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Data updated: May 26, 2026

REGONOL (pyridostigmine bromide)

Other Approved 1973-08-14

REGONOL is indicated for the treatment of Neuromuscular Blockade.

Source: FDA Label • Novartis
1
Indication
--
Phase 3 Trials
52
Years on Market

Details

Status
Prescription
First Approved
1973-08-14
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: PYRIDOSTIGMINE BROMIDE

REGONOL Approval History

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Original
New Indication
New Form
Label Update
19 FDA actions from 1973 to 2021
Apr 2021 SUPPL
Label · Labeling
May 2016 SUPPL
Mfg · Manufacturing (CMC)
Jul 2013 SUPPL
Mfg · Manufacturing (CMC)

What REGONOL Treats

1 indications

REGONOL is approved for 1 conditions since its original approval in 1973. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Neuromuscular Blockade
Source: FDA Label

REGONOL Competitive Set

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Indication competitors

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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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Shared indications:
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Shared indications:
Neuromuscular Blockade
PREVDUO
GLYCOPYRROLATE
1 shared
AZURITY
Shared indications:
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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

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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.