Drugs / Acetylcysteine
Acetylcysteine
also known as
NAC · N-acetylcysteine · Mucomyst · ACC · Acetadote · AR10 · Flucistein · fluimucil 100mg/ml · +3 more
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ACETADOTE | — | 2024-11-26 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | MUCOMYST | — | 1985-01-31 – 2009-03-13 | fda.gov ↗ |
| Approved | US (FDA) | MUCOMYST | — | 1963-09-14 | fda.gov ↗ |
Trials 38
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07387666 | Jun 2026 → Jul 2027 expected | glioblastoma | University of Texas Southwestern Medical Center | Recruiting | No outcome recorded |
| Phase 14 trials · 1 met primary | ||||||
| Phase 1 | NCT07097727 | Oct 2023 → Sep 2024 | bacterial pneumonia | Tanta University | Completed | No outcome recorded |
| Phase 1 | NCT05220605 | Jul → Aug 2022 | acute respiratory distress syndrome, pneumonia | Mucpharm Pty Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02723669 | Apr → May 2014 | — | Arbor Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 1 | NCT00238173 | Dec 2004 → Feb 2006 | bone marrow disorder, central nervous system cancer, chemotherapy-induced toxicity | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07414212 | Nov 2025 → Nov 2026 expected | amyotrophic lateral sclerosis | Biogipuzkoa Health Research Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05258682 | May → Sep 2022 | COVID-19, acute respiratory distress syndrome, pneumonia | Mucpharm Pty Ltd | Unknown | No outcome recorded |
| Phase 1/2 | NCT03460808 | Mar 2018 → Jan 2020 | autoimmune thrombocytopenia | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 28 trials · 1 missed | ||||||
| Phase 2 | NCT07364747 | Dec 2024 → Dec 2026 expected | drug-induced hearing loss, platinum-induced ototoxicity | Siriraj Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04918719 | Nov 2023 → Sep 2024 | ischemic stroke | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03976973 | May 2022 → Nov 2023 | pseudomyxoma peritonei | Mucpharm Pty Ltd | Unknown | No outcome recorded |
| Phase 2 | NCT04154982 | Sep 2020 → Dec 2024 | cardiac rhythm disease | Centro Cardiologico Monzino | Completed | No outcome recorded |
| Phase 2 | NCT04368598 | Apr 2019 → Dec 2020 | autoimmune thrombocytopenia | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02569957 | Oct 2015 → Jun 2016 | endometrioid tumor, fallopian tube carcinoma, malignant ovarian serous tumor, ovarian carcinoma +1 | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02123511 | Apr 2014 → Mar 2016 | adenoid cystic carcinoma, larynx verrucous carcinoma, lymphoepithelial-like carcinoma, mucositis +8 | Mayo Clinic | Completed | Missed primary |
| Phase 2 | NCT00230191 | Jan 2003 → Dec 2005 | head and neck squamous cell carcinoma, ulcerative stomatitis | RxKinetix | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02882477 | Dec 2016 → May 2018 | diabetes mellitus, iron metabolism disease, optic atrophy, peptic ulcer disease +2 | Hadassah Medical Organization | Unknown | No outcome recorded |
| Phase 36 trials · 1 missed | ||||||
| Phase 3 | NCT05070650 | Sep 2024 → Apr 2025 | common cold | Sandoz | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04945096 | Jul 2021 → Jul 2025 | graft versus host disease | The First Affiliated Hospital of Soochow University | Unknown | No outcome recorded |
| Phase 3 | NCT04123405 | Oct 2020 → Apr 2021 | sinusitis | Sandoz | Completed | No outcome recorded |
| Phase 3 | NCT02822287 | Feb → Mar 2016 | common cold | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01118663 | Sep 2010 → Nov 2012 | paracetamol poisoning | Cumberland Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT00736866 | Aug 2008 → Jul 2010 | acute kidney injury | Hospital do Coracao | Completed | Missed primary |
| Phase 410 trials · 1 met primary | ||||||
| Phase 4 | NCT07409727 | Mar 2026 → Mar 2028 expected | ventilation pneumonitis | Cairo University | Recruiting | No outcome recorded |
| Phase 4 | NCT03388853 | Feb 2018 → Dec 2019 | chronic obstructive pulmonary disease | Neutec Ar-Ge San ve Tic A.Ş | Completed | No outcome recorded |
| Phase 4 | NCT02788292 | Aug 2016 → Nov 2020 | breast disorder, lipodystrophy, transplant rejection | Nova Scotia Health Authority | Withdrawn | No outcome recorded |
| Phase 4 | NCT01050270 | Sep 2010 → Dec 2012 | poisoning | University of Edinburgh | Completed | Met primary |
| Phase 4 | NCT00996424 | Jan → Sep 2010 | cystic fibrosis | University Hospital, Ghent | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00568113 | Jul → Dec 2007 | — | Assiut University | Completed | No outcome recorded |
| Phase 4 | NCT00247507 | Sep → Dec 2005 | anemia, atherosclerosis, disorder of defective peroxisome oxidative status, end stage renal failure | Far Eastern Memorial Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00569465 | Jan 2005 → Jan 2006 | essential hypertension, type 2 diabetes mellitus | University of Turin, Italy | Terminated | No outcome recorded |
| Phase 4 | NCT01223326 | Jan 2003 → Oct 2007 | — | Clinica Universidad de Navarra, Universidad de Navarra | Completed | No outcome recorded |
| Phase 4 | NCT00492518 | Feb 2002 → Oct 2004 | acute tubulointerstitial nephritis, kidney failure | Technical University of Munich | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT02818270 | Jun → Dec 2016 | chronic obstructive pulmonary disease | Chang Gung University | Completed | No outcome recorded |
| — | NCT01564303 | May → Nov 2012 | — | The Nazareth Hospital | Unknown | No outcome recorded |
| — | NCT01137591 | Apr 2009 → ? | acute liver failure, drug-induced liver injury | Columbia University | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT00396396 | Oct 2006 → ? | — | Eastern Virginia Medical School | Unknown | No outcome recorded |
| — | NCT00399256 | Mar 2004 → Mar 2006 | chronic renal failure syndrome | Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) | Terminated | No outcome recorded |
| Comparator or background therapy17 trials | ||||||
| Phase 1 | NCT03177395 Background | Jun 2017 → Aug 2018 | paracetamol poisoning | Egetis Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT02080182 Comparator | Jan 2014 → Apr 2016 | acute pyelonephritis | Shahid Beheshti University of Medical Sciences | Completed | No outcome recorded |
| Phase 2 | NCT02760901 Comparator | Nov 2013 → Oct 2015 | cisplatin toxicity | Ain Shams University | Completed | No outcome recorded |
| Phase 2 | NCT00003346 Background | Nov 1997 → Feb 2003 | cutaneous melanoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT05906498 Comparator | Dec 2022 → Nov 2023 | psoriasis | Badr University | Unknown | No outcome recorded |
| Phase 4 | NCT05936528 Comparator | Sep 2025 → Jul 2026 | — | Mansoura University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04766450 Comparator | Dec 2021 → Nov 2022 | diabetic neuropathy | Ain Shams University | Unknown | No outcome recorded |
| Phase 4 | NCT03354572 Comparator | Oct 2017 → Oct 2018 | — | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02357303 Comparator | Apr → Dec 2015 | stomach disorder | Portuguese Oncology Institute, Coimbra | Completed | No outcome recorded |
| Phase 4 | NCT02168387 Comparator | Dec 2010 → May 2012 | lung disorder | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT00558142 Comparator | Feb 2008 → Jan 2015 | — | University of Edinburgh | Completed | No outcome recorded |
| Phase 4 | NCT00525551 Comparator | Sep 2007 → Apr 2013 | otosclerosis | Karolinska University Hospital | Completed | No outcome recorded |
| — | NCT05804123 Background | Oct 2021 → Apr 2024 | respiratory tract infectious disorder | Anabio R&D | Completed | No outcome recorded |
| — | NCT07470242 Comparator | Oct 2021 → Mar 2023 | chronic rhinosinusitis | Pusan National University Hospital | Completed | No outcome recorded |
| — | NCT02159196 Comparator | Jul 2014 → Mar 2017 | respiratory failure | Academic Medical Center - University of Amsterdam | Completed | No outcome recorded |
| — | NCT01160627 Comparator | Apr 2010 → Mar 2013 | acute tubulointerstitial nephritis | Odense University Hospital | Completed | No outcome recorded |
| — | NCT01612013 Comparator | May 2005 → May 2009 | acute kidney injury | Federal University of São Paulo | Completed | No outcome recorded |
Press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-12-10 | Cumberland Pharmaceuticals | New Dosing Regimen for APAP Overdose Antidote Acetadote Approved cumberlandpharma.com ↗ |
| 2018-07-21 | Zydus Lifesciences Limited | Zydus receives final approval from the USFDA for Acetylcysteine Injection zyduslife.com ↗ |
| 2013-01-07 | Perrigo Company | Perrigo Announces Launch of Authorized Generic Version of Acetadote® (acetylcysteine) Injection perrigo.com ↗ |
| 2012-11-13 | Perrigo Company | Perrigo Confirms Settlement Of Generic Version Of Acetadote® (acetylcysteine) Injection Patent Litigation perrigo.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 59 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Acetyl cysteine | “Acetylcysteine (Flucistein 100 mg/ml, Neo Química, Brazil) was given via IV bolus at a rate of 150 mg/kg in 500 ml dextrose 5% over 60 min immediately before contrast exposure...” NCT01612013 ↗52“Subgroup B1 will receive standard antioxidant drug (Acetyl cysteine 600 mg / 12 hr) orally to be compared with lactoferrin A1 subgroup.” NCT05936528 ↗ “Clear oral solution containing 2% acetylcysteine (g/mL) in a 100 mL amber glass bottle.” NCT02822287 ↗ “BromAc is a product that combines two existing products (Bromelain and Acetylcysteine)” NCT05220605 ↗ “effect of Acetyl cysteine compared to normal saline” NCT00996424 ↗ “acetylcysteine solution; oral 20% (200 mg/mL)” NCT02723669 ↗ “acetylcysteine” NCT01118663 ↗ |
| Known as | ACC | “The antioxidant acetylcysteine (ACC) was effective in patients with impaired renal function in at least six studies, but it was not preventive in at least 21 trials and two...” NCT00492518 ↗ |
| Known as | Acetadote | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07387666 ↗ |
| Known as | AR10 | “AR10 (acetylcysteine effervescent tablets for oral solution” NCT02723669 ↗ |
| Known as | Flucistein | “Acetylcysteine (Flucistein 100 mg/ml, Neo Química, Brazil) was given via IV bolus at a rate of 150 mg/kg in 500 ml dextrose 5% over 60 min immediately before contrast exposure...” NCT01612013 ↗ |
| Known as | fluimucil 100mg/ml | “3 mL-solution of acetylcysteine (fluimucil 100mg/ml)” NCT02159196 ↗ |
| Known as | Mucomyst | “The purpose of this study is to investigate the exact role of Acetylcysteine (Mucomyst) in altering creatinine clearance.” NCT00396396 ↗1“Acetylcysteine (Mucomyst) Nasal Irrigation” NCT07470242 ↗ |
| Known as | N-acetyl-L-cysteine | “For decades N-acetyl-L-cysteine (NAC) has been used for its mucolytic properties orally in different respiratory diseases like chronic obstructive pulmonary disease (COPD),...” NCT07409727 ↗ |
| Known as | N-acetylcysteine | “BACKGROUND: N-acetylcysteine (NAC) or sodium bicarbonate (NaHCO3), singly or combined, inconsistently prevent patients exposed to radiographic contrast media from developing...” PMID 25254489 ↗ Sep 20146“Using block-stratified randomization, 156 adult patients undergoing stapedotomy were assigned to intravenous N-Acetylcysteine (150 mg/kg body weight) or matching placebo (1:1...” PMID 25763866 ↗ Mar 2015 “The purpose of this study is to evaluate the efficacy of N-acetylcysteine (NAC) in preventing cisplatin-induced ototoxicity in patients receiving cisplatin-based chemotherapy.” NCT07364747 ↗ “The intravenous (IV) N-acetylcysteine (NAC) regimen introduced in the 1970s has continued effectively unchanged.” PMID 23556549 ↗ Apr 2013 “N-Acetylcysteine (NAC) is on the market since 1968 and is an over the counter available agent” NCT03354572 ↗ “N-acetyl cysteine (NAC) is synthetic cysteine amino acid” NCT05906498 ↗ “inhaled N-Acetylcysteine (NAC) to improve lung function” NCT00996424 ↗ |
| Known as | NAC | “For decades N-acetyl-L-cysteine (NAC) has been used for its mucolytic properties orally in different respiratory diseases like chronic obstructive pulmonary disease (COPD),...” NCT07409727 ↗9“BACKGROUND: N-acetylcysteine (NAC) or sodium bicarbonate (NaHCO3), singly or combined, inconsistently prevent patients exposed to radiographic contrast media from developing...” PMID 25254489 ↗ Sep 2014 “Acetylcysteine group (NAC+S) , aside with the saline, patients will be given orally Acetylcysteine at a dose of 600 mg twice daily, on the day before and on the day of...” NCT01564303 ↗ “The purpose of this study is to evaluate the efficacy of N-acetylcysteine (NAC) in preventing cisplatin-induced ototoxicity in patients receiving cisplatin-based chemotherapy.” NCT07364747 ↗ “The intravenous (IV) N-acetylcysteine (NAC) regimen introduced in the 1970s has continued effectively unchanged.” PMID 23556549 ↗ Apr 2013 “high dose oral N-acetyl cysteine (NAC) as adjuvant therapy on clinical outcome of DPN” PMID 40038825 ↗ Mar 2025 “N-acetyl cysteine (NAC) is synthetic cysteine amino acid” NCT05906498 ↗ “inhaled N-Acetylcysteine (NAC) to improve lung function” NCT00996424 ↗ “Drug: Acetylcysteine (NAC)” NCT01223326 ↗ |
| Known as | NAC: n-acetylcysteine; Mucomyst | “NAC: n-acetylcysteine; Mucomyst” NCT01137591 ↗ |
| Known as | RK-0202 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00230191 ↗ |
| Action | Inhibit | “acetylcysteine has been demonstrated to inhibit the production of ox-LDL by ROS.” NCT00247507 ↗ |
| Modality | Other / unclassified | “mucolytic agents like Pronase or N-Acetylcysteine” NCT02357303 ↗ |
| Route | Intravenous | “acetylcysteine IV over 20 hours” NCT00003346 ↗ |