SYMPROIC
Peaknaldemedine
NDAORALTABLET
Approved
Mar 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
9
Data completeness
4/8 — Partial
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SYMPROIC (naldemedine) is an oral small-molecule peripheral mu-opioid receptor antagonist approved in March 2017 for opioid-induced constipation (OIC) in adult patients receiving opioid therapy for chronic pain. It selectively blocks opioid receptors in the gastrointestinal tract without crossing the blood-brain barrier, preserving systemic analgesia while reversing constipation.
$12.0MPart D
PeakStable
6.6 years to LOEProduct is in peak commercial phase with modest spending (~$12M in 2023) suggesting stable market presence; brand team likely lean and maintenance-focused.
Mechanism 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 (9)
Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced CONstipation: Clinical Outcomes and Patient Experience
Started Jan 2026
100 enrolled
CancerOpioid Induced Constipation (OIC)
Prophylactic Use of Naldemedine on Opioid-induced Nausea and Vomiting in Patients With Cancer: POSEIDON Study
Started Jun 2025
120 enrolled
Opioid-Induced Nausea and Vomitting(OINV)
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
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.