Drug

Acetylcysteine

Established medicine

ResearchOngoing clinical research

Also known as (2R)-2-acetylamino-3-sulfanylpropanoic acid, (R)-2-acetylamino-3-mercaptopropanoic acid, (R)-mercapturic acid, Acetadote+18 more

(2R)-2-acetylamino-3-sulfanylpropanoic acid, (R)-2-acetylamino-3-mercaptopropanoic acid, (R)-mercapturic acid, Acetadote, Acetilcisteina, Acys-5, Cetylev, L-acetylcysteine, Mercapturic acid, Mucomyst-10, Mucomyst-20, N Acetyl L Cysteine, N acetyl cysteine, N-AC, N-Acetyl Cysteine, N-acetyl-L-(+)-cysteine, N-acetyl-L-cysteine, N-acetylcysteine, NAC, NAC - N-acetyl cysteine, ACETYL CYSTEINE, Acetylcysteinum.

RxNorm197 ChEMBLCHEMBL600 ATCR05CB01 ATCS01XA08 ATCV03AB23UNIIWYQ7N0BPYC

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease: A 2x2 Factorial Randomized Phase II Trial Testing N-Acetyl Cysteine and Dexamethasone

Clinical trial2026-08-26Results expected Q3 2028 · ClinicalTrials.gov

A Pilot Study Investigating the Efficacy of Minocycline and N-Acetyl Cysteine for Bipolar Depression

Clinical trial2026-08-01Suspended · ClinicalTrials.gov

Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

Recall (Class II): ACETYLCYSTEINE

Regulatory2026-07-24FDA

Recall (Class II): ACETYLCYSTEINE

Regulatory2026-07-24FDA

The Role of N-Acetylcysteine Inhalation in Critically Ill Mechanically Ventilated Patients

Clinical trial2026-07-10Results expected Q1 2028 · ClinicalTrials.gov

Evaluation of N-acetylcysteine as an Intracanal and Adjunctive Systemic Medication in Root Canal Treatment of Necrotic Mature Teeth With Apical Periodontitis: a Randomized Controlled Clinical Trial

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

A Prospective, Open-label Phase 0 Single-center Study to Assess the Effect of Acetadote on Metabolism in Newly Diagnosed Glioblastoma

Clinical trial2026-06-23Results expected Q3 2027 · ClinicalTrials.gov

The antioxidant N-acetyl cysteine inhibits cytokine and prostaglandin release in human fetal membranes stimulated ex vivo with lipoteichoic acid or live group B streptococcus.

Research2024-01-01American journal of reproductive immunology (New York, N.Y. : 1989)

Hypertrophy Regression With N-Acetylcysteine in Hypertrophic Cardiomyopathy (HALT-HCM): A Randomized, Placebo-Controlled, Double-Blind Pilot Study.

Research2018-03-14Circulation research

A Double-Blind, Randomized, Controlled Pilot Trial of N-Acetylcysteine in Veterans With Posttraumatic Stress Disorder and Substance Use Disorders.

Research2016-11-01The Journal of clinical psychiatry

The antioxidant N-Acetylcysteine does not improve glucose tolerance or β-cell function in type 2 diabetes.

Research2016-02-05Journal of diabetes and its complications

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Acetylcysteine

Aliases & brands

(2R)-2-acetylamino-3-sulfanylpropanoic acid(R)-2-acetylamino-3-mercaptopropanoic acid(R)-mercapturic acidAcetadoteAcetilcisteinaAcys-5CetylevL-acetylcysteineMercapturic acidMucomyst-10Mucomyst-20N Acetyl L CysteineN acetyl cysteineN-ACN-Acetyl CysteineN-acetyl-L-(+)-cysteineN-acetyl-L-cysteineN-acetylcysteineNACNAC - N-acetyl cysteineACETYL CYSTEINEAcetylcysteinum

RxNorm CUI

197

ChEMBL ID

CHEMBL600

ATC codes

R05CB01S01XA08V03AB23

UNII

WYQ7N0BPYC

Regulatory jurisdictions

fda

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities

FDA

Total events

fdaU.S. Food and Drug Administration· 2 events

2026-07-24RecallSafety

Recall (Class II): ACETYLCYSTEINE

Evidence ↗

2026-07-24RecallSafety

Recall (Class II): ACETYLCYSTEINE

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

196 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

196

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

116

Completed

Discontinued

PHASE DISTRIBUTIONn = 196

Early Phase 113Phase 119Phase 1 / 217Phase 254Phase 2 / 310Phase 322Phase 436Phase N / A25

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

The Role of N-Acetylcysteine Inhalation in Critically Ill Mechanically Ventilated Patients

RecruitingPH IVCairo Universityn=802028

Prevention of Cartilage Cell Death Following a Pilon Fracture With Intra-articular Injection of N-Acetylcysteine (Pilon NAC)

RecruitingPH IVUniversity of Missouri-Columbian=302026

The Use of N-acetylcysteine Supplementation in Addition to Night Splinting for Treatment of Mild to Moderate Carpal Tunnel Syndrome: A Randomized, Double-blind, Placebo-controlled Trial

RecruitingPH IVEmily Kraussn=2402026

A Pilot Study Investigating the Efficacy of Minocycline and N-Acetyl Cysteine for Bipolar Depression

SuspendedPH IVMassachusetts General Hospitaln=402026

Microbiological Characteristics of Biofilm on Double J Ureteral Stents After Lithotripsy: A Randomized Controlled Trial

Not yet recruitingPH IVMenoufia Universityn=1002026

Recent completions

Trials that read out recently, adding to the completed evidence base.

Glutamatergic Mechanisms in Opioid and Cocaine Co-Use

CompletedPH IWilliam Stoopsn=122026

Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial

CompletedPH IIIFernando J Martinezn=2022026

Role of Oxidative Stress and Inflammation in Type 1 Gaucher Disease (GD1): Potential Use of Antioxidant/Anti-inflammatory Medications

CompletedPH IIUniversity of Minnesotan=332025

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

CompletedPH I/IITanta Universityn=462025

Efficacy of Intravenous N-Acetylcysteine in Preventing Linezolid-Induced Thrombocytopenia in Critically Ill Patients: A Double-Blind Randomized Placebo-Controlled Trial

CompletedPH IVHelwan Universityn=2502025

Chlorhexidin Versus N-Asetil Sistein Irrigation in Mandibular Molar Teeth with Chronic Apical Periodontitis on Postoperative Pain and Periapical Tissue Healing: a Randomized Controlled Trial

CompletedN/ACukurova Universityn=782025

Research activity

8 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20122024

Most influential

A randomized controlled pilot trial of oral N-acetylcysteine in children with autism.

Biological psychiatry · 2012 · 187 cites

N-Acetylcysteine boosts brain and blood glutathione in Gaucher and Parkinson diseases.

Clinical neuropharmacology · 2013 · 165 cites

A Double-Blind, Randomized, Controlled Pilot Trial of N-Acetylcysteine in Veterans With Posttraumatic Stress Disorder and Substance Use Disorders.

The Journal of clinical psychiatry · 2016 · 71 cites

Hypertrophy Regression With N-Acetylcysteine in Hypertrophic Cardiomyopathy (HALT-HCM): A Randomized, Placebo-Controlled, Double-Blind Pilot Study.

Circulation research · 2018 · 46 cites

Antenatal pharmacokinetics and placental transfer of N-acetylcysteine in chorioamnionitis for fetal neuroprotection.

The Journal of pediatrics · 2014 · 41 cites

The antioxidant N-Acetylcysteine does not improve glucose tolerance or β-cell function in type 2 diabetes.

Journal of diabetes and its complications · 2016 · 25 cites

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Dinoprostone

Studied across 2 of the same disease areas as Acetylcysteine in the shared literature.

2 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.