SILIQ (brodalumab)
SILIQ is indicated for the treatment of Plaque Psoriasis.
How SILIQ Works
Brodalumab is a human monoclonal IgG2 antibody that selectively binds to human IL-17RA, a protein expressed on the cell surface. By binding to this receptor, the drug inhibits interactions with multiple cytokines, including IL-17A, IL-17F, IL-17C, the IL-17A/F heterodimer, and IL-25. This blockade prevents the IL-17 cytokine-induced release of pro-inflammatory cytokines and chemokines.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-02-15
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SILIQ Approval History
What SILIQ Treats
1 indicationsSILIQ is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Plaque Psoriasis
SILIQ Boxed Warning
SUICIDAL IDEATION AND BEHAVIOR Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. Prior to prescribing SILIQ, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional, as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicid...
WARNING: SUICIDAL IDEATION AND BEHAVIOR Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. Prior to prescribing SILIQ, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional, as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes [ see Warnings and Precautions ( 5.1 ) ]. Because of the observed suicidal behavior in subjects treated with SILIQ, SILIQ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SILIQ REMS Program [see Warnings and Precautions ( 5.2 ) ]. WARNING: SUICIDAL IDEATION AND BEHAVIOR See full prescribing information for complete boxed warning. Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. ( 5.1 , 6.1 ) Prior to prescribing, weigh potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. ( 5.1 ) Patients with new or worsening suicidal thoughts and behavior should be referred to a mental health professional, as appropriate. ( 5.1 ) Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes. ( 5.1 ) SILIQ is available only through a restricted program called the SILIQ REMS Program. ( 5.2 )
SILIQ Target & Pathway
ProTarget
A pro-inflammatory cytokine produced by Th17 cells that plays a key role in psoriasis, psoriatic arthritis, and ankylosing spondylitis. Blocking IL-17 reduces the inflammatory cascade that causes skin plaques and joint inflammation.
SILIQ Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SILIQ
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06673329 | AAAV1382 | Ph 1 | recruiting | Brodalumab in the Treatment of Immune-Related Adverse Events |
| NCT04306315 ADJUST | LP0160-1329 2017-004998-13, U1111-1282-4507 | Ph 4 | completed | Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight |
| NCT04340076 BeNeBio | 80-85200-98-18562 2019-004230-42 | Ph 4 | completed | Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis |
| NCT03240809 | V01-BROA-401 | Ph 4 | active not recruiting | An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects |
| NCT04533737 COBRA results posted | LP0160-1510 2019-004099-20, U1111-1283-7584 | Ph 4 | terminated | Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab |
| NCT04305327 EMBRACE 1 results posted | LP0160-1396 2019-001868-30, U1111-1282-4459 | Ph 3 | terminated | Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis |
| NCT03331835 results posted | LP0160-1327 2016-003867-21 | Ph 4 | completed | A Trial Comparing the Efficacy of Subcutaneous Injections of Brodalumab to Oral Administrations of Fumaric Acid Esters in Adults With Moderate to Severe Plaque Psoriasis |
| NCT02985983 | 4827-006 | Ph 3 | completed | A Study of Brodalumab in Subjects With Axial Spondyloarthritis (axSpA) |
| NCT01902290 results posted | 20120141 2012-003351-11 | Ph 2 | terminated | Study of Efficacy and Safety of Brodalumab Compared With Placebo in Adults With Inadequately Controlled Asthma With High Bronchodilator Reversibility |
| NCT01150890 results posted | 20090072 2010-019544-39 | Ph 2 | terminated | Brodalumab (AMG 827) in Adults With Moderate to Severe Crohn's Disease |
| NCT01199302 results posted | 20100008 2010-020881-53 | Ph 2 | terminated | Long-term Safety Study of Brodalumab in Adults With Crohn's Disease |
| NCT00950989 results posted | 20090061 | Ph 2 | completed | Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to Methotrexate |
| NCT00771030 results posted | 20070264 | Ph 1, Ph 2 | completed | Study to Evaluate the Safety, PK, PD and Efficacy of AMG 827 in Adults With Rheumatoid Arthritis |
| NCT03403036 results posted | GCO 17-1581 | Ph 4 | completed | Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17A Therapies |
| NCT02173392 results posted | 20130307 | Ph 1 | completed | A Bioequivalence Study Comparing a Single 1.5mL Dose of Brodalumab vs. Two Doses (1.0mL + 0.5mL) of Brodalumab |
| NCT01937260 results posted | 20110184 | Ph 1 | completed | Brodalumab Drug-Drug Interaction (DDI) and Intensive Pharmacodynamic (PK) Study in Psoriasis Subjects |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SILIQ FDA Label Details
Indications & Usage
FDA Label (PDF)SILIQ is indicated for the treatment of Plaque Psoriasis.
WARNING: SUICIDAL IDEATION AND BEHAVIOR Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. Prior to prescribing SILIQ, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. Patien...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment