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	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
Mavrilimumab** GM-CSFRα	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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