IGC Pharma Completes Enrollment in Phase 2 CALMA Alzheimer's Trial; Topline Results Expected Q4 2026

The study has moved from recruitment toward patient follow-up, with database lock and unblinding still ahead.

Rhea-AI Summary

IGC Pharma (IGC) completed enrollment of 168 participants in its Phase 2 CALMA trial of IGC-AD1 for agitation in Alzheimer's dementia. The randomized, double-blind, placebo-controlled trial tests an investigational oral solution given twice daily for six weeks. Its primary endpoint measures change in agitation from baseline to week six using the Cohen-Mansfield Agitation Inventory. IGC says planned over-enrollment is intended to support end-of-treatment, secondary and exploratory analyses.

Final participant dosing is expected to finish in early November, followed by database lock, unblinding and analysis. Topline results are expected in Q4 2026. The company remains blinded to treatment assignments. A safety monitoring committee has recommended continuing without modification at each review to date. At the most recent safety reporting, blinded monitoring had not identified any serious adverse events as related to study treatment. Final safety review remains pending.

Positive

• 168 participants randomized; target enrollment is complete, including planned over-enrollment.
• Safety committee recommended continuing the trial without modification at each review to date.
• Blinded safety monitoring had not identified serious adverse events as related to study treatment at the most recent reporting.
• Final participant dosing is expected to finish in early November.
• Topline results are expected in Q4 2026.

Negative

• Efficacy findings remain pending database lock, unblinding and analysis.
• Safety data remain subject to final review and analysis after database lock and unblinding.

Market Context

Earlier CALMA enrollment updates reported 146 randomized participants on June 11 and 160 on Aug 11, ...

Analysis

Earlier CALMA enrollment updates reported 146 randomized participants on June 11 and 160 on Aug 11, followed by 0.53% and 5.01% gains; these are historical progression comparisons, not a forecast.

Key Figures

Participants randomized: 168 participants Treatment period: Six weeks Final participant dosing: Early November +1 more

Participants randomized

168 participants

CALMA Phase 2 trial; enrollment complete, including planned over-enrollment

Treatment period

Six weeks

Protocol-defined CALMA treatment period

Final participant dosing

Early November

Expected completion

Topline results

Q4 2026

Expected timing

Previous Clinical trial Reports

2 past events · Latest: Aug 11

Same Type 2 events

1. Aug 11

   Trial enrollment update

   24h Move

   +5.0%

   Reported 160 randomized participants, with up to eight more expected before enrollment closure.

2. Jun 11

   Enrollment target reached

   24h Move

   +0.5%

   Reached the 146-participant enrollment target, with limited over-enrollment planned to support analyses.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

double-blind, placebo-controlled, primary endpoint, database lock, +2 more

6 terms

double-blind medical

"multicenter, randomized, double-blind, placebo-controlled Phase 2 trial"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"randomized, double-blind, placebo-controlled Phase 2 trial"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

primary endpoint medical

"The primary endpoint is change in agitation from baseline to week six"

The primary endpoint is the single main result a clinical study is designed to measure to decide if a treatment works, like the finish line in a race that tells you who won. Investors care because meeting or missing this goal drives regulatory decisions, future sales expectations and stock value — it turns trial data into a clear yes-or-no signal about a drug’s commercial prospects.

database lock medical

"proceed toward database lock, unblinding, and topline analysis"

A database lock is the point in a clinical trial when the collected study data are finalized and no further changes or corrections are allowed, so analysts can run the official statistical tests. For investors this matters because it usually precedes public results or regulatory filings—think of it like sealing and signing off an exam before grading: once locked, the timing and content of the readout become clearer and uncertainty about last-minute data edits is reduced.

serious adverse events medical

"had not identified any treatment-related serious adverse events"

Serious adverse events are significant problems or negative outcomes that occur during a medical treatment or clinical trial, such as severe side effects, hospitalizations, or life-threatening conditions. They matter to investors because such events can impact a company's reputation, lead to regulatory scrutiny, or delay the development of new products, ultimately affecting the company’s financial performance.

multicenter medical

"CALMA is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial"

A multicenter study or trial is conducted at several independent locations or clinics rather than a single site, so researchers collect data from diverse groups and settings. For investors, multicenter designs matter because they increase the credibility and generalizability of results, reduce the risk that findings are due to one local population or practice, and often speed enrollment — all factors that can affect regulatory outcomes, market confidence and commercial prospects.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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POTOMAC, MD / ACCESS Newswire / September 28, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company") today announced it has completed enrollment in its CALMA Phase 2 trial evaluating lead asset, IGC-AD1, for agitation in Alzheimer's dementia.

• Enrollment complete; final participant dosing expected to conclude in early November; topline results expected Q4 2026

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 complete in early November, after which the Company expects to proceed toward database lock, unblinding, and topline analysis, with topline results expected in the fourth quarter of 2026.

"With target enrollment complete, CALMA has officially transitioned from recruitment to the final stage ahead of topline results," said Ram Mukunda, Chief Executive Officer of IGC Pharma. "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."

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, for agitation in Alzheimer's dementia. The primary endpoint is change in agitation from baseline to week six on the Cohen-Mansfield Agitation Inventory. The trial was conducted across clinical sites in the United States and Canada, including academic and specialty centers such as Baycrest Academy for Research and Education, Butler Hospital - Memory and Aging Program, Hamilton Health Sciences, McGill University, and Miami Jewish Health.

The enrolled population had an average age of approximately 78 years, reflecting an older Alzheimer's dementia population, and approximately 53% of participants were female. Based on available race data, approximately 77% of participants were White, 16% were Black or African American, and the remaining participants identified as other races or were not listed.

Agitation is one of the hardest symptoms of Alzheimer's dementia for families and caregivers to manage. It can contribute to emergency care, caregiver distress, earlier placement in residential care, and increased healthcare costs. IGC-AD1 is being developed as a potential treatment option for this high-burden patient population.

The Data Safety Monitoring Committee has conducted periodic safety reviews and at each review to date, has recommended that the trial continue without modification. The Company remains blinded to treatment assignment. As of the Company's most recent safety reporting, blinded safety monitoring had not identified any treatment-related serious adverse events as related to study treatment. Safety data remain subject to final review and analysis after database lock and unblinding.

"Completing enrollment is a defining clinical milestone for IGC Pharma," Mr. Mukunda continued. "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-AD1 and CALMA

IGC-AD1 is IGC Pharma's lead investigational therapeutic candidate for agitation in Alzheimer's dementia. CALMA is a randomized, double-blind, placebo-controlled Phase 2 clinical trial designed to evaluate the safety and efficacy of IGC-AD1 in this population. The trial's primary efficacy endpoint is change in agitation as measured by the Cohen-Mansfield Agitation Inventory, a commonly used clinical assessment of agitation behaviors in dementia.

About IGC Pharma

IGC Pharma, Inc. (NYSE American: IGC) is a clinical-stage biotechnology company developing therapeutics for Alzheimer's disease and other indications. The Company's lead asset, IGC-AD1, is being evaluated in the Phase 2 CALMA clinical trial for agitation in Alzheimer's dementia. The Company is also developing AI-enabled tools intended to support biomedical discovery, data harmonization, and clinical development.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Phase 2 CALMA trial, final participant dosing, participant visits and follow-up, database lock, unblinding, data analysis, anticipated timing of topline results in the fourth quarter of 2026, clinical and regulatory development plans for IGC-AD1, safety monitoring, AI-enabled data science capabilities, potential next-stage development planning, and future clinical milestones.
These statements are based on current expectations, estimates, and projections and involve known and unknown risks and uncertainties that could cause actual results, timelines, or outcomes to differ materially from those expressed or implied. Such risks and uncertainties include, among others, risks related to clinical trial timelines and outcomes; patient follow-up; data quality, reconciliation, and evaluability; database lock and statistical analysis; safety and efficacy results; regulatory feedback or approvals; financing needs; third-party service providers; software development and validation; and other factors discussed in the Company's filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-KT and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Contact Information
Andres Sanchez
Investor Relations
info@igcpharma.com
+1 301-983-0998 / +1 (202) 569-2566

SOURCE: IGC Pharma, Inc.

View the original press release on ACCESS Newswire

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When does IGC Pharma expect CALMA Phase 2 topline results?

IGC Pharma expects topline results in Q4 2026. Final participant dosing is expected to finish in early November, after which the company expects to proceed toward database lock, unblinding and analysis.

What is the primary endpoint of IGC Pharma's CALMA trial?

The primary endpoint is the change in agitation from baseline to week six, measured using the Cohen-Mansfield Agitation Inventory. CALMA evaluates IGC-AD1 for agitation in Alzheimer's dementia.

Who enrolled in IGC Pharma's CALMA Alzheimer's trial?

The 168 randomized participants had an average age of approximately 78 years, and approximately 53% were female. Based on available race data, approximately 77% were White and 16% were Black or African American; the remaining participants identified as other races or were not listed.