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Gamma- Glutamylcysteine

Phase 1

Mild Cognitive Impairment (MCI) | Small molecule | Other |Viatris Inc.|Last Updated: May 13, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMC
Total Trials1
Total Enrollment9
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07583251Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI PatientsPHASE1 NOT YET_RECRUITING 9Jun 1, 2026Feb 1, 2027May 13, 20261 United States
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Study Endpoints
Primary Endpoints
No. of participants with abnormal kidney and liver function tests after 30 days of supplementation.
1 month

Safety: Creatinine not more than 1.5mg/dL, AST and ALT levels not more than 1.5 X ULN.

Number of participants with treatment-related adverse events with one dose of GGC as assessed by CTCAE.
3 months

Safety and Tolerability

Number of participants with treatment-related adverse events with two doses of GGC as assessed by CTCAE.
3 months

Safety and tolerability

Number of participants with treatment-related adverse events with three doses of GGC as assessed by CTCAE.
3 months

Safety and tolerabitily

Number of participants with abnormal laboratory test results after 3 months of GGC supplementation.
3 months

Safety and tolerability: The number of participants experiencing clinically significant abnormal laboratory test results (hematology, kidney, and liver function tests) during 3 months of GGC supplementation, compared with baseline.

Secondary Endpoints
Changes in baseline blood glutathione levels (µmol/l) in people with MCI due to GGC supplementation.
3.5 months
Changes in blood iron levels(ng/μl) in people with MCI due to GGC supplementation.
3.5 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Gamma - Glutamylcystiene 400EXPERIMENTALEach participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg once a day for 3 months.
Gamma - Glutamylcystiene 800EXPERIMENTALEach participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg two times(morning-evening) a day for 3 months
Gamma - Glutamylcystiene 1200EXPERIMENTALEach participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg three times (morning-afternoon - evening) a day for 3 months
Interventions
NameTypeDescription
Gamma- GlutamylcysteineDRUG400mg capsules once a day
Gamma- GlutamylcusteineDRUG400mg capsules orally (three times) per day
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Eligibility Criteria
Age Range55 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Memory complaints; 2. MCI diagnosis 3. MoCA score between 18-25 4. Age 55 - 80 years old. 5. Ability to read and write in English Exclusion Criteria: 1. Subjects with acute head trauma or head injury involving loss of consciousness; 2. Subjects with a history of cancer; 3. ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07583251studyFirstPostDate: changed
LOWMay 21, 2026NCT07583251NEW_TRIAL: changed
LOWMay 21, 2026NCT07583251NEW_TRIAL: changed