Drugs / Baricitinib
Baricitinib
also known as
LY3009104 · Olumiant · BARI · BARICITINIB (INCB028050) · BARICITINIB (LY3009104) · BARICITINIB PHOSPHATE · BARICITINIB PHOSPHATE SALT · INCB-28050 · +1 more
Small molecule targets AAK1, JAK1, JAK2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | OLUMIANT | — | 2019-10-08 – 2022-06-13 | fda.gov ↗ |
| Approved | US (FDA) | OLUMIANT | — | 2018-05-31 | fda.gov ↗ |
| Approved | EU (EMA) | Olumiant | — | 2017-02-13 | europa.eu ↗ |
Trials 154 · started per year
today
EU approved 2017
US approved 2018
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03945760 | Sep 2020 → Oct 2023 | allergic contact dermatitis | Wright State Physicians | Completed | No outcome recorded |
| Phase 119 trials | ||||||
| Phase 1 | NCT07262983 | Jul 2026 → May 2030 expected | atopic eczema, hyper-IgE recurrent infection syndrome 4A, autosomal dominant, lupus erythematosus | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 1 | NCT04131738 | Apr 2020 → Nov 2021 | graft versus host disease | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT03212638 | Jun → Jul 2017 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02758613 | May → Jul 2016 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02340104 | Jan → Feb 2015 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02263911 | Nov → Dec 2014 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01960140 | Oct → Dec 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01925144 | Oct → Nov 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01968057 | Oct → Dec 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01937026 | Sep → Nov 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01910311 | Aug → Oct 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01924299 | Aug → Nov 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01896726 | Jul → Oct 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01870388 | Jun → Jul 2013 | liver disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01859078 | May → Aug 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01536951 | Feb 2012 → May 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01398475 | Jul → Sep 2011 | rheumatoid arthritis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01299285 | Feb → Mar 2011 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01247350 | Nov 2010 → Apr 2011 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT07535645 | Apr 2026 → Dec 2027 expected | disease related to hematopoietic stem cell transplant, thrombocytopenia | Peking University People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06548802 | Feb 2024 → Jun 2026 overdue | lung disorder | Tianjin Medical University General Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05792462 | Apr 2023 → Dec 2025 overdue | neuromyelitis optica | Tianjin Medical University General Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05189106 | Dec 2022 → Apr 2025 | Alzheimer disease, amyotrophic lateral sclerosis, cognitive impairment with or without cerebellar ataxia | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT04916756 | Jan → Dec 2020 | Sjogren syndrome | Peking Union Medical College Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT02759731 | Nov 2016 → Jun 2022 | chronic graft versus host disease | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 251 trials | ||||||
| Phase 2 | NCT07209267 | Sep 2026 → Jan 2028 expected | HIV infectious disease | Emory University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07669675 | Jul 2026 → Dec 2027 expected | autoimmune thrombocytopenia | Peking University People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07608796 | Jun 2026 → Oct 2027 expected | cognitive disorder, depressive disorder | Emory University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06381661 | May 2026 → Jun 2028 expected | infectious disease with sepsis | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07081763 | May 2026 → May 2029 expected | HIV infectious disease | ANRS, Emerging Infectious Diseases | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07268534 | Apr 2026 → Nov 2029 expected | Quinquaud's folliculitis decalvans | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06868381 | Apr 2026 → Jul 2028 expected | cardiac sarcoidosis | Stanford University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06923072 | Feb 2026 → Dec 2030 expected | malignant atrophic papulosis | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | No outcome recorded |
| Phase 2 | NCT07028385 | Sep 2025 → Apr 2026 | HIV infectious disease | Fight AIDS and Infectious Diseases Foundation | Completed | No outcome recorded |
| Phase 2 | NCT07003997 | Sep 2025 → Feb 2030 expected | major depressive disorder | Emory University | Recruiting | No outcome recorded |
| Phase 2 | NCT06797310 | Jan → Dec 2025 overdue | alopecia areata | National Taiwan University Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06849908 | Nov 2024 → Jun 2027 expected | Behcet disease | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06490757 | Oct 2024 → Sep 2028 expected | hepatocellular adenoma | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 2 | NCT06439615 | Aug 2024 → Dec 2026 expected | subarachnoid hemorrhage | Tang-Du Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06158113 | Mar 2024 → Aug 2026 overdue | lichen planus, oral | University of North Carolina, Chapel Hill | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05849038 | Dec 2023 → Nov 2027 expected | HIV infectious disease, atypical depressive disorder, depressive disorder | Emory University | Recruiting | No outcome recorded |
| Phase 2 | NCT06065046 | Nov 2023 → Jun 2026 overdue | traumatic brain injury | Tang-Du Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06114407 | Oct 2023 → Jun 2024 | spondyloarthropathy | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Unknown | No outcome recorded |
| Phase 2 | NCT04901325 | Oct 2023 → Jan 2025 | pyoderma gangrenosum, ulcer disease | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 2 | NCT05897372 | Aug 2023 → Sep 2024 | diabetic kidney disease | Iain Bressendorff | Terminated | No outcome recorded |
| Phase 2 | NCT05932524 | Jul 2023 → Jun 2024 | autoimmune thrombocytopenia | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05452564 | May 2023 → Jan 2028 expected | HIV infectious disease | William Tyor | Recruiting | No outcome recorded |
| Phase 2 | NCT05852847 | May 2023 → Nov 2024 | autoimmune thrombocytopenia | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05852171 | May 2023 → Apr 2025 | granulomatous mastitis, mastitis | First Affiliated Hospital of Zhejiang University | Unknown | No outcome recorded |
| Phase 2 | NCT05237388 | Apr 2023 → Apr 2026 | chronic kidney disease | Duke University | Completed | No outcome recorded |
| Phase 2 | NCT06662721 | Apr → Dec 2023 | Takayasu arteritis | Liu Tian | Completed | No outcome recorded |
| Phase 2 | NCT05524311 | Nov 2022 → May 2025 | juvenile dermatomyositis | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT05016297 | Jul 2022 → Aug 2024 | Sjogren syndrome | Peking Union Medical College Hospital | Completed | No outcome recorded |
| Phase 2 | NCT05446831 | Jul 2022 → Jun 2023 | autoimmune thrombocytopenic purpura, thrombocytopenia due to immune destruction | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05400889 | Jun 2022 → Mar 2023 | idiopathic inflammatory myopathy | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05361109 | Jun 2022 → Mar 2023 | dermatomyositis | University of Washington | Withdrawn | No outcome recorded |
| Phase 2 | NCT05263505 | Feb 2022 → Sep 2023 | conjunctivitis, mucous membrane pemphigoid | Washington University School of Medicine | Terminated | No outcome recorded |
| Phase 2 | NCT05188521 | Jan 2022 → May 2023 | lichen planus | Aaron R. Mangold | Completed | No outcome recorded |
| Phase 2 | NCT04208464 | Oct 2021 → Sep 2023 | idiopathic inflammatory myopathy | University of Manchester | Completed | No outcome recorded |
| Phase 2 | NCT04822584 | Jul 2021 → Apr 2023 | vitiligo | University Hospital, Bordeaux | Completed | No outcome recorded |
| Phase 2 | NCT04027101 | Dec 2020 → Aug 2023 | polymyalgia rheumatica | University Hospital, Brest | Completed | No outcome recorded |
| Phase 2 | NCT04393051 | May → Jun 2020 | COVID-19, severe acute respiratory syndrome | Azienda Ospedaliero, Universitaria Pisana | Unknown | No outcome recorded |
| Phase 2 | NCT04399798 | May → Sep 2020 | COVID-19 | Fondazione IRCCS Policlinico San Matteo di Pavia | Unknown | No outcome recorded |
| Phase 2 | NCT04346147 | May 2020 → Jun 2021 | pneumonia | Hospital Universitario de Fuenlabrada | Unknown | No outcome recorded |
| Phase 2 | NCT04373044 | May 2020 → May 2021 | COVID-19 | University of Southern California | Terminated | No outcome recorded |
| Phase 2 | NCT04321993 | Apr 2020 → Apr 2024 | COVID-19 | Lisa Barrett | Unknown | No outcome recorded |
| Phase 2 | NCT03921554 | Jun 2019 → Jan 2024 | Aicardi-Goutieres syndrome | Adeline Vanderver, MD | Completed | No outcome recorded |
| Phase 2 | NCT03742973 | Mar → Sep 2019 | primary biliary cholangitis | Eli Lilly and Company | Terminated | No outcome recorded |
| Phase 2 | NCT03026504 | Mar 2017 → Apr 2021 | temporal arteritis | Matthew J Koster | Completed | No outcome recorded |
| Phase 2 | NCT02708095 | Mar 2016 → Oct 2017 | systemic lupus erythematosus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT02576938 | Feb 2016 → Feb 2017 | atopic eczema | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT01683409 | Aug 2012 → Sep 2014 | diabetic kidney disease | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT01490632 | Dec 2011 → Dec 2012 | psoriasis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT01469013 | Nov 2011 → Nov 2012 | rheumatoid arthritis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT01185353 | Oct 2010 → Dec 2011 | rheumatoid arthritis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00902486 | May 2009 → Jun 2010 | rheumatoid arthritis | Incyte Corporation | Completed | No outcome recorded |
| Phase 2/310 trials | ||||||
| Phase 2/3 | NCT07449910 | Mar 2026 → Aug 2027 expected | anterior cerebral artery infarction | The First Affiliated Hospital of University of Science and Technology of China | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06475820 | Dec 2023 → Jul 2024 overdue | acute biphenotypic leukemia, myelodysplastic syndrome | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT05914584 | Jul 2023 → Aug 2025 | nosocomial infection | Nantes University Hospital | Unknown | No outcome recorded |
| Phase 2/3 | NCT05686746 | Jun 2022 → Jun 2023 | nephritis, systemic lupus erythematosus | Assiut University | Unknown | No outcome recorded |
| Phase 2/3 | NCT04891133 | Jun 2021 → Dec 2022 | COVID-19 | Oslo University Hospital | Terminated | No outcome recorded |
| Phase 2/3 | NCT04340232 | Mar → Aug 2021 | COVID-19 | University of Colorado, Denver | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT04517253 | Oct 2020 → Apr 2023 | Aicardi-Goutieres syndrome, STING-associated vasculopathy with onset in infancy, proteosome-associated autoinflammatory syndrome | Eli Lilly and Company | Terminated | No outcome recorded |
| Phase 2/3 | NCT04320277 | May → Jun 2020 | — | Hospital of Prato | Unknown | No outcome recorded |
| Phase 2/3 | NCT04358614 | Mar → Apr 2020 | COVID-19, pneumonia | Fabrizio Cantini | Completed | No outcome recorded |
| Phase 2/3 | NCT03570749 | Sep 2018 → Feb 2021 | alopecia areata | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 345 trials | ||||||
| Phase 3 | NCT07543458 | Oct 2026 → Jul 2030 expected | arbovirus infection, dengue disease, hemorrhagic fever | Oxford University Clinical Research Unit, Vietnam | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05651880 | Jul 2026 → Dec 2029 expected | uveitis | University Hospital, Rouen | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07222332 | Feb 2026 → Jul 2028 expected | type 1 diabetes mellitus | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT07222137 | Jan 2026 → Jul 2031 expected | type 1 diabetes mellitus | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT06631287 | Oct 2024 → Nov 2026 expected | COVID-19, long COVID-19 | Wes Ely | Recruiting | No outcome recorded |
| Phase 3 | NCT05858515 | Oct 2024 → Dec 2027 | post-COVID-19 disorder | Vanderbilt University Medical Center | Withdrawn | No outcome recorded |
| Phase 3 | NCT06936215 | Jan 2024 → May 2025 overdue | diffuse cutaneous systemic sclerosis | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Recruiting | No outcome recorded |
| Phase 3 | NCT05379322 | Mar 2023 | rheumatoid arthritis | Abu Dhabi Stem Cells Center | Withdrawn | No outcome recorded |
| Phase 3 | NCT05723198 | Feb 2023 → Mar 2028 expected | alopecia areata, hypotrichosis, skin disorder | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT04972760 | Aug 2022 → Feb 2028 expected | dermatomyositis | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT05432531 | Jun → Dec 2022 | lupus nephritis | Assiut University | Unknown | No outcome recorded |
| Phase 3 | NCT05074420 | Dec 2021 → Sep 2024 | COVID-19 | Eli Lilly and Company | Terminated | No outcome recorded |
| Phase 3 | NCT05056558 | Oct 2021 → Apr 2022 | COVID-19 | Incepta Pharmaceuticals Ltd | Unknown | No outcome recorded |
| Phase 3 | NCT04870203 | Jul 2021 → Mar 2027 expected | rheumatoid arthritis | University Hospital, Bordeaux | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04970719 | Jul → Dec 2021 | pneumonia | Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders | Withdrawn | No outcome recorded |
| Phase 3 | NCT04832880 | Apr 2021 → Mar 2022 | COVID-19 | ASST Fatebenefratelli Sacco | Unknown | No outcome recorded |
| Phase 3 | NCT04640168 | Dec 2020 → May 2021 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT04693026 | Sep 2020 → Feb 2021 | COVID-19, acute respiratory distress syndrome | M Abdur Rahim Medical College and Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04421027 | Jun 2020 → Feb 2021 | COVID-19 | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT04401579 | May → Jul 2020 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT04890626 | Apr 2020 → Jul 2023 | COVID-19 | Instituto de Investigación Hospital Universitario La Paz | Completed | No outcome recorded |
| Phase 3 | NCT04088396 | Feb 2020 → Oct 2026 expected | systemic-onset juvenile idiopathic arthritis | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04088409 | Oct 2019 → Jul 2023 overdue | uveitis | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03843125 | Sep 2019 → Apr 2022 | systemic lupus erythematosus | Eli Lilly and Company | Terminated | No outcome recorded |
| Phase 3 | NCT03899259 | Jul 2019 → Jan 2021 | alopecia areata | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT03952559 | May 2019 → Apr 2022 overdue | atopic eczema | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03773965 | Apr 2019 → Jul 2031 expected | juvenile idiopathic arthritis | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT03773978 | Dec 2018 → Jan 2022 | juvenile idiopathic arthritis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT03733301 | Nov 2018 → Jul 2019 | atopic eczema | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT03701789 | Sep 2018 → Oct 2021 | bone remodeling disease, rheumatoid arthritis | University of Erlangen-Nürnberg Medical School | Unknown | No outcome recorded |
| Phase 3 | NCT03616912 | Aug 2018 → Nov 2021 | systemic lupus erythematosus | Eli Lilly and Company | Terminated | No outcome recorded |
| Phase 3 | NCT03616964 | Aug 2018 → Sep 2021 | systemic lupus erythematosus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT03559270 | Jun 2018 → Oct 2021 | atopic eczema | Eli Lilly and Company | Terminated | No outcome recorded |
| Phase 3 | NCT03428100 | May 2018 → Nov 2019 | atopic eczema | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT03334435 | Mar 2018 → Sep 2020 | atopic eczema | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT03435081 | Feb 2018 → Dec 2019 | atopic eczema | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT03334422 | Nov 2017 → Dec 2018 | atopic eczema | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT03334396 | Nov 2017 → Dec 2018 | atopic eczema | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT02735707 | Apr 2016 → Feb 2026 overdue | pneumonia | UMC Utrecht | Recruiting | No outcome recorded |
| Phase 3 | NCT02265705 | Oct 2014 → May 2017 | rheumatoid arthritis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT01885078 | Jun 2013 → Nov 2020 | rheumatoid arthritis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT01721044 | Jan 2013 → Jun 2014 | rheumatoid arthritis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT01721057 | Dec 2012 → Sep 2014 | rheumatoid arthritis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT01711359 | Nov 2012 → Feb 2015 | rheumatoid arthritis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT01710358 | Oct 2012 → Mar 2015 | rheumatoid arthritis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 414 trials | ||||||
| Phase 4 | NCT07357649 | Jan → Apr 2026 overdue | rheumatoid arthritis | Tanta University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07160231 | Sep 2025 → May 2028 expected | psoriatic arthritis, spondyloarthropathy | Sint Maartenskliniek | Recruiting | No outcome recorded |
| Phase 4 | NCT06240351 | Apr 2024 → Oct 2026 expected | frontal fibrosing alopecia | University of Alabama at Birmingham | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05955066 | Dec 2023 → Feb 2026 overdue | rheumatoid arthritis | Chinese University of Hong Kong | Recruiting | No outcome recorded |
| Phase 4 | NCT06366932 | Sep 2023 → Sep 2025 | atopic eczema | Instituto de Investigación Hospital Universitario La Paz | Unknown | No outcome recorded |
| Phase 4 | NCT05827497 | Apr 2023 → Mar 2024 | rheumatoid arthritis | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Unknown | No outcome recorded |
| Phase 4 | NCT05660655 | Oct 2022 → Sep 2023 | rheumatoid arthritis | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Completed | No outcome recorded |
| Phase 4 | NCT05238896 | Jun 2022 → Feb 2023 | rheumatoid arthritis | Assistance Publique - Hôpitaux de Paris | Terminated | No outcome recorded |
| Phase 4 | NCT05300932 | Mar 2022 → Aug 2026 overdue | systemic sclerosis | Tongji Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05080218 | Nov 2021 → Apr 2024 | psoriatic arthritis, spondyloarthropathy | Jeffrey Curtis | Completed | No outcome recorded |
| Phase 4 | NCT04390464 | May 2020 → May 2021 | COVID-19 | Cambridge University Hospitals NHS Foundation Trust | Unknown | No outcome recorded |
| Phase 4 | NCT04086745 | Feb 2020 → May 2025 | rheumatoid arthritis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT03915964 | Apr 2019 → May 2025 | rheumatoid arthritis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT02714634 | Mar 2016 → Mar 2029 expected | rheumatoid arthritis | University Hospital, Strasbourg, France | Recruiting | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT07406932 | May 2026 → Jul 2027 expected | antisynthetase syndrome, interstitial lung disease | China-Japan Friendship Hospital | Recruiting | No outcome recorded |
| — | NCT05969730 | Aug 2023 → Apr 2025 | atopic eczema | Mazandaran University of Medical Sciences | Completed | No outcome recorded |
| — | NCT05305066 | Feb 2023 → Dec 2028 expected | rheumatoid arthritis | Marie Hudson, MD | Recruiting | No outcome recorded |
| — | NCT05781516 | Jan 2023 → Jun 2024 | immunoglobulin G4-related sclerosing disease | Wen Zhang | Unknown | No outcome recorded |
| — | NCT05082714 | Oct 2021 → Jun 2022 | COVID-19 | University Hospital of Patras | Completed | No outcome recorded |
| — | NCT05003310 | Oct 2021 → Jul 2027 expected | rheumatoid arthritis | Galvani Bioelectronics | Recruiting | No outcome recorded |
| — | NCT04378621 | Oct 2020 → Sep 2025 | depressive disorder, rheumatoid arthritis, subjective cognitive decline | Vastra Gotaland Region | Unknown | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01724580 | — | Aicardi-Goutieres syndrome, STING-associated vasculopathy with onset in infancy, juvenile dermatomyositis, proteosome-associated autoinflammatory syndrome | Eli Lilly and Company | Approved for marketing | No outcome recorded |
Also used as a comparator or background therapy in 15 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07554222 Comparator | Apr 2026 → Dec 2027 expected | alopecia areata, vitiligo | Innovent Biologics (Suzhou) Co. Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT06545110 Comparator | Sep 2023 → Sep 2024 overdue | alopecia areata | South Valley University | Active not recruiting | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06768294 Comparator | Jan 2025 → Jun 2026 overdue | chondrocalcinosis | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04774224 Comparator | Oct 2020 → Jan 2023 | type 1 diabetes mellitus | St Vincent's Institute of Medical Research | Completed | No outcome recorded |
| Phase 2 | NCT03755466 Comparator | Nov 2018 → Nov 2023 | rheumatoid arthritis | Shinshu University | Unknown | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06768840 Comparator | Oct 2024 → Aug 2025 overdue | generalized vitiligo | South Valley University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05545020 Comparator | Dec 2022 → Jan 2024 | rheumatoid arthritis | Alexandria University | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT07279688 Comparator | Dec 2025 → Nov 2028 expected | polymyalgia rheumatica | University Hospital, Brest | Recruiting | No outcome recorded |
| Phase 3 | NCT04692493 Comparator | Sep 2021 → May 2029 expected | rheumatoid arthritis | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 3 | NCT05187793 Background | Jul 2021 → Oct 2022 | COVID-19 | R-Pharm | Unknown | No outcome recorded |
| Phase 3 | NCT04381936 Comparator | Mar 2020 → Sep 2028 expected | pneumonia | University of Oxford | Recruiting | No outcome recorded |
| Phase 3 | NCT03414502 Comparator | Dec 2007 → Mar 2028 expected | rheumatoid arthritis | University of Nebraska | Recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06687551 Comparator | Jan 2025 → Apr 2029 expected | rheumatoid arthritis | University Hospital, Toulouse | Not yet recruiting | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07645430 Comparator | Jan 2023 → Jan 2024 | alopecia areata | Benha University | Completed | No outcome recorded |
| — | NCT05279391 Comparator | Oct 2020 → Nov 2021 | respiratory failure | Democritus University of Thrace | Unknown | No outcome recorded |
Press releases naming this drug 64 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-06-13 | Incyte Corporation | FDA Approves Lilly and Incyte's OLUMIANT® (baricitinib) As First and Only Systemic Medicine for Adults with Severe Alopecia Areata incyte.com ↗ |
| 2022-05-20 | Incyte Corporation | CHMP Recommends Approval of Lilly and Incyte's OLUMIANT® (baricitinib) as the First and Only Centrally-Authorized Treatment for Adults with Severe Alopecia Areata (AA) incyte.com ↗ |
| 2022-05-11 | Incyte Corporation | FDA Approves Lilly and Incyte's OLUMIANT® (baricitinib) for the Treatment of Certain Hospitalized Patients with COVID-19 incyte.com ↗ |
| 2022-01-28 | Incyte Corporation | Updates on OLUMIANT® (baricitinib) Phase 3 lupus program and FDA review for atopic dermatitis incyte.com ↗ |
| 2021-11-09 | Incyte Corporation | OLUMIANT® Long-Term Safety Profile Established Up to 9.3 Years in Integrated Analysis of More Than 3,700 Patients with Rheumatoid Arthritis incyte.com ↗ |
| 2021-09-30 | Incyte Corporation | OLUMIANT® Significantly Improved Hair Regrowth to At Least 80% Scalp Coverage as Early as 24 Weeks Across First Completed Phase 3 Studies for Alopecia Areata incyte.com ↗ |
| 2021-08-03 | Incyte Corporation | Lilly and Incyte's baricitinib reduced deaths among patients with COVID-19 receiving invasive mechanical ventilation incyte.com ↗ |
| 2021-07-29 | Incyte Corporation | FDA broadens existing emergency use of Lilly and Incyte's baricitinib in patients hospitalized with COVID-19 requiring oxygen incyte.com ↗ |
| 2021-07-16 | Incyte Corporation | Lilly and Incyte provide update on supplemental New Drug Application for baricitinib for the treatment of moderate to severe atopic dermatitis incyte.com ↗ |
| 2021-06-01 | Incyte Corporation | OLUMIANT® Improved Pain, Physical Function and Morning Joint Stiffness in Rheumatoid Arthritis in Phase 3 Post-Hoc Analyses incyte.com ↗ |
| 2021-04-23 | Incyte Corporation | OLUMIANT® Showed Significant Improvements in the Severity and Extent of Atopic Dermatitis and Other Patient-Reported Outcomes in Phase 3 Study Analyses incyte.com ↗ |
| 2021-04-20 | Incyte Corporation | Lilly and Incyte's Baricitinib Improved Hair Regrowth for Alopecia Areata Patients in Second Phase 3 Study incyte.com ↗ |
| 2021-04-08 | Incyte Corporation | Lilly and Incyte announce results from the Phase 3 COV-BARRIER study of baricitinib in hospitalized COVID-19 patients incyte.com ↗ |
| 2021-04-06 | Incyte Corporation | Lilly and Incyte communicate review extension of supplemental New Drug Application for baricitinib for the treatment of moderate to severe atopic dermatitis incyte.com ↗ |
| 2021-03-03 | Incyte Corporation | Baricitinib is First JAK-Inhibitor to Demonstrate Hair Regrowth in Phase 3 Alopecia Areata (AA) Trial incyte.com ↗ |
| 2020-12-11 | Incyte Corporation | Data from ACTT-2 Trial of Baricitinib in Hospitalized COVID-19 Patients Supportive of the EUA Published in New England Journal of Medicine incyte.com ↗ |
| 2020-11-19 | Incyte Corporation | Baricitinib Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19 incyte.com ↗ |
| 2020-11-19 | Incyte Corporation | Baricitinib Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19 incyte.com ↗ |
| 2020-10-31 | Incyte Corporation | EADV 2020: Lilly and Incyte Showcase New Data for Baricitinib for the Treatment of Moderate to Severe Atopic Dermatitis incyte.com ↗ |
| 2020-10-30 | Incyte Corporation | Fall Clinical Dermatology 2020: Lilly and Incyte Showcase Positive New Data for Baricitinib in Adult Patients with Alopecia Areata incyte.com ↗ |
| 2020-10-08 | Incyte Corporation | Baricitinib has Significant Effect on Recovery Time, Most Impactful in COVID-19 Patients Requiring Oxygen incyte.com ↗ |
| 2020-09-18 | Incyte Corporation | CHMP Recommends Approval of Lilly's Baricitinib for the Treatment of Adults with Moderate to Severe Atopic Dermatitis incyte.com ↗ |
| 2020-09-14 | Incyte Corporation | Baricitinib in Combination with Remdesivir Reduces Time to Recovery in Hospitalized Patients with COVID-19 in NIAID-Sponsored ACTT-2 Trial incyte.com ↗ |
| 2020-03-16 | Incyte Corporation | Lilly Receives FDA Breakthrough Therapy Designation for Baricitinib for the Treatment of Alopecia Areata incyte.com ↗ |
| 2020-01-30 | Incyte Corporation | Lilly and Incyte Announce Positive Top-Line Results from the North American (BREEZE-AD5) Phase 3 Study of Oral Selective JAK Inhibitor Baricitinib in Patients with Moderate to Severe Atopic Dermatitis incyte.com ↗ |
| 2020-01-27 | Incyte Corporation | Lilly and Incyte Announce Top-Line Results from Phase 3 Study (BREEZE-AD4) of Oral Selective JAK Inhibitor Baricitinib in Combination with Topical Corticosteroids in Patients with Moderate to Severe Atopic Dermatitis Not Controlled with Cyclosporine incyte.com ↗ |
| 2019-08-23 | Incyte Corporation | Lilly Announces Top-Line Phase 3 Results for Oral JAK Inhibitor Baricitinib, in Combination with Topical Corticosteroids in Adult Patients with Moderate to Severe Atopic Dermatitis incyte.com ↗ |
| 2019-02-04 | Incyte Corporation | Lilly Announces Top-Line Phase 3 Results for Baricitinib in Patients with Moderate to Severe Atopic Dermatitis incyte.com ↗ |
| 2018-12-13 | Incyte Corporation | FDA Grants Fast Track Designation to the Baricitinib Development Program for the Treatment of Systemic Lupus Erythematosus (SLE) incyte.com ↗ |
| 2018-10-21 | Incyte Corporation | ACR 2018: Lilly Shares Updated Safety Analysis of OLUMIANT® (baricitinib) in Patients with Moderately-to-Severely Active Rheumatoid Arthritis incyte.com ↗ |
| 2018-07-19 | Incyte Corporation | Study Published in The Lancet Shows Benefit of Baricitinib 4 mg for the Treatment of Systemic Lupus Erythematosus (SLE) incyte.com ↗ |
| 2018-06-01 | Incyte Corporation | FDA Approves OLUMIANT® (baricitinib) 2-mg Tablets for the Treatment of Adults with Moderately-to-Severely Active Rheumatoid Arthritis incyte.com ↗ |
| 2018-04-23 | Incyte Corporation | FDA Advisory Committee Recommends the Approval of Baricitinib 2mg, but not 4mg, for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis incyte.com ↗ |
| 2017-11-05 | Incyte Corporation | ACR/ARHP 2017: New Analysis Shows Rheumatoid Arthritis Patients Treated with Baricitinib Reported Greater Improvements in Pain Compared to Adalimumab or Placebo incyte.com ↗ |
| 2017-09-14 | Incyte Corporation | Baricitinib Meets Primary Endpoint in Phase 2 Study of Patients with Moderate-to-Severe Atopic Dermatitis incyte.com ↗ |
| 2017-08-30 | Incyte Corporation | Lilly to File Baricitinib Resubmission to U.S. FDA before end of January 2018 incyte.com ↗ |
| 2017-07-25 | Incyte Corporation | Lilly and Incyte Provide Update on Baricitinib incyte.com ↗ |
| 2017-07-03 | Incyte Corporation | Japan Ministry of Health, Labor and Welfare (MHLW) Grants Marketing Approval For Olumiant® (baricitinib) for the Treatment of Rheumatoid Arthritis incyte.com ↗ |
| 2017-06-16 | Incyte Corporation | New Safety and Long-Term Efficacy Data from Baricitinib Clinical Trials in Patients with Moderate-to-Severe Rheumatoid Arthritis Presented at EULAR 2017 incyte.com ↗ |
| 2017-06-13 | Incyte Corporation | Lilly to Present New Data on Olumiant® (baricitinib) in Rheumatoid Arthritis and Taltz® (ixekizumab) in Psoriatic Arthritis at the Annual European Congress of Rheumatology (EULAR 2017) incyte.com ↗ |
| 2017-04-14 | Incyte Corporation | U.S. FDA Issues Complete Response Letter for Baricitinib incyte.com ↗ |
| 2017-02-15 | Incyte Corporation | Additional results from pivotal RA-BEAM study published in New England Journal of Medicine show baricitinib-treated patients demonstrated sustained improvement in rheumatoid arthritis compared to adalimumab and placebo incyte.com ↗ |
| 2017-02-13 | Incyte Corporation | European Commission Approves Once-Daily Olumiant Tablets for Treatment of Adults with Moderate-to-Severe Active Rheumatoid Arthritis incyte.com ↗ |
| 2017-01-13 | Incyte Corporation | U.S. FDA Extends Review Period for Baricitinib, an Investigational Rheumatoid Arthritis Treatment incyte.com ↗ |
| 2016-12-16 | Incyte Corporation | CHMP Recommends Approval of Lilly's Baricitinib for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis (RA) incyte.com ↗ |
| 2016-11-14 | Incyte Corporation | New Analyses of Phase 3 Trials Show Improvements in Rheumatoid Arthritis Symptoms Following Treatment with Baricitinib Across Diverse Population of Patients incyte.com ↗ |
| 2016-11-14 | Incyte Corporation | Baricitinib Demonstrates Early Response Compared to Placebo and Significant Improvement Compared to Adalimumab in Patient-Reported Outcomes incyte.com ↗ |
| 2016-11-02 | Incyte Corporation | New data from pivotal RA-BEACON study show significant improvement in patient-reported outcomes in rheumatoid arthritis patients treated with baricitinib compared to placebo incyte.com ↗ |
| 2016-06-09 | Incyte Corporation | Patient-reported outcomes across phase 3 studies of baricitinib demonstrate statistically significant improvements in physical function and quality of life symptoms in patients with rheumatoid arthritis (RA) incyte.com ↗ |
| 2016-06-09 | Incyte Corporation | Baricitinib significantly reduces joint damage progression in rheumatoid arthritis in patients who do not respond to conventional DMARDs incyte.com ↗ |
| 2016-03-31 | Incyte Corporation | Phase 3 Study Findings Demonstrate Treatment with Baricitinib Results in Significant Improvements for Patients with Rheumatoid Arthritis Who Had Inadequate Response to Biologics incyte.com ↗ |
| 2016-01-19 | Incyte Corporation | Lilly and Incyte Announce Submission of New Drug Application to FDA for Oral Once-Daily Baricitinib for Treatment of Moderate-to-Severe Rheumatoid Arthritis incyte.com ↗ |
| 2015-11-07 | Incyte Corporation | Lilly and Incyte Announce Patients Treated with Baricitinib Demonstrated Significant Improvement in Signs and Symptoms of Rheumatoid Arthritis Compared with Methotrexate incyte.com ↗ |
| 2015-11-07 | Incyte Corporation | Detailed Results Demonstrate Baricitinib Superiority to Adalimumab in Improving Signs and Symptoms of Rheumatoid Arthritis incyte.com ↗ |
| 2015-10-14 | Incyte Corporation | Baricitinib Demonstrates Superiority to Adalimumab in Improving Signs and Symptoms of Rheumatoid Arthritis in Pivotal Phase 3 Study incyte.com ↗ |
| 2015-09-29 | Incyte Corporation | Baricitinib Superior to Methotrexate in Reducing Signs and Symptoms in Pivotal Phase 3 Study in Patients with Rheumatoid Arthritis incyte.com ↗ |
| 2015-06-10 | Incyte Corporation | Lilly and Incyte unveil detailed data on two pivotal studies of baricitinib in rheumatoid arthritis incyte.com ↗ |
| 2015-05-28 | Incyte Corporation | Lilly and Incyte Announce Webcast to Discuss Baricitinib Phase III Data incyte.com ↗ |
| 2015-02-23 | Incyte Corporation | Baricitinib Superior to Placebo in Reducing Rheumatoid Arthritis Disease Activity in Second Phase 3 Study incyte.com ↗ |
| 2014-12-09 | Incyte Corporation | Lilly and Incyte Announce Positive Top-Line Results From Phase 3 Trial of Baricitinib in Moderate to Severe Rheumatoid Arthritis incyte.com ↗ |
| 2013-06-13 | Incyte Corporation | Lilly and Incyte Announce Baricitinib Efficacy and Safety Data from the Open-Label, Long-Term Extension of the Phase 2b JADA Study in Patients with Rheumatoid Arthritis incyte.com ↗ |
| 2012-11-15 | Incyte Corporation | Incyte Achieves $50 Million Milestone as Oral JAK1/JAK2 Inhibitor Baricitinib Advances into Phase III Development for Rheumatoid Arthritis incyte.com ↗ |
| 2012-11-13 | Incyte Corporation | Lilly and Incyte Announce Additional Phase IIb Baricitinib Data, Including MRI Results, in Patients with Rheumatoid Arthritis incyte.com ↗ |
| 2012-06-08 | Incyte Corporation | Lilly and Incyte's Oral JAK1 and JAK2 Inhibitor, Baricitinib, Showed Positive Results in Phase IIb Study in Patients with Active Rheumatoid Arthritis incyte.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 173 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Baricitinib | “Patients with moderate to severe atopic dermatitis refractory to topical medication, who also have previous experience with cyclosporine and an unsatisfactory response, or in...” NCT06366932 ↗162“Oral JAK inhibitors (tofacitinib 5 mg twice daily, or baricitinib 4 mg once daily, or upadacitinib 15 mg once daily) administered in combination with standard glucocorticoid...” NCT07406932 ↗ “Switching to a targeted synthetic DMARD (choice from targeted synthetic DMARDs; currently available are tofacitinib, baricitinib, upadacitinib) in people with active RA despite...” NCT04692493 ↗ “Baricitinib, a second-generation Janus kinase (JAK) inhibitor has shown potential in preclinical studies to reduce HIV reactivation and modulate immune activation.” NCT07028385 ↗ “Tofacitinib 5mg was taken orally once or twice a day and baricitinib 2mg or 4mg was taken orally once a day for 6 months.” NCT05400889 ↗ “Baricitinib is one of the emerging DMARDs with strong anti-rheumatic effects but has serious side effects.” PMID 39030450 ↗ Jul 2024 “Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor” NCT05432531 ↗ “JAK-inhibitors: Baricitinib (Olumiant), Tofacitinib (Xeljanz)” NCT04378621 ↗ “baricitinib 2 mg po qd (JAK 1/2 inhibitor)” NCT05305066 ↗ “Methotrexate or leflunomide + baricitinib” NCT02714634 ↗ “Tofacitinib, baricitinib, or upadacitinib” NCT05379322 ↗ “Baricitinib, 4 mg, film coated tablets” NCT05187793 ↗ “Baricitinib 4 mg once daily” NCT07160231 ↗ |
| Known as | BARI | “In this study, we evaluated the effect of JAKi through baricitinib (BARI) on 1) volumetric bone mineral density (vBMD), bone microstructure, biomechanics, and erosion repair...” PMID 37229650 ↗ Sep 2023 |
| Known as | BARICITINIB (INCB028050) | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105759 ↗ |
| Known as | BARICITINIB (LY3009104) | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105759 ↗ |
| Known as | BARICITINIB PHOSPHATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105759 ↗ |
| Known as | BARICITINIB PHOSPHATE SALT | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105759 ↗ |
| Known as | INCB-28050 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105759 ↗ |
| Known as | INCB028050 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00902486 ↗ |
| Known as | LY3009104 | “A Study to Investigate the Potential Impact of Organic Anion Transporter 3 Inhibition by Probenecid on the Pharmacokinetics of Baricitinib (LY3009104) in Healthy Subjects” NCT01937026 ↗10“A Drug Drug Interaction (DDI) Study of Baricitinib (LY3009104) and Digoxin in Healthy Participants” NCT01859078 ↗ “Baricitinib (LY3009104) 4 mg” NCT06868381 ↗ “Baricitinib (LY3009104) 4 mg” NCT06687551 ↗ “Baricitinib (LY3009104) 2 mg” NCT05188521 ↗ “Baricitinib (LY3009104) 2 mg” NCT07209267 ↗ |
| Known as | Olumiant | “Baricitinib Oral Tablet [Olumiant]” NCT05238896 ↗3“Drug: Baricitinib 2 MG [Olumiant]” NCT05263505 ↗ “Baricitinib 2 MG [Olumiant]” NCT05852847 ↗ “"Baricitinib", "olumiant®"” NCT03755466 ↗ |
| Action | Inhibit | “inhibitor of JAK1/JAK2” PMID 25431052 ↗ Nov 2014 |
| Modality | Small molecule | “This small molecule” NCT03026504 ↗ |
| Route | Oral | “oral baricitinib administered once daily” PMID 29463520 ↗ Feb 2018 |
| Target | JAK1 | “inhibitor of JAK1/JAK2” PMID 25431052 ↗ Nov 2014 |
| Target | JAK2 | “inhibitor of JAK1/JAK2” PMID 25431052 ↗ Nov 2014 |