Acetylcysteine

Generic Name: Acetylcysteine

Brand Names: Acetadote

Drug Type: Small Molecule

Chemical Formula: C_₅H_₉NO_₃S

CAS Number: 616-91-1

Unique Ingredient Identifier: WYQ7N0BPYC

Background: Acetylcysteine is an antioxidant and glutathione inducer indicated for mucolytic therapy and the treatment of acetaminophen overdose. Acetylcysteine has also been studied for a wide variety of off-label indications with mixed results.

Acetylcysteine was granted FDA approval on 14 September 1963.

Indication: Acetylcysteine is indicated for mucolytic therapy and in the management of acetaminophen overdose.

Associated Conditions: Acetaminophen Overdose, Chronic Rhinitis, Corneal Diseases, Corneal ulceration, Crusting Rhinitis, Keratopathy, Rhinitis, Sinusitis, Vasomotor Rhinitis, Acute Rhinitis, Subacute Rhinitis

Associated Therapies: Airway secretion clearance therapy

Clinical Trials

Effect of N-Acetylcysteine on Autologous Fat Graft Survival

Phase 4

Withdrawn

Conditions: Adipose Tissue Atrophy
Graft Loss
Deformity of Reconstructed Breast

Interventions: Drug: Acetylcysteine

First Posted Date: 2016-06-02

Last Posted Date: 2024-08-21

Lead Sponsor: Nova Scotia Health Authority

Registration Number: NCT02788292

Evaluation of the Effect of Acetazolamide, Mannitol and N-acetylcysteine on Cisplatin-Induced Nephrotoxicity

Phase 2

Completed

Conditions: Cisplatin Nephrotoxicity

Interventions: Drug: Acetazolamide
Drug: Mannitol
Drug: Acetylcysteine
Drug: saline
Drug: Cisplatin

First Posted Date: 2016-05-04

Last Posted Date: 2017-01-24

Lead Sponsor: Ain Shams University

Target Recruit Count: 52

Registration Number: NCT02760901

A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia

Phase 4

Completed

Conditions: Kidney Diseases
Contrast Media Reaction

Interventions: Drug: Sodium bicarbonate
Drug: N-acetylcysteine

First Posted Date: 2016-05-04

Last Posted Date: 2016-05-04

Lead Sponsor: Clinical Hospital Centre Zagreb

Target Recruit Count: 90

Registration Number: NCT02761577

Amiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thoracic Surgery

Phase 3

Active, not recruiting

Conditions: Thoracic Surgery
Atrial Fibrillation in High Risk Patients

Interventions: Drug: Amiodarone
Drug: Placebo
Drug: N-Acetylcysteine

First Posted Date: 2016-04-25

Last Posted Date: 2024-05-16

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 184

Registration Number: NCT02750319

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge (Consent only), Basking Ridge, New Jersey, United States
🇺🇸
University of Washington School of Medicine in St. Louis, Saint Louis, Missouri, United States
🇺🇸
Memorial Sloan Kettering Bergen (Consent only), Montvale, New Jersey, United States

and more 6 locations

Relative Bioavailability of AR10 Compared to Reference Product

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: AR10
Drug: acetylcysteine

First Posted Date: 2016-03-30

Last Posted Date: 2016-03-30

Lead Sponsor: Arbor Pharmaceuticals, Inc.

Target Recruit Count: 30

Registration Number: NCT02723669

High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure

Not Applicable

Completed

Conditions: Acute Liver Failure

Interventions: Biological: Plasma Exchange
Other: Transfer to Intensive Care Unit
Drug: Prophylactic Antibiotics
Other: Intubation of trachea
Other: Administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure
Other: Volume Replacement
Other: Pressor Support
Drug: N-acetyl-L-cysteine
Other: Correction of metabolic parameters
Dietary Supplement: Correction of nutrition

First Posted Date: 2016-03-24

Last Posted Date: 2019-11-20

Lead Sponsor: Institute of Liver and Biliary Sciences, India

Target Recruit Count: 40

Registration Number: NCT02718079

Locations: 🇮🇳
Institute of liver and Biliary Sciences, New Delhi, Delhi, India

A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF)

Phase 2

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Matching Placebo
Drug: N-acetylcysteine
Drug: Pirfenidone

First Posted Date: 2016-03-14

Last Posted Date: 2016-05-20

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 123

Registration Number: NCT02707640

Efficacy of N-acetylcysteine With or Without Steroids in Drug Induced Liver Injury

Not Applicable

Terminated

Conditions: Drug Induced Liver Injury

Interventions: Drug: Prednisolone
Drug: N-Acetylcysteine

First Posted Date: 2016-02-19

Last Posted Date: 2017-12-18

Lead Sponsor: Institute of Liver and Biliary Sciences, India

Target Recruit Count: 4

Registration Number: NCT02686385

Locations: 🇮🇳
Institute of liver and Biliary Sciences, New Delhi, Delhi, India

Role of Oxidative Stress and Inflammation in Type 1 Gaucher Disease (GD1)

Phase 2

Recruiting

Conditions: Gaucher Disease Type 1

Interventions: Drug: N-acetylcysteine

First Posted Date: 2015-10-22

Last Posted Date: 2024-11-18

Lead Sponsor: University of Minnesota

Target Recruit Count: 50

Registration Number: NCT02583672

Locations: 🇺🇸
New York University, New York, New York, United States
🇺🇸
University of Minnesota, Minneapolis, Minnesota, United States

Effects of N-acetylcysteine on Cardiorespiratory Control in COPD Patients With Mild-to-moderate Airflow Obstruction

Phase 4

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Placebo
Drug: N-acetylcysteine

First Posted Date: 2015-10-20

Last Posted Date: 2018-06-14

Lead Sponsor: Queen's University

Target Recruit Count: 13

Registration Number: NCT02579772

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