MESTINON (pyridostigmine bromide)
Mestinon treats myasthenia gravis, a condition that affects the communication between nerves and muscles. It helps patients with this disorder by providing a longer duration of action compared to similar medications like neostigmine. This drug is often used because it tends to cause fewer gastrointestinal side effects while managing symptoms.
How MESTINON Works
This medication works by stopping the enzyme cholinesterase from breaking down acetylcholine. By preserving this chemical messenger, the drug allows nerve impulses to pass more freely across the neuromuscular junction. This improved transmission helps strengthen the connection between the nervous system and the muscles.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1955-04-06
- Routes
- ORAL, INJECTION
- Dosage Forms
- SYRUP, INJECTABLE, TABLET, EXTENDED RELEASE, TABLET
MESTINON Approval History
What MESTINON Treats
1 indicationsMESTINON is approved for 1 conditions since its original approval in 1955. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Myasthenia Gravis
MESTINON Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MESTINON
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05603715 | STUDY00001877 | Ph 2 | recruiting | Pyridostigmine for the Treatment of Constipation in Parkinson Disease |
| NCT05334485 PESTI | 21-915 | Ph 2, Ph 3 | recruiting | Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery |
| NCT02893553 results posted | WEC-16-015 | Ph 2 | completed | The Effects of Normalizing Blood Pressure on Cerebral Blood Flow in Hypotensive Individuals With Spinal Cord Injury |
| NCT02227823 EMOTAS | 1376 | Ph 2 | completed | Safety and Efficacy Study of Pyridostigmine on Patients With Spinal Muscular Atrophy Type 3 |
| NCT03674541 results posted | 2018P001871 | Ph 2 | completed | The Exercise Response to Pharmacologic Cholinergic Stimulation in Myalgic Encephalomyelitis / Chronic Fatigue Syndrome |
| NCT02308124 results posted | 1409066609 | Ph 4 | completed | Treatment and Prognosis of Neurogenic Orthostatic Hypotension : A Prospective Randomized Study |
| NCT01993680 | KEK-ZH-NR. 2011-0358 | Ph 2 | completed | Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease -Treatment |
| NCT03312244 | Ref. 1873 | Ph 2 | suspended | Pyridostigmine as Immunomodulator in People Living With HIV |
| NCT01415921 APP-HF results posted | 10-02167 10-02167, 1R01HL103988 | Ph 2 | completed | Safety Study of Pyridostigmine in Heart Failure |
| NCT02307526 results posted | WEC-11-04 | Ph 2 | completed | Acetylcholinesterase Inhibition and Orthostatic Hypotension in SCI |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MESTINON FDA Label Details
Indications & Usage
FDA Label (PDF)MESTINON is indicated for the treatment of Myasthenia Gravis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment