Pipeline

Our pipeline of immune-modulating, clinical-stage product candidates are based on strong biologic rationale or validated mechanisms, target underserved conditions and offer the potential for differentiation.

Program & Target Therapeutic Area Preclinical Phase 1 Phase 2 Phase 3 Commercial Rights
ARCALYST (rilonacept)1* IL-1α & IL-1β Recurrent Pericarditis Commercial
Worldwide (excluding the Middle East and North Africa)
Cryopyrin-Associated Periodic Syndromes (CAPS) Commercial
U.S. and Japan
Deficiency of IL-1 Receptor Antagonist (DIRA) Commercial
U.S. and Japan
Mavrilimumab** GM-CSFRα COVID-19-related ARDS Mid Phase 3
Worldwide
Giant Cell Arteritis Phase 2
Worldwide
Vixarelimab*** OSMRβ Prurigo Nodularis Phase 2
Worldwide
KPL-404 CD40 Rheumatoid Arthritis**** End Phase 1
Worldwide
1 Approved in the U.S.
*The FDA granted Breakthrough Therapy designation to rilonacept for recurrent pericarditis in 2019 and Orphan Drug designation to rilonacept for pericarditis in 2020.
** The FDA granted Orphan Drug designation to mavrilimumab for giant cell arteritis in 2020.
***The FDA granted Breakthrough Therapy designation to vixarelimab for pruritus associated with prurigo nodularis in 2020.
****Kiniksa plans to initiate a Phase 2 proof-of-concept trial in patients in the second half of 2021. The planned trial will provide safety and characterization of chronic administration as well as the potential to evaluate KPL-404 across a range of other autoimmune diseases.

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