This section highlights FDA-related milestones and regulatory updates for drugs developed by Kiniksa Pharmaceuticals International (KNSA).
Over the past two years, Kiniksa Pharmaceuticals International has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
abiprubart and KPL-387. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
abiprubart - FDA Regulatory Timeline and Events
abiprubart is a drug developed by Kiniksa Pharmaceuticals International for the following indication: In Sjogren's Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- abiprubart
- Announced Date:
- July 9, 2024
- Indication:
- In Sjogren's Disease
Announcement
Kiniksa Pharmaceuticals announced that it has commenced enrollment of the Phase 2b clinical trial of abiprubart in Sjögren's Disease. Abiprubart is an investigational humanized anti-CD40 monoclonal antibody designed to inhibit CD40-CD154 (CD40 ligand) interaction.
AI Summary
Kiniksa Pharmaceuticals has started enrolling patients in a Phase 2b clinical trial to test abiprubart for treating Sjögren's Disease, a chronic autoimmune condition with no FDA-approved therapies. The trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety and effectiveness of abiprubart when given as a subcutaneous injection every two weeks or monthly over 24 weeks. Abiprubart is an investigational humanized anti-CD40 monoclonal antibody designed to block the CD40-CD154 interaction, which is important in immune system signaling. The study will involve around 201 patients divided equally among the treatment and placebo groups. After the initial trial period, patients will have the option to continue with active treatment in a long-term extension phase. Kiniksa is fully funding this trial and expects to stay cash flow positive while advancing this promising treatment option for patients with Sjögren’s Disease.
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KPL-387 - FDA Regulatory Timeline and Events
KPL-387 is a drug developed by Kiniksa Pharmaceuticals International for the following indication: In recurrent pericarditis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KPL-387
- Announced Date:
- June 5, 2025
- Indication:
- In recurrent pericarditis
Announcement
Kiniksa Pharmaceuticals International, plc announced details for its planned Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis, expected to initiate in the middle of 2025. KPL-387 is an independently developed monoclonal antibody that binds human interleukin-1 receptor 1 (IL-1R1), inhibiting the signaling activity of the cytokines interleukin-1α (IL-1α) and interleukin-1β (IL-1β).
AI Summary
Kiniksa Pharmaceuticals International, plc has unveiled plans for a pivotal Phase 2/3 clinical trial of its investigational drug KPL-387 for recurrent pericarditis, with the study expected to begin in mid-2025. KPL-387 is a fully human monoclonal antibody that targets the interleukin-1 receptor 1 (IL-1R1), effectively blocking the signaling actions of the cytokines IL-1α and IL-1β. Supported by positive Phase 1 data that indicate a favorable profile for monthly dosing, the trial will test different dosing regimens—including a single subcutaneous injection in a liquid formulation—to determine the most effective schedule. Additionally, Phase 2 data are anticipated in the second half of 2026. This strategic clinical move aims to expand therapeutic options, potentially offering a convenient and effective treatment alternative for patients with recurrent pericarditis.
Read Announcement- Drug:
- KPL-387
- Announced Date:
- June 5, 2025
- Estimated Event Date Range:
- July 1, 2026 - December 31, 2026
- Target Action Date:
- H2 2026
- Indication:
- In recurrent pericarditis
Announcement
Kiniksa Pharmaceuticals International announced that Phase 2 data expected in 2H 2026
AI Summary
Kiniksa Pharmaceuticals International announced plans to initiate a Phase 2/3 clinical trial for KPL-387, a novel monoclonal antibody targeting recurrent pericarditis, in mid-2025. The study is designed to evaluate various dosing regimens, including monthly dosing with a single subcutaneous injection, and will enroll patients in multiple overlapping portions. A key detail is that Phase 2 data from the dose-focusing segment of the trial is expected in the second half of 2026.
The trial will involve up to 80 patients in the initial dosing portion, aiming to assess the treatment’s safety and efficacy, followed by a larger pivotal phase. Kiniksa’s advancement of KPL-387 with this study is part of its ongoing effort to expand therapeutic options in cardiovascular indications and provide meaningful improvements for patients with recurrent pericarditis.
Read Announcement- Drug:
- KPL-387
- Announced Date:
- June 5, 2025
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- In recurrent pericarditis
Announcement
Kiniksa Pharmaceuticals International Phase 2/3 trial on track to initiate in mid-2025
AI Summary
Kiniksa Pharmaceuticals International is preparing to begin a Phase 2/3 clinical trial of its new drug candidate, KPL-387, in patients with recurrent pericarditis. The study is set to start in mid-2025 and will assess both the safety and effectiveness of the treatment. KPL-387 is designed as a monoclonal antibody that blocks interleukin-1 receptors, potentially reducing inflammation associated with the condition.
The trial will include several parts: a dose-focusing segment to determine the best dosing options, followed by a pivotal segment to further explore the drug’s benefits. Early support from Phase 1 data suggests that monthly dosing through a single subcutaneous injection is effective. Kiniksa expects initial data from the dose-focusing phase in the second half of 2026, aiming to offer a new and convenient treatment option for patients in need.
Read Announcement- Drug:
- KPL-387
- Announced Date:
- February 25, 2025
- Indication:
- In recurrent pericarditis
Announcement
Kiniksa Pharmaceuticals announced the development program for KPL-387 in recurrent pericarditis and provided an update on its corporate strategy.
AI Summary
Kiniksa Pharmaceuticals announced a new development program for its investigational drug KPL-387 to treat recurrent pericarditis. KPL-387 is a monoclonal antibody that targets the IL-1 receptor, aiming to block key cytokine signals. Early Phase 1 data suggest that the drug may allow for monthly dosing in a single subcutaneous injection using a liquid formulation. The company plans to start a Phase 2/3 clinical trial in mid-2025, with Phase 2 data expected in the second half of 2026.
Along with the KPL-387 initiative, Kiniksa provided an update on its corporate strategy. The company is sharpening its focus on diseases with unmet medical needs, particularly in cardiovascular indications, building on the success of its ARCALYST therapy. This strategy is designed to expand treatment options for patients with recurrent pericarditis while streamlining the company’s overall development efforts.
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