REGONOL (pyridostigmine bromide)
REGONOL is indicated for the treatment of Neuromuscular Blockade.
Details
- Status
- Prescription
- First Approved
- 1973-08-14
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
REGONOL Approval History
What REGONOL Treats
1 indicationsREGONOL is approved for 1 conditions since its original approval in 1973. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Neuromuscular Blockade
REGONOL Competitive Set
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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.
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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.
REGONOL FDA Label Details
Indications & Usage
FDA Label (PDF)REGONOL is indicated for the treatment of Neuromuscular Blockade.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.