NDAORALTABLET, EXTENDED RELEASE
Approved
Oct 2024
Lifecycle
Growth
Competitive Pressure
0/100
Data completeness
3/8 — Basic
PYRIDOSTIGMINE BROMIDE (pyridostigmine bromide) by Novartis is clinical pharmacology regonol (pyridostigmine bromide injection, usp) an analogue of neostigmine, facilitates the transmission of impulses across the myoneural junction by inhibiting the destruction of acetylcholine by cholinesterase. First approved in 2024.
Drug data last refreshed 22h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Pyridostigmine bromide is an anticholinesterase agent that inhibits the destruction of acetylcholine at the myoneural junction, facilitating neuromuscular transmission. The extended-release oral formulation (approved October 2024) is used to treat myasthenia gravis and reverse neuromuscular blockade from nondepolarizing muscle relaxants. Pyridostigmine has a longer duration of action and lower incidence of side effects (bradycardia, salivation, GI stimulation) compared to neostigmine.
Growth11.9 years to LOE
Recent 2024 approval positions this as a growth-stage product with expansion potential; commercial teams will focus on market penetration in specialty neurology and perioperative settings.
Mechanism of Action
CLINICAL PHARMACOLOGY REGONOL (pyridostigmine bromide injection, USP) an analogue of neostigmine, facilitates the transmission of impulses across the myoneural junction by inhibiting the destruction of acetylcholine by cholinesterase. Currently available data indicate that pyridostigmine may have a…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.