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MoonLake Immunotherapeutics (MLTX)
NASDAQ:MLTX
Sonelokimab
Hidradenitis Suppurativa
Phase III
Enrolling By Invitation
A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa
May 28, 2025
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Sonelokimab
Relative Bioequivalence
Phase I
Active Not Recruiting
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
May 20, 2025
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Sonelokimab
Hidradenitis Suppurativa
Phase III
Recruiting
An 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
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Risankizumab, Sonelokimab
Arthritis, Psoriatic
Phase III
Recruiting
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response
Oct 11, 2024
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Sonelokimab
Arthritis, Psoriatic
Phase III
Recruiting
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug
Oct 11, 2024
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Sonelokimab
Hidradenitis Suppurativa
Phase III
Active Not Recruiting
Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
May 08, 2024
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Sonelokimab
Hidradenitis Suppurativa
Phase III
Active Not Recruiting
A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
May 08, 2024
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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
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
MLTX is currently developing the following drugs: Sonelokimab, Sonelokimab, Sonelokimab. These drug candidates are in various stages of clinical development as the company works toward FDA approval.