At a glance
- Glutathione is an FDA-approved drug, marketed as Bss (first approval: October 28, 1981).
- PubMed lists 2,926 publications mentioning it, including 151 randomized controlled trials and 1,580 animal-only studies.
- ClinicalTrials.gov lists 274 registered studies testing it (44 active).
- FDA's adverse event system (FAERS) holds 2,594 reports mentioning it; 2,050 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA018469 | BSS PLUS | Approved, marketed | October 28, 1981 | ALCON |
| NDA020079 | METHOTREXATE SODIUM | Approved, discontinued | November 27, 1991 | EPIC PHARMA LLC |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Irrigation fluid absorption induces metabolic and oxidative stress dysregulation activating NLRP3 and NF-κB pathways to drive hippocampal inflammatory responses.
- Mycogenic synthesis of copper oxide nanoparticles using response surface methodology and assessment of their biological potential.
- Systemic mitochondrial injection protects against methanol-induced optic neuropathy through restoration of mitochondrial function and attenuation of oxidative stress.
- Placental endothelial ferroptosis induced by neutrophil NETosis leads to intrauterine growth restriction in dengue virus infection.
- Enzymatic/Mitochondrial Import Bottleneck in Sepsis with Possible Extensions to DIC: IV Glutathione and Hinokitiol as Potential Therapeutic Candidates.
- Augmentation strategies for intravenous ketamine in treatment-resistant depression: A systematic review and meta-analysis.
- Therapeutic potential of neural stem cell-derived exosomes and PRP in Parkinson's disease: A novel regenerative approach.
- Fisetin attenuates oxidative and haemolytic damage induced by quinuclidine derivatives in human erythrocytes.
- Mesenchymal stem cell-conditioned medium attenuates early diabetic renal injury associated with suppression of NF-κB, COX-2, and iNOS signaling in STZ-induced diabetic rats.
- Glycyrrhizic acid enhances disposition kinetics and therapeutic efficacy of oxytetracycline against experimental Chlamydia psittaci infection in pigeons.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 274
- Active
- 44
- With posted results
- 33
Conditions studied
| Study | Status | Phase | Start |
|---|---|---|---|
| FEAST and HOPE: Redox PSC Pilot Study | Not yet recruiting | Phase 2 | Jan 2027 |
| SPI-1005 in Adults Receiving Cochlear Implant | Recruiting | Phase 2 | Dec 2026 |
| The Effect of Light Therapy on Cellular Energy and Oxidative Stress in Healthy Adults and Type 1 Diabetic Patients | Not yet recruiting | N/A | October 13, 2026 |
| Therapeutics for Moderate and Severe Dengue | Not yet recruiting | Phase 3 | October 1, 2026 |
| Tolerability of Enteral NAC in Infants | Not yet recruiting | Phase 1 | Oct 2026 |
| Understanding Lifespan Trajectories of Social Cognition, Brain Microstructure and Iron Dysregulation in Schizophrenia | Recruiting | — | September 1, 2026 |
| S-Acetyl Glutathione and Performance Recovery in Soccer | Not yet recruiting | N/A | September 1, 2026 |
| 26DT052; Scaling Busulfan Dose to Body Surface Area in Children | Not yet recruiting | Phase 1 | Sep 2026 |
| GAIP ASD Research Study | Recruiting | Phase 1 | June 1, 2026 |
| Adia Med of Winter Park LLC Chronic Kidney Disease Research Study | Recruiting | Phase 1 | May 18, 2026 |
Show 40 more studies
All 274 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 2,594
- Serious
- 2,050
- With death outcome
- 206
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
- Kidney Tonic I
- Nephroplex
- Glutathione
- Apizelen
- Free Radical
- Free Radical
- Kidney Tonic II
- Glutathione
- Hepataplex
- Visual Detox 6037
- SAMe Liquescence 3036
- Hepatatox
- GLUTATHIONE
- FEELSHION Dark Spot Remover Serum
- Strength M
- Occuloplex I
- BSS PLUS
- BSS PLUS
- ANTI AGE STRESS
- Immune Support
- Telomere - DNA
Source: DailyMed / openFDA
In the news
Latest headlines and official notices that mention this substance, in their original language. Third-party content, not medical advice.
Change history
No changes since monitoring began on October 30, 2026.