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MoonLake Immunotherapeutics (MLTX) Drug Pipeline

Drug pipeline
Drug NameConditionStageStatusStudy NameTrial Start DateArticle
SonelokimabArthritis, PsoriaticPhase IIIEnrolling By InvitationA Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic ArthritisOct 20, 2025―
SonelokimabHidradenitis SuppurativaPhase IIIEnrolling By InvitationA Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis SuppurativaMay 28, 2025
SonelokimabRelative BioequivalencePhase IActive Not RecruitingAn 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 AutoinjectorMay 20, 2025―
SonelokimabHidradenitis SuppurativaPhase IIIRecruitingAn Open-label, Single-arm Study to Evaluate Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents With Moderate to Severe Hidradenitis Suppurativa (VELA-TEEN)Nov 29, 2024
Risankizumab, SonelokimabArthritis, PsoriaticPhase IIIRecruitingEvaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate ResponseOct 11, 2024
SonelokimabArthritis, PsoriaticPhase IIIRecruitingEvaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic DrugOct 11, 2024
SonelokimabHidradenitis SuppurativaPhase IIIActive Not RecruitingStudy to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis SuppurativaMay 08, 2024―
SonelokimabHidradenitis SuppurativaPhase IIIActive Not RecruitingA Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis SuppurativaMay 08, 2024―

FAQ

What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Moonlake Immunotherapeutics (MLTX) have in its pipeline
MoonLake Immunotherapeutics MLTX is currently developing the following drugs: Sonelokimab, Risankizumab, Sonelokimab. These drug candidates are in various stages of clinical development as the company works toward FDA approval.