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Siliq

(Brodalumab)

ApprovedMonoclonal antibody

BBausch Health Americas, Inc.

Brodalumab is used to treat moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches. It works by reducing inflammation in the body that causes these skin problems.[2] Siliq is currently approved and in use across 5 indications[4].[1]

Siliq is one of 99 biologic programs targeting Psoriasis Vulgaris. It is currently in Approved.

5

Indications

32

Total Trials

4

Active Trials

98

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Psoriasis VulgarisUnknown

Pustular PsoriasisUnknown

Immune System DiseaseUnknown

PediatricActive, not recruiting

Immune-Related Adverse EventsRecruiting

Psoriasis VulgarisPreclinical

Unknown

Pustular PsoriasisPreclinical

Unknown

Immune System DiseasePreclinical

Unknown

PediatricApproved

Active, not recruiting

Immune-Related Adverse EventsPhase 1

Recruiting

Competition

Competitive Landscape

55 competitors in Immune System Disease

#DrugCompanyPhaseTrials

Siliq

BBausch Health Americas, Inc.

Tecfidera

Trexall

Jazz Pharmaceuticals

Thalomid

Bristol-Myers Squibb

Cellcept

Avelox

Neoral

Medrol

Crestor

Otezla

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Immune-Related Adverse Events

NCT06673329

Q2 2029

Post-ApprovalActive, not recruiting

Pediatric

NCT03240809

Clinical

Trials by Indication[1]

Psoriasis14 trials

P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis

Terminated·BBausch Health Americas, Inc.·Phase 3·NCT01708603·1,831 enrolled

Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects

Terminated·BBausch Health Americas, Inc.·Phase 3·NCT01708590·661 enrolled

Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects

Terminated·BBausch Health Americas, Inc.·Phase 3·NCT01708629·1,881 enrolled

Show 11 more trials

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

Completed·RRadboud University Medical Center·Phase 4·NCT04340076·244 enrolled

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

Completed· LEO Pharma logo

LEO Pharma·Phase 4·NCT03331835·210 enrolled

Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight

Completed· LEO Pharma logo

LEO Pharma·Phase 4·NCT04306315·385 enrolled

Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17A Therapies

Completed·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT03403036·39 enrolled

Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab

Terminated· LEO Pharma logo

LEO Pharma·Phase 4·NCT04533737·113 enrolled

LTS of Siliq vs. Other Therapies Treating of Adults With Moderate-to-Severe Psoriasis

Enrolling by invitation·BBausch Health Americas, Inc.··NCT03254667·3,500 enrolled

A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen

Completed·BBausch Health Americas, Inc.··NCT04149587·252 enrolled

Effect of Brodalumab Compared to Placebo on Vascular Inflammation in Moderate-to-severe Psoriasis

Unknown status·—·Phase 4·NCT03478280·50 enrolled

Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis

Terminated· LEO Pharma logo

LEO Pharma·Phase 3·NCT04305327·12 enrolled

Brodalumab in Palmoplantar Psoriasis

Unknown status·FFirst OC Dermatology·Phase 4·NCT04622033·10 enrolled

Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Work Productivity

Active, not recruiting·BBausch Health Americas, Inc.··NCT05132231·394 enrolled

Hidradenitis Suppurativa4 trials

An Alternative Dose Interval Study in Participants With Hidradenitis Suppurativa Receiving Brodalumab

Withdrawn·RRockefeller University·Phase 1·NCT04249713

Treatment of Moderate Hidradenitis Suppurativa

Unknown status·FFlorida Academic Dermatology Centers·Phase 2·NCT03910803·20 enrolled

Biomarkers In Hidradenitis Suppurativa Participants Receiving Brodalumab

Completed·RRockefeller University·Phase 1·NCT03960268·10 enrolled

Show 1 more trial

Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa

Completed·RRockefeller University·Phase 1·NCT04979520·4 enrolled

Psoriatic Arthritis2 trials

Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis

Completed·BBausch Health Americas, Inc.·Phase 3·NCT02024646·484 enrolled

Study of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis

Terminated·BBausch Health Americas, Inc.·Phase 3·NCT02029495·478 enrolled

Arthritis2 trials

Study of Efficacy and Safety of Brodalumab Compared With Placebo in Subjects With Axial Spondyloarthritis

Withdrawn· Amgen logo

Amgen·Phase 2·NCT02429882

A Study of Brodalumab in Subjects With Axial Spondyloarthritis (axSpA)

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 3·NCT02985983·159 enrolled

Rheumatoid Arthritis2 trials

Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to Methotrexate

Completed· Amgen logo

Amgen·Phase 2·NCT00950989·252 enrolled

Study to Evaluate the Safety, PK, PD and Efficacy of AMG 827 in Adults With Rheumatoid Arthritis

Completed· Amgen logo

Amgen·Phase 1/2·NCT00771030·40 enrolled

8 more indications

Interaction1 trial

Brodalumab Drug-Drug Interaction (DDI) and Intensive Pharmacodynamic (PK) Study in Psoriasis Subjects

Completed·BBausch Health Americas, Inc.·Phase 1·NCT01937260·31 enrolled

Immune-related Adverse Events1 trial

Brodalumab in the Treatment of Immune-Related Adverse Events

Recruiting·—·Phase 1·NCT06673329·11 enrolled

Asthma1 trial

Study of Efficacy and Safety of Brodalumab Compared With Placebo in Adults With Inadequately Controlled Asthma With High Bronchodilator Reversibility

Terminated· Amgen logo

Amgen·Phase 2·NCT01902290·421 enrolled

MPA1 trial

A Bioequivalence Study Comparing a Single 1.5mL Dose of Brodalumab vs. Two Doses (1.0mL + 0.5mL) of Brodalumab

Completed·BBausch Health Americas, Inc.·Phase 1·NCT02173392·145 enrolled

Pediatric1 trial

An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects

Active, not recruiting·BBausch Health Americas, Inc.·Phase 4·NCT03240809·2 enrolled

Crohn's Disease1 trial

Long-term Safety Study of Brodalumab in Adults With Crohn's Disease

Terminated· Amgen logo

Amgen·Phase 2·NCT01199302·67 enrolled

Moderate to Severe Crohn's Disease1 trial

Brodalumab (AMG 827) in Adults With Moderate to Severe Crohn's Disease

Terminated· Amgen logo

Amgen·Phase 2·NCT01150890·130 enrolled

Unspecified1 trial

Study to Evaluate Broadlumab vs Placebo and Ustekinumab

Terminated·MMedDerm Associates·Phase 3·NCT02786732·15 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 15, 2017

SILIQ

BLA BLA761032

Sources

References

[1]
ClinicalTrials.gov — 32 trial records for Brodalumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Siliq drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Brodalumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Brodalumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (BLA BLA761032). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Bausch Health Americas, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Interleukin-17 Receptor a Antagonist[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: BBausch Health Americas, Inc.

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