Drugs / Alvimopan
Alvimopan
also known as
Entereg · ADL 8-2698 · Alvimopan anhydrous · Alvimopan dihydrate · Anhydrous alvimopan · LY-246736 · LY-246736 DIHYDRATE
Small molecule targets OPRM1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ENTEREG | — | 2013-10-18 | fda.gov ↗ |
| Approved | US (FDA) | ENTEREG | — | 2008-05-20 | fda.gov ↗ |
Trials 19 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 trials | ||||||
| Phase 2 | NCT03352414 | Mar 2018 → Apr 2020 | ileus | University of California, San Diego | Terminated | No outcome recorded |
| Phase 2 | NCT00331045 | Apr → Oct 2006 | cancer, constipation disorder | Merck & Co., Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT00135577 | Sep 2004 → Apr 2007 | bowel dysfunction, cancer | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00101998 | Oct 2003 → May 2006 | constipation disorder | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 310 trials | ||||||
| Phase 3 | NCT06703476 | Nov 2024 → Nov 2028 expected | urinary bladder cancer | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 3 | NCT02742181 | Dec 2015 → Jul 2018 | ileus | Sharon Stein | Terminated | No outcome recorded |
| Phase 3 | NCT01704651 | Jan 2013 → Aug 2015 | fallopian tube cancer, ovarian cancer, peritoneum cancer | Jamie N. Bakkum-Gamez | Completed | No outcome recorded |
| Phase 3 | NCT00241722 | Aug 2005 → Feb 2007 | constipation disorder | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00256932 | Aug 2005 → May 2006 | constipation disorder | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00259922 | Aug 2005 → Jun 2006 | constipation disorder | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00205842 | Jun 2004 → Dec 2005 | ileus | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00388401 | Jan 2002 → Jun 2003 | ileus | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00388479 | Dec 2001 → Nov 2003 | ileus | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00388258 | Mar 2001 → Dec 2002 | ileus | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT04405037 | Aug 2020 → Apr 2024 | bowel dysfunction, ileus | Scott Steele | Completed | No outcome recorded |
| Phase 4 | NCT03068975 | Sep 2017 → Nov 2019 | ileus | University of Puerto Rico | Terminated | No outcome recorded |
| Phase 4 | NCT00708201 | Mar 2009 → Jan 2012 | ileus | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02379858 | Jul 2015 → May 2018 | — | Medical College of Wisconsin | Terminated | No outcome recorded |
| — | NCT02218190 | Aug 2014 → Jan 2016 | ileus | Washington University School of Medicine | Completed | No outcome recorded |
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01258569 Comparator | Nov 2010 → Jul 2015 | — | Hartford Hospital | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03216525 Comparator | Oct 2018 → Dec 2023 overdue | urinary bladder cancer | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02785003 Background | Jul 2016 → Aug 2017 | neuropathy, painful | Medical College of Wisconsin | Withdrawn | No outcome recorded |
| Phase 4 | NCT02789111 Comparator | Jun 2016 → Dec 2018 | constipation disorder | University of Virginia | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01143259 Comparator | May 2010 → Jun 2012 | ileus | Intermountain Health Care, Inc. | Completed | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Alvimopan | “Alvimopan (Entereg), an oral peripherally- acting mu-opioid receptor antagonist, is the first and only drug approved by the FDA to accelerate the time to upper and lower GI...” NCT01258569 ↗23“The treatment group will receive 12mg of Alvimopan by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.” NCT01143259 ↗ “Alvimopan is a peripheral-acting opiate antagonist designed to decrease the gastrointestinal complications of perioperative systemic opioid administration.” NCT02789111 ↗ |
| Known as | ADL 8-2698 | ChEMBL registry synonym — accepted as the source's own label CHEMBL270190 ↗ |
| Known as | Alvimopan anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL270190 ↗ |
| Known as | Alvimopan dihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL270190 ↗ |
| Known as | Anhydrous alvimopan | ChEMBL registry synonym — accepted as the source's own label CHEMBL270190 ↗ |
| Known as | Entereg | “Alvimopan (Entereg), an oral peripherally- acting mu-opioid receptor antagonist, is the first and only drug approved by the FDA to accelerate the time to upper and lower GI...” NCT01258569 ↗1“Oral Alvimopan (Entereg, Merck) 12 mg between 30 minutes and 3 hours before surgery start and twice-daily oral doses postoperatively beginning on day one (AM and PM dosing)...” NCT03216525 ↗ |
| Known as | LY-246736 | ChEMBL registry synonym — accepted as the source's own label CHEMBL270190 ↗ |
| Known as | LY-246736 DIHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL270190 ↗ |
| Action | Inhibit | “a peripherally acting mu-opioid receptor (PAM-OR) antagonist” PMID 20526599 ↗ Sep 20101“Mu opioid receptor antagonist” CHEMBL270190 ↗ |
| Modality | Small molecule | — CHEMBL270190 ↗ |
| Route | Oral | “0.5 milligrams (mg) of alvimopan was administered orally BID for 3 weeks.” NCT00101998 ↗ |
| Target | OPRM1 | “Mu opioid receptor antagonist” CHEMBL270190 ↗ |