CLINICAL TRIALS PROFILE FOR ENTEREG

All Clinical Trials for ENTEREG

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01143259 ↗	Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use	Completed	Cubist Pharmaceuticals LLC	N/A	2010-05-01	The purpose of this study is to determine if the addition of alvimopan to our care process model for colon resection patients will decrease length of stay. The care process model is a combination of optimal IV fluid management, early feeding, early ambulation, patient education, and pain management.
NCT01143259 ↗	Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use	Completed	Intermountain Health Care, Inc.	N/A	2010-05-01	The purpose of this study is to determine if the addition of alvimopan to our care process model for colon resection patients will decrease length of stay. The care process model is a combination of optimal IV fluid management, early feeding, early ambulation, patient education, and pain management.
NCT00708201 ↗	A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy	Completed	Cubist Pharmaceuticals LLC	Phase 4	2009-03-01	This study is being conducted to determine whether alvimopan can accelerate recovery of gastrointestinal function following radical cystectomy when compared with a placebo. Secondary objectives of the study are: - to evaluate the effect of alvimopan on hospital length of stay - to evaluate the effect of alvimopan on prespecified postoperative ileus (POI)-related morbidities - to evaluate the overall and cardiovascular safety of alvimopan
NCT00256932 ↗	Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain	Completed	GlaxoSmithKline	Phase 3	2005-08-01	Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.
NCT00256932 ↗	Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain	Completed	Cubist Pharmaceuticals LLC	Phase 3	2005-08-01	Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.
NCT00259922 ↗	Alvimopan For The Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain	Completed	GlaxoSmithKline	Phase 3	2005-08-01	Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one of 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.
NCT00259922 ↗	Alvimopan For The Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain	Completed	Cubist Pharmaceuticals LLC	Phase 3	2005-08-01	Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one of 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.

Clinical Trial Conditions for ENTEREG

Condition Name

Condition Name for ENTEREG
Intervention	Trials
Ileus	6
Constipation	3
Bowel Dysfunction	2
Colorectal Surgery	2

Condition MeSH

Condition MeSH for ENTEREG
Intervention	Trials
Ileus	7
Constipation	3
Intestinal Diseases	2
Gastrointestinal Diseases	2

Clinical Trial Locations for ENTEREG

Trials by Country

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−

Trials by Country for ENTEREG
Location	Trials
United States	94
Canada	12
Germany	8
United Kingdom	7
Australia	5

Trials by US State

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−

Trials by US State for ENTEREG
Location	Trials
Ohio	5
California	4
North Carolina	4
Missouri	3
Mississippi	3

Clinical Trial Progress for ENTEREG

Clinical Trial Phase

Clinical Trial Phase for ENTEREG
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	5
Phase 2	2

Clinical Trial Status

Clinical Trial Status for ENTEREG
Clinical Trial Phase	Trials
Completed	9
Terminated	3
Recruiting	2

Clinical Trial Sponsors for ENTEREG

Sponsor Name

Sponsor Name for ENTEREG
Sponsor	Trials
Cubist Pharmaceuticals LLC	7
Merck Sharp & Dohme Corp.	5
GlaxoSmithKline	3

Sponsor Type

Sponsor Type for ENTEREG
Sponsor	Trials
Industry	15
Other	15

Entereg (Alvimopan): Clinical Trials, Market Analysis, and Projections

Introduction

Entereg, also known as alvimopan, is a peripherally acting μ-opioid receptor antagonist that has been approved by the FDA to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

Phase 4 Study

In a significant Phase 4 study, Entereg demonstrated its efficacy in accelerating gastrointestinal (GI) recovery and reducing hospital stay lengths. The study involved 280 patients undergoing radical cystectomy, where patients received either Entereg 12mg or a placebo once preoperatively and twice daily postoperatively for a maximum of 15 hospital doses. The results showed that the median time to achieve GI recovery was 1.2 days, and the mean and median postoperative hospital length of stay were 2.6 and 1.0 days shorter, respectively, for patients receiving Entereg compared to those receiving a placebo[3].

Efficacy and Safety

The efficacy of Entereg was assessed over a ten-day observation period, and safety was evaluated through 30 days after the last dose. The treatment-related adverse events included hypokalemia, anemia, and postoperative ileus. Notably, the incidence of cardiovascular events was lower in Entereg-treated patients (8.4%) compared to placebo-treated patients (15%)[3].

Multicenter Trials

Other multicenter, double-blind, placebo-controlled trials have also supported the efficacy of Entereg. These studies have consistently shown that Entereg accelerates the recovery of both upper and lower GI function and reduces the length of hospital stay following bowel resection surgeries[4].

Market Analysis

Market Size and Growth

The global Entereg (alvimopan) market has shown significant growth, driven by advancements in healthcare infrastructure and the rising demand for minimally invasive surgeries. As of 2024, the market size was estimated to be USD 6.51 billion, with a projected compound annual growth rate (CAGR) of 5.23% until 2030, reaching an estimated market value of USD 8.87 billion[5].

Key Growth Factors

• Advancements in Healthcare Infrastructure: Improved healthcare facilities and increased access to advanced surgical procedures have boosted the demand for Entereg.
• Rising Demand for Minimally Invasive Surgeries: The preference for minimally invasive surgeries, which often involve bowel resections, has increased the need for drugs like Entereg to manage postoperative ileus[5].

Market Segmentation

The market is segmented by therapeutic application and end-user. The primary therapeutic application is the prevention of postoperative ileus, while the key end-users are hospitals and surgical centers. The Americas, particularly the United States, and the Asia-Pacific region are significant markets for Entereg[5].

Competitive Landscape

The competitive landscape is characterized by a few key players, with Cubist Pharmaceuticals (now part of Merck) being a major player. The market is influenced by factors such as market share, business strategies, product portfolios, and regulatory approvals. The threat of new entrants and generic competition are also significant considerations[5].

Market Projections

Regional Analysis

The market is expected to grow significantly in emerging regions due to increasing awareness and improvements in healthcare infrastructure. The Americas and Asia-Pacific regions are anticipated to dominate the market during the forecast period[5].

Opportunities and Challenges

• Opportunities: Expanding presence in emerging markets, conducting awareness campaigns about enhanced recovery after surgery (ERAS) protocols, and developing improved formulations for broader patient applicability.
• Challenges: High costs, potential side effects, stringent regulatory frameworks, and the requirement of hospitalization for drug administration, which may restrict outpatient adoption[5].

Technological and Regulatory Trends

The market is influenced by technological advancements and regulatory factors. Innovations in manufacturing and R&D efforts are expected to drive the market forward. However, the drug's availability is restricted due to the Risk Evaluation and Mitigation Strategy (REMS) program, which limits its use to short-term administration (15 doses) due to the potential risk of myocardial infarction with long-term use[1][5].

Key Takeaways

• Clinical Efficacy: Entereg has consistently shown to accelerate GI recovery and reduce hospital stay lengths in clinical trials.
• Market Growth: The global Entereg market is projected to grow at a CAGR of 5.23% until 2030, driven by advancements in healthcare and rising demand for minimally invasive surgeries.
• Market Segmentation: The market is segmented by therapeutic application and end-user, with hospitals and surgical centers being key end-users.
• Challenges and Opportunities: Despite growth opportunities, the market faces challenges such as high costs, potential side effects, and stringent regulatory frameworks.

FAQs

What is Entereg (alvimopan) used for?

Entereg is used to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis[1].

What are the key findings from the Phase 4 study of Entereg?

The Phase 4 study showed that Entereg accelerated GI recovery and reduced hospital stay lengths compared to placebo. The median time to achieve GI recovery was 1.2 days, and the mean and median postoperative hospital length of stay were significantly shorter for Entereg-treated patients[3].

What is the projected market size of Entereg by 2030?

The global Entereg market is projected to reach an estimated value of USD 8.87 billion by 2030, growing at a CAGR of 5.23%[5].

What are the main challenges facing the Entereg market?

The main challenges include high costs, potential side effects, stringent regulatory frameworks, and the requirement of hospitalization for drug administration, which may restrict outpatient adoption[5].

Which regions are expected to dominate the Entereg market during the forecast period?

The Americas and Asia-Pacific regions are anticipated to dominate the market during the forecast period due to increasing awareness and improvements in healthcare infrastructure[5].

Sources

1. FDA Label for Entereg: "ENTEREG (alvimopan) capsules, for oral use" - FDA.
2. Global Entereg alvimopan Market Report 2024: Cognitivemarketresearch.com.
3. Cubist Entereg drug meets Phase 4 study endpoints: Clinicaltrialsarena.com.
4. Gastrointestinal Tract Recovery in Patients Undergoing Bowel Resection: Jamanetwork.com.
5. Alvimopan Market Size, Competitors & Forecast to 2030: Researchandmarkets.com.