NDAORALSOLUTION
Approved
May 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
4/8 — Partial
AXID (nizatidine) by ANI Pharmaceuticals is clinical pharmacology nizatidine is a competitive, reversible inhibitor of histamine at the histamine h 2 -receptors, particularly those in the gastric parietal cells. Approved for schizophrenia. First approved in 2004.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AXID (nizatidine) is an H2-receptor antagonist that competitively inhibits histamine-mediated gastric acid secretion for up to 12 hours, indicated for schizophrenia treatment as an oral solution. The drug works by blocking histamine at parietal cell H2-receptors, significantly reducing nocturnal and stimulated acid output with >70% oral bioavailability and rapid clearance (1-2 hour half-life).
LOE Approaching
Product is in decline phase with loss of exclusivity imminent; expect contraction of commercial team and shift toward generic management.
Mechanism of Action
CLINICAL PHARMACOLOGY Nizatidine is a competitive, reversible inhibitor of histamine at the histamine H 2 -receptors, particularly those in the gastric parietal cells. Antisecretory Activity Effects on Acid Secretion Nizatidine significantly inhibited nocturnal gastric acid secretion for up to 12…
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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.