Acetylcysteine
Acetadote (acetylcysteine) is a small molecule pharmaceutical. Acetylcysteine was first approved as Mucomyst on 1982-01-01. It is used to treat amyloidosis, bronchiectasis, bronchitis, cystic fibrosis, and pneumonia amongst others in the USA.
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Acetadote (generic drugs available since 1994-08-30, discontinued: Cetylev, Mucomyst, Mucosil)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Acetylcysteine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ACETADOTE | Cumberland Pharmaceuticals | N-021539 RX | 2004-01-23 | 1 products, RLD, RS |
Show 2 discontinued
Acetylcysteine
+
Isoproterenol hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MUCOMYST W/ ISOPROTERENOL | Mead Johnson Nutrition | N-017366 DISCN | 1982-01-01 | 1 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| acetadote | New Drug Application | 2023-01-27 |
| acetylcysteine | ANDA | 2023-11-08 |
| premasol - sulfite-free (amino acid) | ANDA | 2022-08-04 |
| trophamine | New Drug Application | 2022-08-22 |
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Agency Specific
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Patent Expiration
ATC Codes
R: Respiratory system drugs
— R05: Cough and cold preparations
— R05C: Expectorants, excl. combinations with cough suppressants
— R05CB: Mucolytics
— R05CB01: Acetylcysteine
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01X: Other ophthalmologicals in atc
— S01XA: Other ophthalmologicals in atc
— S01XA08: Acetylcysteine
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AB: Antidotes
— V03AB23: Acetylcysteine
HCPCS
Code | Description |
|---|---|
| J0132 | Injection, acetylcysteine, 100 mg |
| J7604 | Acetylcysteine, inhalation solution, compounded product, administered through dme, unit dose form, per gram |
| J7608 | Acetylcysteine, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose form, per gram |
Clinical
Clinical Trials
657 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Oxidative stress | D018384 | EFO_1001905 | — | 4 | 5 | 3 | 1 | 6 | 18 |
| Chronic renal insufficiency | D051436 | — | N18 | 1 | 3 | 7 | 1 | 3 | 14 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | 2 | 3 | 3 | 6 | 14 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | 2 | 5 | 5 | 12 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 3 | 8 | — | 2 | — | 12 |
| Cocaine-related disorders | D019970 | — | F14 | 5 | 4 | — | 1 | 1 | 11 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | 2 | 2 | 4 | 3 | 11 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 1 | 4 | — | 3 | 1 | 9 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 3 | 3 | — | 2 | 1 | 8 |
| Hypertension | D006973 | EFO_0000537 | I10 | 2 | — | — | 3 | 2 | 7 |
Show 61 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | U07.1 | 9 | 8 | 4 | — | 3 | 21 |
| Healthy volunteers/patients | — | — | — | 7 | — | 1 | — | 4 | 12 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | 1 | 3 | 2 | — | 3 | 7 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | 2 | 4 | 1 | — | 1 | 6 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 1 | 1 | 2 | — | 2 | 5 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | 4 | 2 | — | 1 | 5 |
| Bronchiectasis | D001987 | HP_0002110 | J47 | — | — | 1 | — | 3 | 4 |
| Retinitis pigmentosa | D012174 | HP_0000580 | H35.52 | 2 | 1 | 1 | — | — | 4 |
| Inflammation | D007249 | MP_0001845 | — | 2 | 1 | 1 | — | 1 | 4 |
| Diabetic foot | D017719 | EFO_1001459 | — | — | — | 1 | — | 3 | 4 |
Show 51 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | 3 | 4 | — | — | 3 | 9 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | 4 | 5 | — | — | 3 | 9 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 2 | 3 | — | — | 2 | 6 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 2 | 1 | — | — | 4 | 6 |
| Liver failure | D017093 | HP_0001399 | K72.9 | — | 3 | — | — | 2 | 5 |
| Aging | D000375 | GO_0007568 | R41.81 | 3 | 2 | — | — | — | 4 |
| Proteinuria | D011507 | HP_0000093 | R80 | — | 2 | — | — | 2 | 4 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 1 | 2 | — | — | 1 | 4 |
| Traumatic brain injuries | D000070642 | — | S06 | 1 | 3 | — | — | 1 | 4 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 4 | — | — | — | 4 |
Show 126 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | — | — | — | 1 | 3 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | — | — | — | 1 | 2 |
| Open-angle glaucoma | D005902 | EFO_0004190 | H40.1 | 1 | — | — | — | 1 | 2 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | 1 | — | — | — | 1 | 2 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | 1 | — | — | — | 1 | 2 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | 1 | — | — | — | — | 1 |
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | 1 | — | — | — | — | 1 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 1 | — | — | — | — | 1 |
| Central nervous system neoplasms | D016543 | — | — | 1 | — | — | — | — | 1 |
| Amyotrophic lateral sclerosis | D000690 | HP_0007354 | G12.21 | 1 | — | — | — | — | 1 |
Show 22 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Eye diseases | D005128 | EFO_0003966 | H44 | — | — | — | — | 4 | 4 |
| Insulin resistance | D007333 | HP_0000855 | E88.819 | — | — | — | — | 3 | 3 |
| Vascular dementia | D015140 | — | F01 | — | — | — | — | 2 | 2 |
| Male infertility | D007248 | EFO_0004248 | N46 | — | — | — | — | 2 | 2 |
| Humans | D006801 | — | STY/T016 | — | — | — | — | 2 | 2 |
| Culture media | D003470 | — | — | — | — | — | — | 2 | 2 |
| Blastocystis | D016844 | — | — | — | — | — | — | 2 | 2 |
| Lewy body disease | D020961 | EFO_0006792 | G31.83 | — | — | — | — | 1 | 1 |
| Neurodegenerative diseases | D019636 | EFO_0005772 | G31.9 | — | — | — | — | 1 | 1 |
| Hyperhomocysteinemia | D020138 | — | — | — | — | — | — | 1 | 1 |
Show 66 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Acetylcysteine |
| INN | acetylcysteine |
| Description | N-acetyl-L-cysteine is an N-acetyl-L-amino acid that is the N-acetylated derivative of the natural amino acid L-cysteine. It has a role as an antiinfective agent, an antioxidant, an antiviral drug, an antidote to paracetamol poisoning, a vulnerary, a mucolytic, a human metabolite, a radical scavenger, a ferroptosis inhibitor and a geroprotector. It is a L-cysteine derivative, an acetylcysteine and a N-acetyl-L-amino acid. It is a conjugate acid of a N-acetyl-L-cysteinate. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)N[C@@H](CS)C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 616-91-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL600 |
| ChEBI ID | 28939 |
| PubChem CID | 12035 |
| DrugBank | DB06151 |
| UNII ID | WYQ7N0BPYC (ChemIDplus, GSRS) |
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Acetadote – Cumberland Pharmaceuticals
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Acetylcysteine
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Trends
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Safety
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138,905 adverse events reported
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