Naldemedine
- Generic Name
- Naldemedine
- Brand Names
- Symproic, Rizmoic
- Drug Type
- Small Molecule
- Chemical Formula
- C32H34N4O6
- CAS Number
- 916072-89-4
- Unique Ingredient Identifier
- 03KSI6WLXH
- Background
Naldemedine is an opioid receptor antagonist . It is a modified form of Naltrexone to which a side chain has been added to increase molecular weight and polar surface area resulting in restricted transport across the blood brain barrier. Naldemedine was approved in 2017 in both the US and Japan for the treatment of Opioid-induced Constipation.
- Indication
For the treatment of opioid-induced constipation .
- Associated Conditions
- Opioid Induced Constipation (OIC)
- Associated Therapies
- -
The Effect of Naldemedine on Opioid-induced Bowel Dysfunction
- Conditions
- Interventions
- First Posted Date
- 2024-03-27
- Last Posted Date
- 2024-03-28
- Lead Sponsor
- Asbjørn Mohr Drewes
- Target Recruit Count
- 20
- Registration Number
- NCT06334198
- Locations
- 🇩🇰
Aalborg University Hospital, Aalborg, Denmark
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
- First Posted Date
- 2022-10-20
- Last Posted Date
- 2024-10-14
- Lead Sponsor
- Shionogi
- Target Recruit Count
- 24
- Registration Number
- NCT05588323
- Locations
- 🇫🇷
Chu de Caen, Caen, France
A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection
- Conditions
- Interventions
- First Posted Date
- 2020-04-21
- Last Posted Date
- 2022-01-18
- Lead Sponsor
- Shionogi
- Target Recruit Count
- 2
- Registration Number
- NCT04355169
- Locations
- 🇺🇸
Norton Hospital, Louisville, Kentucky, United States
🇺🇸Banner University Medical Center - Tucson, Tucson, Arizona, United States
🇺🇸CHRISTUS Trinity Clinic Research, Tyler, Texas, United States
Risk of Major Adverse Cardiovascular Events for Naldemedine and Other Medications for Opioid Induced Constipation in Adults With Chronic Non-Cancer Pain
- Conditions
- Interventions
- First Posted Date
- 2018-10-25
- Last Posted Date
- 2022-03-02
- Lead Sponsor
- BioDelivery Sciences International
- Target Recruit Count
- 34532
- Registration Number
- NCT03720613
- Locations
- 🇺🇸
Research Site, Wilmington, Delaware, United States
Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation
- First Posted Date
- 2013-11-25
- Last Posted Date
- 2017-05-30
- Lead Sponsor
- Shionogi
- Target Recruit Count
- 553
- Registration Number
- NCT01993940
- Locations
- 🇺🇸
Shionogi Research Site, Clarksburg, West Virginia, United States
Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation
- First Posted Date
- 2013-10-18
- Last Posted Date
- 2017-05-30
- Lead Sponsor
- Shionogi
- Target Recruit Count
- 547
- Registration Number
- NCT01965158
- Locations
- 🇬🇧
Shionogi Research Site, Tomairt, United Kingdom
Long Term Safety of Naldemedine
- First Posted Date
- 2013-10-18
- Last Posted Date
- 2018-04-18
- Lead Sponsor
- Shionogi
- Target Recruit Count
- 1246
- Registration Number
- NCT01965652
- Locations
- 🇬🇧
Shionogi Research Site, York, United Kingdom
A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy
- First Posted Date
- 2011-09-29
- Last Posted Date
- 2017-06-26
- Lead Sponsor
- Shionogi
- Target Recruit Count
- 244
- Registration Number
- NCT01443403
- Locations
- 🇺🇸
Shionogi Research Site, Salt Lake City, Utah, United States
Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain
- Conditions
- Interventions
- First Posted Date
- 2010-05-12
- Last Posted Date
- 2017-05-30
- Lead Sponsor
- Shionogi
- Target Recruit Count
- 72
- Registration Number
- NCT01122030
- Locations
- 🇺🇸
Shionogi Research Site, Salt Lake City, Utah, United States
Drug Development Updates
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