Drugs / Brodalumab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Kyntheum | — | 2017-07-17 | europa.eu ↗ |
| Approved | US (FDA) | SILIQ | — | 2017-02-15 | fda.gov ↗ |
Trials 45 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT04979520 | Aug 2021 → Jul 2022 | hidradenitis suppurativa | Rockefeller University | Completed | No outcome recorded |
| Phase 0 | NCT04249713 | Feb → Jul 2020 | hidradenitis suppurativa | Rockefeller University | Withdrawn | No outcome recorded |
| Phase 0 | NCT03960268 | May 2019 → Jun 2020 | hidradenitis suppurativa | Rockefeller University | Completed | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT06673329 | Mar 2025 → May 2027 expected | brain neoplasm, breast cancer, colon carcinoma, esophageal cancer +13 | Brian Henick, MD | Recruiting | No outcome recorded |
| Phase 1 | NCT04368403 | Oct 2017 → Jan 2019 | systemic sclerosis | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01937260 | Sep 2013 → Jul 2014 | psoriasis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01488201 | Nov 2011 → Sep 2012 | psoriasis | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01395485 | Jun 2011 → Jun 2012 | asthma | Amgen | Withdrawn | No outcome recorded |
| Phase 1 | NCT00867100 | Dec 2007 → Sep 2009 | psoriasis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00771030 | Oct 2008 → May 2010 | rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 211 trials | ||||||
| Phase 2 | NCT03910803 | May → Dec 2019 | hidradenitis suppurativa | Florida Academic Dermatology Centers | Unknown | No outcome recorded |
| Phase 2 | NCT01902290 | May 2013 → May 2015 | asthma | Amgen | Terminated | No outcome recorded |
| Phase 2 | NCT01748539 | Dec 2012 → Sep 2013 | psoriasis | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01516957 | Oct 2011 → Sep 2012 | psoriatic arthritis | Bausch Health Americas, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT01199302 | Feb → Oct 2011 | Crohn disease | Amgen | Terminated | No outcome recorded |
| Phase 2 | NCT01150890 | Nov 2010 → Oct 2011 | Crohn disease | Amgen | Terminated | No outcome recorded |
| Phase 2 | NCT01199289 | Oct 2010 → Dec 2011 | asthma | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT01059448 | Jun 2010 → Apr 2011 | rheumatoid arthritis | Amgen | Terminated | No outcome recorded |
| Phase 2 | NCT01101100 | Apr 2010 → Sep 2015 | psoriasis | Bausch Health Americas, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT00950989 | Dec 2009 → Feb 2011 | rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00975637 | Dec 2009 → Jul 2010 | psoriasis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 314 trials | ||||||
| Phase 3 | NCT04305327 | Dec 2022 → May 2023 | psoriasis | LEO Pharma | Terminated | No outcome recorded |
| Phase 3 | NCT04061252 | Aug 2019 → Aug 2021 | palmoplantar pustulosis | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03957681 | May 2019 → Oct 2020 | systemic sclerosis | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02985983 | Mar 2017 → Sep 2019 | spondyloarthropathy | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02982005 | Jan 2017 → Aug 2018 | psoriasis | Kyowa Kirin Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02029495 | Mar 2014 → Oct 2015 | psoriatic arthritis | Bausch Health Americas, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT02024646 | Mar 2014 → Oct 2015 | psoriatic arthritis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02052609 | Feb 2014 → Jan 2015 | palmoplantar pustulosis, psoriatic arthritis | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01782924 | Mar 2013 → Feb 2015 | psoriasis | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01782937 | Feb 2013 → Dec 2014 | psoriasis | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01708629 | Sep 2012 → Aug 2014 | psoriasis | Bausch Health Americas, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT01708603 | Aug 2012 → Sep 2014 | psoriasis | Bausch Health Americas, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT02786732 | Aug 2012 → Jun 2017 | psoriasis | MedDerm Associates | Terminated | No outcome recorded |
| Phase 3 | NCT01708590 | Aug 2012 → May 2014 | psoriasis | Bausch Health Americas, Inc. | Terminated | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT07149792 | Jul 2025 → Dec 2026 expected | psoriasis, psoriatic arthritis | Taichung Veterans General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04306315 | Jul 2022 → Aug 2025 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 4 | NCT04614298 | Jan 2021 → Feb 2022 | psoriasis | Kyowa Kirin, Inc. | Withdrawn | No outcome recorded |
| Phase 4 | NCT04533737 | Dec 2020 → Sep 2022 | psoriasis | LEO Pharma | Terminated | No outcome recorded |
| Phase 4 | NCT04622033 | Dec 2020 → Nov 2021 | psoriasis | First OC Dermatology | Unknown | No outcome recorded |
| Phase 4 | NCT04340076 | Aug 2020 → Jan 2025 | psoriasis | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT03240809 | Jan 2020 → Dec 2028 expected | psoriasis | Bausch Health Americas, Inc. | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03331835 | Nov 2017 → Jan 2019 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 4 | NCT03403036 | Oct 2017 → Aug 2018 | psoriasis | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 4 | NCT04183881 | Jul 2016 → Jan 2017 | palmoplantar pustulosis, psoriatic arthritis | Kyowa Kirin, Inc. | Completed | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT02429882 Comparator | May 2015 | spondyloarthropathy | Amgen | Withdrawn | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT03478280 Comparator | Sep 2018 → Mar 2020 | psoriasis | Aarhus University Hospital | Unknown | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-05-22 | Amgen | Amgen to Terminate Participation in Co-development and Commercialization of Brodalumab amgen.com ↗ |
| 2014-12-11 | Amgen | Amgen And AstraZeneca To Present Results From Phase 3 AMAGINE-1™ Study Evaluating Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis amgen.com ↗ |
| 2014-11-25 | Amgen | Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis amgen.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 51 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Brodalumab | “Brodalumab (KHK4827 or AMG 827) is a human monoclonal antibody that binds to the human interleukin (IL)-17 receptor A and blocks the biological activities of IL-17A, IL-17F,...” PMID 26547109 ↗ Oct 201534“Brodalumab is a fully human anti-interleukin-17 receptor A monoclonal antibody efficacious for the treatment of adults with moderate-to-severe plaque psoriasis.” PMID 32207067 ↗ Jun 2020 “Brodalumab, a fully human anti-interleukin-17 receptor A monoclonal antibody, is being investigated for use in PPP treatment.” PMID 38954226 ↗ Jul 2024 “A Phase 4 Study of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis” NCT04614298 ↗ “KHK4827 (brodalumab)” NCT02982005 ↗ “Brodalumab (Lumicef)” NCT07149792 ↗ |
| Known as | AMG 827 | “Brodalumab (KHK4827 or AMG 827) is a human monoclonal antibody that binds to the human interleukin (IL)-17 receptor A and blocks the biological activities of IL-17A, IL-17F,...” PMID 26547109 ↗ Oct 20157“Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827” NCT00867100 ↗ “Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to Methotrexate” NCT00950989 ↗ |
| Known as | KHK4827 | “A Phase 4 Study of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis” NCT04614298 ↗ |
| Known as | Kyntheum | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742996 ↗ |
| Known as | Lumicef | “Brodalumab (Lumicef)” NCT07149792 ↗ |
| Known as | Siliq | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742996 ↗ |
| Action | Inhibit | “Brodalumab treatment resulted in inhibition of IL-17 receptor signaling” PMID 24286136 ↗ Oct 2013 |
| Modality | Monoclonal antibody | “a human, anti-IL-17 receptor A (IL-17RA) monoclonal antibody” PMID 24286136 ↗ Oct 2013 |
| Route | Intravenous | “brodalumab (50 mg, 140 mg, or 210 mg subcutaneously every two weeks for 6 doses per group; or 420 mg or 700 mg intravenously every 4 weeks for two doses per group)” PMID 24286136 ↗ Oct 2013 |
| Route | Subcutaneous | “brodalumab (50 mg, 140 mg, or 210 mg subcutaneously every two weeks for 6 doses per group; or 420 mg or 700 mg intravenously every 4 weeks for two doses per group)” PMID 24286136 ↗ Oct 2013 |
| Target | IL17RA | “anti-IL17RA monoclonal antibody” PMID 33827787 ↗ Apr 2021 |