N-acetylcysteine (NAC), a plant antioxidant naturally found in onion, is a precursor to glutathione. It has been used as a drug since the 1960s and is listed on the World Health Organization (WHO) Model List of Essential Medicines as an antidote in poisonings. There are numerous other uses or proposed uses in medicine that are still in preclinical and clinical investigations. NAC is also used in food supplements and cosmetics. Despite its abundant use, there are projections that the NAC global market will grow in the next five years; therefore, the purpose of this work is to provide a balanced view of further uses of NAC as a dietary supplement. Although NAC is considered a safe substance, the results among clinical trials are sometimes controversial or incomplete, like for many other antioxidants. More clinical trials are underway that will improve our understanding of NAC applicability.
Route | Administration | Strength | No.* | Medical Condition/ Therapy Type |
Indication |
---|---|---|---|---|---|
Solution | |||||
Inhalation | |||||
10% | 20% | 3 |
Status | Count | ||||
Completed | 159 | ||||
Not yet recruiting | 14 | ||||
Active | 54 | ||||
Withdrawn/terminated/suspended | 24 | ||||
Unknown status | 40 | ||||
Grand Total | 291 | ||||
Medical Conditions (Active Studies) | Count | ||||
Addiction | 12 | ||||
Cancer/chemotherapy side effects | 5 | ||||
Cardiovascular diseases | 5 | ||||
Gastrointestinal diseases | 4 | ||||
Genetic disorders | 1 | ||||
Graft/stem cell complications/trauma | 4 | ||||
Infectious diseases | 1 | ||||
Metabolic diseases | 1 | ||||
Neuro/psychiatric disorders | 12 | ||||
Obstetrics | 2 | ||||
Poisoning antidote | 1 | ||||
Pulmonary diseases | 1 | ||||
Surgery complications/trauma | 5 | ||||
Grand Total | 54 | ||||
Medical Conditions (Completed Studies) | Count | ||||
Addiction | 17 | ||||
Blood disorders | 4 | ||||
Cancer/chemotherapy side effects | 2 | ||||
Cardiovascular diseases | 10 | ||||
Dermatologic disorders | 2 | ||||
Gastrointestinal diseases | 15 | ||||
Genetic disorders | 1 | ||||
Infectious diseases | 3 | ||||
Metabolic diseases | 8 | ||||
Muscle disorders | 1 | ||||
Neuro/psychiatric disorders | 24 | ||||
Obstetrics | 11 | ||||
Ophthalmological diseases | 5 | ||||
ORL | 5 | ||||
Other | 4 | ||||
Poisoning antidote | 2 | ||||
Pulmonary diseases | 13 | ||||
Renal disorders | 31 | ||||
Surgery complications/trauma | 1 | ||||
Grand Total | 159 | ||||
Phase/Medical Conditions (Active Studies) | Count | ||||
Early Phase 1 | 5 | ||||
Addiction | 2 | ||||
Metabolic diseases | 1 | ||||
Neuro/psychiatric disorders | 1 | ||||
Pulmonary diseases | 1 | ||||
Not Applicable | 10 | ||||
Cardiovascular diseases | 2 | ||||
Gastrointestinal diseases | 1 | ||||
Graft/stem cell complications/trauma | 1 | ||||
Neuro/psychiatric disorders | 4 | ||||
Obstetrics | 1 | ||||
Surgery complications/trauma | 1 | ||||
Phase 1 | 4 | ||||
Addiction | 1 | ||||
Cancer/chemotherapy side effects | 1 | ||||
Neuro/psychiatric disorders | 1 | ||||
Poisoning antidote | 1 | ||||
Phase 1|Phase 2 | 3 | ||||
Cancer/chemotherapy side effects | 2 | ||||
Gastrointestinal diseases | 1 | ||||
Phase 2 | 13 | ||||
Addiction | 6 | ||||
Cancer/chemotherapy side effects | 1 | ||||
Gastrointestinal diseases | 1 | ||||
Genetic disorders | 1 | ||||
Graft/stem cell complications/trauma | 1 | ||||
Infectious diseases | 1 | ||||
Neuro/psychiatric disorders | 2 | ||||
Phase 2|Phase 3 | 3 | ||||
Addiction | 1 | ||||
Graft/stem cell complications/trauma | 1 | ||||
Obstetrics | 1 | ||||
Phase 3 | 8 | ||||
Cancer/chemotherapy side effects | 1 | ||||
Cardiovascular diseases | 3 | ||||
Neuro/psychiatric disorders | 2 | ||||
Surgery complications/trauma | 2 | ||||
Phase 4 | 8 | ||||
Addiction | 2 | ||||
Gastrointestinal diseases | 1 | ||||
Graft/stem cell complications/trauma | 1 | ||||
Neuro/psychiatric disorders | 2 | ||||
Surgery complications/trauma | 2 | ||||
Grand Total | 54 | ||||
Phase/Medical Conditions (Completed Studies) | Count | ||||
Early Phase 1 | 3 | ||||
Addiction | 1 | ||||
Blood disorders | 1 | ||||
ORL | 1 | ||||
Not Applicable | 18 | ||||
Cardiovascular diseases | 1 | ||||
Gastrointestinal diseases | 3 | ||||
Metabolic diseases | 3 | ||||
Neuro/psychiatric disorders | 2 | ||||
Obstetrics | 2 | ||||
Pulmonary diseases | 2 | ||||
Renal disorders | 5 | ||||
Phase 1 | 22 | ||||
Addiction | 3 | ||||
Cancer/chemotherapy side effects | 1 | ||||
Cardiovascular diseases | 1 | ||||
Gastrointestinal diseases | 2 | ||||
Neuro/psychiatric disorders | 4 | ||||
Ophthalmological diseases | 4 | ||||
ORL | 1 | ||||
Other | 4 | ||||
Pulmonary diseases | 1 | ||||
Renal disorders | 1 | ||||
Phase 1|Phase 2 | 12 | ||||
Addiction | 2 | ||||
Blood disorders | 1 | ||||
Infectious diseases | 1 | ||||
Metabolic diseases | 3 | ||||
Neuro/psychiatric disorders | 2 | ||||
Obstetrics | 2 | ||||
Renal disorders | 1 | ||||
Phase 2 | 47 | ||||
Addiction | 8 | ||||
Blood disorders | 1 | ||||
Cancer/chemotherapy side effects | 1 | ||||
Cardiovascular diseases | 4 | ||||
Dermatologic disorders | 1 | ||||
Gastrointestinal diseases | 2 | ||||
Genetic disorders | 1 | ||||
Infectious diseases | 1 | ||||
Metabolic diseases | 1 | ||||
Muscle disorders | 1 | ||||
Neuro/psychiatric disorders | 14 | ||||
Obstetrics | 1 | ||||
Ophthalmological diseases | 1 | ||||
ORL | 1 | ||||
Pulmonary diseases | 2 | ||||
Renal disorders | 7 | ||||
Phase 2|Phase 3 | 8 | ||||
Gastrointestinal diseases | 1 | ||||
Obstetrics | 1 | ||||
ORL | 1 | ||||
Renal disorders | 5 | ||||
Phase 3 | 20 | ||||
Addiction | 2 | ||||
Blood disorders | 1 | ||||
Cardiovascular diseases | 2 | ||||
Dermatologic disorders | 1 | ||||
Gastrointestinal diseases | 4 | ||||
Infectious diseases | 1 | ||||
Obstetrics | 2 | ||||
Pulmonary diseases | 2 | ||||
Renal disorders | 5 | ||||
Phase 4 | 29 | ||||
Addiction | 1 | ||||
Cardiovascular diseases | 2 | ||||
Gastrointestinal diseases | 3 | ||||
Metabolic diseases | 1 | ||||
Neuro/psychiatric disorders | 2 | ||||
Obstetrics | 3 | ||||
ORL | 1 | ||||
Poisoning antidote | 2 | ||||
Pulmonary diseases | 6 | ||||
Renal disorders | 7 | ||||
Surgery complications/trauma | 1 | ||||
Grand Total | 159 | ||||
Injectable | Intravenous | 200 mg/mL (6 g/30 mL) |
7 | Poisoning/ antidote |
Acetaminophen overdose reduction; Prevention of acute hepatic injury; Hepatic injury from repeated supratherapeutic ingestion. |
Effervescent tablet | Oral |
Status/Medical Condition | Listed | Phase | Termination Reason | ||||
---|---|---|---|---|---|---|---|
SUSPENDED | 4 | ||||||
Autoimmune Disorders | 500 mg 2.5 g |
1 | |||||
Solution | Oral | 10% 20% |
3 | Bronchopulmonary disorders/ Adjuvant therapy |
Abnormal, viscid, inspissated mucous secretions in chronic** and acute*** bronchopulmonary disease; Pulmonary complications of cystic fibrosis; Tracheostomy care; | ||
Systemic Lupus Erythematosus | Pulmonary complications associated with surgery; | 1 | Use during anesthesia; | Post-traumatic chest conditions; Atelectasis due to mucous obstruction and diagnostic bronchial studies****. |
|||
1|2 | Short of funds | ||||||
Cardiovascular Diseases | |||||||
Cardiovascular Disease|Renal Insufficiency, Acute|Cardiopulmonary Bypass | 1 | 4 | Opposite result | ||||
Infectious Diseases | |||||||
Hepatitis C | 1 | N/A | Short of funds | ||||
Metabolic diseases | |||||||
Insulin Resistance|Metabolic Syndrome | 1 | N/A | N/A | ||||
TERMINATED/ | 15 | ||||||
Addiction | |||||||
Acetaminophen Overdose | 1 | 3 | Insufficient enrollment | ||||
Prevention of Hangover Using NAC | 1 | N/A | Insufficient enrollment | ||||
Cancer/Chemotherapy Side Effects | |||||||
Bone Marrow Suppression|Brain and Central Nervous System Tumors|Drug/Agent Toxicity by Tissue/Organ|Long-term Effects Secondary to Cancer Therapy in Children | 1 | 1 | N/A | ||||
Malignant Ovarian Endometrioid Tumor|Malignant Ovarian Serous Tumor|Recurrent Fallopian Tube Carcinoma|Recurrent Ovarian Carcinoma|Recurrent Primary Peritoneal Carcinoma | 1 | 2 | Slow accrual | ||||
Gastrointestinal Diseases | |||||||
Acute Liver Failure|Fulminant Hepatic Failure | 1 | 4 | Insufficient enrollment | ||||
Drug Induced Liver Injury | 1 | N/A | 2 sepsis cases after steroid admin. | ||||
Genetic disorders | |||||||
Cystic Fibrosis | 1 | 4 | Insufficient enrollment | ||||
Infectious Diseases | |||||||
Helicobacter pylori Infection | 1 | 1|2 | Efficacy of eradication: 2 out of 31 | ||||
Metabolic diseases | |||||||
Type 2 Diabetes Mellitus|Hypertension | 1 | 4 | N/A | ||||
Neuro/Psychiatric Disorders | |||||||
Borderline Personality Disorder|Self-Injurious Behavior | 1 | 2 | Poor subject compliance | ||||
Bulimia Nervosa | 1 | 2|3; 3 | No meaningful improvements | ||||
Obsessive-Compulsive Disorder | 1 | 2 | Insufficient enrollment | ||||
Pulmonary Diseases | |||||||
COPD|Chronic Bronchitis | 1 | N/A | PI’s discretion | ||||
Renal Disorders | |||||||
Chronic Kidney Failure | 1 | N/A | N/A | ||||
Surgery Complications/Trauma | |||||||
Ischemic Reperfusion Injury|Insufficiency; Hepatic, Postoperative|Liver Tumour | 1 | 2 | N/A | ||||
WITHDRAWN/ | 4 | ||||||
Cancer/Chemotherapy Side Effects | |||||||
Ovarian Carcinoma, Stage 3 or 4|Epithelial Ovarian Carcinoma|Primary Peritoneal Carcinoma | 1 | 1 | No funding for the cost of NAC | ||||
Gastrointestinal Diseases | |||||||
Liver Failure|Liver Failure, Acute|Drug Induced Liver Injury|Prevention and Control|Fever | 1 | N/A | Short of funds | ||||
Neuro/Psychiatric Disorders | |||||||
Autistic Disorder|Seizures|Irritability | 1 | N/A | No eligible subjects located | ||||
Posttraumatic Stress Disorder | 1 | 2 | Cancelled research project | ||||
Grand Total | 23 |