Overview
A cholinesterase inhibitor used in the treatment of myasthenia gravis and to reverse the effects of muscle relaxants such as gallamine and tubocurarine. Neostigmine, unlike physostigmine, does not cross the blood-brain barrier.
Indication
Neostigmine is used for the symptomatic treatment of myasthenia gravis by improving muscle tone.
Associated Conditions
- Curarization therapy
- Myasthenia Gravis
- Neuromuscular Blockade
- Postoperative Urinary Retention (POUR)
- Acute Colonic Pseudo-Obstruction
- Post-operative intestinal atony
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/21 | Phase 1 | Completed | |||
2025/01/27 | Phase 1 | Recruiting | |||
2024/12/20 | N/A | Completed | |||
2024/12/11 | Phase 1 | Not yet recruiting | |||
2024/11/13 | N/A | Completed | Zulekha Hospitals | ||
2024/11/07 | Not Applicable | Not yet recruiting | |||
2024/10/08 | N/A | Completed | |||
2024/07/22 | Phase 2 | Not yet recruiting | |||
2024/07/15 | Early Phase 1 | Completed | |||
2024/07/10 | Phase 4 | Not yet recruiting | Minia University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Meitheal Pharmaceuticals Inc. | 71288-501 | INTRAVENOUS | 1.02 mg in 1 mL | 4/5/2021 | |
| Caplin Steriles Limited | 65145-112 | INTRAVENOUS | 1 mg in 1 mL | 4/26/2021 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-517 | INTRAVENOUS | 0.5 mg in 1 mL | 12/2/2022 | |
| BE Pharmaceuticals Inc. | 71839-106 | INTRAVENOUS | 1 mg in 1 mL | 3/17/2022 | |
| Amneal Pharmaceuticals LLC | 70121-1478 | INTRAVENOUS | 0.5 mg in 1 mL | 2/25/2021 | |
| Fresenius Kabi USA, LLC | 76045-214 | INTRAVENOUS | 1 mg in 1 mL | 3/30/2022 | |
| Gland Pharma Limited | 68083-384 | INTRAVENOUS | 1 mg in 1 mL | 2/17/2021 | |
| Civica, Inc. | 72572-462 | INTRAVENOUS | 1 mg in 1 mL | 4/7/2023 | |
| Medical Purchasing Solutions, LLC | 71872-7178 | INTRAVENOUS | 1 mg in 1 mL | 5/15/2023 | |
| Amphastar Pharmaceuticals, Inc. | 0548-9601 | INTRAVENOUS | 0.5 mg in 1 mL | 10/13/2017 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SETISIN INJECTION 2.5 mg/ml | SIN10993P | INJECTION | 2.5 mg/ml | 6/26/1999 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Neostigmine Methylsulfate for Injection | 国药准字H20040691 | 化学药品 | 注射剂 | 7/23/2020 | |
| Neostigmine Methylsulfate Injection | 国药准字H20258016 | 化学药品 | 注射剂 | 2/18/2025 | |
| Neostigmine Methylsulfate Injection | 国药准字H20057097 | 化学药品 | 注射剂 | 6/12/2024 | |
| Neostigmine Methylsulfate Injection | 国药准字H20253701 | 化学药品 | 注射剂 | 3/25/2025 | |
| Neostigmine Methylsulfate Injection | 国药准字H20249341 | 化学药品 | 注射剂 | 11/15/2024 | |
| Neostigmine Methylsulfate Injection | 国药准字H20253700 | 化学药品 | 注射剂 | 3/25/2025 | |
| Neostigmine Methylsulfate Injection | 国药准字H20244657 | 化学药品 | 注射剂 | 8/13/2024 | |
| Neostigmine Methylsulfate Injection | 国药准字H20244656 | 化学药品 | 注射剂 | 8/13/2024 | |
| Neostigmine Methylsulfate Injection | 国药准字H20233878 | 化学药品 | 注射剂 | 6/30/2023 | |
| Neostigmine Methylsulfate Injection | 国药准字H20243285 | 化学药品 | 注射剂 | 2/23/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| NEOSTIGMINE JUNO neostigmine methylsulfate 2.5 mg/1 mL solution for injection ampoule | 219054 | Medicine | A | 1/27/2015 | |
| NEOSTIGMINE JN neostigmine methylsulfate 0.5 mg/1 mL solution for injection ampoule | 11973 | Medicine | A | 7/31/1991 | |
| NOVISTIG glycopyrronium bromide (glycopyrrolate)/neostigmine methylsulfate 0.5 mg/2.5 mg per 1 mL injection solution ampoule | 303637 | Medicine | A | 8/20/2019 | |
| GLNEO 0.5/2.5 glycopyrronium bromide (glycopyrrolate) 0.5 mg/ neostigmine methylsulfate 2.5 mg in 1 mL solution for injection ampoule | 370932 | Medicine | A | 7/21/2022 | |
| GLYCONEO 0.5/2.5 glycopyrronium bromide (glycopyrrolate) 0.5 mg/neostigmine methylsulfate 2.5 mg in 1 mL solution for injection ampoule | 370931 | Medicine | A | 7/21/2022 |
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