SYMPROIC
Peaknaldemedine
NDAORALTABLET
Approved
Mar 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
8
Data completeness
4/8 — Partial
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SYMPROIC (naldemedine) is an oral tablet approved in March 2017 as a peripheral mu-opioid receptor antagonist for the treatment of opioid-induced constipation (OIC) in adult patients receiving opioid therapy for chronic pain. The drug works by blocking opioid receptors in the gastrointestinal tract without crossing the blood-brain barrier, thereby reversing constipation while preserving systemic analgesia. SYMPROIC represents a peripherally-selective mechanism distinct from systemic mu-opioid antagonists and addresses a significant unmet need in pain management.
$0.0BPart D
7.0 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
Prophylactic Use of Naldemedine on Opioid-induced Nausea and Vomiting in Patients With Cancer: POSEIDON Study
Started Jun 2025
120 enrolled
Opioid-Induced Constipation (OIC)
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
Started Jan 2023
24 enrolled
Opioid-Induced Constipation (OIC)
A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection
Started Nov 2020
2 enrolled
Postoperative Gastrointestinal Dysfunction
Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation
Started Nov 2013
553 enrolled
Opioid-induced Constipation
Long Term Safety of Naldemedine
Started Sep 2013
1,246 enrolled
Opioid-induced Constipation
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.