Cysteine Hydrochloride

(N-acetylcysteine)

ApprovedSmall molecule

Novartis

Cysteine Hydrochloride is one of 642 small molecule programs targeting Neurotoxicity. It is currently in Approved.

Indications

204

Total Trials

Active Trials

641

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

NeurotoxicityActive, not recruiting

Kidney TransplantActive, not recruiting

BronchitisActive, not recruiting

Visceral LeishmaniasisActive, not recruiting

Chronic BronchitisActive, not recruiting

Oral MucositisActive, not recruiting

Alcohol DrinkingActive, not recruiting

PancreatitisActive, not recruiting

ProteinuriaActive, not recruiting

Hepatocellular CarcinomaActive, not recruiting

NeurotoxicityPreclinical

Active, not recruiting

Kidney TransplantPreclinical

Active, not recruiting

BronchitisPreclinical

Active, not recruiting

Visceral LeishmaniasisPreclinical

Active, not recruiting

Chronic BronchitisPreclinical

Active, not recruiting

Oral MucositisPreclinical

Active, not recruiting

Alcohol DrinkingPreclinical

Active, not recruiting

PancreatitisApproved

Active, not recruiting

ProteinuriaPreclinical

Active, not recruiting

Hepatocellular CarcinomaPreclinical

Active, not recruiting

Showing 10 of 32 indications

Competition

Competitive Landscape

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

Cysteine Hydrochloride

Novartis

Approved

1 2

Cabenuva

GSK

Preclinical

1 3

Norvir

AbbVie

Preclinical

1 4

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 5

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 6

Nuvigil

NNuvo Research GmbH

Preclinical

1 7

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—8

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—9

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Systemic Therapy

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Lymphoma

NCT05081479

Phase 1/2Recruiting

Myeloproliferative Neoplasms

NCT05123365

N/ARecruiting

Efficacy

NCT06377410

N/ARecruiting

Hepatitis

NCT05294744

Phase 1Recruiting

Opioids

NCT05610072

Q3 2027

Post-ApprovalNot yet recruiting

Psychosis

NCT06546475

Clinical

Trials by Indication[1]

Nephropathy7 trials

N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patients

Completed·—·Phase 2·NCT00780962·399 enrolled

Prevention of Contrast Nephropathy by Sodium Bicarbonate Versus Sodium Chloride and N-acetylcysteine

Completed·SShaare Zedek Medical Center·N/A·NCT00353340·250 enrolled

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

Completed·—·Phase 4·NCT02761577·90 enrolled

Show 4 more trials

Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy

Unknown status·TThe University of The West Indies·N/A·NCT01891292·30 enrolled

Theophylline, N-acetylcysteine, and Theophylline Plus N-acetylcysteine in Preventing Contrast-induced Nephropathy

Unknown status·IIsfahan University of Medical Sciences·Phase 2/3·NCT02088502·96 enrolled

Possible Ameliorating Effect of N- Acetylcysteine (NAC) on Type-II Diabetes Induced Nephropathy

Unknown status·—·Phase 2/3·NCT04531163·60 enrolled

Safety Study Of N-Acetylcysteine For Prevention Of Contrast Induced Nephropathy In Patients w/Stage 3 Renal Failure

Terminated·OOregon Health and Science University·Phase 1·NCT00575419·6 enrolled

Oxidative Stress7 trials

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

Completed·UUniversity of Utah·Phase 2·NCT01612221·100 enrolled

Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation

Completed·—·N/A·NCT00463671·50 enrolled

THE USE OF N-ACETYLCYSTEINE ATTENUATING CISPLATIN-INDUCED TOXICITIES BY OXIDATIVE STRESS

Unknown status·UUniversity of Campinas, Brazil·Phase 4·NCT02241876·60 enrolled

Show 4 more trials

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

Completed·UUniversity of Minnesota·Phase 2·NCT02583672·33 enrolled

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

Completed·—·Phase 2·NCT01495260·13 enrolled

Pilot Study of Losartan and N-acetylcysteine as Inhibitors of Muscle Oxidative Stress in Elderly

Completed·TThe University of Texas Medical Branch, Galveston·Phase 1/2·NCT01384591·6 enrolled

Effect of N-acetylcysteine on Oxidative Stress in COVID-19 Patients

Completed·—·Phase 3·NCT04792021·60 enrolled

Chronic Kidney Disease6 trials

Effect of N-acetylcysteine on Renal Functioning of Chronic Kidney Diseases(CKD) Patients After General Anesthesia

Unknown status·—·Phase 1·NCT01251029

Effect of N-acetylcysteine (NAC) on Hydrogen Sulfide (H2S) in Chronic Kidney Disease (CKD)

Completed·AA.C. Abrahams·Phase 3·NCT01232257·28 enrolled

The Effect of Administration on N-Acetylcysteine on Serum Creatinine Levels in Patients With Chronic Kidney Disease

Completed·UUniversity of Vermont·N/A·NCT00498342

Show 3 more trials

Effect of N-Acetylcysteine (NAC) on Creatinine in Chronic Kidney Disease

Completed·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 3·NCT00506506·60 enrolled

Efficacy of N-Acetylcysteine in Prevention of Post-Catheterization Contrast-Induced Nephropathy in Diabetic Patients With Chronic Kidney Disease

Completed·TTehran University of Medical Sciences·Phase 3·NCT00808795·90 enrolled

Effect of Hydration With Sodium Bicarbonate for Long-Term Clinical Outcomes in Patients With Chronic Kidney Disease Undergoing an Emergent Coronary Procedure

Unknown status·OOsaka General Medical Center·Phase 4·NCT00716001

Schizophrenia5 trials

N-Acetyl-Cysteine (NAC) in Early Phase Schizophrenia Spectrum Psychosis

Completed·—·Phase 2·NCT01354132·20 enrolled

N-acetylcysteine (NAC) for Improving Cognitive Dysfunction in Schizophrenia

Completed·VVA Greater Los Angeles Healthcare System·Phase 1·NCT01885338·26 enrolled

The Effects of Kynurenine Aminotransferase Inhibition in People With Schizophrenia

Completed·UUniversity of Maryland, Baltimore·Phase 1/2·NCT04013555·88 enrolled

Show 2 more trials

Sodium Benzoate and/or N-Acetylcysteine Added to TAU in Patients With Early Schizophrenia Spectrum Disorder.

Completed·PPakistan Institute of Living and Learning·Phase 2·NCT03510741·64 enrolled

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

Completed·UUniversity of California, Los Angeles·Phase 4·NCT02505477·51 enrolled

COVID-195 trials

Clinical Trial With N-acetylcysteine and Bromhexine for COVID-19

Unknown status·UUniversidade Federal do Ceara·Phase 3·NCT04928495·219 enrolled

NAC for Attenuation of COVID-19 Symptomatology

Unknown status·CCambridge Health Alliance·Phase 2·NCT05074121·200 enrolled

Exploratory Efficacy of N-Acetylcysteine in Patients With History of COVID-19

Unknown status·FFondazione Policlinico Universitario Agostino Gemelli IRCCS·Phase 2·NCT05736887·80 enrolled

Show 2 more trials

A Study of N-acetylcysteine in Patients With COVID-19 Infection

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04374461·48 enrolled

Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease

Completed·CCambridge Health Alliance·Phase 2·NCT04419025·165 enrolled

128 more indications

Treatment5 trials

NAC for Treatment-Resistant OCD and Other Related Disorders

Active, not recruiting·GGuangdong Provincial People's Hospital·Phase 4·NCT06956157·90 enrolled

Study of N-acetylcysteine in the Treatment of Patients With the m.3243A>G Mutation and Low Brain Glutathione Levels

Recruiting·MMichio Hirano, MD·Phase 1·NCT05241262·18 enrolled

N-acetylcysteine in the Treatment of PTSD and Addiction

Completed·MMedical University of South Carolina·Phase 2·NCT02499029·35 enrolled

Show 2 more trials

COPD on Primary Care Treatment (COOPT)

Completed·RRadboud University Medical Center·Phase 4·NCT00184977·270 enrolled

Achieving Cannabis Cessation-Evaluating N-Acetylcysteine Treatment

Completed·MMedical University of South Carolina·Phase 3·NCT01675661·302 enrolled

Effectiveness4 trials

Evaluating the Effectiveness of Prednisone, Azathioprine, and N-acetylcysteine in Patients With IPF

Completed·—·Phase 3·NCT00650091·264 enrolled

Effectiveness of N-Acetylcysteine (NAC) in Motivational Enhancement Therapy for Nicotine Addiction

Completed·IIndonesia University·Phase 4·NCT05903014·90 enrolled

Effectiveness of N-Acetylcysteine (NAC) in Treating Cocaine Dependent Individuals - 1

Completed·MMedical University of South Carolina·Phase 2·NCT00218491·111 enrolled

Show 1 more trial

Effectiveness of N-acetylcysteine in Treating Cocaine Dependent Individuals - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00136825·17 enrolled

Parkinson's Disease4 trials

Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's Disease

Completed·UUniversity of Minnesota·Phase 2·NCT02212678·8 enrolled

Does N-Acetylcysteine Decrease Spontaneous Oxidation of Central Neural Dopamine in Parkinson's Disease?

Terminated·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 1·NCT03104725·6 enrolled

N-Acetylcysteine for Neuroprotection in Parkinson's Disease

Completed·WWeill Medical College of Cornell University·Phase 1/2·NCT01470027·50 enrolled

Show 1 more trial

Intravenous N-acetylcysteine for the Treatment of Gaucher's Disease and Parkinson's Disease

Completed·UUniversity of Minnesota·Phase 1·NCT01427517·9 enrolled

Hepatitis3 trials

G-CSF Plus NAC In Severe Alcoholic Hepatitis

Unknown status·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 4·NCT02971306·60 enrolled

N-Acetylcysteine in Severe Acute Alcoholic Hepatitis

Completed·EErasme University Hospital·Phase 3·NCT00962442·44 enrolled

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

Recruiting·—·N/A·NCT05294744·390 enrolled

Acute Liver Failure3 trials

Randomized Study of Acetylcysteine in Patients With Acute Liver Failure Not Caused by Acetaminophen

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 3·NCT00004467·173 enrolled

Study of N-Acetylcysteine in Acute Liver Failure (ALF)

Terminated·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT00896025·255 enrolled

N-acetylcysteine in Non-Acetaminophen Pediatric Acute Liver Failure

Completed·UUniversity of Pittsburgh·Phase 3·NCT00248625·184 enrolled

Obsessive-Compulsive Disorder3 trials

Efficacy Study of add-on Therapy With N-Acetylcysteine in Resistant Obsessive-compulsive Disorder

Completed·UUniversity of Sao Paulo·Phase 2·NCT01555970·40 enrolled

N-acetylcysteine (NAC) for Pediatric Obsessive-Compulsive Disorder

Completed·YYale University·Phase 2·NCT01172275·11 enrolled

N-Acetylcysteine Augmentation in Treatment-Refractory Obsessive-Compulsive Disorder

Terminated·YYale University·Phase 2·NCT00539513·10 enrolled

Toxicity3 trials

N-acetylcysteine Protects From Aminoglycosides Induced Nephrotoxicity

Completed·SSoroka University Medical Center·Phase 2/3·NCT00267384

Role of N-Acetylcysteine for Prevention of Cisplatin-induced Nephrotoxicity

Unknown status·FFoundation University Islamabad·N/A·NCT06019520·70 enrolled

Drug Nephrotoxicity Amelioration by N-acetylcysteine

Completed·HHelwan University·N/A·NCT06122311·100 enrolled

NAC3 trials

Use of N-Acetylcysteine (NAC) in Fingernail Biting

Completed·—·Phase 3·NCT01993849·23 enrolled

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

Completed·ZZambon SpA·Phase 1·NCT02265224·48 enrolled

A Study of NAC for AUD

Withdrawn·UUniformed Services University of the Health Sciences·Phase 2·NCT04964843

Liver Transplant3 trials

Effectiveness of N-acetylcysteine on Preservation Solution During Liver Transplantation

Completed·IInstituto de Investigacion Sanitaria La Fe·Phase 3·NCT01866644·214 enrolled

Acute Renal Failure Post Liver Transplantation

Completed·—·N/A·NCT01907061·30 enrolled

N-acetylcysteine in Liver Transplantation

Completed·IIbtesam Hilmi·N/A·NCT00736541·100 enrolled

Ototoxicity3 trials

Prevention of Drug Induced Ototoxicity in Peritoneal Dialysis Patients by N-Acetylcysteine

Completed·TTC Erciyes University·Phase 2·NCT01131468·60 enrolled

Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer

Completed·—·N/A·NCT03400709·45 enrolled

Protective Effect of N-acetylcysteine Against From Ototoxicity

Completed·TTC Erciyes University·Phase 2/3·NCT01271088·60 enrolled

Injury3 trials

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

Terminated·IInstitute of Liver and Biliary Sciences, India·N/A·NCT02686385·4 enrolled

N-Acetylcysteine for Preventing Renal Injury After Cardiac Surgery

Completed·UUniversity Health Network, Toronto·Phase 3·NCT00188630·176 enrolled

Modulation of Lung Injury Complicating Lung Resection

Completed·IImperial College London·Phase 2·NCT00655928·52 enrolled

Adolescent2 trials

An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents

Completed·MMedical University of South Carolina·Phase 1/2·NCT00542750·24 enrolled

A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana

Completed·MMedical University of South Carolina·Phase 2·NCT01005810·116 enrolled

Psychosis2 trials

"Multimodal Prevention of Psychosis - Investigating Efficacy of N-Acetylcysteine and Psychotherapy in CHR-Patients"

Terminated·UUniversity Hospital, Bonn·Phase 3·NCT03149107·48 enrolled

A Pilot Trial of Tapering Antipsychotics for Patients in Remitted Psychosis Co-administering With N-Acetylcysteine

Not yet recruiting·NNational Taiwan University Hospital·Phase 4·NCT06546475·20 enrolled

Major Depressive Disorder2 trials

A New Treatment Approach for Major Depressive Disorder Based Upon Targeting Monoamine Oxidase A (MAO-A)

Completed·CCentre for Addiction and Mental Health·Phase 1·NCT02269540·10 enrolled

N-Acetyl Cysteine Supplementation in Therapy Refractory Major Depressive Disorders

Unknown status·TTianjin Anding Hospital·N/A·NCT02972398·200 enrolled

Bulimia Nervosa2 trials

N-acetylcysteine in Bulimia Nervosa

Terminated·LLindner Center of HOPE·Phase 2/3·NCT01131572·11 enrolled

N-acetylcysteine in the Treatment of Bulimia Nervosa

Terminated·LLindner Center of HOPE·Phase 3·NCT01033149·11 enrolled

Renal Failure2 trials

N-acetylcysteine to Prevent Renal Failure

Unknown status·IInstituto do Coracao·N/A·NCT01359722·50 enrolled

Acetylcysteine in the Prevention of Renal Failure After Bypass Surgery

Completed·MMinneapolis Veterans Affairs Medical Center·Phase 1/2·NCT00211653·102 enrolled

Homocystinuria2 trials

Homocystinuria: Treatment With N-Acetylcysteine

Completed·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 2·NCT00483314·5 enrolled

Effect of Acetaminophen and N-Acetylcysteine on Liver Metabolism on Homocystinuria

Suspended·HHospital de Clinicas de Porto Alegre·Phase 1/2·NCT04015557·10 enrolled

Autism2 trials

Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Single-dose

Recruiting·SStanford University·Phase 2·NCT04278898·24 enrolled

Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Open Label

Enrolling by invitation·SStanford University·Phase 2/3·NCT05494398·144 enrolled

Autism Spectrum Disorder2 trials

A Feasibility Study of N-acetylcysteine for Self-injurious Behavior in Children With Autism Spectrum Disorder

Completed·EEmory University·Phase 2·NCT03008889·8 enrolled

A Study of Oral N-Acetylcysteine in Children With Autism Spectrum Disorders

Completed·IIndiana University School of Medicine·Phase 2·NCT00453180·31 enrolled

Sickle Cell Disease2 trials

N-Acetylcysteine in Patients With Sickle Cell Disease

Completed·—·Phase 3·NCT01849016·96 enrolled

A Pilot Study of N-acetylcysteine in Patients With Sickle Cell Disease

Completed·BBloodworks·Phase 1/2·NCT01800526·21 enrolled

Idiopathic Pulmonary Fibrosis2 trials

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

Completed· Roche logo

Roche·Phase 2·NCT02707640·123 enrolled

Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF)

Completed·ZZambon SpA·Phase 3·NCT00639496·184 enrolled

Efficacy2 trials

Evaluation of N-Acetylcysteine Efficacy to Reduce the Craving and to Prolong Abstinence Time of Coca Paste

Completed·—·Phase 2·NCT03556371·140 enrolled

Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients

Recruiting·NNational University of Malaysia·N/A·NCT06377410·100 enrolled

Alcohol Use Disorder2 trials

N-acetylcysteine Treatment of Alcohol Use Disorder In Veterans With TBI

Completed·UUniversity of California, San Francisco·Phase 2·NCT02791945·30 enrolled

N-Acetylcysteine for Adolescent Alcohol Use Disorder

Completed·MMedical University of South Carolina·Phase 2·NCT03707951·126 enrolled

AIN2 trials

Neurocircuit Strategy to Decrease Cocaine Cue Reactivity

Completed·MMedical University of South Carolina·Phase 2·NCT04155632·32 enrolled

n-Acetylcysteine and Cocaine

Completed·UUniversity of Kentucky·Phase 1·NCT02141620·15 enrolled

Clinical Trial2 trials

Inpatient Clinical Trial of NAC

Terminated·UUniversity of California, San Francisco·Phase 4·NCT03581084·1 enrolled

A Clinical Trial for CTD-ILD Treatment

Terminated·UUniversity of Michigan·Phase 2/3·NCT01424033·5 enrolled

Chronic Obstructive Pulmonary Disease2 trials

The Anti-oxidant Effects of N-Acetylcysteine in Chronic Obstructive Pulmonary Disease (COPD)

Completed·SSiriraj Hospital·Phase 3·NCT03956888·35 enrolled

Pilot Study to Assess the Effect of High Dose N-acetylcysteine (NAC) in Chronic Obstructive Pulmonary Disease (COPD) Patients

Completed·UUniversity Hospital, Antwerp·Phase 4·NCT00969904·12 enrolled

Pseudomyxoma Peritonei1 trial

Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei

Unknown status·MMaimónides Biomedical Research Institute of Córdoba·Phase 1·NCT04982146·10 enrolled

HIE1 trial

Effect of Long-term, High-dose N-acetylcysteine on Exacerbations of Bronchiectaisis

Completed·QQilu Hospital of Shandong University·N/A·NCT02088216·161 enrolled

Premature Birth1 trial

Correction of Neonatal Glutathione by N-acetylcysteine in Pregnant Women at Risk of Premature Birth (GSH MAP)

Terminated·NNantes University Hospital·Phase 2/3·NCT03596125·39 enrolled

Hermansky-Pudlak syndrome1 trial

Pilot Study of a Multi-Drug Regimen for Severe Pulmonary Fibrosis in Hermansky-Pudlak Syndrome

Terminated·NNational Human Genome Research Institute (NHGRI)·Phase 1/2·NCT00467831·3 enrolled

Endothelial Function1 trial

ROS Signaling in Endothelial Function

Completed·—·N/A·NCT01037465·72 enrolled

Myopathy1 trial

Antioxidant Therapy in RYR1-Related Congenital Myopathy

Completed·NNational Institute of Nursing Research (NINR)·Phase 1/2·NCT02362425·63 enrolled

Methamphetamine Dependence1 trial

NAC as a Potential Treatment for Methamphetamine Dependence

Completed·—·Phase 1·NCT01063205·10 enrolled

Function1 trial

N-acetyl-cysteine (NAC) and Kidney Graft Function

Completed·IInstitut d'Anesthesiologie des Alpes Maritimes·Phase 3·NCT00998972·236 enrolled

Oxygenation1 trial

Influence of N-Acetylcysteine on Morbidity, Oxygenation and Cytokine Levels in Partial or Total Esophagectomy for Cancer

Completed·UUniversity Hospital, Basel, Switzerland·Phase 4·NCT00512265·29 enrolled

Premedication1 trial

Premedication With Simethicone or Simethicone Plus N-acetylcysteine in Improving Visibility During Upper Endoscopy

Completed·PPontificia Universidad Catolica de Chile·Phase 4·NCT01653171·230 enrolled

Endoscopy1 trial

The Efficacy of N-acetylcysteine on Alleviating Symptom Caused by Lugol Chromoendoscopy

Completed·XXijing Hospital of Digestive Diseases·N/A·NCT04764643·140 enrolled

Periodontitis1 trial

N-acetylcysteine for Root Canal Treatment of Necrotic Teeth With Apical Periodontitis

Active, not recruiting·—·Phase 2·NCT07262554·40 enrolled

Primary Sjögren's Syndrome1 trial

N-acetylcysteine for Primary Sjögren's Syndrome

Completed·UUniversity of Sao Paulo General Hospital·N/A·NCT04793646·60 enrolled

Kidney Injury1 trial

N-Acetylcysteine Roles in Preserving Renal Function Measured by Urinary KIM-1 (Kidney Injury Molecule-1) and Serum Creatinine on Cancer Patients With Cisplatin Based Chemotherapy: A Randomized Placebo-Controlled Trial

Not yet recruiting·FFakultas Kedokteran Universitas Indonesia·Phase 2/3·NCT07156786·72 enrolled

OCD1 trial

Effect of N-acetylcysteine as Add on Therapy With SSRI in Moderate to Severe OCD Patients

Unknown status·—·N/A·NCT04904952·60 enrolled

Oral Mucositis1 trial

N Acetylcystene in Treatment of Radiotherapy Induced Oral Mucositis in Oral Cancer Patients

Completed·HHams Hamed Abdelrahman·N/A·NCT07082621·40 enrolled

Noise-Induced Hearing Loss1 trial

Antioxidation Medication for Noise-induced Hearing Loss

Completed·NNational Taiwan University Hospital·Phase 2·NCT00552786·53 enrolled

Cystic Fibrosis1 trial

NAC Phase IIB: A Multi-Center, Phase IIB, Randomized, Placebo-controlled, Double-Blind Study Of The Effects Of N-Acetylcysteine On Redox Changes and Lung Inflammation In Cystic Fibrosis Patients

Completed·SStanford University·Phase 2·NCT00809094·70 enrolled

Respiratory Tract Diseases1 trial

A Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily, Ambroxol Hydrochloride 30 mg Twice Daily and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretions

Completed·ZZambon SpA·Phase 3·NCT03843541·333 enrolled

Tourette syndrome1 trial

N-acetylcysteine (NAC) for Children With Tourette Syndrome

Completed·YYale University·Phase 2·NCT01172288·31 enrolled

Addiction1 trial

Translational Neuropsychopharmacology Research of Nicotine Addiction

Completed·MMedical University of South Carolina·Phase 2·NCT02723162·67 enrolled

Renal insufficiency1 trial

RENACTIF: Reduction of the Thrombotic Phenotype in Renal Insufficiency With N-AcetylCysteine

Completed·AAssistance Publique Hopitaux De Marseille·Phase 2·NCT03636932·40 enrolled

ART1 trial

The Anti-Anginal Effects of N-Acetylcysteine (NAC) in Patients with Angina and Non-Obstructive Coronary Arteries (ANOCA)

Not yet recruiting·UUniversity of Adelaide·Phase 2·NCT06890507·25 enrolled

Cardiopulmonary Bypass1 trial

A Study of The Effectiveness of N-Acetylcysteine in Kidney Protection Following Cardiopulmonary Bypass

Completed·SSunnybrook Health Sciences Centre·Phase 2·NCT00187330·104 enrolled

Hypoxia1 trial

The Role of S-nitrosohemoglobin in Regulating Systemic Blood Flow During Hypoxia and Normoxia

Terminated·—·Phase 1·NCT01905696·10 enrolled

Breast1 trial

The Impact of N-Acetylcysteine on Volumetric Retention of Autologous Fat Graft for Breast Asymmetry Correction

Unknown status·CCentre of Postgraduate Medical Education·Phase 4·NCT03197103·15 enrolled

Systemic Sclerosis1 trial

High Dose Intravenous N-Acetylcysteine Versus Iloprost for Early, Rapidly Progressive Diffuse Systemic Sclerosis

Unknown status·UUniversità Politecnica delle Marche·Phase 2/3·NCT00428883·45 enrolled

Neurofibromatosis Type 11 trial

Antioxidant Therapy With N-acetylcysteine for Learning and Motor Behavior in Children With Neurofibromatosis Type 1

Completed·—·Phase 2·NCT04481035·5 enrolled

Randomized Controlled Trial1 trial

A Pilot Randomized Controlled Trial of Intravenous N-acetyl Cysteine in STEMI

Completed·UUniversity of Alberta·Phase 2·NCT04023266·44 enrolled

Pancreatitis1 trial

Pharmacological Prophylaxis of Post- Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

Unknown status·—·Phase 4·NCT03708458·250 enrolled

Tobacco Use Disorder1 trial

N-acetylcysteine for Tobacco Use Disorder

Completed·MMedical University of South Carolina·Phase 2·NCT02737358·114 enrolled

Hepatitis C1 trial

Mucomyst for Hepatitis C

Suspended·UUS Department of Veterans Affairs·N/A·NCT00493610·5 enrolled

Proteinuria1 trial

Use of Mucomyst to Ameliorate Oxidant Stress in Diabetics With Proteinuria

Completed·UUS Department of Veterans Affairs·N/A·NCT00493727·15 enrolled

Tuberculosis1 trial

Investigation of the Effect of N Acetylcysteine Against Anti-Tuberculosis Drugs Induced Liver Toxicity

Completed·—·N/A·NCT00564642·60 enrolled

Alcohol1 trial

Imaging GABAergic/Glutamatergic Drugs in Bipolar Alcoholics Alcoholics

Completed·MMedical University of South Carolina·Phase 2·NCT03220776·54 enrolled

Peritoneal Dialysis (PD)1 trial

Anti-Oxidant Effect on Peritoneal Membrane in Peritoneal Dialysis (PD) Patients

Unknown status·EEwha Womans University·Phase 4·NCT01111422·66 enrolled

Infants1 trial

Tolerability of Enteral NAC in Infants

Not yet recruiting·SSanjiv Harpavat·Phase 1·NCT06260566·12 enrolled

Coronary Artery Bypass1 trial

Effect of N-acetylcysteine on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass Graft

Completed·YYonsei University·Phase 4·NCT01394419·115 enrolled

Exercise Training1 trial

Effect of an Antioxidant on Cancer-Cachectic Patients Undergoing Exercise Training

Completed·GGerman Cancer Research Center·Phase 2·NCT00196885·60 enrolled

Lymphoma1 trial

A Study of N-Acetylcysteine (N-AC) in People Receiving CAR T-cell Therapy for Lymphoma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT05081479·9 enrolled

PTSD1 trial

NAC for Treating Comorbid PTSD and SUD

Completed·MMedical University of South Carolina·Phase 2·NCT02911285·90 enrolled

Homeostasis1 trial

The Effects of N-acetylcysteine on Performance and Redox Homeostasis

Completed·—·Phase 2·NCT03121222·36 enrolled

Rhabdomyolysis1 trial

Study of N-Acetylcysteine (NAC) and Continuous Renal Replacement Therapy (CRRT) for the Treatment of Rhabdomyolysis

Completed·—·Phase 2·NCT00391911·3 enrolled

CAR1 trial

COmbined N-acetylcysteine and Bicarbonate in PCI To Reduce Adverse Side Effect of contrasT

Completed·NNational University Hospital, Singapore·Phase 2/3·NCT00497328·477 enrolled

Cardiac Surgery1 trial

High-Dose N-Acetylcysteine in Cardiac Surgery

Completed·AAustin Health·Phase 2·NCT00332631·60 enrolled

Alcohol Dependence1 trial

N-acetylcysteine in Alcohol Dependence

Completed·MMinneapolis Veterans Affairs Medical Center·Phase 1/2·NCT00568087·46 enrolled

Bronchitis1 trial

N-Acetylcysteine for Patients With COPD and ChronicBronchitis

Unknown status·CCenter for Veterans Research and Education·N/A·NCT01599884·65 enrolled

Systemic Lupus Erythematosus1 trial

Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine

Recruiting·SState University of New York - Upstate Medical University·Phase 2·NCT00775476·290 enrolled

Atherosclerosis1 trial

NAC Treatment and Outcomes in Patients With Advanced Atherosclerosis and DM

Withdrawn·UUniversity of Missouri-Columbia·Phase 1·NCT05908513

Atrial Fibrillation1 trial

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

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 3·NCT02750319·184 enrolled

Renal Protection1 trial

An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery

Completed·—·Phase 2·NCT00122018·80 enrolled

Tobacco Smoking1 trial

N-acetylcysteine for Tobacco Smoking

Unknown status·UUniversidade Estadual de Londrina·Phase 3·NCT02124525·32 enrolled

Visceral Leishmaniasis1 trial

Immune Response of Visceral Leishmaniasis PatientsTreated With Antimonial Plus N-Acetylcysteine

Unknown status·HHospital Universitário Professor Edgard Santos·N/A·NCT01138956·40 enrolled

Chorioamnionitis1 trial

Safety of N-acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio)

Completed·MMedical University of South Carolina·Phase 1/2·NCT00724594·46 enrolled

Neurotoxicity1 trial

N-AcetylCysteine vs. Placebo to Prevent Neurotoxicity Induced by Platinum Containing Chemotherapy

Terminated·RRijnstate Hospital·N/A·NCT00637624·69 enrolled

Kidney Transplant1 trial

Impact of N-Acetylcysteine on Oxidative Stress and Renal Function in Deceased Kidney Transplant Recipients

Completed·UUniversity of Sao Paulo·N/A·NCT00851708

Opioids1 trial

Behavioral Effects of Drugs (Inpatient): 43 (Opioids, Cocaine, n-Acetylcysteine)

Recruiting·WWilliam Stoops·Phase 1·NCT05610072·24 enrolled

Self-injurious behavior1 trial

N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD

Terminated·YYale University·Phase 2·NCT00539188·6 enrolled

Hospitalized Patients1 trial

Efficacy of N-acetylcysteine on the Craving Symptoms of Abstinent Hospitalized Patients With Cocaine Addiction

Terminated·SSalvatore Campanella·Phase 2·NCT03423667·33 enrolled

Rheumatic Heart Disease1 trial

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

Completed·—·Phase 2·NCT01704482·60 enrolled

Safety and Efficacy1 trial

A Safety and Efficacy Study of NAC in Patients With TA-TMA

Completed·TThe First Affiliated Hospital of Soochow University·Phase 3·NCT03252925·170 enrolled

Overdose1 trial

Macrophage Markers, Soluble CD163 (sCD163) and Soluble CD206 (sCD206) in Paracetamol Overdose

Completed·UUniversity of Aarhus·Phase 1·NCT03679442·16 enrolled

Hearing Loss1 trial

NAC to Prevent Cisplatin-induced Hearing Loss

Completed·—·Phase 1·NCT02094625·52 enrolled

Exacerbation of COPD1 trial

N-acetylcysteine (NAC) for the Treatment of Acute Exacerbation of COPD

Unknown status·QQueen Mary Hospital, Hong Kong·Phase 3·NCT05706402·80 enrolled

Alcohol Drinking1 trial

N-acetylcysteine Reduces Acetaldehyde Levels in Binge Alcohol Drinking

Completed·UUniversity Medical Centre Ljubljana·N/A·NCT05911282·40 enrolled

Hepatocellular Carcinoma1 trial

Comparison of Dexamethasone and N Acetylcysteine (NAC) Versus N Acetylcysteine (NAC) Alone in the Prevention of Post Embolization Syndrome in Patients With Hepatocellular Carcinoma Following Transarterial Chemoembolization.

Unknown status·IInstitute of Liver and Biliary Sciences, India·N/A·NCT06039280·150 enrolled

Common Cold1 trial

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

Completed· Novartis logo

Novartis·Phase 2·NCT02379637·70 enrolled

Heart Failure1 trial

N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure

Unknown status·BBayside Health·Phase 2/3·NCT00532688·10 enrolled

Thrombocytopenia1 trial

A Pilot Study of N-acetylcysteine in Thrombotic Thrombocytopenia Purpura

Completed·BBloodworks·Phase 1·NCT01808521·3 enrolled

Myeloproliferative Neoplasms1 trial

An Optimal Dose Finding Study of N-Acetylcysteine in Patients With Myeloproliferative Neoplasms

Recruiting·UUniversity of California, Irvine·Phase 1/2·NCT05123365·27 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Rifaximin With NAC in IBS-D

Completed·—·Phase 1/2·NCT04557215·45 enrolled

Retinitis Pigmentosa1 trial

Oral N-acetylcysteine for Retinitis Pigmentosa

Active, not recruiting·JJohns Hopkins University·Phase 3·NCT05537220·485 enrolled

Neonatal1 trial

N-Acetylcysteine in Neonatal Congenital Heart Surgery (INACT Study)

Completed·UUniversity of Michigan·Phase 2·NCT00374088·21 enrolled

Leukemia1 trial

N-Acetylcysteine vs Placebo as Adjunctive Treatment in Pediatric Leukemia

Terminated·TTeny Tjitra Sari·Phase 4·NCT05611086·16 enrolled

Ovarian Cancer1 trial

N-acetylcysteine Given IV With Cisplatin and Paclitaxel in Patients With Ovarian Cancer

Withdrawn·OOHSU Knight Cancer Institute·Phase 1·NCT01138137

Cannabis Dependence1 trial

N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms

Unknown status·UUniversitair Ziekenhuis Brussel·Phase 4·NCT03221231·75 enrolled

Alcohol Use1 trial

Neuroscience-Informed Treatment Development for Adolescent Alcohol Use

Completed·MMedical University of South Carolina·Phase 2·NCT03238300·57 enrolled

Smoking Reduction1 trial

N-Acetylcysteine and Smoking Reduction

Completed·MMedical University of South Carolina·Phase 2·NCT00751257·33 enrolled

PCOS1 trial

N-Acetylcysteine and L-carnitine in Pcos

Completed·ZZagazig University·Phase 2·NCT03164421·164 enrolled

Fracture1 trial

Pilon Fracture With Intra-articular Injection of N-Acetylcysteine (Pilon NAC)

Recruiting·UUniversity of Missouri-Columbia·Phase 4·NCT03652753·30 enrolled

Hematopoietic Stem Cell Transplantation1 trial

Efficacy of N-acetylcysteine Versus Placebo as Prophylaxis of Sinusoidal Obstruction Syndrome in Patients Undergoing Hematopoietic Stem Cell Transplantation

Unknown status·IInstituto Brasileiro de Controle do Cancer·Phase 2·NCT04712435·80 enrolled

Antiplatelet1 trial

Effects of Antiplatelet and Antioxidant Agents on Drusen Progression: A Pilot, Prospective Cohort Study

Recruiting·NNavamindradhiraj University·Phase 3·NCT06165068·174 enrolled

Prospective1 trial

A Prospective, Randomized TrialComparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate

Terminated·UUniversity of Nebraska·N/A·NCT00579995·41 enrolled

Critically Ill Patients1 trial

N-Acetylcysteine in Critically Ill Patients Undergoing Contrast Enhanced Computed Tomography

Completed·UUnity Health Toronto·Phase 2/3·NCT00830193·45 enrolled

Diabetic Foot1 trial

Effects of N-acetylcysteine on Diabetic Foot Oxygenation

Completed·UUniversity of Turin, Italy·Phase 3·NCT01082445·100 enrolled

Altitude1 trial

Study of Cobalt's Role in Excessive Erythrocytosis Among High Altitude Dwellers in Cerro de Pasco, Peru

Completed·UUniversity of Colorado, Denver·Phase 1/2·NCT01187108·85 enrolled

COPD1 trial

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

Completed·QQueen's University·Phase 4·NCT02579772·13 enrolled

Depression1 trial

Prefrontal Glutamatergic Modulation by NAC and MBCT for Depression in Youth

Recruiting·UUniversity of Cincinnati·Phase 3·NCT07464886·160 enrolled

Type 2 Diabetes1 trial

Effect of the Anti-oxidant N-acetylcysteine on Beta-cell Function in Type 2 Diabetes

Completed·—·N/A·NCT01394510·13 enrolled

Regression1 trial

Hypertrophic Regression With N-Acetylcysteine in HCM

Completed·TThe University of Texas Health Science Center, Houston·Phase 1·NCT01537926·42 enrolled

Septic Shock1 trial

Clinical Trial of Antioxidant Therapy in Patients With Septic Shock

Unknown status·—·Phase 3·NCT03557229·131 enrolled

Chronic Bronchitis1 trial

N-Acetylcysteine for Patients With COPD and Chronic Bronchitis

Terminated·UUniversity of Minnesota·N/A·NCT01739790·51 enrolled

Diabetic Nephropathy1 trial

Efficacy of N-Acetylcysteine in Treatment of Overt Diabetic Nephropathy

Completed·SShiraz University of Medical Sciences·Phase 2/3·NCT00556465·60 enrolled

Depressive Symptoms1 trial

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

Completed·RRegion Syddanmark·Phase 2·NCT02294591·80 enrolled

Renal Transplant1 trial

Protective Effect of N-acetylcysteine on Early Outcomes of Deceased Renal Transplant

Unknown status·UUniversity of Sao Paulo General Hospital·N/A·NCT00994305·74 enrolled

Adverse Events1 trial

Prevention of Serious Adverse Events Following Angiography

Completed·VVA Office of Research and Development·Phase 3·NCT01467466·5,177 enrolled

Intravenous1 trial

A Study to Evaluate Pharmacokinetics, Safety and Tolerability of Single and Multiple Intravenous Doses of N-acetylcysteine (NAC) in Chinese Healthy Volunteers

Completed·ZZambon SpA·Phase 1·NCT03881163·24 enrolled

Methylprednisolone1 trial

Methylprednisolone N Acetylcysteine in Hepatic Resections

Terminated·IIstituto Clinico Humanitas·Phase 2·NCT01726465·50 enrolled

Memory1 trial

Memory and Antioxidants in Vascular Impairment Trial

Completed·SSunnybrook Health Sciences Centre·Phase 2·NCT03306979·60 enrolled

Trichotillomania1 trial

N-Acetylcysteine for Pediatric Trichotillomania

Completed·YYale University·Phase 2·NCT00993265·39 enrolled

Dialysis Patients1 trial

Effect of N-Acetylcysteine on Residual Renal Function in Chronic Hemodialysis Patients

Unknown status·—·N/A·NCT00507052

Unspecified2 trials

N-acetylcysteine Effects on Tetrahydrocannabinol

Terminated·YYale University·Phase 1·NCT02335060·5 enrolled

Effects of N-acetylcysteine on Low T3 Syndrome

Completed·FFederal University of Rio Grande do Sul·Phase 4·NCT01501110·83 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 22, 1986

CYSTEINE HYDROCHLORIDE

NDA NDA019523

Apr 16, 2019

ELCYS

NDA NDA210660

Dec 13, 2019

NOURESS

NDA NDA212535

Sources

References

[1]
ClinicalTrials.gov — 204 trial records for N-acetylcysteine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — N-acetylcysteine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for N-acetylcysteine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA212535). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Cysteine Hydrochloride. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Novartis

Patent Landscape[5]

Patent Cliff

Jan 15, 2039

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11510942Jan 15, 2039

11648262Jan 15, 2039

10912795Jan 15, 2039

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