IGC Pharma Reaches 80% Enrollment in Phase 2 CALMA Trial, Entering Final Phase Ahead of Enrollment Completion and Data Readout

IGC Pharma (NYSE:IGC) announced it has reached approximately 80% enrollment in the Phase 2 CALMA trial of IGC-AD1 for agitation in Alzheimer’s disease, with enrollment completion expected in mid-2026.

Rhea-AI Summary

IGC Pharma (NYSE:IGC) announced it has reached approximately 80% enrollment in the Phase 2 CALMA trial of IGC-AD1 for agitation in Alzheimer’s disease, with enrollment completion expected in mid-2026.

The randomized, double-blind, placebo-controlled study now enters its final recruitment phase, positioning the company to progress toward database lock and topline results that constitute a defined clinical catalyst.

Positive

• Enrollment ~80% in Phase 2 CALMA trial
• Expected enrollment completion mid-2026, creating a near-term catalyst
• Randomized, double-blind, placebo-controlled design preserves trial integrity

Negative

• No efficacy data yet; topline results pending, preserving uncertainty for investors
• Study uses no ongoing interim efficacy analyses, delaying early signal visibility

Argus Apr 14 session

+4.41% close to close Open Argus

Details

News Market Reaction – IGC

In the Apr 14 session, IGC gained 4.41%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights that the CALMA Phase 2 trial for IGC-AD1 has reached about 80% enrollme...

Analysis

This announcement highlights that the CALMA Phase 2 trial for IGC-AD1 has reached about 80% enrollment, moving closer to the mid-2026 completion and topline data catalyst. Historical clinical-trial updates have triggered modest stock moves averaging 1.17%, underscoring a pattern of incremental de-risking. Investors may monitor continued enrollment progress, future regulatory filings, and the company’s reported cash of roughly $900,000 alongside upcoming data readouts and financing decisions.

Key Figures

CALMA enrollment: ≈80% Agitation prevalence: up to 76% Initial cohort size: n=26 +5 more

CALMA enrollment

≈80%

Phase 2 CALMA trial for agitation in Alzheimer’s disease

Agitation prevalence

up to 76%

Share of Alzheimer’s patients affected by agitation cited in release

Initial cohort size

n=26

Interim cohort with agitation and sleep signals in 10-KT filing

Active trial sites

23 sites, 26 locations

CALMA network across US, Canada, and Colombia

Resale registration shares

978,235 shares

Amended S-3/A covering common stock for selling holders

Share purchase amount

$200,000

2024 share purchase agreement at $0.34 per share

Transition-period cash

$900,000

Cash and cash equivalents as of Dec 31, 2025 (10-KT)

Shares outstanding

98,796,089

Common shares outstanding as of Mar 11, 2026

Previous Clinical trial Reports

5 past events · Latest: Apr 07

Same Type 5 events

1. Apr 07

   Trial site addition

   24h Move

   +0.9%

   New Tandem Clinical Research site added with enrollment over 70% complete.

2. Feb 23

   Site network expansion

   24h Move

   +2.2%

   Visionary Investigators Network added as site; ~70% of enrollment completed.

3. Feb 17

   Patent allowance

   24h Move

   +0.0%

   North American composition protection for IGC-AD1 as CALMA nears 70% enrolled.

4. Feb 09

   International site added

   24h Move

   +1.2%

   CALMA expanded into Colombia; network grew to 23 sites, ~70% enrollment reached.

5. Feb 02

   70% enrollment milestone

   24h Move

   +1.5%

   CALMA hit ~70% enrollment with hybrid decentralized model and mid-2026 target.

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

Key Terms

phase 2, randomized, double-blind, placebo-controlled, +3 more

7 terms

phase 2 medical

"Phase 2 CALMA clinical trial evaluating IGC-AD1 for agitation associated"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

randomized medical

"As a randomized, double-blind, placebo-controlled study, efficacy outcomes"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

double-blind medical

"As a randomized, double-blind, placebo-controlled study, efficacy outcomes"

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

"As a randomized, double-blind, placebo-controlled study, efficacy outcomes"

"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.

topline results medical

"toward database lock and topline results. Enrollment progress across"

Topline results are the initial, high-level summary of the most important outcomes from an event such as a clinical trial or a company reporting period — for a drug study this means whether the main goals were met and basic safety info, and for a company it often means headline revenue and profit figures. Investors care because these summaries act like a headline that quickly signals whether prospects have improved or worsened, often driving immediate market reactions before the full details are released.

database lock medical

"expected in mid-2026, and positions the Company to progress toward database lock"

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.

neuropsychiatric medical

"Agitation is a devastating neuropsychiatric symptom that often leads"

Conditions or symptoms that involve both the brain’s biology and a person’s mood, thinking or behavior; they sit at the intersection of neurology and psychiatry. Investors care because neuropsychiatric issues often require specialized drugs, devices or diagnostics, carry distinct regulatory and safety risks, and can affect patient populations and market size — think of them as disorders where hardware (brain circuitry) and software (behavior) problems overlap.

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

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POTOMAC, MD / ACCESS Newswire / April 14, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company") today announced that it has approximately 80% patient enrollment in its Phase 2 CALMA clinical trial evaluating IGC-AD1 for agitation associated with Alzheimer's disease.

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.

Approaching a Defined Clinical Catalyst
"Reaching 80% enrollment marks an important milestone as we advance toward completion of the CALMA trial," said Ram Mukunda, CEO of IGC Pharma. "We have entered the final phase of recruitment with strong momentum. Every patient enrolled brings us one step closer to evaluating the full potential of IGC-AD1. Our focus is now on 100% enrollment and preparing for the data readout that could potentially redefine the treatment landscape for Alzheimer's disease."

Enrollment completion represents the primary operational gating step ahead of clinical data readout. As a randomized, double-blind, placebo-controlled study, efficacy outcomes are not analyzed on an ongoing interim basis in order to preserve trial integrity.

Final Phase of Execution
As the trial progresses through the final phase of recruitment, the Company continues to benefit from:

• Sustained enrollment momentum across a diversified US and Canadian clinical network

• Imminent Catalyst: Completion of enrollment in mid-2026 sets the stage for the highly anticipated Phase 2 topline results.

• Unmet Need: While the first medication for agitation was recently approved, the market remains largely underserved. With agitation affecting up to 76% of Alzheimer's patients, IGC is positioning as a Next-Generation Disruptor in a multi-billion-dollar CNS market where the demand for diverse and safer treatment options remains critical.

Advancing Toward a Defined Clinical Catalyst
IGC-AD1 is an investigational therapy being evaluated in a randomized, double-blind, placebo-controlled Phase 2 clinical trial designed to assess both safety and efficacy in patients with Alzheimer's disease experiencing agitation.

Agitation is a devastating neuropsychiatric symptom that often leads to premature institutionalization and severe caregiver burnout. Each successive enrollment reduces operational risk and supports IGC's progression toward a defined clinical data catalyst that could help transform the lives of patients and caregivers worldwide. With enrollment now at approximately 80%, the Company believes the CALMA trial is entering its final operational phase ahead of a defined clinical 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:
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

FAQ

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

How far along is IGC's CALMA trial for IGC-AD1 as of April 14, 2026 (IGC)?

IGC has reached approximately 80% enrollment in the CALMA Phase 2 trial. According to the company, enrollment completion is expected in mid-2026, after which the study moves toward database lock and topline results.

When does IGC expect enrollment to finish for the CALMA Phase 2 study (IGC)?

IGC expects to complete enrollment in mid-2026. According to the company, finishing recruitment then positions the trial for database lock and a subsequent topline data readout.

What trial design is IGC using for IGC-AD1 in the CALMA study (IGC)?

The CALMA trial is a randomized, double-blind, placebo-controlled Phase 2 study. According to the company, this design preserves integrity by not analyzing efficacy on an ongoing interim basis.

What investor catalyst does IGC highlight after reaching 80% enrollment (IGC)?

The primary near-term catalyst is completion of enrollment and a topline data readout. According to the company, these steps will move the program toward database lock and potential transformational clinical results.

How does IGC describe the unmet need addressed by IGC-AD1 in CALMA (IGC)?

IGC states agitation affects up to 76% of Alzheimer’s patients and the market remains largely underserved. According to the company, IGC-AD1 aims to offer a next-generation, safer treatment option in a multi-billion-dollar CNS market.