosing ILDs with a progressive phenotype prnewswire.com ↗
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Ofev® (nintedanib) as the first treatment for people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. |
| 2019-11-07 | Boehringer Ingelheim | Results New analysis of patients with autoimmune-related ILDs in the INBUILD study shown as poster presentation at the 2019 ACR/ARP Annual Meeting prnewswire.com ↗
Boehringer Ingelheim presented results from a new subgroup analyses that support the primary endpoint results from the Phase III INBUILD ® trial that showed Ofev ® (nintedanib) reduced the rate of lung function decline in patients with autoimmune-related interstitial lung diseases (ILDs). |
| 2019-10-10 | Boehringer Ingelheim | Regulatory FDA Grants Ofev® Breakthrough Therapy Designation for Chronic Fibrosing ILDs with a Progressive Phenotype prnewswire.com ↗
Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Ofev® (nintedanib), which is currently under FDA review for the treatment of people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. |
| 2019-09-30 | Boehringer Ingelheim | Results INBUILD® meets primary endpoint: study evaluated Ofev® in patients across a range of progressive fibrosing interstitial lung diseases prnewswire.com ↗
Just published in the New England Journal of Medicine and presented at the European Respiratory Society (ERS) Congress in Madrid, Spain , the study met its primary endpoint in patients with a broad range of fibrosing ILDs other than idiopathic pulmonary fibrosis (IPF). |
| 2019-09-09 | Boehringer Ingelheim | Regulatory FDA approves Ofev® as the first and only therapy to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated ILD prnewswire.com ↗
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Ofev ® (nintedanib) as the first and only medicine to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). |
| 2019-07-25 | Boehringer Ingelheim | Regulatory FDA Advisory Committee Recommends Approval of Ofev® for the Treatment of Systemic Sclerosis Associated ILD prnewswire.com ↗
Boehringer Ingelheim today announced that the FDA's Arthritis Advisory Committee recommended (10-7 vote) to approve Ofev® (nintedanib) for the treatment of systemic sclerosis associated interstitial lung disease, or SSc-ILD. |
| 2019-05-20 | Boehringer Ingelheim | Results Phase III study showed Ofev® slows the loss of pulmonary function in people living with systemic sclerosis associated ILD prnewswire.com ↗
Results showed that Ofev® (nintedanib) slows the loss of pulmonary function by 44% in patients with SSc-ILD relative to placebo, as measured by FVC over 52 weeks. |
| 2019-05-07 | Starpharma Pty Ltd | Results Starpharma to present at US Drug Delivery Conference starpharma.com ↗
Positive interim trial results for both arms show notable lack of bone marrow toxicity (e.g. neutropenia) and encouraging efficacy signals |
| 2019-04-02 | Starpharma Pty Ltd | Results Starpharma Investor Presentation to Goldman Sachs Conference starpharma.com ↗
Based on positive interim results in the DEP® docetaxel + nintedanib combination arm (no protocol-defined DLTs, efficacy signals, lack of bone marrow toxicity), recruitment has been expanded. |
| 2019-03-18 | Boehringer Ingelheim | Regulatory Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD prnewswire.com ↗
Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA and EMA. |
| 2018-11-29 | Starpharma Pty Ltd | Results AGM - Chairman address and CEO presentation starpharma.com ↗
Based on positive interim results in the DEP® docetaxel + nintedanib combination arm (no protocol-defined DLTs, efficacy signals, no neutropenia), recruitment is now being expanded; efficacy signals observed include stable disease & tumour shrinkage. |
| 2018-09-17 | Boehringer Ingelheim | Results New study results provide evidence that Ofev® (nintedanib) slows progression of IPF beyond four years with consistent safety prnewswire.com ↗
These data suggest that the effect of Ofev on slowing disease progression of IPF persists beyond four years. |
| 2018-07-18 | Boehringer Ingelheim | Regulatory Governo avalia a incorporação de medicamento para Fibrose Pulmonar Idiopática prnewswire.com ↗ |
| 2018-05-21 | Boehringer Ingelheim | Results Efficacy and safety of Ofev® (nintedanib) reinforced in new presentations at ATS 2018 prnewswire.com ↗
Based on these differences, the analysis suggests that Ofev may be associated with a 26.8% relative reduction in the risk of death compared with placebo over one year. |
| 2018-03-19 | Boehringer Ingelheim | Regulatory FDA grants Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease prnewswire.com ↗
Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD). |
| 2017-10-23 | Boehringer Ingelheim | Results Ofev® demonstrates consistent long-term efficacy in IPF regardless of baseline lung function prnewswire.com ↗
Ofev demonstrated a consistent slowing in the annual rate of decline in lung function, as measured by forced vital capacity (FVC), over 96 weeks regardless of baseline FVC. |
| 2017-09-13 | Hoffmann-La Roche | Results Results of a six-month study combining Roche’s Esbriet with nintedanib in patients with IPF presented at ERS roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results of a six month study combining Esbriet (pirfenidone) and nintedanib treatment, showing a similar safety profile for the combination treatment to that expected for each treatment alone. |
| 2017-09-11 | Boehringer Ingelheim | Results Results from the INJOURNEY™ trial investigating Ofev® with add-on pirfenidone provide new insights into this combination treatment for IPF prnewswire.com ↗
The data show that the safety and tolerability profile of nintedanib with add-on pirfenidone is consistent with the known profiles of the individual drugs in patients with IPF. |
| 2017-06-05 | Boehringer Ingelheim | Results Encouraging Phase II survival data for oral nintedanib in malignant pleural mesothelioma presented at ASCO 2017 prnewswire.com ↗
Nintedanib, an oral triple angiokinase inhibitor, demonstrated improved progression-free survival (PFS, primary endpoint) and overall survival (OS, secondary endpoint) when added to standard first-line chemotherapy of pemetrexed/cisplatin in patients with malignant pleural mesothelioma (MPM) compared to chemotherapy alone. |
| 2017-05-24 | Boehringer Ingelheim | Results IPF patients treated with Ofev® (nintedanib) versus placebo were twice as likely to have improved or stable lung function prnewswire.com ↗
Overall, the incidence of MACE was similar between the treatment groups both in patients with a high CV risk (3.5%, Ofev vs. 3.3%, placebo) and low CV risk (4.5%, Ofev vs. 5.3%, placebo) at baseline. |
| 2016-12-14 | Boehringer Ingelheim | Regulatory Nintedanib granted orphan drug designation for treatment of mesothelioma prnewswire.com ↗
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to nintedanib for the treatment of mesothelioma. |
| 2016-12-07 | Boehringer Ingelheim | Results Clinically meaningful data for oral nintedanib in mesothelioma presented at World Conference on Lung Cancer prnewswire.com ↗
Boehringer Ingelheim today announced that the LUME-Meso Phase II trial in patients with unresectable malignant pleural mesothelioma (MPM) met its primary endpoint of progression-free survival (PFS). |
| 2016-10-24 | Boehringer Ingelheim | Results Efficacy of Ofev® (nintedanib) Reinforced in Range of Patients with IPF in New Analyses Presented at CHEST prnewswire.com ↗
The analysis showed a similar reduction in disease progression with Ofev versus placebo regardless of GAP stage (no significant difference between GAP stage I versus GAP stage II/III). |
| 2016-10-09 | Boehringer Ingelheim | Results Phase III nintedanib trial results in patients with metastatic colorectal cancer announced at ESMO prnewswire.com ↗
While nintedanib showed clear anti-tumor activity and significantly reduced the risk of disease progression by 42% versus BSC, this did not translate into an overall survival (OS) benefit, the second co-primary endpoint. |
| 2016-09-09 | Boehringer Ingelheim | Regulatory Orphan Drug Designation Granted to Nintedanib for Treatment of Systemic Sclerosis, including Associated Interstitial Lung Disease prnewswire.com ↗
Boehringer Ingelheim today announced that the European Commission (EC) and U.S. Food and Drug Administration (FDA) have granted Orphan Drug Designation to nintedanib for the treatment of systemic sclerosis (SSc, also known as scleroderma), including the associated interstitial lung disease (SSc-ILD). |
| 2016-09-07 | Boehringer Ingelheim | Results New Long-Term Data Demonstrates Continued Safety and Beneficial Effect of Ofev® (Nintedanib) for Patients with IPF prnewswire.com ↗
The results demonstrated that Ofev has a long-term effect on slowing disease progression and a manageable side effect profile in patients with IPF, and were consistent with results previously observed in the INPULSIS® trials. |
| 2016-06-27 | Boehringer Ingelheim | Results New analysis of INPULSIS™ trials demonstrates efficacy of OFEV® (nintedanib) across a range of IPF patients using broader diagnostic criteria prnewswire.com ↗
In patients with confirmed UIP pattern, including honeycombing and/or biopsy, the adjusted annual rate of decline in FVC was −108.7 mL/year in the nintedanib group and -225.7 mL/year in the placebo group (difference versus placebo of 117.0 mL/year). |
| 2016-05-16 | Boehringer Ingelheim | Results New Presentations at ATS 2016 Reinforce OFEV® (nintedanib) Efficacy, Safety and Tolerability Across Range of Patients with IPF prnewswire.com ↗
OFEV significantly reduced the risk of a first investigator-reported acute exacerbation (reported as a serious adverse event) by 43% versus placebo based on pooled data from the INPULSIS trials. |
| 2015-09-29 | Boehringer Ingelheim | Results New Data Shows OFEV® (nintedanib) Efficacy is Sustained Long-term with No New Safety Signals in Patients with IPF prnewswire.com ↗
An interim analysis of the INPULSIS™-ON open-label extension trial of OFEV® (nintedanib) shows efficacy and safety that is consistent to that in the two identically-designed Phase III INPULSIS™ trials in patients with idiopathic pulmonary fibrosis (IPF). |
| 2015-05-18 | Boehringer Ingelheim | Results Boehringer Ingelheim Presents New Data and Analyses Reinforcing the Safety and Efficacy of OFEV® (nintedanib) Capsules prnewswire.com ↗
Boehringer Ingelheim announced new data and analyses that provide further evidence to support the efficacy, safety and tolerability of OFEV® (nintedanib) capsules in patients with idiopathic pulmonary fibrosis (IPF). |
| 2014-10-15 | Boehringer Ingelheim | Regulatory FDA Approves Boehringer Ingelheim's OFEV® (nintedanib) as First Kinase Inhibitor to Treat Idiopathic Pulmonary Fibrosis prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved OFEV® (nintedanib) capsules for oral use for the treatment of idiopathic pulmonary fibrosis (IPF). |
| 2014-09-09 | Boehringer Ingelheim | Results New Analysis of Phase III Trials Examines the Impact of Boehringer Ingelheim's IPF Therapy Nintedanib on Lung Function Decline Based on Patients' Baseline Severity prnewswire.com ↗ |
| 2014-07-16 | Boehringer Ingelheim | Regulatory Boehringer Ingelheim's Investigational Therapy Nintedanib Receives FDA Breakthrough Therapy Designation prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy designation to nintedanib, an investigational therapy currently under FDA review for the treatment of people with idiopathic pulmonary fibrosis (IPF). |
| 2014-07-02 | Boehringer Ingelheim | Regulatory U.S. FDA Accepts NDA Filing for Boehringer Ingelheim's Investigational Nintedanib and Grants Priority Review Designation for the Treatment of Idiopathic Pulmonary Fibrosis prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the New Drug Application (NDA) for its investigational compound nintedanib has been accepted for filing by the U.S. Food & Drug Administration (FDA) and granted Priority Review designation. |
| 2014-05-18 | Boehringer Ingelheim | Results Phase 3 INPULSIS™ Trials Published in the New England Journal of Medicine Show Investigational Nintedanib Slowed Lung Function Loss in People with Idiopathic Pulmonary Fibrosis prnewswire.com ↗
In these trials, nintedanib reduced the annual rate of FVC decline compared to placebo by 48% in INPULSIS™-1 (-114.7 vs. -239.9 mL/year, respectively [95% CI: 77.7, 172.8]) and by 55% in INPULSIS™-2 (-113.6 vs. -207.3 mL/year, respectively [95% CI: 44.8, 142.7]). |
| 2013-06-03 | Boehringer Ingelheim | Results Primary Progression-Free Survival Endpoint Met in Phase III Study of Nintedanib Plus Docetaxel in Second-Line Advanced NSCLC prnewswire.com ↗
results showed patients treated with nintedanib plus docetaxel lived for a median of 3.4 months before their tumor started to grow again, versus 2.7 months with docetaxel alone (HR 0.79; p=0.0019). |
| 2013-05-15 | Boehringer Ingelheim | Results Boehringer Ingelheim Presents Progression-Free Survival Data for Investigational Afatinib and Nintedanib in Advanced NSCLC prnewswire.com ↗
Based on the available data from 713 patients enrolled, an increased PFS was observed in patients treated with the nintedanib combination versus pemetrexed alone. |
| 2011-09-27 | Boehringer Ingelheim | Results Interim Data Announced for BIBF 1120 as Compared to bevacizumab in Combination Chemotherapy in Metastatic Colorectal Cancer prnewswire.com ↗
The median PFS was numerically similar between both groups at 10.6 months ([95% CI: 9.4-12.3] for the BIBF 1120 arm and [95% CI: 9.1-NA] for the bevacizumab arm). |
| 2011-09-21 | Boehringer Ingelheim | Results New Study Published in New England Journal of Medicine Shows Investigational BIBF 1120 Demonstrated Positive Trend in Reducing Lung Function Loss in Idiopathic Pulmonary Fibrosis prnewswire.com ↗
Boehringer Ingelheim's investigational tyrosine kinase inhibitor (TKI) BIBF 1120 demonstrated a positive trend in reducing lung function decline in patients with idiopathic pulmonary fibrosis (IPF), according to phase II clinical trial results published today online in the New England Journal of Medicine (NEJM) . |
All press releases naming this drug 71 releases
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 ↗ |
| 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 | BIBF1120 | “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 ↗ |
| Known as | MNKD-201 | “Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis” NCT07679893 ↗1“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 100 MG [Ofev]” NCT05635071 ↗ “Nintedanib 150 MG [Ofev]” NCT04161014 ↗ “Nintedanib 150 MG [Ofev]” NCT04541680 ↗ |
| Known as | Vargatef | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03361319 ↗ |
| 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 ↗ |