USPTO Grants IGC Pharma Patent Covering IGC-AD1 for Novel Composition Targeting Alzheimer's Disease and Central Nervous System Disorders

Rhea-AI Summary

IGC Pharma (NYSE:IGC) announced that the USPTO granted U.S. Patent No. 12,465,589 on November 11, 2025 for "Methods and Composition for Treating CNS Disorders."

The patent covers the proprietary formulation used in IGC-AD1, the company's lead candidate now in the Phase 2 CALMA trial for agitation in Alzheimer's disease, and claims effects on amyloid-beta, tau phosphorylation, mitochondrial function, and behavioral symptoms including agitation, memory, cognition, anxiety, and sleep disturbances.

Positive

• USPTO grant of U.S. Patent No. 12,465,589 on November 11, 2025
• Patent covers IGC-AD1 composition targeting amyloid, tau, mitochondrial dysfunction, and symptoms
• IGC-AD1 is an active asset in a Phase 2 CALMA trial for agitation in Alzheimer's disease

Negative

• Patent grant does not equal FDA approval or demonstrated clinical efficacy

POTOMAC, MARYLAND / ACCESS Newswire / November 13, 2025 / IGC Pharma, Inc. ("IGC Pharma," "IGC," or the "Company") (NYSE American:IGC), a clinical-stage biotechnology company leveraging Artificial Intelligence ("AI") to develop innovative treatments for Alzheimer's disease, today announced that the United States Patent and Trademark Office ("USPTO") has granted the company U.S. Patent No. 12,465,589, titled "Methods and Composition for Treating CNS Disorders." The patent covers the propriety formulation used in IGC-AD1, the Company's lead drug candidate currently being evaluated in the Phase 2 CALMA (Clinically Advanced Lead Molecule for Agitation) trial for agitation in Alzheimer's disease.

The patent granted on November 11, 2025, covers a proprietary composition for treating Alzheimer's disease including amyloid plaque, tau tangles as well as symptoms associated with Alzheimer's, such as agitation, memory, cognition, anxiety, and sleep disturbances.

Ram Mukunda, CEO of IGC Pharma, commented, "This patent further strengthens the robustness of our intellectual property portfolio as we move closer to commercialization of IGC-AD1. It reinforces our position in developing differentiated therapies that target both the behavioral and disease-modifying aspects of Alzheimer's disease, with the goal of delivering safer, more effective solutions for patients and caregivers."

This patented composition is designed to reduce amyloid-beta (Aβ) expression and aggregation, enhance mitochondrial function, decrease phosphorylation of GSK3β, and lower tau phosphorylation, thereby addressing both behavioral symptoms and core disease mechanisms of Alzheimer's. Importantly, the combination seeks to achieve these effects without serious side effects, a critical advancement in the development of safer, more effective therapies for neurodegenerative diseases.

The company's research focus continues to target the mechanisms that underlie Alzheimer's progression, including Aβ aggregation, tau pathology, mitochondrial dysfunction, and neuroinflammation-pathways long associated with cognitive decline and behavioral symptoms.

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 cannabinoid-based 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. These forward-looking statements are based largely on IGC Pharma's expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company's failure or inability to commercialize one or more of the Company's products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA's general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma's U.S. Securities and Exchange Commission ("SEC") filings. IGC incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 27, 2025, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur. IGC Pharma, Inc. assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

Contact Information:

Rosalyn Christian/John Nesbett
IMS Investor Relations
igc@imsinvestorrelations.com
(203) 972-9200

SOURCE: IGC Pharma, Inc.

View the original press release on ACCESS Newswire

FAQ

What does USPTO U.S. Patent No. 12,465,589 granted on November 11, 2025 cover for IGC (NYSE:IGC)?

The patent covers a proprietary composition used in IGC-AD1 for treating Alzheimer's disease and related symptoms, including effects on amyloid-beta, tau phosphorylation, and mitochondrial function.

How does the November 11, 2025 patent affect IGC-AD1's commercialization prospects for IGC (NYSE:IGC)?

The patent strengthens the company's intellectual property around IGC-AD1, potentially supporting future commercialization efforts but it does not guarantee regulatory approval or market entry.

What stage is IGC-AD1 in and what trial is ongoing as of November 13, 2025 for IGC (NYSE:IGC)?

IGC-AD1 is currently being evaluated in the Phase 2 CALMA trial for agitation in Alzheimer's disease.

Does the patent announcement for IGC (NYSE:IGC) include Phase 2 CALMA clinical results?

No. The announcement states the patent grant and biological targets but does not disclose Phase 2 CALMA efficacy or safety results.

Which Alzheimer's disease mechanisms does the IGC (NYSE:IGC) patent claim to address?

The patent describes addressing Aβ expression and aggregation, GSK3β phosphorylation, tau phosphorylation, and mitochondrial dysfunction.