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N-acetylcysteine
N-acetylcysteine is a Antioxidant, mucolytic agent Small molecule drug developed by University of Turin, Italy. It is currently FDA-approved for Chronic obstructive pulmonary disease (COPD) with mucus hypersecretion, Acetaminophen (paracetamol) overdose, Cystic fibrosis. Also known as: Fluimucil (R) 600 mg, tablets, NAC, N-acetyl-cysteine, Acetylcysteine.
N-acetylcysteine replenishes intracellular glutathione, a major antioxidant, and directly scavenges reactive oxygen species and electrophiles.
N-acetylcysteine is a small molecule that acts as a glutathione precursor. It is used to treat paracetamol (acetaminophen) overdose and to loosen thick mucus in individuals with chronic bronchopulmonary disorders, such as pneumonia and bronchitis.
At a glance
| Generic name | N-acetylcysteine |
|---|---|
| Also known as | Fluimucil (R) 600 mg, tablets, NAC, N-acetyl-cysteine, Acetylcysteine, N-Acetylcysteine 2400 mg/d |
| Sponsor | University of Turin, Italy |
| Drug class | Antioxidant, mucolytic agent |
| Target | Glutathione synthesis pathway; reactive oxygen species |
| Modality | Small molecule |
| Therapeutic area | Respiratory, Toxicology, General Medicine |
| Phase | FDA-approved |
Mechanism of action
N-acetylcysteine is a prodrug that is deacetylated to cysteine, which serves as a precursor for glutathione synthesis. By increasing cellular glutathione levels, it enhances antioxidant defense and detoxification capacity. Additionally, NAC can directly bind to and neutralize toxic compounds and free radicals, making it useful in conditions involving oxidative stress or toxin exposure.
Approved indications
- Chronic obstructive pulmonary disease (COPD) with mucus hypersecretion
- Acetaminophen (paracetamol) overdose
- Cystic fibrosis
- Idiopathic pulmonary fibrosis
- Acute respiratory distress syndrome (ARDS)
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Rash
- Fever
- Bronchospasm
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-acetylcysteine CI brief — competitive landscape report
- N-acetylcysteine updates RSS · CI watch RSS
- University of Turin, Italy portfolio CI
Frequently asked questions about N-acetylcysteine
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Related
- Drug class: All Antioxidant, mucolytic agent drugs
- Target: All drugs targeting Glutathione synthesis pathway; reactive oxygen species
- Manufacturer: University of Turin, Italy — full pipeline
- Therapeutic area: All drugs in Respiratory, Toxicology, General Medicine
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD) with mucus hypersecretion
- Indication: Drugs for Acetaminophen (paracetamol) overdose
- Indication: Drugs for Cystic fibrosis
- Also known as: Fluimucil (R) 600 mg, tablets, NAC, N-acetyl-cysteine, Acetylcysteine, N-Acetylcysteine 2400 mg/d
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing