NDAORALTABLET
Approved
Dec 1980
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
REGLAN (metoclopramide hydrochloride) by ANI Pharmaceuticals is clinical pharmacology metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. First approved in 1980.
Drug data last refreshed 22h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REGLAN (metoclopramide HCl) is an oral small-molecule dopamine antagonist that enhances upper GI motility and prevents nausea/vomiting by blocking chemoreceptor trigger zone stimulation. It accelerates gastric emptying and increases lower esophageal sphincter pressure, making it effective for gastroparesis, gastroesophageal reflux, and post-operative nausea. The drug sensitizes GI tissues to acetylcholine while antagonizing central and peripheral dopamine receptors.
$0.088MPart D
LOE ApproachingLate-stage lifecycle with minimal Part D utilization (155 claims, $88K spending in 2023) indicates shrinking market; expect consolidation of commercial support and shift toward generic management focus.
Mechanism of Action
CLINICAL PHARMACOLOGY Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. Its mode of action is unclear. It seems to sensitize tissues to the action of acetylcholine. The effect of metoclopramide on motility is not…
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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.