Immune-modulating, clinical-stage product candidates targeting underserved conditions and offering the potential for differentiation.

Pipeline

Program & Target
Preclinical
Phase 1
Phase 2
Phase 3
Commercial
Kiniksa rights

PROGRAM & TARGET

ARCALYST®
(rilonacept)1,2

IL-1α & IL-1β

PHASE: COMMERCIAL

Recurrent Pericarditis
Cryopyrin-Associated Periodic Syndromes (CAPS)
Worldwide5
(Excluding MENA)
Deficiency of the interleukin-1 receptor antagonist (DIRA)
Commercial Rights
Recurrent Pericarditis: Worldwide5 (Excluding MENA)
Cryopyrin-Associated Periodic Syndromes (CAPS): US & Japan
Deficiency of the interleukin-1 receptor antagonist (DIRA): US & Japan

PROGRAM & TARGET

KPL-404

CD40

PHASE: 2

Rheumatoid Arthritis
Worldwide

PROGRAM & TARGET

Mavrilimumab

GM-CSFRα

PHASE: 1

Evaluating development in rare cardiovascular diseases4
Worldwide5
License Agreement
VixarelimabOSMRβ
Roche and Genentech
GLOBAL rights FOR ALL INDICATIONS3

1 Approved in the U.S.

2 The FDA granted Breakthrough Therapy designation to ARCALYST for recurrent pericarditis in 2019; the FDA granted Orphan Drug exclusivity to ARCALYST in March 2021 for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and pediatric patients 12 years and older. The European Commission granted Orphan Drug designation to ARCALYST for the treatment of idiopathic pericarditis in 2020.

3 In August 2022, Kiniksa entered into an agreement to grant Genentech and Roche exclusive global rights to develop and commercialize vixarelimab, subject to certain closing conditions.

4 Phase 2 clinical trials of mavrilimumab in rheumatoid arthritis and giant cell arteritis achieved their primary and secondary endpoints with statistical significance.

5 Kiniksa granted Huadong Medicine exclusive rights in the Asia Pacific Region, excluding Japan; IL-1α = interleukin-1α ; IL-1β = interleukin-1β; GM-CSFRα = granulocyte macrophage colony stimulating factor receptor alpha; OSMRβ = oncostatin M receptor beta; MENA = Middle East and North Africa.

 

Patient Support & Treatment Access