Acetadote

(acetylcysteine)

ApprovedSmall molecule

AArbor Pharmaceuticals, Inc.

Acetadote is one of 1585 small molecule programs targeting Homocystinuria. It is currently in Approved.

111

Indications

Total Trials

Active Trials

1,584

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

HomocystinuriaApproved

Mitochondrial DiseaseApproved

Systemic Lupus ErythematosusApproved

Cocaine AbuseApproved

Neurofibromatosis Type 1Approved

Uterine FibroidApproved

Polycystic Ovary SyndromeApproved

Atrial FibrillationApproved

Oral MucositisApproved

HomocystinuriaApproved

Approved

Mitochondrial DiseaseApproved

Approved

Systemic Lupus ErythematosusApproved

Approved

Cocaine AbuseApproved

Approved

Neurofibromatosis Type 1Approved

Approved

Uterine FibroidApproved

Approved

Polycystic Ovary SyndromeApproved

Approved

Atrial FibrillationApproved

Approved

Oral MucositisApproved

Approved

Showing 10 of 110 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Acetadote

AArbor Pharmaceuticals, Inc.

Approved

38 2

Adenocard

Astellas

Preclinical

2 3

Lexiscan

Astellas

Preclinical

1 4

Duragesic

CCephalon

Preclinical

1 5

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 6

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 7

Tianeptine

Pfizer

Preclinical

1 8

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

1 9

Tc99m Sestamibi

MM.D. Anderson Cancer Center

Preclinical

2 10

Perflutren Lipid Microsphere

IImaRx Therapeutics

Preclinical

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

Timeline

Expected Milestones

Q4 2027

Phase 1/2Recruiting

Amyotrophic Lateral Sclerosis

NCT07414212

Q3 2028

Phase 1Recruiting

Glioblastoma

NCT07387666

Clinical

Trials by Indication[1]

Nephropathy3 trials

Acetylcysteine, Theophylline, and a Combination of Both in the Prophylaxis of Contrast-Induced Nephropathy

Completed·TTechnical University of Munich·Phase 4·NCT00492518·254 enrolled

Improved Estimation of GFR by Cystatin C in Preventing Contrast Induced Nephropathy by NAC or Zn

Terminated·RRobert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)·N/A·NCT00399256·60 enrolled

The Acetylcysteine for Contrast-Induced Nephropathy Trial

Completed·HHospital do Coracao·Phase 3·NCT00736866·2,300 enrolled

Function2 trials

The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function

Terminated·UUniversity Hospital, Ghent·Phase 4·NCT00996424·19 enrolled

Mechanisms for the Effect of Acetylcysteine on Renal Function After Exposure to Radiographic Contrast Material

Completed·UUniversity of Edinburgh·Phase 4·NCT00558142·107 enrolled

Mechanical Ventilation2 trials

Effectiveness of Routine Nebulization of Mucolytics and Bronchodilators During Mechanical Ventilation

Completed·—·N/A·NCT02159196·950 enrolled

Evaluation of Aerosolized Drugs Deposition During Mechanical Ventilation

Completed·—·N/A·NCT02818270·30 enrolled

Overdose1 trial

PP100-01 (Calmangafodipir) for Overdose of Paracetamol

Completed·EEgetis Therapeutics·Phase 1·NCT03177395·24 enrolled

Ventilation Therapy1 trial

Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient

Completed·—·Phase 4·NCT02168387·39 enrolled

29 more indications

MPA1 trial

Relative Bioavailability of AR10 Compared to Reference Product

Completed·AArbor Pharmaceuticals, Inc.·Phase 1·NCT02723669·30 enrolled

Mucositis1 trial

Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy

Completed·MMayo Clinic·Phase 2·NCT02123511·34 enrolled

CLE1 trial

Role of Acetylcysteine in Creatinine Clearance

Unknown status·—·N/A·NCT00396396·35 enrolled

Survival1 trial

Effect of N-Acetylcysteine on Autologous Fat Graft Survival

Withdrawn·NNova Scotia Health Authority·Phase 4·NCT02788292

Efficacy1 trial

Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis

Completed·KKarolinska University Hospital·Phase 4·NCT00525551·152 enrolled

Randomized Controlled Trial1 trial

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

Completed·PPortuguese Oncology Institute, Coimbra·Phase 4·NCT02357303·300 enrolled

Oxidative Stress1 trial

The Effects of Acetylcysteine on Alleviating Damage of Oxidative Stress in Hemodialysis Patients

Unknown status·FFar Eastern Memorial Hospital·Phase 4·NCT00247507

Poisoning1 trial

Scottish and Newcastle Anti-emetic Pre-treatment for Paracetamol Poisoning Study (SNAP)

Completed·UUniversity of Edinburgh·Phase 4·NCT01050270·222 enrolled

Immune Thrombocytopenia1 trial

The Combination of Atorvastatin, Acetylcysteine and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 1/2·NCT03460808·200 enrolled

Acute Myocardial Infarction1 trial

Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction

Completed·OOdense University Hospital·N/A·NCT01160627·720 enrolled

Dexamethasone1 trial

The Combination of High-dose Dexamethasone and Acetylcysteine as the Treatment of Newly-diagnosed ITP

Unknown status·PPeking University People's Hospital·Phase 2·NCT04368598·44 enrolled

Amyotrophic Lateral Sclerosis1 trial

Evaluation of the Combined Therapy of EH-301 and N-acetylcysteine Together With Riluzole in Amyotrophic Lateral Sclerosis (ALS)

Recruiting·—·Phase 1/2·NCT07414212·90 enrolled

Ischemic stroke1 trial

Intravenous N-Acetylcysteine for the Treatment of Acute Ischemic Stroke

Completed·LLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·Phase 2·NCT04918719·4 enrolled

Pyelonephritis1 trial

Effect of Acetylcysteine in Pediatric Acute Pyelonephritis.

Completed·SShahid Beheshti University of Medical Sciences·Phase 2·NCT02080182·70 enrolled

Melanoma1 trial

Combination Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00003346·80 enrolled

Common Cold1 trial

Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold

Withdrawn· Novartis logo

Novartis·Phase 3·NCT05070650

Toxicity1 trial

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

Completed·—·Phase 2·NCT02760901·52 enrolled

Bronchitis1 trial

N-Acetylcysteine for Patients With COPD and ChronicBronchitis

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

Ischemia1 trial

N-acetylcysteine to Reduce Ischemia/Reperfusion Injury in Liver Resection

Completed·—·Phase 4·NCT01223326·46 enrolled

Sinusitis1 trial

Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis

Completed· Novartis logo

Novartis·Phase 3·NCT04123405·944 enrolled

Pseudomyxoma Peritonei1 trial

BromAc for Recurrent Peritoneal Mucinous Tumour or Pseudomyxoma Peritonei

Unknown status·MMucpharm Pty Ltd·Phase 2·NCT03976973·62 enrolled

Otitis media1 trial

LiveSpo Navax® Supports the Treatment of Acute Rhinosinusitis and Otitis Media

Completed·AAnabio R&D·N/A·NCT05804123·175 enrolled

COVID-191 trial

Safety of Nebulized Combination Therapy BromAc® in COVID-19 Respiratory Disease

Unknown status·MMucpharm Pty Ltd·Phase 1/2·NCT05258682·30 enrolled

Malignant Brain Tumors1 trial

Acetylcysteine, Mannitol, Combination Chemotherapy, and Sodium Thiosulfate in Treating Children With Malignant Brain Tumors

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT00238173·2 enrolled

Wolfram syndrome1 trial

Treatment of Wolfram Syndrome Type 2 With the Chelator Deferiprone and Incretin Based Therapy

Unknown status·HHadassah Medical Organization·Phase 2/3·NCT02882477·20 enrolled

Fallopian Tube Cancer1 trial

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

Terminated·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 2·NCT02569957·1 enrolled

Outcome1 trial

Outcomes of Patients After Allo-HSCT With Decitabine and NAC

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 3·NCT04945096·100 enrolled

Glioblastoma1 trial

A Prospective, Open-label Phase 0 Single-center Study to Assess the Effect of Acetadote on Metabolism in Newly Diagnosed Glioblastoma

Recruiting·UUniversity of Texas Southwestern Medical Center·Phase 1·NCT07387666·10 enrolled

Unspecified1 trial

N-Acetylcysteine and Arginine Administration in Diabetic Patients

Terminated·UUniversity of Turin, Italy·Phase 4·NCT00569465·24 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

MUCOMYST

NDA NDA013601

Jan 23, 2004

ACETADOTE

NDA NDA021539

Jan 29, 2016

CETYLEV

NDA NDA207916

Sources

References

[1]
ClinicalTrials.gov — 38 trial records for acetylcysteine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — acetylcysteine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for acetylcysteine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA207916). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Acetadote. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Arbor Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AArbor Pharmaceuticals, Inc.

Patent Landscape[5]

Patent Cliff

Jul 21, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8148356May 21, 2026

9327028Jul 21, 2031

8722738Apr 6, 2032

8747894May 8, 2032

9561204May 8, 2032

1 more patents

9427421May 8, 2032

Acetadote

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q3 2028

Trials by Indication[1]

Nephropathy3 trials

Function2 trials

Mechanical Ventilation2 trials

Overdose1 trial

Ventilation Therapy1 trial

MPA1 trial

Mucositis1 trial

CLE1 trial

Survival1 trial

Efficacy1 trial

Randomized Controlled Trial1 trial

Oxidative Stress1 trial

Poisoning1 trial

Immune Thrombocytopenia1 trial

Acute Myocardial Infarction1 trial

Dexamethasone1 trial

Amyotrophic Lateral Sclerosis1 trial

Ischemic stroke1 trial

Pyelonephritis1 trial

Melanoma1 trial

Common Cold1 trial

Toxicity1 trial

Bronchitis1 trial

Ischemia1 trial

Sinusitis1 trial

Pseudomyxoma Peritonei1 trial

Otitis media1 trial

COVID-191 trial

Malignant Brain Tumors1 trial

Wolfram syndrome1 trial

Fallopian Tube Cancer1 trial

Outcome1 trial

Glioblastoma1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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