Aisa Pharma's AISA-021 Cuts Raynaud's Attacks 43% in Phase 2
BOSTON – November 10, 2026 -- Aisa Pharma, Inc. reported that its once-daily oral drug AISA-021 (cilnidipine) cut the mean frequency of Raynaud's attacks by 43% from baseline in the Part B crossover phase of the Phase 2 RECONNOITER-1 trial in systemic sclerosis-associated Raynaud's phenomenon (SSc RP). Placebo-treated patients saw a 26% reduction (p=0.028). The company has asked the U.S. Food and Drug Administration (FDA) for a Type C meeting on its development strategy and potential registration pathway, and is preparing a global Phase 3 pivotal study.
Attack-free days rise nearly fourfold from baseline in AISA-021 arm
AISA-021 delivered a placebo-adjusted improvement of more than 155% in the proportion of attack-free days, a nearly fourfold increase from baseline (p=0.013). The drug also significantly shortened attack duration (p=0.02) and improved skin temperature measured by thermography at the proximal interphalangeal joint (p=0.047).