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).
In the first treatment sequence, which precedes any potential carryover effect in the crossover design, attack frequency fell 41.7% on AISA-021 versus 14.2% on placebo (p=0.028). The company says this bears directly on the planned Phase 3, which will be a parallel-arm, randomized, double-blind, placebo-controlled study.
Pain reduction of 42% narrowly misses statistical significance
Scleroderma-related pain fell 42% from baseline on AISA-021 versus 15% on placebo (p=0.07), which the company describes as a strong trend. Across Raynaud's metrics and several scleroderma measures captured by the SHAQ patient-reported instrument, AISA-021 showed numerical benefit over placebo.
Higher plasma exposure tracks with stronger efficacy
Plasma drug concentration varied more than tenfold among 24 patients. Patients in the top half of modeled concentration did better on the ASRAP patient-reported measure of Raynaud's burden (p=0.009) and on weekly attack reduction (p=0.03) than those in the lower half.
Effects were larger in patients diagnosed less than seven years earlier (n=6), who had 5.5 fewer attacks (p=0.05), and in patients with limited rather than diffuse disease (n=23, p=0.02).
Add-on design tested drug in a long-standing, heavily treated population
RECONNOITER (ACTRN12621000459820) was a randomized, double-blind, placebo-controlled crossover study that enrolled 64 patients in two parts. Part B, presented at the American College of Rheumatology (ACR) Convergence 2026 in Orlando, evaluated 37 patients. AISA-021 was added to existing regimens. Presenter Francesco Del Galdo of Leeds said median disease duration was nearly 15 years and more than 70% of patients were already on active Raynaud's therapy optimized before entry. He added that many responders had previously shown inadequate efficacy or poor tolerability with conventional calcium channel blockers.
The primary endpoint was change from baseline in mean weekly attacks. Secondary endpoints included severity, duration, Raynaud's condition score, pain and attack-free days.
Safety profile matches placebo with no treatment-related serious events
No treatment-related serious adverse events were reported in any group, and overall adverse event incidence was comparable to placebo.
Aisa Pharma says no oral drug has been approved anywhere in the world for Raynaud's. AISA-021 was first approved in Japan in 1995 for hypertension, and the company has developed a proprietary drug substance process and a new formulation for Raynaud's. The FDA has granted it Orphan Drug Designation for systemic sclerosis. Initial RECONNOITER results were first presented at the World Systemic Sclerosis Congress in Athens in March 2026.
Systemic sclerosis affects approximately 148,000 patients in the United States, according to the company, and 95% of patients experience Raynaud's symptoms.