# Glutathione

Glutathione is in Category 1: pharmacies may use it while FDA decides, which is not approval. It is also sold as a dietary supplement. The evidence grade is limited-human: small trials with mixed results, and FDA reports of harm from tainted drips.

Status checked: 2026-10-26. Last verified: 2026-10-26. Primary source: https://www.fda.gov/media/94155/download

This page has not been individually reviewed by a clinician.

Information, not medical advice.

| Fact | Value | Tier | Checked | Source |
|---|---|---|---|---|
| Also called | L-glutathione | primary | 2026-10-26 | [source](https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables) |
| Class | other | peer-reviewed | 2026-10-26 | [source](https://pubmed.ncbi.nlm.nih.gov/28436395/) |
| Regulatory status | category-1 | primary | 2026-10-26 | [source](https://www.fda.gov/media/94155/download) |
| Status source read | 2026-10-26 | primary | 2026-10-26 | [source](https://www.fda.gov/media/94155/download) |
| Evidence grade | limited-human | our assessment | 2026-10-26 | [source](https://peptideindex.ai/methodology#evidence-grade) |

## Name

Glutathione

Source: https://www.fda.gov/media/94155/download

## Summary

A substance sold in the US for use in dietary supplements. Pharmacies also make it into shots and drips into a vein.

Source: https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables

## Short answer

Glutathione is in Category 1: pharmacies may use it while FDA decides, which is not approval. It is also sold as a dietary supplement. The evidence grade is limited-human: small trials with mixed results, and FDA reports of harm from tainted drips.

Source: https://peptideindex.ai/methodology#short-answer

## Status by route

Source: https://www.fda.gov/media/94155/download

### Compounded by a pharmacy, such as shots, drips and nasal sprays

Status: category-1

Source: https://www.fda.gov/media/94155/download

### Sold as an ingredient in dietary supplements

Status: dietary-supplement

Source: https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables

## Advisory committee record

vote no 5, yes 8, abstain 1, outcome The committee recommended adding glutathione to the 503A bulks list, against FDA's proposal to leave it off, meeting date 2022-06-08, indication reviewed Skin lightening and more than 20 other uses, including lung disease, Parkinson's disease, autism and heavy metal poisoning

Source: https://www.fda.gov/media/161293/download

## Known risks

- In August 2026, FDA reported at least 30 patients harmed after glutathione drips made from a supplement-grade ingredient. Some went to the hospital [^7].
- The harms matched poisoning by endotoxin, a toxin from bacteria. Endotoxin can cause fever, chills, low blood pressure, shock and death [^6] [^7].
- In 2019, FDA reported seven clinic patients who fell ill within minutes of glutathione drips. One went to the hospital [^6].
- In October 2026, a pharmacy recalled glutathione shots that may hold too much endotoxin. Two patients went to the ER after it was put in a vein [^8].
- In a trial of a nasal spray, one person given glutathione got a heart muscle disease [^16].
- A 2025 skin review advised against glutathione drips, because of harms and no clear benefit [^14].

Source: https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables

## What nobody knows yet

- Nobody knows if raising glutathione levels with pills prevents any disease. The pill trial measured levels in the blood, not health [^13].
- Nobody knows if pills or creams lighten skin for good. Reviews call the studies few and of mixed quality [^14] [^15].
- It is not settled whether nasal glutathione helps Parkinson's disease. The trial authors call for larger and longer trials [^16].
- FDA has not yet decided whether to add glutathione to the federal list, years after the 2022 committee vote [^1] [^4].

Source: https://pubmed.ncbi.nlm.nih.gov/24791752/

## What it is

Glutathione is a small molecule the body makes. It is a chain of three amino acids, so it is a very short peptide [^16]. Cells use it to fight oxidative stress, a kind of chemical damage [^13]. Levels fall early in Parkinson's disease, which is one reason researchers test it [^16].

It is sold in several forms. Pills and powders are sold as dietary supplements [^6] [^15]. Pharmacies make it as shots, drips into a vein and nasal sprays [^7] [^18]. Creams are tested for skin lightening [^14]. A result for one form does not carry over to another [^14] [^15].

The body making glutathione does not mean that taking more of it helps. That is a separate question, and the evidence is mixed [^13] [^15].

Source: https://www.fda.gov/media/94155/download

## Where it stands legally

Glutathione is in Category 1: FDA's list of substances pharmacies may use while FDA decides whether to add them to the federal list [^1] [^2]. That is not approval, and FDA is still deciding [^1] [^2]. Checked 26 October 2026.

For Category 1, FDA says it does not plan to act against a pharmacy that meets the policy's conditions [^2]. That is a choice not to act, not approval of glutathione as a drug [^2]. Glutathione is also in Category 1 on FDA's list for outsourcing facilities, which make larger batches [^3]. It is not in Category 2, FDA's list of substances that may present significant safety risks [^1] [^11].

On 8 June 2022, FDA's Pharmacy Compounding Advisory Committee reviewed glutathione for skin lightening and more than 20 other uses [^4] [^5]. FDA proposed leaving it off the federal list. The committee voted 8 to 5, with 1 abstaining, to add it [^4]. The committee gives advice only, and FDA decides by writing a rule [^2] [^12]. FDA's May 2026 list still shows glutathione in Category 1 [^1].

As a supplement, glutathione falls under a different law. FDA calls it a dietary ingredient, and one maker told FDA it sells it in the US only for supplements [^6]. FDA does not approve a dietary supplement before it is sold. The maker is responsible for its safety and label [^9] [^10].

Source: https://www.fda.gov/media/94155/download

## What the evidence shows

The evidence grade is limited-human: there are a few small human trials, and their results are mixed [^13] [^14] [^16] [^17].

By mouth: in a six-month trial in 54 healthy adults, glutathione pills raised glutathione levels in the blood [^13]. Levels fell back a month after people stopped [^13]. The trial did not test whether people got healthier [^13].

Skin lightening: a 2025 review found that pills and creams lightened skin in small trials [^14]. About half the studies had a high risk of bias, and the review said the gains do not last [^14]. A 2019 review of four studies called the evidence inconclusive [^15]. The 2025 review advised against drips for skin lightening [^14].

Parkinson's disease: in a 2017 trial of 45 people, a nasal spray did no better than a salt-water spray over three months [^16]. In a 2009 pilot trial of 21 people, drips into a vein did no better than a dummy drip [^17].

Antioxidant claims: the pill trial saw a drop in one blood marker of oxidative stress [^13]. It did not show that this prevents disease [^13]. A 2013 survey of nasal spray users relied on their own reports, with no comparison group [^18].

Source: https://pubmed.ncbi.nlm.nih.gov/24791752/

## Legitimate ways to get it

FDA's committee papers say glutathione is not part of any FDA-approved drug [^4]. The legal ways to get it are as a dietary supplement, from a pharmacy that compounds it, or in a clinical trial [^1] [^6].

Glutathione pills and powders are sold as dietary supplements [^6] [^15]. FDA does not approve a supplement before it is sold, and the maker is responsible for its safety [^9].

A prescriber can order glutathione made by a pharmacy, because it is in Category 1 [^1] [^2]. That is not FDA approval [^2]. FDA has told pharmacies not to make shots from supplement-grade glutathione [^7].

Trials are testing glutathione in the US, for example as a nasal spray in Parkinson's disease and as a pill before heart surgery [^19] [^20]. The trials block on this page lists open trials with their dates.

Source: https://www.fda.gov/media/94155/download

## How people are getting it anyway

This section describes what happens and is not a recommendation.

Glutathione drips and shots reach people through clinics, drip bars and home delivery [^6] [^22]. Compounding pharmacies make these products [^7] [^8].

The main documented harm is endotoxin, a toxin from bacteria, in products made from supplement-grade glutathione [^6] [^7]. In 2019, FDA reported seven clinic patients who fell ill within minutes of a drip [^6]. In August 2026, FDA reported at least 30 patients harmed, some in the hospital [^7]. FDA knew of two Texas pharmacies that recalled glutathione shots for high endotoxin [^7]. A news report described a recall of drip vials sent to patients' homes [^22].

FDA says supplement-grade ingredients are not fit for shots and may carry endotoxin [^7]. FDA has told compounders not to use them for shots [^6] [^7].

Source: https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables

## Access routes

Source: https://www.fda.gov/media/94155/download

### Dietary supplement

Detail: Sold as a dietary supplement. FDA calls glutathione a dietary ingredient, and one maker told FDA it sells it in the US only for supplements.

Source: https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables

### Lawful compounding

Detail: A pharmacy may compound glutathione because it is in Category 1. FDA does not intend to act against it when the policy conditions are met. That is not FDA approval.

Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act

### Clinical trial

Detail: Trials of glutathione are recruiting in the US, for example a nasal spray in Parkinson's disease. The trials block lists open trials.

Source: https://clinicaltrials.gov/study/NCT05266417

## Unofficial channels

Source: https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables

### Compounding outside the rules

What it is: Glutathione shots and drips that pharmacies make from supplement-grade powder, which is not meant for injection.

Legal position: FDA says compounders must use ingredients fit for injection, and should not use supplement-grade ingredients to make shots. (source: https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables)

Documented risks:

- FDA reported at least 30 patients harmed after drips made from one supplement-grade lot of glutathione. Some went to the hospital. (source: https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables)
- A pharmacy recalled glutathione shots for possible high endotoxin after two patients needed emergency care. (source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/greenwich-rx-issues-voluntary-nationwide-recall-compounded-glutathione-due-elevated-endotoxin-levels)

Enforcement:

- 2026-08-27: FDA compounding alert: compounders should not use supplement-grade glutathione to make injectable drugs, after reports of at least 30 harmed patients. (source: https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables)
- 2026-10-01: Recall notice posted by FDA: a 503A compounding pharmacy recalled glutathione shots for possible high endotoxin. (source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/greenwich-rx-issues-voluntary-nationwide-recall-compounded-glutathione-due-elevated-endotoxin-levels)

Source: https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables

### Clinic or med spa

What it is: Clinics, med spas and drip bars that give glutathione by drip into a vein, often for skin or general wellness.

Legal position: A clinic's glutathione drip is a compounded drug. Category 1 lets a pharmacy use glutathione under FDA's conditions, which is not approval. (source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act)

Documented risks:

- Seven patients at an outpatient clinic fell ill within minutes of glutathione drips. One went to the hospital. (source: https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables)
- A 2025 skin review advised against glutathione drips for skin lightening, because of harms and no clear benefit. (source: https://pubmed.ncbi.nlm.nih.gov/39444151/)

Enforcement:

- 2019-06-07: FDA compounding alert: drips made from a dietary-ingredient glutathione powder carried too much endotoxin and harmed clinic patients. (source: https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables)

Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act

## Recruiting trials

Snapshot date: 2026-10-26.

A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record.

- nct NCT06340633, url https://clinicaltrials.gov/study/NCT06340633, phase Phase 2, title SPI-1005 in Adults Receiving Cochlear Implant, status recruiting, sponsor Sound Pharmaceuticals, Incorporated, countries United States, us states Iowa, Ohio, Pennsylvania, South Carolina, Texas, Wisconsin
- nct NCT07833865, url https://clinicaltrials.gov/study/NCT07833865, phase Not applicable, title The Effect of Light Therapy on Cellular Energy and Oxidative Stress in Healthy Adults and Type 1 Diabetic Patients, status not-yet-recruiting, sponsor University of Thi-Qar, countries Iraq, us states none listed
- nct NCT06260566, url https://clinicaltrials.gov/study/NCT06260566, phase Phase 1, title Tolerability of Enteral NAC in Infants, status not-yet-recruiting, sponsor Sanjiv Harpavat, countries none listed, us states none listed
- nct NCT07543458, url https://clinicaltrials.gov/study/NCT07543458, phase Phase 3, title Therapeutics for Moderate and Severe Dengue, status not-yet-recruiting, sponsor Oxford University Clinical Research Unit, Vietnam, countries Bangladesh, Brazil, Colombia, Indonesia, Malaysia, Nepal, Peru, Philippines, Thailand, Vietnam, us states none listed
- nct NCT07792369, url https://clinicaltrials.gov/study/NCT07792369, phase Phase 1, title 26DT052; Scaling Busulfan Dose to Body Surface Area in Children, status not-yet-recruiting, sponsor Children's Hospital of Philadelphia, countries United States, us states Pennsylvania
- nct NCT07856381, url https://clinicaltrials.gov/study/NCT07856381, phase Not stated, title Understanding Lifespan Trajectories of Social Cognition, Brain Microstructure and Iron Dysregulation in Schizophrenia, status recruiting, sponsor Medical University Innsbruck, countries Austria, us states none listed
- nct NCT07690124, url https://clinicaltrials.gov/study/NCT07690124, phase Not applicable, title S-Acetyl Glutathione and Performance Recovery in Soccer, status not-yet-recruiting, sponsor University of Thessaly, countries Greece, us states none listed
- nct NCT07622316, url https://clinicaltrials.gov/study/NCT07622316, phase Phase 1, title GAIP ASD Research Study, status recruiting, sponsor Greater Atlanta Integrative Pediatrics, countries United States, us states Georgia
- nct NCT07572890, url https://clinicaltrials.gov/study/NCT07572890, phase Phase 1, title Adia Med of Winter Park LLC Chronic Kidney Disease Research Study, status recruiting, sponsor Adia Med of Winter Park LLC, countries United States, us states Florida
- nct NCT07304440, url https://clinicaltrials.gov/study/NCT07304440, phase Phase 1, title Adia Med of Winter Park LLC Autism Spectrum Disorder Research Study, status recruiting, sponsor Adia Med of Winter Park LLC, countries United States, us states Florida, Wisconsin
- nct NCT07050173, url https://clinicaltrials.gov/study/NCT07050173, phase Phase 1, title Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supplementation, status recruiting, sponsor Pravat Mandal, countries United States, us states Pennsylvania
- nct NCT07064005, url https://clinicaltrials.gov/study/NCT07064005, phase Phase 1, title Enrichment of Glutathione Using Gamma-glutamylcysteine Supplementation in Parkinson's Disease Patients., status recruiting, sponsor Pravat Mandal, countries United States, us states Pennsylvania
- nct NCT07448415, url https://clinicaltrials.gov/study/NCT07448415, phase Phase 2/Phase 3, title Evaluation of the Efficacy of Oral Tranexamic Acid and Glutathione-assisted Microneedling in Treatment of Melasma, status not-yet-recruiting, sponsor Assiut University, countries none listed, us states none listed
- nct NCT07379216, url https://clinicaltrials.gov/study/NCT07379216, phase Not applicable, title Efficacy Evaluation Study of Vitamin C and Glutathione Liquid Sachet, status recruiting, sponsor TCI Co., Ltd., countries Taiwan, us states none listed
- nct NCT07634991, url https://clinicaltrials.gov/study/NCT07634991, phase Phase 4, title To Evaluate the Efficacy and Safety of N-acetyl Cysteine Administration in Patients With Diabetic Retinopathy, status recruiting, sponsor Ain Shams University, countries Egypt, us states none listed
- nct NCT07314359, url https://clinicaltrials.gov/study/NCT07314359, phase Not applicable, title Rapid Effects of a Biofield Patch on Antioxidant Status and Cellular Energy, status recruiting, sponsor Natural Immune Systems Inc, countries United States, us states Oregon
- nct NCT07595705, url https://clinicaltrials.gov/study/NCT07595705, phase Phase 2, title Gingival Hyperpigmentation Treatment, status recruiting, sponsor Cairo University, countries Egypt, us states none listed
- nct NCT06922669, url https://clinicaltrials.gov/study/NCT06922669, phase Not applicable, title Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia, status recruiting, sponsor General Hospital of Shenyang Military Region, countries China, us states none listed
- nct NCT06896422, url https://clinicaltrials.gov/study/NCT06896422, phase Phase 1, title Randomized Trial of Glutathione With Anti-PD-1 and Chemotherapy in Advanced NSCLC, status recruiting, sponsor The First Affiliated Hospital of Zhengzhou University, countries China, us states none listed
- nct NCT06213857, url https://clinicaltrials.gov/study/NCT06213857, phase Phase 2, title Beneficial Effect of Silymarin in Ulcerative Colitis, status recruiting, sponsor Tanta University, countries Egypt, us states none listed
- nct NCT06957808, url https://clinicaltrials.gov/study/NCT06957808, phase Not applicable, title Investigating the Effect of Diroximel Fumarate on Glutathione in Schizophrenia, status recruiting, sponsor King's College London, countries United Kingdom, us states none listed
- nct NCT07202156, url https://clinicaltrials.gov/study/NCT07202156, phase Not applicable, title Ultrasound-Enhanced Delivery of Compound TXA Solution in Melasma, status recruiting, sponsor The First Affiliated Hospital with Nanjing Medical University, countries China, us states none listed
- nct NCT06554392, url https://clinicaltrials.gov/study/NCT06554392, phase Not stated, title Identification of Serum Level of Glutathione Peroxidase 4, status not-yet-recruiting, sponsor Assiut University, countries none listed, us states none listed
- nct NCT06620523, url https://clinicaltrials.gov/study/NCT06620523, phase Phase 2, title Prevent Cardiac Surgery Associated AKI Trial, status recruiting, sponsor George Washington University, countries United States, us states District of Columbia
- nct NCT06354712, url https://clinicaltrials.gov/study/NCT06354712, phase Phase 2, title Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients., status recruiting, sponsor Mansoura University, countries Egypt, us states none listed
- nct NCT05241262, url https://clinicaltrials.gov/study/NCT05241262, phase Phase 1, title Study of N-acetylcysteine in the Treatment of Patients With the m.3243A>G Mutation and Low Brain Glutathione Levels, status recruiting, sponsor Michio Hirano, MD, countries United States, us states New York
- nct NCT05654922, url https://clinicaltrials.gov/study/NCT05654922, phase Phase 3, title Study to Evaluate ARINA-1 in the Prevention of Bronchiolitis Obliterans Progression in Participants With Bilateral Lung Transplant, status recruiting, sponsor Renovion, Inc., countries United States, us states Arizona, California, Florida, Illinois, Iowa, Maryland, Minnesota, Missouri, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia
- nct NCT05689645, url https://clinicaltrials.gov/study/NCT05689645, phase Phase 2, title F573 for Injection for the Treatment of Liver Injury/Failure, status recruiting, sponsor Beijing Continent Pharmaceutical Co, Ltd., countries China, us states none listed
- nct NCT05266417, url https://clinicaltrials.gov/study/NCT05266417, phase Phase 2, title Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease, status recruiting, sponsor Gateway Institute for Brain Research, countries United States, us states Florida

Source: https://clinicaltrials.gov/api/v2/studies?query.intr=glutathione&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState

## Sources

Source: https://www.fda.gov/media/94155/download

### 1. FDA: 503A bulk drug substances category list, updated May 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/94155/download

### 2. FDA: bulk drug substances used in compounding under section 503A

Type: regulatory

Tier: primary

Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act

### 3. FDA: 503B bulk drug substances category list, updated March 2025

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/94164/download

### 4. FDA: Pharmacy Compounding Advisory Committee summary minutes, 8 June 2022

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/161293/download

### 5. FDA: Pharmacy Compounding Advisory Committee questions, 8 June 2022

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/159041/download

### 6. FDA compounding alert: dietary ingredient glutathione in sterile injectables, June 2019

Type: regulatory

Tier: primary

Source: https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables

### 7. FDA compounding alert: supplement-grade glutathione not for injectables, August 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables

### 8. FDA-posted recall notice: compounded glutathione shots, possible high endotoxin, October 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/greenwich-rx-issues-voluntary-nationwide-recall-compounded-glutathione-due-elevated-endotoxin-levels

### 9. FDA: dietary supplements

Type: regulatory

Tier: primary

Source: https://www.fda.gov/food/dietary-supplements

### 10. FDA: new dietary ingredient notification process

Type: regulatory

Tier: primary

Source: https://www.fda.gov/food/dietary-supplements/new-dietary-ingredient-ndi-notification-process

### 11. FDA: bulk drug substances that may present significant safety risks

Type: regulatory

Tier: primary

Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

### 12. Buchanan Ingersoll & Rooney: guide to FDA's interim policy on bulk drug substances

Type: legal-analysis

Tier: legal-analysis

Source: https://www.bipc.com/navigating-the-fda-final-interim-policy-on-compounding-with-bulk-drug-substances-a-guide-for-503a-pharmacies-and-503b-outsourcing-facilities

### 13. Randomized trial: oral glutathione and body stores in healthy adults, 2015

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/24791752/

### 14. Systematic review: glutathione for skin lightening and melasma, 2025

Type: systematic-review

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/39444151/

### 15. Systematic review: glutathione and skin color, 2019

Type: systematic-review

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/30895708/

### 16. Phase IIb trial: intranasal glutathione in Parkinson's disease, 2017

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/28436395/

### 17. Pilot randomized trial: intravenous glutathione in Parkinson's disease, 2009

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/19230029/

### 18. Survey: safety of intranasal glutathione as reported by users, 2013

Type: human-trial

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/23240940/

### 19. ClinicalTrials.gov NCT05266417: intranasal insulin and glutathione in Parkinson's disease

Type: reference

Tier: primary

Source: https://clinicaltrials.gov/study/NCT05266417

### 20. ClinicalTrials.gov NCT06620523: oral glutathione to prevent kidney injury after heart surgery

Type: reference

Tier: primary

Source: https://clinicaltrials.gov/study/NCT06620523

### 21. ClinicalTrials.gov NCT06896422: glutathione with immunotherapy and chemotherapy in lung cancer

Type: reference

Tier: primary

Source: https://clinicaltrials.gov/study/NCT06896422

### 22. Newsweek: recall of at-home IV vials for endotoxin risk, 2026

Type: reference

Tier: established-news

Source: https://www.newsweek.com/at-home-iv-recall-warns-of-potentially-fatal-endotoxin-risk-12436818

Last verified: 2026-10-26.

Sources:

- https://clinicaltrials.gov/api/v2/studies?query.intr=glutathione&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState
- https://peptideindex.ai/methodology#evidence-grade
- https://peptideindex.ai/methodology#short-answer
- https://pubmed.ncbi.nlm.nih.gov/24791752/
- https://pubmed.ncbi.nlm.nih.gov/28436395/
- https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables
- https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables
- https://www.fda.gov/media/161293/download
- https://www.fda.gov/media/94155/download

[^1]: FDA: 503A bulk drug substances category list, updated May 2026 https://www.fda.gov/media/94155/download
[^2]: FDA: bulk drug substances used in compounding under section 503A https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
[^3]: FDA: 503B bulk drug substances category list, updated March 2025 https://www.fda.gov/media/94164/download
[^4]: FDA: Pharmacy Compounding Advisory Committee summary minutes, 8 June 2022 https://www.fda.gov/media/161293/download
[^5]: FDA: Pharmacy Compounding Advisory Committee questions, 8 June 2022 https://www.fda.gov/media/159041/download
[^6]: FDA compounding alert: dietary ingredient glutathione in sterile injectables, June 2019 https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables
[^7]: FDA compounding alert: supplement-grade glutathione not for injectables, August 2026 https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables
[^8]: FDA-posted recall notice: compounded glutathione shots, possible high endotoxin, October 2026 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/greenwich-rx-issues-voluntary-nationwide-recall-compounded-glutathione-due-elevated-endotoxin-levels
[^9]: FDA: dietary supplements https://www.fda.gov/food/dietary-supplements
[^10]: FDA: new dietary ingredient notification process https://www.fda.gov/food/dietary-supplements/new-dietary-ingredient-ndi-notification-process
[^11]: FDA: bulk drug substances that may present significant safety risks https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
[^12]: Buchanan Ingersoll & Rooney: guide to FDA's interim policy on bulk drug substances https://www.bipc.com/navigating-the-fda-final-interim-policy-on-compounding-with-bulk-drug-substances-a-guide-for-503a-pharmacies-and-503b-outsourcing-facilities
[^13]: Randomized trial: oral glutathione and body stores in healthy adults, 2015 https://pubmed.ncbi.nlm.nih.gov/24791752/
[^14]: Systematic review: glutathione for skin lightening and melasma, 2025 https://pubmed.ncbi.nlm.nih.gov/39444151/
[^15]: Systematic review: glutathione and skin color, 2019 https://pubmed.ncbi.nlm.nih.gov/30895708/
[^16]: Phase IIb trial: intranasal glutathione in Parkinson's disease, 2017 https://pubmed.ncbi.nlm.nih.gov/28436395/
[^17]: Pilot randomized trial: intravenous glutathione in Parkinson's disease, 2009 https://pubmed.ncbi.nlm.nih.gov/19230029/
[^18]: Survey: safety of intranasal glutathione as reported by users, 2013 https://pubmed.ncbi.nlm.nih.gov/23240940/
[^19]: ClinicalTrials.gov NCT05266417: intranasal insulin and glutathione in Parkinson's disease https://clinicaltrials.gov/study/NCT05266417
[^20]: ClinicalTrials.gov NCT06620523: oral glutathione to prevent kidney injury after heart surgery https://clinicaltrials.gov/study/NCT06620523
[^22]: Newsweek: recall of at-home IV vials for endotoxin risk, 2026 https://www.newsweek.com/at-home-iv-recall-warns-of-potentially-fatal-endotoxin-risk-12436818