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

N-Acetylcysteine for Patients With COPD and Chronic Bronchitis

Not Applicable

Terminated

Conditions: COPD
Chronic Bronchitis

Interventions: Drug: N-Acetylcysteine
Drug: Placebo

First Posted Date: 2012-12-03

Last Posted Date: 2017-09-13

Lead Sponsor: University of Minnesota

Target Recruit Count: 51

Registration Number: NCT01739790

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

Methylprednisolone N Acetylcysteine in Hepatic Resections

Phase 2

Terminated

Conditions: Ischemic Reperfusion Injury
Insufficiency; Hepatic, Postoperative
Liver Tumour

Interventions: Drug: N-acetylcysteine
Drug: Methylprednisolone

First Posted Date: 2012-11-15

Last Posted Date: 2013-11-13

Lead Sponsor: Istituto Clinico Humanitas

Target Recruit Count: 50

Registration Number: NCT01726465

Locations: 🇮🇹
Istituto Clinico Humanitas IRCCS, Rozzano, Milano, Italy

N-acetylcysteine for Renal Protection in Patients With Rheumatic Heart Disease Undergoing Valve Replacement

Phase 2

Completed

Conditions: Cardiac Surgery for Rheumatic Valvular Heart Disease
Renal Dysfunction

Interventions: Drug: placebo
Drug: N-acetylcysteine

First Posted Date: 2012-10-11

Last Posted Date: 2012-10-11

Lead Sponsor: Assiut University

Target Recruit Count: 60

Registration Number: NCT01704482

Locations: 🇪🇬
Assiut University hospital, Assiut, Egypt

Achieving Cannabis Cessation-Evaluating N-Acetylcysteine Treatment

Phase 3

Completed

Conditions: Cannabis Dependence

Interventions: Drug: Placebo
Drug: N-Acetylcysteine

First Posted Date: 2012-08-30

Last Posted Date: 2018-05-24

Lead Sponsor: Medical University of South Carolina

Target Recruit Count: 302

Registration Number: NCT01675661

Locations: 🇺🇸
CODA, Inc., Portland, Oregon, United States
🇺🇸
Behavioral Health Services of Pickens County, Pickens, South Carolina, United States
🇺🇸
UCLA Integrated Substance Abuse Programs, Los Angeles, California, United States

and more 3 locations

Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder

Phase 2

Withdrawn

Conditions: Posttraumatic Stress Disorder

Interventions: Drug: N-acetylcysteine
Drug: Placebo

First Posted Date: 2012-08-14

Last Posted Date: 2018-02-09

Lead Sponsor: Ewha Womans University

Registration Number: NCT01664260

Locations: 🇰🇷
Ewha Womans University Medical Center, Seoul, Korea, Republic of

Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo

Phase 2

Completed

Conditions: Patients at Risk for Melanoma

Interventions: Other: Placebo arm
Drug: N-acetylcysteine

First Posted Date: 2012-06-05

Last Posted Date: 2017-07-31

Lead Sponsor: University of Utah

Target Recruit Count: 100

Registration Number: NCT01612221

Locations: 🇺🇸
Huntsman Cancer Institute, Salt Lake City, Utah, United States

N-Acetylcysteine for Patients With COPD and ChronicBronchitis

Not Applicable

Conditions: Chronic Obstructive Pulmonary Disease
Chronic Bronchitis

Interventions: Drug: N-acetylcysteine
Drug: Oral acetylcysteine

First Posted Date: 2012-05-16

Last Posted Date: 2012-05-16

Lead Sponsor: Center for Veterans Research and Education

Target Recruit Count: 65

Registration Number: NCT01599884

Locations: 🇺🇸
Minneapolis VA Health Care System, Minneapolis, Minnesota, United States

Hypertrophic Regression With N-Acetylcysteine in HCM

Phase 1

Completed

Conditions: Hypertrophic Cardiomyopathy

Interventions: Drug: Placebo
Drug: N-acetylcysteine

First Posted Date: 2012-02-23

Last Posted Date: 2021-11-02

Lead Sponsor: The University of Texas Health Science Center, Houston

Target Recruit Count: 42

Registration Number: NCT01537926

Locations: 🇺🇸
The University of Texas Health Science Center at Houston, Houston, Texas, United States

Effects of N-acetylcysteine on Low T3 Syndrome

Phase 4

Completed

Conditions: Euthyroid Sick Syndrome
Ischemic Heart Disease
Acute Myocardial Infarction

Interventions: Drug: N-acetylcysteine

First Posted Date: 2011-12-29

Last Posted Date: 2015-03-31

Lead Sponsor: Federal University of Rio Grande do Sul

Target Recruit Count: 83

Registration Number: NCT01501110

Locations: 🇧🇷
Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil
🇧🇷
Instituto de Cardiologia, Porto Alegre, Rio Grande do Sul, Brazil

A Clinical Trial for AMN: Validation of Biomarkers of Oxidative Stress, Efficacy and Safety of a Mixture of Antioxidants

Phase 2

Completed

Conditions: Adrenomyeloneuropathy

Interventions: Drug: N-acetylcysteine
Drug: lipoic acid
Drug: vitamin E

First Posted Date: 2011-12-19

Last Posted Date: 2019-03-11

Lead Sponsor: Pujol, Aurora, M.D.

Target Recruit Count: 13

Registration Number: NCT01495260

Locations: 🇪🇸
Hospital Universitari de Bellvitge, L'Hospitalet de LLobregat, Barcelona, Spain

Drug Development Updates

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