PeptideTrace
Research CompoundEndogenous Tripeptide Antioxidant

Glutathione (Peptide-Adjacent)

GSH, L-Glutathione, Reduced Glutathione

E

Evidence Grade E — Very limited evidence. 0 published studies. 256 registered clinical trials.

256 trialsUSEUCA

Overview

Glutathione is the body's primary built-in antioxidant — a tripeptide found in virtually every human cell. While technically a peptide, it functions as a metabolic workhorse rather than a signalling molecule. Oral supplements, liposomal formulations, and intravenous infusions are widely marketed in wellness and skin-lightening contexts. It has no pharmaceutical approval for any therapeutic use.

Research Activity

No published studies found on PubMed.

Regulatory Status

US
FDA-approved(FDA)
EU
Not authorised by EMA(EMA)
CA
Health Canada approved(Health Canada)

Legal Status

USPrescription drug (Rx)
EUNot applicable (not authorised)
CANon-prescription (OTC)

Summary

Glutathione has no pharmaceutical marketing authorisation for any therapeutic indication. A 6-month randomised controlled trial of oral glutathione showed increased blood levels and immune cell function. Smaller studies have investigated skin-lightening effects.

The evidence base for supplemental glutathione is mixed. Oral bioavailability has historically been questioned, though liposomal formulations may improve absorption. Intravenous glutathione is marketed through wellness clinics but has not been evaluated in rigorous clinical trials for any specific indication. Glutathione is a naturally occurring molecule with well-characterised biochemistry — the question is whether supplementation provides clinically meaningful benefit.

Mechanism of Action

Glutathione's biochemistry is well established: it neutralises reactive oxygen species, participates in detoxification reactions, and maintains other antioxidants in their active forms. These are normal cellular functions. The therapeutic question is whether exogenous supplementation meaningfully augments these processes beyond what the body already produces — and whether this translates to clinical benefit.

Research Summary

Research suggests a 6-month randomised trial established that oral glutathione supplements do raise blood levels, resolving an earlier debate about bioavailability. Small trials have shown skin-lightening effects. Safety for oral supplementation appears excellent. However, no large-scale placebo-controlled trials (over 500 participants) exist for any clinical outcome, no data extend beyond 6 months, and most trials are small (20-80 participants) with high individual variability. Intravenous glutathione infusions marketed through wellness clinics have not been evaluated in rigorous trials. Some regulatory agencies have issued advisories against IV glutathione for skin whitening.

Clinical Trials

NCT06931262N/AUnknown

Expanded Access Treatment Protocol With DCA for Patients With PDCD

Saol Therapeutics Inc
NCT06260566Phase INot Yet Recruiting

Tolerability of Enteral NAC in Infants

Sanjiv HarpavatEndpoint: No emesis within 30 minutes of administration of at least 3 of 4 total doses of oral NACCompletion: 2031-10-01
NCT07050173Phase IRecruiting

Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supplementation

Pravat MandalEndpoint: Changes in brain glutathione levels (mM) in people with Repetitive Head Injury (RHI) using Magnetic Resonance Spectroscopy in pre and post supplementation.Completion: 2027-12-27
NCT07064005Phase IRecruiting

Enrichment of Glutathione Using Gamma-glutamylcysteine Supplementation in Parkinson's Disease Patients.

Pravat MandalEndpoint: Changes in brain glutathione levels (mM) in people with Parkinson's Disease using Magnetic Resonance Spectroscopy compared to post-supplementation with GGC.Completion: 2027-11-27
NCT07448415Phase IIINot Yet Recruiting

Evaluation of the Efficacy of Oral Tranexamic Acid and Glutathione-assisted Microneedling in Treatment of Melasma

Assiut UniversityEndpoint: compare reduction of Melasma Area and Severity Index (MASI) score in any treatment modalitiesCompletion: 2027-04-01
View all 256 trials on ClinicalTrials.gov →

Regulatory Timeline

1981
Regulatory

FDA ORIG 1

1982
Regulatory

FDA SUPPL 1

1982
Regulatory

FDA SUPPL 2

1982
Regulatory

FDA SUPPL 3

1982
Regulatory

Health Canada Market Authorisation

1983
Regulatory

FDA SUPPL 4

1985
Regulatory

FDA SUPPL 6

1985
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FDA SUPPL 7

1986
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FDA SUPPL 5

1986
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FDA SUPPL 8

1986
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FDA SUPPL 11

1987
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FDA SUPPL 10

1987
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FDA SUPPL 12

1988
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FDA SUPPL 13

1988
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FDA SUPPL 15

1988
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FDA SUPPL 18

1988
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FDA SUPPL 14

1988
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FDA SUPPL 16

1989
Regulatory

FDA SUPPL 19

1990
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FDA SUPPL 21

1990
Regulatory

FDA SUPPL 24

1991
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FDA SUPPL 26

1992
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FDA SUPPL 25

1993
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FDA SUPPL 17

1993
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FDA SUPPL 27

1993
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FDA SUPPL 23

1994
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FDA SUPPL 29

1994
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FDA SUPPL 28

1997
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FDA SUPPL 30

1997
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FDA SUPPL 31

1997
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FDA SUPPL 33

1998
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FDA SUPPL 34

1998
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FDA SUPPL 32

1999
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FDA SUPPL 35

2003
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FDA SUPPL 36

2003
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FDA SUPPL 37

2004
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FDA SUPPL 38

2004
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FDA SUPPL 39

2004
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FDA SUPPL 40

2004
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FDA SUPPL 41

2013
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FDA SUPPL 52

2015
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FDA SUPPL 53

2015
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FDA SUPPL 54

2015
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FDA SUPPL 55

2016
Regulatory

FDA SUPPL 56

2023
Regulatory

FDA SUPPL 60

The information on this page is provided for educational and research reference purposes only. This is not medical advice. Always consult a qualified healthcare professional before making any health-related decisions.

Related Compounds

Corticotropin

Approved
Repository ACTH Preparation

Corticotropin is marketed as H.P. Acthar Gel (currently ANI Pharmaceuticals). It carries approximately 19 FDA-labelled indications including infantile spasms (its strongest evidence base), nephrotic syndrome, multiple sclerosis relapses, and rheumatic disorders. Acthar Gel has been at the centre of major pricing and legal controversies. The price rose from approximately $40 per vial in 2001 to over $40,000, driven by successive acquisitions and orphan-like positioning despite broad labelling. The former manufacturer Mallinckrodt agreed to a $260 million settlement over antitrust concerns. Clinically, the strongest evidence supports its use in infantile spasms, where it is considered a first-line treatment. For most other indications, debate continues over whether it offers meaningful advantages over far less expensive oral corticosteroids.

Enfuvirtide

Approved
HIV Fusion Inhibitor (Peptide)

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Vancomycin

Approved
Glycopeptide Antibiotic

Vancomycin is marketed as Vancocin and Firvanq (approved 1958, with oral solution Firvanq approved 2018). It is the standard treatment for serious MRSA infections (bloodstream infections, endocarditis, pneumonia, bone infections) and is first-line for severe C. difficile colitis. Vancomycin requires therapeutic drug monitoring — blood levels must be checked regularly to ensure the dose is effective without causing kidney damage or hearing loss. The rise of vancomycin-resistant enterococci (VRE) and occasional vancomycin-intermediate S. aureus (VISA) strains represent ongoing challenges. Despite being nearly 70 years old, vancomycin remains irreplaceable for many serious infections, though newer alternatives like daptomycin and the lipoglycopeptides offer advantages in specific settings.