Entereg

(Alvimopan)

ApprovedSmall molecule

Alvimopan is used to help restore normal bowel function after abdominal surgery by blocking opioid medications from slowing down the digestive system.[2] Entereg is currently approved and in use across 9 indications[4].[1]

Entereg is one of 156 small molecule programs targeting Ventral Hernia. It is currently in Approved.

Indications

Total Trials

Active Trials

155

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Ventral HerniaActive, not recruiting

Peritoneum CancerApproved

Urinary Bladder CarcinomaApproved

IleusTerminated

Gastrointestinal DiseaseActive, not recruiting

Fallopian Tube CancerApproved

Ovarian CancerApproved

Bladder CancerRecruiting

Urinary Bladder CancerApproved

Ventral HerniaPreclinical

Active, not recruiting

Peritoneum CancerApproved

Approved

Urinary Bladder CarcinomaApproved

Approved

IleusApproved

Terminated

Gastrointestinal DiseaseApproved

Active, not recruiting

Fallopian Tube CancerApproved

Approved

Ovarian CancerApproved

Approved

Bladder CancerPhase 3

Recruiting

Urinary Bladder CancerApproved

Approved

Competition

Competitive Landscape

209 competitors in Ovarian Cancer

#DrugCompanyPhaseTrials

Entereg

Merck & Co.

Approved

23 2

Avastin

Roche

Phase 3

92 3

Gemzar

Johnson & Johnson

Phase 3

33 4

Keytruda

Merck & Co.

Phase 3

28 5

Hycamtin

MMeitheal

Phase 3

26 6

Cytoxan

BBaxter Healthcare Corporation

Phase 3

24 7

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

24 8

Femara

Novartis

Phase 3

8 9

Imfinzi

AstraZeneca

Phase 3

8 10

Opdivo

Bristol-Myers Squibb

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2028

Phase 3Recruiting

Bladder Cancer

NCT06703476

Clinical

Trials by Indication[1]

Postoperative Ileus6 trials

A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00708201·280 enrolled

Alvimopan as a Rescue Treatment of Postoperative Ileus

Completed·SScott Steele·Phase 4·NCT04405037·65 enrolled

Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00205842·660 enrolled

Show 3 more trials

Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00388401·510 enrolled

Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/ Postoperative Ileus

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00388479·666 enrolled

Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00388258·451 enrolled

Constipation5 trials

Alvimopan For The Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00259922·485 enrolled

Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00101998·233 enrolled

Clinical Evaluation Of Alvimopan (SB767905) On Constipation And Related Symptoms Associated With Opioid

Terminated· Merck & Co. logo

Merck & Co.·Phase 2·NCT00331045·21 enrolled

Show 2 more trials

Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00241722·805 enrolled

Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00256932·518 enrolled

Ileus2 trials

Alvimopan and Ileus in PSF

Completed·WWashington University School of Medicine·N/A·NCT02218190·31 enrolled

Alvimopan as Rescue in Post op Ileus

Terminated·SSharon Stein·Phase 3·NCT02742181·14 enrolled

Spine Surgery1 trial

Trial of Alvimopan in Major Spine Surgery

Completed·UUniversity of Virginia·Phase 4·NCT02789111·49 enrolled

Enhanced Recovery1 trial

Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol

Recruiting·—·Phase 3·NCT03216525·136 enrolled

8 more indications

Gastrointestinal1 trial

Accelerating Gastrointestinal Recovery

Completed·—·Phase 3·NCT01704651·146 enrolled

Polytrauma1 trial

Alvimopan Use in Polytraumatized Patients

Terminated·UUniversity of Puerto Rico·Phase 4·NCT03068975·3 enrolled

Outcome1 trial

Clinical Outcomes After Bowel Resection in Patients Receiving Alvimopan Versus Patients Not Receiving Alvimopan in the Premier Perspective Database

Completed· Merck & Co. logo

Merck & Co.··NCT01150760·7,050 enrolled

Colorectal Surgery1 trial

Ketamine in Colorectal Surgery

Withdrawn·MMedical College of Wisconsin·Phase 4·NCT02785003

Cancer Pain1 trial

Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00135577·67 enrolled

Phase 21 trial

Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC

Terminated·UUniversity of California, San Diego·Phase 2·NCT03352414·84 enrolled

Ventral Hernia1 trial

Gastrointestinal Tract Recovery in Patients Undergoing Open Ventral Hernia Repair

Terminated·MMedical College of Wisconsin·N/A·NCT02379858·10 enrolled

Bladder Cancer1 trial

A Clinically Integrated Randomized Clinical Trial (RCT) of Modifications to Radical Cystectomy and Postoperative Care

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 3·NCT06703476·530 enrolled

Regulatory

FDA Approval Timeline[5]

May 20, 2008

ENTEREG

NDA NDA021775

Sources

References

[1]
ClinicalTrials.gov — 23 trial records for Alvimopan. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Entereg drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Alvimopan compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Alvimopan. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021775). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Entereg. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Merck & Co. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Mu Opioid Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Merck & Co.

Patent Landscape[6]

Patent Cliff

Feb 12, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8946262Feb 12, 2030

Entereg

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2028

Trials by Indication[1]

Postoperative Ileus6 trials

Constipation5 trials

Ileus2 trials

Spine Surgery1 trial

Enhanced Recovery1 trial

Gastrointestinal1 trial

Polytrauma1 trial

Outcome1 trial

Colorectal Surgery1 trial

Cancer Pain1 trial

Phase 21 trial

Ventral Hernia1 trial

Bladder Cancer1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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