Hyalolex (IGC-AD1) / IGC Pharma - LARVOL DELTA

IGC Pharma Strengthens Regulatory Readiness as Phase 2 CALMA Alzheimer's Trial Approaches Enrollment Closure and Q4 Topline Readout (Yahoo Finance) - "CALMA has randomized 160 participants to date. IGC Pharma expects to close enrollment after up to additional participants, marking a key final enrollment milestone before patient follow-up, database lock, unblinding, and topline analysis. This final planned over-enrollment phase is intended to strengthen the dataset for end-of-treatment, secondary, and exploratory analyses...The Company is strengthening these capabilities to support clinical data review, AI-assisted data quality activities, regulatory preparedness for potential engagement with the U.S. Food and Drug Administration ('FDA') and the European Medicines Agency ('EMA'), and strategic evaluation by potential pharmaceutical partners following completion of the Phase 2 CALMA trial."

P2 data • Trial status • Alzheimer's Disease

IGC Pharma Adds Kerwin Medical Center in Dallas to Phase 2 CALMA Trial as Enrollment Advances Toward Completion (Yahoo Finance) - "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."

Trial status • Alzheimer's Disease

IGC-AD1-P2: Clinical Trial on Agitation in Alzheimer's Dementia (clinicaltrials.gov) - P2 | N=164 | Recruiting | Sponsor: IGC Pharma, LLC | Trial completion date: Mar 2026 ➔ Aug 2026 | Trial primary completion date: Mar 2026 ➔ Aug 2026

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Dementia • APOE

IGC Pharma Reaches 80% Enrollment in Phase 2 CALMA Trial, Entering Final Phase Ahead of Enrollment Completion and Data Readout (ACCESS Newswire) - "This milestone represents a significant step in advancing the program toward enrollment completion, expected in mid-2026, and positions the Company to progress toward database lock and topline results. Enrollment progress across the Company's US and Canadian clinical network continues to support consistent execution as the study enters its final phase."

Enrollment status • Alzheimer's Disease

IGC Pharma…announced that the Canadian Intellectual Property Office ('CIPO') has issued a Notice of Allowance covering the proprietary composition underlying IGC-AD1, the Company's Phase 2 clinical stage program for agitation associated with Alzheimer's disease (ACCESS Newswire) - "With this allowance, patent No. 3,095,729, titled 'Method and Composition for Treating CNS Disorders', IGC has secured composition protection for IGC-AD1 across key North American jurisdictions, reinforcing the long-term exclusivity around the formulation as the Phase 2 CALMA trial advances toward enrollment completion. The protection covers the specific low-dose combination central to IGC-AD1's therapeutic strategy."

Patent • Alzheimer's Disease

IGC Pharma…announced the expansion of its Phase 2 CALMA trial for IGC-AD1 into Colombia, South America, through the addition of Grupo de Neurociencias de Antioquia ('GNA') (ACCESS Newswire) - "The GNA site is the latest addition to a clinical network that now spans 23 active sites across 26 locations in the United States and Canada."

Trial status • Alzheimer's Disease

IGC Pharma Reaches 70% Enrollment in Phase 2 CALMA Trial Evaluating IGC-AD1 for Alzheimer's Agitation (ACCESS Newswire) - "The Company has approximately 23 active sites across 26 locations, and enrollment is progressing across this clinical network. IGC expects to complete enrollment by mid-2026."

Enrollment status • Alzheimer's Disease

USPTO Grants IGC Pharma Patent Covering IGC-AD1 for Novel Composition Targeting Alzheimer's Disease and Central Nervous System Disorders (ACCESS Newswire) - "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."

Patent • Alzheimer's Disease

IGC Pharma Expands Phase 2 CALMA Clinical Trial to University of South Florida's Department of Psychiatry and Behavioral Neurosciences (ACCESS Newswire) - "Enrollment at the new site has already begun, with four participants enrolled, marking an important step toward accelerating recruitment and advancing the timeline of the study."

Trial status • Alzheimer's Disease

IGC Pharma…announced the addition of a new clinical trial site to its ongoing Phase 2 study evaluating IGC-AD1, an investigational drug candidate for treating agitation in Alzheimer's disease (ACCESS Newswire) - "The CALMA Phase 2 trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of IGC-AD1 in reducing agitation symptoms in individuals living with Alzheimer's disease."

Trial status • Alzheimer's Disease

IGC Pharma Reports 50% Patient Enrollment Milestone in Phase 2 CALMA Alzheimer's Agitation Trial (ACCESS Newswire) - "With enrollment accelerating across this network of leading centers, IGC Pharma remains on track to complete recruitment in calendar 2026."

Enrollment status • Alzheimer's Disease

IGC Pharma Expands CALMA Phase 2 Trial to Island Health's Royal Jubilee Hospital in Canada (ACCESS Newswire) - "The CALMA Phase 2 trial is a randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of IGC-AD1 in managing agitation in patients with Alzheimer's disease..."

Trial status • Alzheimer's Disease

Strategic & Operational Highlights (ACCESS Newswire) - "During the quarter, IGC expanded trial sites across North America (Ontario, FL, RI, PR, OK) to support enrollment in the CALMA Phase 2 trial of IGC-AD1, a proprietary natural cannabinoid based investigational medication in trials for controlling agitation in Alzheimer's disease, with potential disease-modifying effects....The Company is moving aggressively to cut cost and shift more resources to completing the CALMA Phase 2 trial and completing implementing MINT-AD."

Trial status • Alzheimer's Disease

IGC-AD1-P2: Clinical Trial on Agitation in Alzheimer's Dementia (clinicaltrials.gov) - P2 | N=164 | Recruiting | Sponsor: IGC Pharma, LLC | Trial completion date: Jun 2025 ➔ Mar 2026 | Trial primary completion date: Jun 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Dementia • APOE

IGC Pharma Announces CALMA Phase 2 Trial Expansion with the Addition of Miami Jewish Health (ACCESSWIRE) - "IGC Pharma, Inc...announced the expansion of its Phase 2 clinical trial, CALMA, evaluating IGC-AD1 for the treatment of agitation in Alzheimer's dementia, to MIND Institute at Miami Jewish Health in Miami, Florida. This addition further advances the company's efforts to accelerate the trial's completion and builds on promising interim data suggesting the potential of IGC-AD1 to improve patient outcomes."

Trial status • Alzheimer's Disease • Dementia

IGC Pharma Names IGC-AD1 Phase 2 Clinical Trial for Alzheimer's Agitation 'CALMA' and Expands Recruitment Strategy (ACCESSWIRE) - "IGC Pharma, Inc...announced today that its ongoing Phase 2 trial for agitation in Alzheimer's disease has been officially named CALMA (Calming Agitation in Alzheimer's)...IGC Pharma is expanding the campaign to the other trial locations, with the goal of completing enrollment and the CALMA trial in the second half of 2025."

Enrollment status • Trial completion • Alzheimer's Disease • Dementia

Developing Topics. (PubMed, Alzheimers Dement) - "Future imaging studies could explore the use of radioactive potassium tracers for diagnosis. The study provides insights into a) potassium as a potential blood-based diagnostic biomarker for AD and b) the potential of IGC-AD1 as a disease-modifying medication, given the preliminary data showing a reduction in serum potassium levels in AD subjects post-treatment."

Journal • Alzheimer's Disease • CNS Disorders

Developing Topics. (PubMed, Alzheimers Dement) - "IGC-AD1 demonstrated tolerability and potential efficacy in reducing Neuropsychiatric Symptoms in AD, with NM showing greater reductions after 1- and 2-mL administrations, though similar reductions were observed with 3 mL. Further investigation with a larger sample is continuing."

Journal • Alzheimer's Disease • CNS Disorders • Psychiatry • CYP2C9

Developing Topics. (PubMed, Alzheimers Dement) - P1 | "IGC-AD1 was safe and well-tolerated, without causing or worsening delusions/hallucinations as evaluated by the NPI. Contrary to other findings related to cannabis use, we observed clinical reduction approaching, in some cases, statistical significance. The signals warrant further analysis in a larger trial."

Journal • Alzheimer's Disease • CNS Disorders • Psychiatry

Developing Topics. (PubMed, Alzheimers Dement) - "Based on this safety trial, the findings suggest that the treatment with THC and melatonin does not exert adverse effects on liver function in patients with AD. Overall, the treatment demonstrated good tolerability, with no significant differences in hepatic biomarkers compared to placebo, supporting its potential safety in elderly patients with AD. Future research should continue to monitor these biomarkers in larger, more diverse populations to confirm these findings and assess long-term safety and efficacy."

Biomarker • Clinical • Journal • Alzheimer's Disease • CNS Disorders

Developing Topics. (PubMed, Alzheimers Dement) - P1 | "In this limited sample size and trial, there were no significant differences in AE frequencies between the two CYP2C9 phenotypes IM and NM, suggesting that IGC-AD1 has a safety profile that does not vary greatly, based on these two CYP2C9 polymorphisms. This analysis and initial results are important because the pharmacokinetics of THC are different for IM and NM. We continue to study these and other polymorphisms of CYP2C9 to understand their impact on AEs as it is crucial for personalized treatment strategies for the aged AD population."

Journal • Alzheimer's Disease • Cardiovascular • CNS Disorders • Hypertension • CYP2C9

Developing Topics. (PubMed, Alzheimers Dement) - "Although exogenous melatonin is often associated with sedation, the study indicates that IGC-AD1, containing melatonin, did not lead to the anticipated increase in sleep duration. Further research is needed to understand the underlying mechanisms and optimize therapeutic interventions for sleep disturbances in AD patients."

Clinical • Journal • Alzheimer's Disease • Anesthesia • CNS Disorders • Pain • Sleep Disorder

Developing Topics. (PubMed, Alzheimers Dement) - "Melatonin when administered jointly with THC could play a significant role in THC absorption and PK. We hypothesize, pending more studies, that the higher reported dose-dependent absorption of THC may be related to the effect of melatonin on gastrointestinal transporters and efflux pumps."

Journal • Review • Alzheimer's Disease • CNS Disorders • Gastrointestinal Disorder • Hepatology • Insomnia • Liver Failure • Pain • Sleep Disorder

IGC Pharma Advances IGC-AD1 as a Potential Alzheimer's Therapy Addressing Cognitive Impairment and Underlying Disease Pathology (Yahoo Finance) - "IGC Pharma, Inc...announced today an expansion of its clinical research program for IGC-AD1, an investigational treatment for Alzheimer's disease. Building on Phase 2 interim results demonstrating reductions in agitation and cognitive improvement, the Company is initiating new trials to evaluate IGC-AD1's potential as a disease-modifying therapy...'We plan to initiate a new Phase 2 clinical trial for IGC-AD1 in 2025,'...The ongoing 146-patient Phase 2 trial continues to enroll participants across the USA and Canada. With over 1,000 doses administered and no serious adverse events reported, the trial is on track to deliver comprehensive safety and efficacy data in 2025."

New P2 trial • P2 data • Alzheimer's Disease • CNS Disorders

IGC Pharma Announces Additional Phase 2 Interim Results Highlighting Cognitive Benefits of IGC-AD1 for Alzheimer's Treatment (Businesswire) - P2 | N=164 | IGC-AD1-P2 (NCT05543681) | Sponsor: IGC Pharma LLC | "Interim results from the trial demonstrated that the active treatment group receiving IGC-AD1 twice daily for six weeks showed an average improvement of about 8% on the Mini-Mental State Examination ('MMSE'), a validated clinical tool for assessing cognitive function. By contrast, the placebo group showed no improvement over the same period...As previously disclosed, interim results showed that IGC-AD1 significantly reduced agitation compared to placebo, with improvements observed as early as two weeks. Unlike the existing therapy, which often takes about 6–10 weeks to show results and carries a black box warning, IGC-AD1 offers rapid symptom relief with a favorable safety profile, making it a highly differentiated potential medication for managing agitation in Alzheimer's."

P2 data • Alzheimer's Disease • CNS Disorders