Neostigmine
Bloxiverz, Neostigmine Methylsulfate, Prevduo (neostigmine) is a small molecule pharmaceutical. Neostigmine was first approved as Bloxiverz on 2013-05-31. It is used to treat drug-induced abnormalities, myasthenia gravis, urinary bladder diseases, and urinary retention in the USA. It is known to target acetylcholinesterase.
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Commercial
Trade Name
FDA
EMA
Bloxiverz, Neostigmine methylsulfate (discontinued: Neostigmine methylsulfate)
CombinationsPrevduo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Neostigmine methylsulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BLOXIVERZ | Exela Pharma Sciences | N-204078 RX | 2013-05-31 | 3 products, RLD, RS |
| NEOSTIGMINE METHYLSULFATE | Fresenius Kabi | N-203629 RX | 2015-01-08 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bloxiverz | New Drug Application | 2023-12-31 |
| neostigmine | ANDA | 2023-05-15 |
| neostigmine methylsulfate | ANDA | 2025-07-18 |
| prevduo | New Drug Application | 2024-04-10 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| urinary retention | — | D016055 | R33 |
| myasthenia gravis | EFO_0004991 | D009157 | G70.0 |
| urinary bladder diseases | — | D001745 | N32.9 |
| drug-induced abnormalities | — | D000014 | — |
| respiratory tract diseases | — | D012140 | — |
| peptic ulcer | — | D010437 | K27 |
Agency Specific
FDA
EMA
No data
ATC Codes
N: Nervous system drugs
— N07: Other nervous system drugs in atc
— N07A: Parasympathomimetics
— N07AA: Anticholinesterase parasympathomimetics
— N07AA01: Neostigmine
— N07AA51: Neostigmine, combinations
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01E: Antiglaucoma preparations and miotics
— S01EB: Parasympathomimetics, antiglaucoma preparations and miotics
— S01EB06: Neostigmine
HCPCS
Code | Description |
|---|---|
| J2710 | Injection, neostigmine methylsulfate, up to 0.5 mg |
Clinical
Clinical Trials
273 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuromuscular blockade | D019148 | — | — | 2 | 5 | 7 | 31 | 15 | 58 |
| Delayed emergence from anesthesia | D055191 | — | — | 2 | 3 | — | 13 | 10 | 27 |
| Postoperative pain | D010149 | — | G89.18 | 1 | 4 | 4 | 2 | 7 | 16 |
| Anesthesia | D000758 | — | — | — | — | 2 | 3 | 6 | 11 |
| General anesthesia | D000768 | — | — | 1 | 3 | 5 | 1 | 2 | 11 |
| Post-dural puncture headache | D051299 | — | — | 2 | 3 | 2 | 3 | — | 8 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 5 | — | 1 | 1 | — | 7 |
| Muscle weakness | D018908 | — | — | — | — | 1 | 2 | 3 | 6 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | — | 1 | 1 | 2 | 2 | 6 |
| Urinary retention | D016055 | — | R33 | 1 | 2 | — | 3 | 1 | 6 |
Show 72 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neurogenic bowel | D055496 | EFO_1001061 | K59.2 | 5 | — | 1 | — | — | 6 |
| Constipation | D003248 | — | K59.0 | 3 | — | 1 | — | 1 | 5 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | 1 | 1 | — | 2 | 3 |
| Fecal incontinence | D005242 | — | R15 | 2 | — | 1 | — | — | 3 |
| Inguinal hernia | D006552 | HP_0000023 | K40 | — | 1 | 1 | — | 1 | 2 |
| Hernia | D006547 | — | K40-K46 | — | 1 | 1 | — | 1 | 2 |
| Hypospadias | D007021 | EFO_0004209 | Q54 | — | 1 | 1 | — | — | 1 |
| Burns | D002056 | — | T30.0 | — | — | 1 | — | — | 1 |
| Digestive system abnormalities | D004065 | — | Q45.9 | — | — | 1 | — | — | 1 |
| Muscle fatigue | D018763 | — | — | — | — | 1 | — | — | 1 |
Show 9 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | — | N19 | — | 1 | — | — | 2 | 3 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | 2 | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | 1 | — | — | — | 1 |
| Septic shock | D012772 | — | A48.3 | — | 1 | — | — | — | 1 |
| Pancreatitis | D010195 | EFO_0000278 | K85 | — | 1 | — | — | — | 1 |
| Intra-abdominal hypertension | D059325 | — | — | — | 1 | — | — | — | 1 |
| Systemic inflammatory response syndrome | D018746 | EFO_1001478 | R65.10 | 1 | 1 | — | — | — | 1 |
| Obstructive jaundice | D041781 | EFO_1001068 | — | 1 | 1 | — | — | — | 1 |
| Jaundice | D007565 | — | R17 | 1 | 1 | — | — | — | 1 |
Show 4 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Encopresis | D004688 | — | F98.1 | 2 | — | — | — | — | 2 |
| Gastrointestinal diseases | D005767 | — | — | 1 | — | — | — | 1 | 2 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | — | — | — | — | 1 |
| Labor pain | D048949 | — | — | 1 | — | — | — | — | 1 |
| Snoring | D012913 | — | R06.83 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Local anesthesia | D000772 | — | — | 1 | — | — | — | — | 1 |
| Vitreoretinal surgery | D057586 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Critical illness | D016638 | — | — | — | — | — | — | 4 | 4 |
| Myasthenia gravis | D009157 | EFO_0004991 | G70.0 | — | — | — | — | 4 | 4 |
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | — | — | — | 2 | 2 |
| Gallbladder diseases | D005705 | EFO_0003832 | K82.9 | — | — | — | — | 2 | 2 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | — | — | 2 | 2 |
| Psychomotor agitation | D011595 | — | — | — | — | — | — | 2 | 2 |
| Bariatric surgery | D050110 | — | — | — | — | — | — | 2 | 2 |
| Analgesia | D000698 | — | — | — | — | — | — | 2 | 2 |
| Aortic dissection | D000784 | — | I71.0 | — | — | — | — | 1 | 1 |
| Conduction anesthesia | D000765 | — | — | — | — | — | — | 1 | 1 |
Show 49 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Neostigmine |
| INN | neostigmine bromide |
| Description | Neostigmine is a quaternary ammonium ion comprising an anilinium ion core having three methyl substituents on the aniline nitrogen, and a 3-[(dimethylcarbamoyl)oxy] substituent at position 3. It is a parasympathomimetic which acts as a reversible acetylcholinesterase inhibitor. It has a role as an EC 3.1.1.7 (acetylcholinesterase) inhibitor and an antidote to curare poisoning. |
| Classification | Small molecule |
| Drug class | cholinesterase inhibitors (physostigmine type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN(C)C(=O)Oc1cccc([N+](C)(C)C)c1 |
Identifiers
| PDB | — |
| CAS-ID | 59-99-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL278020 |
| ChEBI ID | 7514 |
| PubChem CID | 4456 |
| DrugBank | DB01400 |
| UNII ID | 005SYP50G5 (ChemIDplus, GSRS) |
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Bloxiverz – Avadel Pharmaceuticals
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Neostigmine
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Safety
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861 adverse events reported
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