Other
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.
This page has not been individually reviewed by a clinician.
Fact sheet · 5 facts
every row cites its source and its date| Fact | Value | Tier | Checked | Source |
|---|---|---|---|---|
| Also called | L-glutathione | primary | fda.gov | |
| Class | other | peer-reviewed | pubmed.ncbi.nlm.nih.gov | |
| Regulatory status | category-1 | primary | fda.gov | |
| Status source read | 2026-10-26 | primary | fda.gov | |
| Evidence grade | limited-human | our assessment | peptideindex.ai |
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.
Our assessment, drawn from the sources below.
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].
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].
- Compounded by a pharmacy, such as shots, drips and nasal sprayscategory-1checked fda.gov
- Sold as an ingredient in dietary supplementsdietary-supplementchecked fda.gov
Advisory committee, : Skin lightening and more than 20 other uses, including lung disease, Parkinson's disease, autism and heavy metal poisoning. Vote 8 yes, 5 no, 1 abstaining. The committee recommended adding glutathione to the 503A bulks list, against FDA's proposal to leave it off. A vote is a recommendation; FDA decides by rulemaking.
What the evidence shows
Evidence grade: limited-human · our assessment
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].
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].
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].
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.
Dietary supplement
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.
Lawful compounding
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.
Clinical trial
Trials of glutathione are recruiting in the US, for example a nasal spray in Parkinson's disease. The trials block lists open trials.
Recruiting trials
A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record.
Snapshot of .clinicaltrials.gov
NCT06340633
SPI-1005 in Adults Receiving Cochlear Implant
Phase: Phase 2 · Sponsor: Sound Pharmaceuticals, Incorporated · Status: Recruiting
Countries: United States
US states: Iowa, Ohio, Pennsylvania, South Carolina, Texas, Wisconsin
NCT07833865
The Effect of Light Therapy on Cellular Energy and Oxidative Stress in Healthy Adults and Type 1 Diabetic Patients
Phase: Not applicable · Sponsor: University of Thi-Qar · Status: Not yet recruiting
Countries: Iraq
US states: none listed
NCT06260566
Tolerability of Enteral NAC in Infants
Phase: Phase 1 · Sponsor: Sanjiv Harpavat · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07543458
Therapeutics for Moderate and Severe Dengue
Phase: Phase 3 · Sponsor: Oxford University Clinical Research Unit, Vietnam · Status: Not yet recruiting
Countries: Bangladesh, Brazil, Colombia, Indonesia, Malaysia, Nepal, Peru, Philippines, Thailand, Vietnam
US states: none listed
NCT07792369
26DT052; Scaling Busulfan Dose to Body Surface Area in Children
Phase: Phase 1 · Sponsor: Children's Hospital of Philadelphia · Status: Not yet recruiting
Countries: United States
US states: Pennsylvania
NCT07856381
Understanding Lifespan Trajectories of Social Cognition, Brain Microstructure and Iron Dysregulation in Schizophrenia
Phase: Not stated · Sponsor: Medical University Innsbruck · Status: Recruiting
Countries: Austria
US states: none listed
NCT07690124
S-Acetyl Glutathione and Performance Recovery in Soccer
Phase: Not applicable · Sponsor: University of Thessaly · Status: Not yet recruiting
Countries: Greece
US states: none listed
NCT07622316
GAIP ASD Research Study
Phase: Phase 1 · Sponsor: Greater Atlanta Integrative Pediatrics · Status: Recruiting
Countries: United States
US states: Georgia
NCT07572890
Adia Med of Winter Park LLC Chronic Kidney Disease Research Study
Phase: Phase 1 · Sponsor: Adia Med of Winter Park LLC · Status: Recruiting
Countries: United States
US states: Florida
NCT07304440
Adia Med of Winter Park LLC Autism Spectrum Disorder Research Study
Phase: Phase 1 · Sponsor: Adia Med of Winter Park LLC · Status: Recruiting
Countries: United States
US states: Florida, Wisconsin
NCT07050173
Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supplementation
Phase: Phase 1 · Sponsor: Pravat Mandal · Status: Recruiting
Countries: United States
US states: Pennsylvania
NCT07064005
Enrichment of Glutathione Using Gamma-glutamylcysteine Supplementation in Parkinson's Disease Patients.
Phase: Phase 1 · Sponsor: Pravat Mandal · Status: Recruiting
Countries: United States
US states: Pennsylvania
NCT07448415
Evaluation of the Efficacy of Oral Tranexamic Acid and Glutathione-assisted Microneedling in Treatment of Melasma
Phase: Phase 2/Phase 3 · Sponsor: Assiut University · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07379216
Efficacy Evaluation Study of Vitamin C and Glutathione Liquid Sachet
Phase: Not applicable · Sponsor: TCI Co., Ltd. · Status: Recruiting
Countries: Taiwan
US states: none listed
NCT07634991
To Evaluate the Efficacy and Safety of N-acetyl Cysteine Administration in Patients With Diabetic Retinopathy
Phase: Phase 4 · Sponsor: Ain Shams University · Status: Recruiting
Countries: Egypt
US states: none listed
NCT07314359
Rapid Effects of a Biofield Patch on Antioxidant Status and Cellular Energy
Phase: Not applicable · Sponsor: Natural Immune Systems Inc · Status: Recruiting
Countries: United States
US states: Oregon
NCT07595705
Gingival Hyperpigmentation Treatment
Phase: Phase 2 · Sponsor: Cairo University · Status: Recruiting
Countries: Egypt
US states: none listed
NCT06922669
Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia
Phase: Not applicable · Sponsor: General Hospital of Shenyang Military Region · Status: Recruiting
Countries: China
US states: none listed
NCT06896422
Randomized Trial of Glutathione With Anti-PD-1 and Chemotherapy in Advanced NSCLC
Phase: Phase 1 · Sponsor: The First Affiliated Hospital of Zhengzhou University · Status: Recruiting
Countries: China
US states: none listed
NCT06213857
Beneficial Effect of Silymarin in Ulcerative Colitis
Phase: Phase 2 · Sponsor: Tanta University · Status: Recruiting
Countries: Egypt
US states: none listed
NCT06957808
Investigating the Effect of Diroximel Fumarate on Glutathione in Schizophrenia
Phase: Not applicable · Sponsor: King's College London · Status: Recruiting
Countries: United Kingdom
US states: none listed
NCT07202156
Ultrasound-Enhanced Delivery of Compound TXA Solution in Melasma
Phase: Not applicable · Sponsor: The First Affiliated Hospital with Nanjing Medical University · Status: Recruiting
Countries: China
US states: none listed
NCT06554392
Identification of Serum Level of Glutathione Peroxidase 4
Phase: Not stated · Sponsor: Assiut University · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT06620523
Prevent Cardiac Surgery Associated AKI Trial
Phase: Phase 2 · Sponsor: George Washington University · Status: Recruiting
Countries: United States
US states: District of Columbia
NCT06354712
Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.
Phase: Phase 2 · Sponsor: Mansoura University · Status: Recruiting
Countries: Egypt
US states: none listed
NCT05241262
Study of N-acetylcysteine in the Treatment of Patients With the m.3243A>G Mutation and Low Brain Glutathione Levels
Phase: Phase 1 · Sponsor: Michio Hirano, MD · Status: Recruiting
Countries: United States
US states: New York
NCT05654922
Study to Evaluate ARINA-1 in the Prevention of Bronchiolitis Obliterans Progression in Participants With Bilateral Lung Transplant
Phase: Phase 3 · Sponsor: Renovion, Inc. · Status: Recruiting
Countries: United States
US states: Arizona, California, Florida, Illinois, Iowa, Maryland, Minnesota, Missouri, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia
NCT05689645
F573 for Injection for the Treatment of Liver Injury/Failure
Phase: Phase 2 · Sponsor: Beijing Continent Pharmaceutical Co, Ltd. · Status: Recruiting
Countries: China
US states: none listed
NCT05266417
Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease
Phase: Phase 2 · Sponsor: Gateway Institute for Brain Research · Status: Recruiting
Countries: United States
US states: Florida
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].
Compounding outside the rules
Glutathione shots and drips that pharmacies make from supplement-grade powder, which is not meant for injection.
The lawFDA says compounders must use ingredients fit for injection, and should not use supplement-grade ingredients to make shots.fda.gov
Documented riskFDA reported at least 30 patients harmed after drips made from one supplement-grade lot of glutathione. Some went to the hospital.fda.gov
Documented riskA pharmacy recalled glutathione shots for possible high endotoxin after two patients needed emergency care.fda.gov
Enforcement FDA compounding alert: compounders should not use supplement-grade glutathione to make injectable drugs, after reports of at least 30 harmed patients.fda.gov
Enforcement Recall notice posted by FDA: a 503A compounding pharmacy recalled glutathione shots for possible high endotoxin.fda.gov
Clinic or med spa
Clinics, med spas and drip bars that give glutathione by drip into a vein, often for skin or general wellness.
The lawA clinic's glutathione drip is a compounded drug. Category 1 lets a pharmacy use glutathione under FDA's conditions, which is not approval.fda.gov
Documented riskSeven patients at an outpatient clinic fell ill within minutes of glutathione drips. One went to the hospital.fda.gov
Documented riskA 2025 skin review advised against glutathione drips for skin lightening, because of harms and no clear benefit.pubmed.ncbi.nlm.nih.gov
Enforcement FDA compounding alert: drips made from a dietary-ingredient glutathione powder carried too much endotoxin and harmed clinic patients.fda.gov
Sources
- [1]FDA: 503A bulk drug substances category list, updated May 2026Regulatory · primary
- [2]FDA: bulk drug substances used in compounding under section 503ARegulatory · primary
- [3]FDA: 503B bulk drug substances category list, updated March 2025Regulatory · primary
- [4]FDA: Pharmacy Compounding Advisory Committee summary minutes, 8 June 2022Regulatory · primary
- [5]FDA: Pharmacy Compounding Advisory Committee questions, 8 June 2022Regulatory · primary
- [6]FDA compounding alert: dietary ingredient glutathione in sterile injectables, June 2019Regulatory · primary
- [7]FDA compounding alert: supplement-grade glutathione not for injectables, August 2026Regulatory · primary
- [8]FDA-posted recall notice: compounded glutathione shots, possible high endotoxin, October 2026Regulatory · primary
- [9]FDA: dietary supplementsRegulatory · primary
- [10]FDA: new dietary ingredient notification processRegulatory · primary
- [11]FDA: bulk drug substances that may present significant safety risksRegulatory · primary
- [12]Buchanan Ingersoll & Rooney: guide to FDA's interim policy on bulk drug substancesLegal analysis · legal-analysis
- [13]Randomized trial: oral glutathione and body stores in healthy adults, 2015Rct · peer-reviewed
- [14]Systematic review: glutathione for skin lightening and melasma, 2025Systematic review · peer-reviewed
- [15]Systematic review: glutathione and skin color, 2019Systematic review · peer-reviewed
- [16]Phase IIb trial: intranasal glutathione in Parkinson's disease, 2017Rct · peer-reviewed
- [17]Pilot randomized trial: intravenous glutathione in Parkinson's disease, 2009Rct · peer-reviewed
- [18]Survey: safety of intranasal glutathione as reported by users, 2013Human trial · peer-reviewed
- [19]ClinicalTrials.gov NCT05266417: intranasal insulin and glutathione in Parkinson's diseaseReference · primary
- [20]ClinicalTrials.gov NCT06620523: oral glutathione to prevent kidney injury after heart surgeryReference · primary
- [21]ClinicalTrials.gov NCT06896422: glutathione with immunotherapy and chemotherapy in lung cancerReference · primary
- [22]Newsweek: recall of at-home IV vials for endotoxin risk, 2026Reference · established-news
Last verified · 5 facts · 9 sources
- clinicaltrials.gov
- peptideindex.ai
- peptideindex.ai
- pubmed.ncbi.nlm.nih.gov
- pubmed.ncbi.nlm.nih.gov
- fda.gov
- fda.gov
- fda.gov
- fda.gov
Primary source: https://www.fda.gov/media/94155/download
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Information, not medical advice.
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