Drug intelligence / Profile preview

navenibart

Development stage
Phase 3
Lead developer
Astria Therapeutics
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Subcutaneous
01

Overview

Navenibart is a humanized monoclonal antibody inhibitor of plasma kallikrein developed for the prevention of hereditary angioedema (HAE) attacks. It is designed to provide long-acting, safe, and effective attack prevention with dosing intervals of every 3 or 6 months. Navenibart works by inhibiting plasma kallikrein activity, thereby reducing the overproduction of bradykinin that leads to HAE attacks. The drug has demonstrated rapid onset and durable efficacy in clinical trials, with reductions in mean monthly attack rates up to 95% and favorable safety/tolerability profiles[1][3][4][5][7]. Developed by Astria Therapeutics (originator Quellis Biosciences), it has received FDA Orphan Drug Designation for HAE.

Brand names
navenibart
Other names
STAR-0215STAR0215STAR 0215QLS-215QLS215QLS 215
02

Targets

KLKB1 (Plasma kallikrein)

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