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N-Acetyl Cysteine (NAC)
N-Acetyl Cysteine (NAC) replenishes intracellular glutathione, a major antioxidant, and provides a free thiol group that directly scavenges reactive oxygen species and electrophiles.
N-Acetyl Cysteine (NAC) replenishes intracellular glutathione, a major antioxidant, and provides a free thiol group that directly scavenges reactive oxygen species and electrophiles. Used for Acetaminophen (paracetamol) overdose and toxicity, Chronic obstructive pulmonary disease (COPD) with mucolytic benefit, Cystic fibrosis.
At a glance
| Generic name | N-Acetyl Cysteine (NAC) |
|---|---|
| Also known as | NAC |
| Sponsor | The Aurum Institute NPC |
| Drug class | Antioxidant / Mucolytic agent |
| Target | Glutathione synthesis pathway; reactive oxygen species (non-specific) |
| Modality | Small molecule |
| Therapeutic area | Respiratory, Toxicology, Nephrology, Hepatology |
| Phase | FDA-approved |
Mechanism of action
NAC is a prodrug that is rapidly deacetylated to cysteine, which serves as a precursor for glutathione synthesis. By increasing glutathione levels, NAC enhances cellular antioxidant defenses and detoxification capacity. Additionally, the free thiol group of NAC itself can directly bind to and neutralize harmful reactive oxygen species and toxic compounds, making it useful in both prevention and treatment of oxidative stress-related conditions.
Approved indications
- Acetaminophen (paracetamol) overdose and toxicity
- Chronic obstructive pulmonary disease (COPD) with mucolytic benefit
- Cystic fibrosis
- Idiopathic pulmonary fibrosis
- Contrast-induced nephropathy prevention
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Abdominal discomfort
- Rash
- Fever
Key clinical trials
- Effects of NAC on Symptoms of CHR Patients (NA)
- Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections: N-Acetylcysteine (PHASE4)
- Glutathione in Mild Cognitive Impairment (EARLY_PHASE1)
- A Study to Explore if Long-term Use of Mucinex Can Help With Symptoms in Patients With Stable Chronic Bronchitis. (PHASE4)
- Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial (PHASE3)
- N-Acetylcysteine for Smoking Cessation in Tobacco and Cannabis Co-Use (PHASE4)
- A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation in Youth (PHASE4)
- Comparative Clinical Study to Evaluate the Possible Efficacy and Safety of Oral N-Acetyl Cysteine Versus Rectal Diclofenac in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- N-Acetyl Cysteine (NAC) CI brief — competitive landscape report
- N-Acetyl Cysteine (NAC) updates RSS · CI watch RSS
- The Aurum Institute NPC portfolio CI