Authorization provides regulated capability to evaluate emerging therapeutic approaches alongside Phase 2 CALMA trial approaching completion
POTOMAC, MD / ACCESS Newswire / April 20, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company developing therapeutics for Alzheimer's disease, today announced that on April 9, 2026, it received authorization in Colombia to synthesize, formulate, and conduct development activities involving psilocybin at its research and development facility in Bogotá.
The authorization, granted under the oversight of the Fondo Nacional de Estupefacientes (FNE), provides IGC Pharma with a regulated capability to work with psilocybin, positioning the Company within an expanding area of scientific and investor interest. The Company believes it is among a limited number of organizations in Colombia with this type of authorization.
This capability allows the Company to evaluate potential applications of psilocybin, for example in neuropsychiatric symptoms (NPS) associated with dementia, including depression and anxiety, conditions affecting a large portion of Alzheimer's patients and representing a significant and underserved market opportunity.
Potential Engine of Growth
Neuropsychiatric symptoms affect about 80% of Alzheimer's patients and broad and heterogeneous, including agitation, depression, anxiety, and mood-related conditions. While IGC Pharma's lead candidate, IGC-AD1, is advancing through a Phase 2 clinical trial targeting agitation, additional symptom domains such as depression and anxiety represent a substantial and largely unaddressed segment of the disease burden. The Company believes that differentiated mechanisms may be required across these symptom clusters, creating the potential for multiple therapeutic pathways.
Strategic Positioning in a High-Growth Area
The psilocybin authorization provides IGC Pharma with a capital-efficient platform to evaluate emerging therapeutic approaches in neuropsychiatric disorders. Compared to traditional drug development pathways, this capability allows for earlier-stage evaluation with greater flexibility and lower cost. This authorization also positions the Company within a rapidly evolving global landscape, where regulatory, scientific, and investor interest in novel neuropsychiatric therapies continues to expand. Early access to regulated development environments may provide a strategic advantage as this field matures.
Complementary to CALMA Clinical Program
The Company continues to prioritize the advancement of its lead program, IGC-AD1, currently being evaluated in the Phase 2 CALMA clinical trial for agitation associated with Alzheimer's disease, which has recently reached approximately 80% patient enrollment and is advancing toward completion.
"IGC-AD1 and CALMA remains our primary near-term focus as we advance toward data readout," said Ram Mukunda, CEO of IGC Pharma. "At the same time, we are not just targeting agitation, we are building a multi-pronged approach to the $1 trillion Alzheimer's crisis. This authorization allows us to build additional assets in Alzheimer's disease using differentiated mechanisms in a capital-efficient manner."
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:
Walter Frank / John Nesbett
IMS Investor Relations
igc@imsinvestorrelations.com
(203) 972-9200
SOURCE: IGC Pharma, Inc.
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/igc-pharma-secures-psilocybin-research-authorization-expanding-focus-on-neuropsychiat-1158954
