Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gamma- Glutamylcysteine · 1 trial · 1 indication
Safety: Creatinine not more than 1.5mg/dL, AST and ALT levels not more than 1.5 X ULN.
Safety and Tolerability
Safety and tolerability
Safety and tolerabitily
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.
| Arm | Type | Description |
|---|---|---|
| Gamma - Glutamylcystiene 400 | EXPERIMENTAL | Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg once a day for 3 months. |
| Gamma - Glutamylcystiene 800 | EXPERIMENTAL | Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg two times(morning-evening) a day for 3 months |
| Gamma - Glutamylcystiene 1200 | EXPERIMENTAL | Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg three times (morning-afternoon - evening) a day for 3 months |
| Name | Type | Description |
|---|---|---|
| Gamma- Glutamylcysteine | DRUG | 400mg capsules once a day |
| Gamma- Glutamylcusteine | DRUG | 400mg capsules orally (three times) per day |
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. ...
Gamma-Glutamylcysteine is an investigational small molecule being developed for the treatment of Mild Cognitive Impairment (MCI), a neurological condition. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Gamma-Glutamylcysteine is being developed by Viatris Inc. (NASDAQ: VTRS). The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug in patients with Mild Cognitive Impairment.
Gamma-Glutamylcysteine is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. The ongoing Phase 1 trial is designed to assess its safety and tolerability in patients with Mild Cognitive Impairment.
Gamma-Glutamylcysteine is being studied in one clinical trial, NCT07583251, titled 'Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI Patients'. This Phase 1 trial is not yet recruiting and plans to enroll 9 participants in the United States.
No, Gamma-Glutamylcysteine is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials for Mild Cognitive Impairment. The drug has not completed clinical development or received marketing authorization from regulatory agencies.