Aisa Pharma Reports Positive Phase II Results for Raynaud’s Therapy

Aisa Pharma has reported positive results from its Phase II RECONNOITER trial evaluating AISA-021 (cilnidipine) for patients with systemic sclerosis-associated Raynaud’s phenomenon (SSc-RP). The findings were presented at the World Systemic Sclerosis Congress in Athens.

The double-blind, randomised, placebo-controlled study included 64 patients with active SSc-RP and assessed the safety and efficacy of once-daily oral AISA-021. The trial consisted of two parts: a parallel-arm design evaluating doses of 10 mg and 20 mg and a crossover segment involving 37 patients.

Results showed a 22.1% reduction in weekly Raynaud’s attacks from baseline with AISA-021, compared with a 12.4% reduction with placebo. Although the primary endpoint did not reach statistical significance, the treatment significantly increased attack-free days, reduced attack duration and improved skin temperature.

The therapy was well tolerated with no treatment-related serious adverse events. The company plans to discuss Phase III development with the U.S. Food and Drug Administration.

09-03-2026