Sonelokimab

Phase 3Monoclonal antibody

MMoonLake Immunotherapeutics AG

Sonelokimab is one of 28 small molecule programs targeting Hidradenitis Suppurativa. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Hidradenitis SuppurativaCompleted

Arthritis, PsoriaticEnrolling by invitation

Hidradenitis SuppurativaPhase 3

Completed

Arthritis, PsoriaticPhase 3

Enrolling by invitation

Competition

Competitive Landscape

28 competitors in Hidradenitis Suppurativa

#DrugCompanyPhaseTrials

Otezla

Amgen

Approved

2 2

Soriatane

GSK

Approved

1 3

Aldactone

Pfizer

Approved

1 4

Daliresp

Botox

1 6

Bimzelx

UCB

Phase 3

5 7

Jakafi

Incyte

Phase 3

4 8

Glucophage

Rhapsido

3 10

Rinvoq

AbbVie

Phase 3

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

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Arthritis, Psoriatic

NCT06641076

Q3 2027

Phase 3Active, not recruiting

Arthritis, Psoriatic

NCT06641089

Clinical

Trials by Indication[1]

Hidradenitis Suppurativa5 trials

Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Active, not recruiting·MMoonLake Immunotherapeutics AG·Phase 3·NCT06411379·418 enrolled

A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa

Enrolling by invitation·MMoonLake Immunotherapeutics AG·Phase 3·NCT07007637·835 enrolled

An Open-label, Single-arm Study to Evaluate Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents With Moderate to Severe Hidradenitis Suppurativa (VELA-TEEN)

Recruiting·MMoonLake Immunotherapeutics AG·Phase 3·NCT06768671·35 enrolled

Show 2 more trials

Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Moderate to Severe Hidradenitis Suppurativa

Completed·MMoonLake Immunotherapeutics AG·Phase 2·NCT05322473·234 enrolled

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Completed·MMoonLake Immunotherapeutics AG·Phase 3·NCT06411899·422 enrolled

Arthritis, Psoriatic4 trials

A Phase 3, Parallel-group, Randomized, Double-blind, 3-arm, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis Who Are Naive to Biologic DMARDs

Active, not recruiting·MMoonLake Immunotherapeutics AG·Phase 3·NCT06641076·960 enrolled

A Phase 3, Parallel-group, Randomized, Double-blind, 4-arm, Placebo-controlled, Multicenter Study With Risankizumab as Active Reference Arm, to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumor Necrosis Factor-α Inhibitors

Active, not recruiting·MMoonLake Immunotherapeutics AG·Phase 3·NCT06641089·600 enrolled

Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Psoriatic Arthritis

Completed·MMoonLake Immunotherapeutics AG·Phase 2·NCT05640245·207 enrolled

Show 1 more trial

A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic Arthritis

Enrolling by invitation·MMoonLake Immunotherapeutics AG·Phase 3·NCT07223138·1,560 enrolled

Adult1 trial

An Open-label Study in Healthy Adults to Evaluate the Relative Bioequivalence of a Single-dose Administration of Sonelokimab Either by a Prefilled Syringe or an Autoinjector

Completed·MMoonLake Immunotherapeutics AG·Phase 1·NCT06994936·120 enrolled

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Sonelokimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sonelokimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Sonelokimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — MoonLake Immunotherapeutics AG company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: MMoonLake Immunotherapeutics AG

Sonelokimab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2027

Trials by Indication[1]

Hidradenitis Suppurativa5 trials

Arthritis, Psoriatic4 trials

Adult1 trial

References

Drug Info

Quick Facts

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