IGC Pharma, Inc. a Potomac, Maryland-based clinical-stage biotechnology company, announced on September 28, 2026 that it has completed enrollment in its CALMA Phase 2 trial evaluating lead asset IGC-AD1 for agitation in Alzheimer’s dementia. CALMA achieved target enrollment with 168 participants randomized, including planned over-enrollment designed to strengthen the evaluable dataset for end-of-treatment, secondary, and exploratory analyses. Following the protocol-defined six-week treatment period, final participant dosing is expected to conclude in early November, after which the company will proceed toward database lock, unblinding, and topline analysis, with results expected in Q4 2026.
Ram Mukunda, CEO of IGC Pharma, said: “With target enrollment complete, CALMA has officially transitioned from recruitment to the final stage ahead of topline results. Our focus is now on patient follow-up and database lock as we prepare this 168-patient dataset for rigorous scientific and regulatory evaluation and potential next-stage development.”
Trial Design and Enrolled Population
CALMA is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial evaluating IGC-AD1, an investigational oral solution dosed twice daily for six weeks, with the primary endpoint measured as change in agitation from baseline to week six on the Cohen-Mansfield Agitation Inventory. The trial ran across sites in the U.S. and Canada, including academic and specialty centers such as Baycrest Academy for Research and Education, Butler Hospital’s Memory and Aging Program, Hamilton Health Sciences, McGill University, and Miami Jewish Health. The enrolled population had an average age of roughly 78, reflecting an older Alzheimer’s dementia population; about 53% of participants were female, and based on available race data, approximately 77% were White and 16% were Black or African American, with the remainder identifying as other races or not listed. Agitation is described as one of the hardest symptoms of Alzheimer’s dementia for families and caregivers to manage, contributing to emergency care, caregiver distress, earlier residential placement, and higher healthcare costs — the population IGC-AD1 is being developed to address.
Safety Monitoring So Far
The trial’s Data Safety Monitoring Committee has conducted periodic safety reviews and, at each review to date, has recommended the trial continue without modification. IGC Pharma remains blinded to treatment assignment, and as of its most recent safety reporting, blinded safety monitoring had not identified any treatment-related serious adverse events. Safety data remain subject to final review and analysis after database lock and unblinding.
Mukunda added: “Completing enrollment is a defining clinical milestone for IGC Pharma. We are grateful to the participants, caregivers, investigators, and clinical teams who made CALMA possible, and we look forward to reporting topline results.”
About IGC Pharma
IGC Pharma is a clinical-stage biotechnology company developing therapeutics for Alzheimer’s disease and other indications. Its lead asset, IGC-AD1, is being evaluated in the Phase 2 CALMA trial for agitation associated with Alzheimer’s dementia, and the company is also developing AI-enabled tools intended to support biomedical discovery, data harmonization, and clinical development.
