Last reviewed 2026-04-20 · How we verify

Symproic (NALDEMEDINE)

Symproic works by blocking the mu-type opioid receptor, which is responsible for slowing down bowel movements.

Naldemedine (Symproic), marketed by Bdsi, is an approved treatment for opioid-induced constipation (OIC) that blocks the mu-type opioid receptor to alleviate symptoms. Its key strength lies in its mechanism of action, which specifically targets the receptor responsible for slowing bowel movements, offering a precise solution for OIC. The primary risk is the competitive landscape, with multiple same-class drugs such as methylnaltrexone, alvimopan, naloxegol, and naloxone, all of which are patent-protected until at least 2028.

At a glance

Mechanism of action

Naldemedine is an opioid antagonist with binding affinities for mu-, delta-, and kappa-opioid receptors. Naldemedine functions as peripherally-acting mu-opioid receptor antagonist in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids.Naldemedine is derivative of naltrexone to which side chain has been added that increases the molecular weight and the polar surface area, thereby reducing its ability to cross the blood-brain barrier (BBB). Naldemedine is also substrate of the P-glycoprotein (P-gp) efflux transporter. Based on these properties, the CNS penetration of naldemedine is expected to be negligible at the recommended dose levels, limiting the potential for interference with centrally-mediated opioid analgesia.

Approved indications

• Opioid-induced constipation (OIC)

Common side effects

• Abdominal pain
• Diarrhea
• Nausea
• Vomiting
• Gastroenteritis
• Opioid withdrawal
• Hyperhidrosis
• Hot flush or flushing
• Chills
• Tremor
• Tachycardia
• Anxiety

Drug interactions

• Strong CYP3A Inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort)
• Other Opioid Antagonists
• Moderate CYP3A Inhibitors (e.g., fluconazole, atazanavir, aprepitant, diltiazem, erythromycin)
• Strong CYP3A Inhibitors (e.g., itraconazole, ketoconazole, clarithromycin, ritonavir, saquinavir)
• P-glycoprotein (P-gp) Inhibitors (e.g., amiodarone, captopril, cyclosporine, quercetin, quinidine, verapamil)

Key clinical trials

• Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced CONstipation: Clinical Outcomes and Patient Experience
• Prophylactic Use of Naldemedine on Opioid-induced Nausea and Vomiting in Patients With Cancer: POSEIDON Study (PHASE4)
• Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids (PHASE1,PHASE2)
• Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
• The Effect of Naldemedine on Opioid-induced Bowel Dysfunction (PHASE2)
• Effects of a Peripherally Acting µ-opioid Receptor Antagonist on Recurrent Acute Pancreatitis (PHASE2,PHASE3)
• A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection (PHASE2)
• Long Term Safety of Naldemedine (PHASE3)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Symproic CI brief — competitive landscape report
• Symproic updates RSS · CI watch RSS
• Bdsi portfolio CI