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Kiniksa Pharmaceuticals (KNSA)
NASDAQ:KNSA
Kpl-387
Recurrent Pericarditis, Pericarditis, Pericarditis Acute
Phase II/III
Recruiting
Phase 2/3 Study of KPL-387 in Recurrent Pericarditis
May 29, 2025
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Abiprubart
Sjögrens Disease
Phase II
Terminated
A Study to Evaluate the Efficacy and Safety of Abiprubart in Participants With Sjögren's Disease
Jul 25, 2024
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Kpl-404
Arthritis, Rheumatoid
Phase II
Completed
Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor
Jan 03, 2022
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Mavrilimumab
Covid
Phase II/III
Completed
Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammation
Jun 23, 2020
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Kpl-716
Plaque Psoriasis, Lichen Simplex Chronicus, Chronic Idiopathic Urticaria, Chronic Idiopathic Pruritus, Lichen Planus
Phase II
Completed
A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases
Feb 27, 2019
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Vixarelimab
Prurigo Nodularis, Pruritis
Phase II
Completed
Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis
Jan 23, 2019
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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 Kiniksa Pharmaceuticals (KNSA) have in its pipeline
KNSA is currently developing the following drugs: Kpl-387, Abiprubart, Kpl-404. These drug candidates are in various stages of clinical development as the company works toward FDA approval.