NDAORALCAPSULE
Approved
May 2008
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
16
Data completeness
4/8 — Partial
ENTEREG (alvimopan) by Merck & Co. is μ-opioid receptor with a ki of 0. First approved in 2008.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ENTEREG (alvimopan) is an oral, peripherally-selective μ-opioid receptor antagonist approved for reducing postoperative ileus in patients receiving opioid analgesics after abdominal surgery. It works by competitively blocking opioid effects on gastrointestinal motility while preserving central pain relief, thereby accelerating bowel recovery and hospital discharge. Alvimopan demonstrates high receptor affinity (Ki 0.4 nM) with selectivity for the GI tract and no activity at 70+ non-opioid targets.
LOE Approaching3.6 years to LOE
Product is at peak lifecycle stage with 3.7 years of patent protection remaining; brand teams are likely focused on defending market share and preparing for generic competition.
Mechanism of Action
μ-opioid receptor with a Ki of 0.4 nM (0.2 ng/mL) and no measurable opioid-agonist effects in standard pharmacologic assays. The dissociation of [H]-alvimopan from the human μ-opioid receptor is slower than that of other opioid ligands, consistent with its higher affinity for the receptor. At…
Indications
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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.