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 Acetylcysteine With Topotecan Hydrochloride on the Tumor Microenvironment in Patients With Persistent or Recurrent High Grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Phase 2

Terminated

Conditions: Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Malignant Ovarian Endometrioid Tumor
Malignant Ovarian Serous Tumor
Recurrent Fallopian Tube Carcinoma

Interventions: Drug: Topotecan Hydrochloride
Drug: Acetylcysteine

First Posted Date: 2015-10-07

Last Posted Date: 2018-01-03

Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Target Recruit Count: 1

Registration Number: NCT02569957

Locations: 🇺🇸
Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Treatment of Cognitive and Negative Symptoms in Schizophrenia With N-acetylcysteine

Phase 4

Completed

Conditions: Schizophrenia
Cognitive Deficits
Schizophrenia; Negative Type

Interventions: Drug: N-acetylcysteine
Other: Treatment as Usual

First Posted Date: 2015-07-22

Last Posted Date: 2023-05-15

Lead Sponsor: University of California, Los Angeles

Target Recruit Count: 51

Registration Number: NCT02505477

Locations: 🇺🇸
UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California, United States

N-acetylcysteine in the Treatment of PTSD and Addiction

Phase 2

Completed

Conditions: PTSD
Addiction

Interventions: Drug: N-acetylcysteine
Drug: Placebo

First Posted Date: 2015-07-15

Last Posted Date: 2018-08-29

Lead Sponsor: Medical University of South Carolina

Target Recruit Count: 35

Registration Number: NCT02499029

NAC, NaHCO3 and NS Prophylaxis for CTPA in the ED on Suspicion of PE: A Randomized Controlled Trial

Phase 4

Completed

Conditions: Radiographic Contrast Agent Nephropathy
Pulmonary Embolism

Interventions: Drug: NAC
Drug: Normal Saline
Drug: NaHCO3

First Posted Date: 2015-06-26

Last Posted Date: 2015-06-26

Lead Sponsor: Karadeniz Technical University

Target Recruit Count: 231

Registration Number: NCT02483143

Locations: 🇹🇷
Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey

Study to Evaluate the Efficacy of N-acetylcysteine (NAC) in the Treatment of the Common Cold and Cough

Phase 2

Completed

Conditions: Common Cold Associated With Cough

Interventions: Drug: N-acetylcysteine
Drug: Placebo

First Posted Date: 2015-03-05

Last Posted Date: 2016-07-11

Lead Sponsor: Novartis

Target Recruit Count: 70

Registration Number: NCT02379637

Antioxidant Therapy in RYR1-Related Congenital Myopathy

Phase 1

Completed

Conditions: Neuromuscular Disease

Interventions: Drug: Placebo
Drug: N-acetylcysteine

First Posted Date: 2015-02-13

Last Posted Date: 2019-12-24

Lead Sponsor: National Institute of Nursing Research (NINR)

Target Recruit Count: 63

Registration Number: NCT02362425

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Simethicone and N-acetylcysteine in Upper Endoscopy - Prospective Double-blinded Randomized Controlled Trial

Phase 4

Completed

Conditions: Gastric Mucosal Lesion

Interventions: Drug: Simethicone
Other: Placebo
Drug: Acetylcysteine

First Posted Date: 2015-02-06

Last Posted Date: 2016-01-08

Lead Sponsor: Portuguese Oncology Institute, Coimbra

Target Recruit Count: 300

Registration Number: NCT02357303

Locations: 🇵🇹
Portuguese Oncology Institute - Coimbra, Coimbra, Portugal

N-acetylcysteine Effects on Tetrahydrocannabinol

Early Phase 1

Terminated

Conditions: Healthy

Interventions: Drug: Delta-9-THC
Drug: Placebo
Drug: N-acetylcysteine

First Posted Date: 2015-01-09

Last Posted Date: 2022-01-31

Lead Sponsor: Yale University

Target Recruit Count: 5

Registration Number: NCT02335060

Locations: 🇺🇸
VA Connecticut Healthcare System, West Haven, Connecticut, United States

NACOS - The Effect of N-acetylcystein for Depressive Symptoms in Patients Suffering From Bipolar Depression

Phase 2

Completed

Conditions: Bipolar Disorder

Interventions: Drug: Placebo
Drug: N-acetylcysteine

First Posted Date: 2014-11-19

Last Posted Date: 2016-11-28

Lead Sponsor: Region Syddanmark

Target Recruit Count: 80

Registration Number: NCT02294591

Locations: 🇩🇰
Mental Health Services Esbjerg, Esbjerg, Denmark

Bioequivalence Study of Two Different Formulations of N-acetyl-cysteine (NAC)

Phase 1

Completed

Conditions: no Condition

Interventions: Drug: N-acetylcysteine

First Posted Date: 2014-10-15

Last Posted Date: 2021-11-05

Lead Sponsor: Zambon SpA

Target Recruit Count: 48

Registration Number: NCT02265224

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