brodalumab
Trade name: siliq
mAbapproved
Approved
Feb 15, 2017
Brodalumab, sold under the brand name Siliq in the US and Kyntheum in the EU, is a human monoclonal antibody designed for the treatment of inflammatory diseases. — Wikipedia
Clinical trial activity
47 trials · 16 clinical orgs · 1 marketing orgs
Phase 1
11
Phase 2
27
Phase 3
14
Phase 4
10
Earliest trial started Dec 1, 2007 (NCT00867100)
Timeline
2000s
- Jan 1, 2007
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2009
Bausch Health Companies — Earliest Phase 2 Sponsor(trial)
2010s
- Jan 1, 2012
Earliest Phase 3 Sponsor(trial)
- Feb 15, 2017
Bausch Health Companies — Earliest FDA Approval
- Feb 15, 2017
Bausch Health Companies — Marketing Organization
- Feb 15, 2017
Bausch Health Companies — NDA Organization
Indications
Approved for
Studied for
- Arthritis, Psoriatic · Phase 4
- Arthritis, Rheumatoid · Phase 2
- Asthma · Phase 2
- Axial Spondyloarthritis · Phase 3
- Brain Neoplasms · Phase 1
- Breast Neoplasms · Phase 1
- Colonic Neoplasms · Phase 1
- Crohn Disease · Phase 2
- Esophageal Neoplasms · Phase 1
- Genital Neoplasms, Female · Phase 1
- Head and Neck Neoplasms · Phase 1
- Hidradenitis Suppurativa · Phase 2
- Kidney Neoplasms · Phase 1
- Liver Neoplasms · Phase 1
- Lung Neoplasms · Phase 1
- Mouth Neoplasms · Phase 1
- Neoplasms · Phase 1
- Pancreatic Neoplasms · Phase 1
- Prostatic Neoplasms · Phase 1
- Rectal Neoplasms · Phase 1
- Scleroderma, Systemic · Phase 1
- Sclerosis · Phase 3
- Skin Neoplasms · Phase 1
- Stomach Neoplasms · Phase 1
- Testicular Neoplasms · Phase 1
- Thyroid Neoplasms · Phase 1
Mechanism of action
- Interleukin-17 receptor AANTAGONIST
IL17RA antagonist
- Interleukin-17 receptor AINHIBITOR
IL17RA inhibitor
Approval history
- approvedFeb 15, 2017
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Black box warningFirst in class
Sources
- WikipediaBrodalumab ↗
- NCATS6ZA31Y954Z ↗
- ChEMBLCHEMBL1742996 ↗
Also known as
- amg 827
- amg 827
- amg-827
- amg-827
- amg-827
- brodalumab
- brodalumab
- brodalumab
- brodalumab
- brodalumab
- brodalumab
- brodalumab
- brodalumab
- brodalumab
- khk4827
- siliq
- siliq
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06673329 | Phase 1 | Nov 30, 2024 | Bausch Health Companies, Columbia University |
| NCT04979520 | Early Phase 1 (Phase 1) | Aug 5, 2021 | Rockefeller University |
| NCT04614298 | Phase 4 | Jan 31, 2021 | Kyowa Hakko Kirin |
| NCT04622033 | Phase 4 | Dec 1, 2020 | First OC Dermatology |
| NCT04533737 | Phase 4 | Nov 11, 2020 | Leo Pharma |
| NCT04306315 | Phase 4 | Jun 15, 2020 | Leo Pharma |
| NCT04305327 | Phase 3 | May 31, 2020 | Leo Pharma |
| NCT04340076 | Phase 4 | May 31, 2020 | Ghent University, Katholieke Universiteit Leuven, Radboud University, ZonMw: The Netherlands Organisation for Health Research and Development |
| NCT04249713 | Early Phase 1 (Phase 1) | Jan 31, 2020 | Rockefeller University |
| NCT04061252 | Phase 3 | Aug 31, 2019 | Kyowa Hakko Kirin |
| NCT03960268 | Early Phase 1 (Phase 1) | May 28, 2019 | Bausch Health Companies, Rockefeller University |
| NCT03957681 | Phase 3 | May 23, 2019 | Kyowa Hakko Kirin |
| NCT03910803 | Phase 2 | May 1, 2019 | Bausch Health Companies, Florida Academic Dermatology Centers |
| NCT03240809 | Phase 4 | Jul 12, 2018 | Bausch Health Companies |
| NCT03478280 | Phase 4 | Apr 15, 2018 | Aarhus University, Leo Pharma |
| NCT03331835 | Phase 4 | Nov 3, 2017 | Leo Pharma |
| NCT03403036 | Phase 4 | Oct 31, 2017 | Icahn School of Medicine at Mount Sinai |
| NCT04368403 | Phase 1 | Oct 6, 2017 | Kyowa Hakko Kirin |
| NCT02982005 | Phase 3 | Jan 1, 2017 | Kyowa Hakko Kirin |
| NCT02985983 | Phase 3 | Nov 1, 2016 | Kyowa Hakko Kirin |
Showing 20 of 47 trials
Page 1 / 3
Organizations
Research & Development (16)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Amgen | For profit | 20 | 17 | 3 | 2007 |
| Kyowa Hakko Kirin | For profit | 13 | 12 | 4 | 2011 |
| Bausch Health Companies | For profit | 7 | 4 | 4 | 2009 |
| Leo Pharma | For profit | 5 | 4 | 2 | 2017 |
| Rockefeller University | Academic/Hospital | 3 | 3 | 1 | 2019 |
| Aarhus University | Academic/Hospital | 1 | 1 | 1 | 2018 |
| AstraZeneca | For profit | 1 | 0 | 1 | 2013 |
| Columbia University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| First OC Dermatology | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Florida Academic Dermatology Centers | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Ghent University | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Icahn School of Medicine at Mount Sinai | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Katholieke Universiteit Leuven | Academic/Hospital | 1 | 0 | 1 | 2020 |
| MedDerm Associates | Academic/Hospital | 1 | 1 | 1 | 2012 |
| Radboud University | Academic/Hospital | 1 | 1 | 1 | 2020 |
| ZonMw: The Netherlands Organisation for Health Research and Development | Academic/Hospital | 1 | 0 | 1 | 2020 |
16 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bausch Health Companies | For profit | MKTG | Feb 15, 2017 |
| Bausch Health Companies | For profit | NDA | Feb 15, 2017 |