Aisa Pharma, a clinical-stage biopharmaceutical company focused on treatments for systemic sclerosis, has announced results from its Phase II RECONNOITER clinical trial evaluating AISA-021 (cilnidipine), a once-daily investigational calcium channel blocker for Systemic Sclerosis-associated Raynaud’s Phenomenon (SSc-RP). The findings were presented during an oral session at the 9th World Systemic Sclerosis Congress held in Athens, Greece from March 5–7, 2026.

Systemic sclerosis-associated Raynaud’s phenomenon is considered one of the most burdensome complications of scleroderma, significantly affecting patients’ quality of life while lacking approved treatment options globally. According to the company, the Phase II trial did not achieve statistical significance for the primary endpoint but demonstrated encouraging clinical benefits across several secondary measures.

The RECONNOITER trial was a randomised, double-blind, placebo-controlled crossover study designed to evaluate the safety and efficacy of oral AISA-021 in patients with active SSc-RP. A total of 64 patients participated in the study, which included dose-evaluation and crossover phases to assess safety, effectiveness and compatibility with existing therapies.

Results showed that patients treated with AISA-021 experienced a 22.1 percent reduction in the weekly frequency of Raynaud’s attacks compared with baseline, compared with a 12.4 percent reduction in the placebo group. Although this did not meet statistical significance for the primary endpoint, the drug delivered meaningful improvements across other clinically relevant measures.

The therapy significantly increased the proportion of attack-free days, demonstrating more than a 155 percent placebo-adjusted increase and nearly a four-fold improvement from baseline. In addition, AISA-021 significantly reduced the duration of Raynaud’s attacks and improved thermographic skin temperature measurements. Patients also reported improvements in symptoms such as pain, gastrointestinal discomfort, breathing difficulties and overall disease severity.

Importantly, the investigational therapy was generally well tolerated, with no treatment-related serious adverse events reported during the trial. Researchers also observed consistent improvements in multiple Raynaud’s-related metrics including pain, severity and overall burden compared with placebo.

Based on these findings, the company plans to engage with the US Food and Drug Administration and other regulatory authorities through an End-of-Phase-II meeting to determine the pathway for Phase III clinical trials and potential regulatory approval.

AISA-021 is an investigational oral dual calcium channel inhibitor designed to promote vasodilation, maintain endothelial function and reduce vasospasm associated with Raynaud’s phenomenon. The compound is derived from cilnidipine, a medication originally approved in Japan in 1995 for hypertension, but reformulated by Aisa Pharma specifically to treat Raynaud’s symptoms. The therapy has already received Orphan Drug Designation from the US Food and Drug Administration.

Beyond Raynaud’s phenomenon, the company is exploring the potential use of AISA-021 for additional conditions including systemic sclerosis, pulmonary fibrosis, neuropathic pain and ocular diseases.

Systemic sclerosis is considered one of the most severe autoimmune diseases, affecting roughly 100,000 patients in the United States. Nearly 95 percent of patients experience Raynaud’s symptoms, which involve reduced blood flow to extremities, often triggered by cold exposure, leading to pain, tingling and numbness in the hands and fingers.