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IGC-AD1

Phase 2

Alzheimer Disease | Small molecule | Neurology |IGC Pharma, Inc.|Last Updated: May 20, 2026

Target and mechanism

ModalitySmall molecule

Also known as IGC AD1, IGC-AD1-Active

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment164

FDA Designations

No designations recorded

Clinical trial landscape

IGC-AD1 · 2 trials · 6 indications

Phase 2 1Phase 1 1
NCT05543681Clinical Trial on Agitation in Alzheimer's DementiaAlzheimer Disease
RECRUITING164 Analytics
PHASE2RECRUITING
Clinical Trial on Agitation in Alzheimer's Dementia
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Agitation
Baseline to week six

Change in mean Cohen Mansfield Agitation Inventory (CMAI) score

Incidence of treatment-emergent adverse events in IGC-AD1 as compared to placebo [Safety and Tolerability]
3 weeks

Evaluate safety and tolerability of IGC AD1 10 participants will be administered the investigational drug and two will be administered placebo. Incidence of treatment emergent adverse events will be assessed to determine safety and tolerability of IGC-AD1.

Secondary Endpoints

Acute Agitation
Baseline to week two
Measurement of efficacy using Neuropsychiatric Inventory (NPI) scale
3 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Active Comparator: IGC-AD1ActiveACTIVE_COMPARATORIGC-AD1-Active, oral solution with two APIs (THC and melatonin).
Placebo Comparator: IGC-AD1 PlaceboPLACEBO_COMPARATORIGC-AD1-Placebo, oral solution similar to Active in color, taste, and texture, with excipients but without APIs.
ActiveACTIVE_COMPARATORIGC AD1
PlaceboPLACEBO_COMPARATORIGC AD1 Placebo

Interventions

NameTypeDescription
IGC-AD1-ActiveDRUGA non-sterile solution for oral administration.
IGC-AD1-PlaceboDRUGA non-sterile solution for oral administration similar in color and texture to the Active.
IGC AD1DRUGIGC AD1 oral Solution
PlaceboDRUGPlacebo of IGC AD1 oral Solution
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Eligibility Criteria

Age Range60 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites31

To be eligible to participate in this study, the participant must meet all the following criteria: Inclusion Criteria 1. Participant and/or Caregiver must provide a signed and dated ICF prior to any study procedures. 2. Must have a Caregiver who is able and willing to comply with all required stud...

Countries:United StatesCanadaColombiaPuerto Rico
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Frequently asked questions about IGC-AD1

What is IGC AD1 used for?

IGC AD1 is an investigational small molecule being developed for the treatment of dementia of Alzheimer type. It is intended for patients with dementia due to Alzheimer's disease. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes IGC AD1?

IGC AD1 is being developed by IGC Pharma, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol IGC. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug for Alzheimer's disease dementia.

What phase is IGC AD1 in?

IGC AD1 is in Phase 1 clinical development. A Phase 1 trial has been completed, which was a randomized, double-blind, placebo-controlled study involving 12 participants. The drug remains investigational and is not yet approved for commercial use.

What clinical trials is IGC AD1 in?

IGC AD1 has one completed clinical trial registered under NCT04749563, titled 'Study of IGC-AD1 in Subjects With Dementia Due to Alzheimer's Disease'. This Phase 1 study was conducted in Puerto Rico with 12 participants aged 60 years and older, and it was randomized, double-blind, and placebo-controlled.

Is IGC AD1 the same as IGC-AD1?

Yes, IGC AD1 is the same drug as IGC-AD1. The compound is referred to by both names in clinical and regulatory contexts. The clinical trial NCT04749563 uses the name IGC-AD1, while the drug is also commonly known as IGC AD1 in other references.