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IGC Pharma Adds Mount Sinai Clinical Site as CALMA Trial Advances Toward Completion and Topline Analysis

Key Takeaway: IGC Pharma has added the Icahn School of Medicine at Mount Sinai as a clinical site for its Phase 2 CALMA trial, which evaluates IGC-AD1 for agitation in Alzheimer's disease. This addition is part of the company's strategy to enhance site quality and patient access as the trial nears completion. With 80% of participants already enrolled, IGC Pharma aims to maintain rigorous standards for data integrity and execution.
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POSITIVE FACTORS

  • Addition of Mount Sinai enhances clinical trial capabilities.
  • Approximately 80% of targeted participants have completed the trial.
  • Focus on maintaining clinical rigor and data integrity.
  • Strong leadership from experienced professionals in Alzheimer's research.

Full Press Release Details

POTOMAC, Maryland – June , 2 , 2026 – IGC Pharma, Inc. (NYSE American: IGC) (“IGC” or the “Company”) , a clinical-stage biotechnology company developing therapeutics for Alzheimer’s disease, today announced the addition of t he Icahn School of Medicine at Mount Sinai in New York as a clinical site in the Company ’s Phase 2 CALMA trial evaluating IGC-AD1 for a gitation associated with Alzheimer’s disease.
The addition comes as the CALMA trial advances through its final phase of enrollment and reflects the Company’s continued focus on strengthening site quality, expanding patient access, and supporting consistent execution across its clinical network. Kerwin Medical Center brings focused experience in Alzheimer’s disease, mild cognitive impairment, frontotemporal dementia, and related neurodegenerative conditions.
The trial, at Mount Sinai, is led by Dr. Rachel Fremont, MD, PhD, Assistant Professor of Psychiatry at the Icahn School of Medicine at Mount Sinai and is board certified in Adult and Geriatric Psychiatry. Her work focuses on the clinical and biological characterization of psychiatric symptoms in neurodegenerative disorders, including Alzheimer’s disease and related dementias. The study will be coordinated locally by Katherine Keller, Clinical Research Coordinator, at Mount Sinai’s campus located at 1468 Madison Avenue, New York, NY 10029.
“Adding Mount Sinai at this stage of CALMA reflects our continued focus on disciplined execution, site quality, and data integrity as the trial advances toward completion,” said Ram Mukunda, CEO of IGC Pharma. “With approximately 80% of targeted participants having completed trial participation, our focus is on completing the remaining study activities efficiently while maintaining the clinical rigor needed for a meaningful data readout.”
About IGC Pharma (dba IGC):
IGC Pharma (NYSE American: IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer’s and metabolic disorders. Our lead asset, IGC-AD1, is a therapy currently in a Phase 2 trial ( CALMA ) for agitation in Alzheimer’s dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize clinical trials , and enhance patient targeting. With a complete patent portfolio and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.
Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially, including risks related to the Company’s ability to complete enrollment in its Phase 2 CALMA trial within anticipated timeframes, demonstrate safety and efficacy, the timing of data readouts, regulatory approvals, and other factors discussed in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including its most recent Annual Report on Form 10-KT. The Company undertakes no obligation to update these statements.
Contact Information:
Andres Sanchez

Frequently Asked Questions

What is the CALMA trial?

The CALMA trial is a Phase 2 clinical study evaluating IGC-AD1 for agitation associated with Alzheimer's disease.

Why was Mount Sinai added to the CALMA trial?

Mount Sinai was added to enhance clinical trial capabilities and improve patient access.

Who is leading the trial at Mount Sinai?

Dr. Rachel Fremont, MD, PhD, is leading the trial at Mount Sinai.

What percentage of participants have completed the trial?

Approximately 80% of the targeted participants have completed their trial participation.

What is IGC-AD1?

IGC-AD1 is a therapy being evaluated in the CALMA trial for treating agitation in Alzheimer's dementia.

Last updated: Jun 2, 2026