Overview
Myasthenia gravis is an autoimmune disease involving dysfunction at the neuromuscular junction, most commonly due to autoantibodies directed against the acetylcholine receptor (AChR), which results in muscle tone loss, muscle weakness, and fatigue. Acetylcholinesterase inhibitors have been the symptomatic treatment of choice in myasthenia gravis since the 1930s with the early use of physostigmine and neostigmine. By inhibiting the breakdown of acetylcholine in the neuromuscular junction, they increase signalling and relieve symptoms. Pyridostigmine is the current drug of choice, with superior pharmacokinetics and reduced side effects compared to neostigmine. In addition to treating myasthenia gravis, pyridostigmine is used to reverse neuromuscular blocks, relieve symptoms in congenital myasthenic syndromes, and protect against certain nerve agents, notably during the Gulf War. Pyridostigmine was granted initial FDA approval on April 6, 1955, as an oral tablet. Possible dose forms have been expanded to include extended-release tablets, syrups, and injections, marketed under various brand and generic names.
Indication
Pyridostigmine is indicated for the treatment of myasthenia gravis. When administered intravenously, it is indicated for the reversal or antagonism of the neuromuscular blocking effects of nondepolarizing muscle relaxants. Pyridostigmine has also been used as a prophylactic agent against irreversible organophosphorus acetylcholinesterase inhibitors, primarily in a military capacity.
Associated Conditions
- Congenital Myasthenia (CM)
- Constipation
- Myasthenia Gravis
- Neuromuscular Blockade
- Post-Poliomyelitis Syndrome
- Orthostatic syncope
- Soman nerve gas poisoning
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/08 | Phase 2 | Withdrawn | |||
2025/03/25 | Phase 4 | Completed | |||
2024/04/16 | Phase 2 | Recruiting | |||
2023/09/13 | Phase 4 | Recruiting | |||
2023/08/01 | Phase 4 | Completed | |||
2023/06/26 | Phase 3 | Recruiting | Leiden University Medical Center | ||
2022/11/03 | Phase 2 | Recruiting | |||
2022/04/19 | Phase 2 | Recruiting | Stefan Holubar MD MS FACS, FASCRS | ||
2021/11/08 | Phase 4 | UNKNOWN | |||
2020/04/20 | Phase 1 | ENROLLING_BY_INVITATION |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Amneal Pharmaceuticals of New York LLC | 0115-2134 | ORAL | 30 mg in 1 1 | 12/31/2023 | |
| Major Pharmaceuticals | 0904-6622 | ORAL | 60 mg in 1 1 | 5/4/2017 | |
| American Health Packaging | 68084-494 | ORAL | 60 mg in 1 1 | 2/23/2024 | |
| Athem LLC | 73152-028 | ORAL | 60 mg in 5 mL | 3/23/2023 | |
| Method Pharmaceuticals, LLC | 58657-810 | ORAL | 30 mg in 1 1 | 12/9/2023 | |
| NuCare Pharmaceuticals,Inc. | 68071-5032 | ORAL | 180 mg in 1 1 | 2/19/2021 | |
| Amneal Pharmaceuticals of New York LLC | 0115-1404 | ORAL | 180 mg in 1 1 | 1/31/2019 | |
| Rising Pharma Holdings, Inc. | 16571-833 | ORAL | 60 mg in 5 mL | 9/7/2022 | |
| VistaPharm, LLC | 66689-406 | ORAL | 60 mg in 5 mL | 9/1/2023 | |
| Acella Pharmaceuticals, LLC | 42192-626 | ORAL | 60 mg in 5 mL | 10/9/2023 |
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 |
|---|---|---|---|---|---|
| MESTINON TABLET 60 mg | SIN02898P | TABLET, SUGAR COATED | 60 mg | 5/22/1989 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| MESTINON pyridostigmine bromide 10mg tablet bottle | 13747 | Medicine | A | 8/23/1991 | |
| MESTINON pyridostigmine bromide 60mg tablet bottle | 13748 | Medicine | A | 8/23/1991 | |
| MESTINON TIMESPAN pyridostigmine bromide 180mg tablet bottle | 13749 | Medicine | A | 8/23/1991 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| MESTINON-SR | bausch health, canada inc. | 00869953 | Tablet (Extended-Release) - Oral | 180 MG | 12/31/1991 |
| REGONOL INJ 5MG/ML | organon canada ltd ltee | 00404217 | Liquid - Intravenous
,
Intramuscular | 5 MG / ML | 12/31/1977 |
| MESTINON | bausch health, canada inc. | 00869961 | Tablet - Oral | 60 MG | 12/31/1990 |
| JAMP PYRIDOSTIGMINE BROMIDE | 02508362 | Tablet - Oral | 60 MG | 3/7/2023 | |
| RIVA-PYRIDOSTIGMINE | laboratoire riva inc. | 02495643 | Tablet - Oral | 60 MG | 8/24/2020 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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