NEOSTIGMINE METHYLSULFATE
Neostigmine methylsulfate helps patients recover from the effects of nondepolarizing neuromuscular blocking agents used during surgery. It is used to restore muscle function by reversing the blockade caused by these medications. This treatment is typically administered to patients in the post-operative period to ensure the effects of surgical blocking agents are neutralized.
How NEOSTIGMINE METHYLSULFATE Works
This medication works by inhibiting cholinesterase, the enzyme that breaks down acetylcholine. By reducing this breakdown, the drug increases the amount of acetylcholine available to compete with blocking agents for binding sites. This process effectively reverses the neuromuscular blockade and allows for the return of normal muscle activity.
Details
- Status
- Prescription
- First Approved
- 2015-01-08
- Routes
- INTRAVENOUS, INJECTION
- Dosage Forms
- SOLUTION, INJECTABLE
Companies
NEOSTIGMINE METHYLSULFATE Approval History
What NEOSTIGMINE METHYLSULFATE Treats
1 indicationsNEOSTIGMINE METHYLSULFATE is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Nondepolarizing neuromuscular blockade (post-surgery)
NEOSTIGMINE METHYLSULFATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
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.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05289323 | IRB NO: 00012098 SN: 0305408 | Ph 4 | completed | Effect of Intrathecal Neostigmine on Post-dural Puncture Headache. |
| NCT03587441 | M335 | Ph 4 | completed | Intrathecal Neostigmine for Prevention of PDPH |
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.
NEOSTIGMINE METHYLSULFATE FDA Label Details
Indications & Usage
FDA Label (PDF)NEOSTIGMINE METHYLSULFATE is indicated for the treatment of Nondepolarizing neuromuscular blockade (post-surgery).
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BLOXIVERZ
Full clinical data, patents, trials, and competitive landscape for neostigmine methylsulfate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.