You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR ALVIMOPAN


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Alvimopan

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00101998 ↗ Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication Completed GlaxoSmithKline Phase 2 2003-10-01 A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. The study will require five visits over a five-week period.
NCT00101998 ↗ Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication Completed Cubist Pharmaceuticals LLC Phase 2 2003-10-01 A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. The study will require five visits over a five-week period.
NCT00135577 ↗ Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects Completed GlaxoSmithKline Phase 2 2004-09-01 Study SB-767905/008 was a multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in participants with cancer pain. Study ABD101684 will serve as an extension to Study SB-767905/008 and offer continued access to blinded investigational product to participants who have completed the original study. The purpose of Study ABD101684 is to evaluate the safety and efficacy of alvimopan compared to placebo in subjects who completed Study SB-767905/008 and elected to participate in this extension study.
NCT00135577 ↗ Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects Completed Cubist Pharmaceuticals LLC Phase 2 2004-09-01 Study SB-767905/008 was a multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in participants with cancer pain. Study ABD101684 will serve as an extension to Study SB-767905/008 and offer continued access to blinded investigational product to participants who have completed the original study. The purpose of Study ABD101684 is to evaluate the safety and efficacy of alvimopan compared to placebo in subjects who completed Study SB-767905/008 and elected to participate in this extension study.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Alvimopan

Condition Name

Condition Name for Alvimopan
Intervention Trials
Ileus 10
Constipation 6
Bowel Dysfunction 6
Postoperative Ileus 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Alvimopan
Intervention Trials
Ileus 14
Intestinal Diseases 10
Constipation 7
Gastrointestinal Diseases 5
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Alvimopan

Trials by Country

Trials by Country for Alvimopan
Location Trials
United States 170
Canada 30
United Kingdom 16
Australia 14
Germany 11
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Alvimopan
Location Trials
California 7
Pennsylvania 7
Ohio 7
North Carolina 7
Florida 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Alvimopan

Clinical Trial Phase

Clinical Trial Phase for Alvimopan
Clinical Trial Phase Trials
Phase 4 6
Phase 3 12
Phase 2 7
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Alvimopan
Clinical Trial Phase Trials
Completed 21
Terminated 4
Recruiting 4
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Alvimopan

Sponsor Name

Sponsor Name for Alvimopan
Sponsor Trials
Cubist Pharmaceuticals LLC 15
GlaxoSmithKline 11
Merck Sharp & Dohme Corp. 6
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Alvimopan
Sponsor Trials
Industry 32
Other 22
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Alvimopan: Clinical Trials, Market Analysis, and Projections

Introduction to Alvimopan

Alvimopan, marketed under the brand name Entereg, is a peripherally acting mu-opioid receptor antagonist (PAM-OR) designed to mitigate the gastrointestinal side effects of opioids without interfering with their analgesic effects on the central nervous system. Here, we delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Accelerated Gastrointestinal Recovery

Clinical trials have consistently shown that alvimopan significantly accelerates gastrointestinal (GI) recovery in patients undergoing bowel resection surgeries. A phase 3 trial demonstrated that alvimopan, administered orally 30 to 90 minutes preoperatively and twice daily postoperatively, accelerated GI-2 and GI-3 recovery, and reduced the time to hospital discharge compared to a standardized accelerated postoperative care pathway alone[1].

Postoperative Ileus Management

Alvimopan has been shown to reduce postoperative ileus (POI) and associated morbidity. In a multicenter, randomized, double-blind, placebo-controlled trial, alvimopan treatment resulted in lower rates of postoperative ileus (5% vs 16%, P < 0.0001) and shorter hospital stays (median 4 vs 5 days, P < 0.0002)[4].

Opioid-Induced GI Side Effects

In a Phase 2b clinical study, alvimopan significantly improved gastrointestinal symptoms associated with opioid use, such as constipation, abdominal pain, and bloating. Patients treated with alvimopan reported a higher frequency of spontaneous bowel movements and improved health-related quality of life (HRQOL) compared to the placebo group[3].

Safety and Adverse Events

While alvimopan has shown significant benefits, it is not without side effects. Common adverse events include abdominal pain, nausea, and diarrhea, with an increased frequency at higher doses of alvimopan. However, these events were generally similar in frequency to those in the placebo group at the lower dose of 0.5 mg twice daily[3].

Market Analysis

Current Market Size and Growth

The alvimopan market was valued at USD 6.20 billion in 2023 and is expected to reach USD 6.51 billion in 2024, with a projected growth to USD 8.87 billion by 2030 at a compound annual growth rate (CAGR) of 5.23%[2].

Market Drivers

  • Rise in Surgical Interventions: The increasing number of abdominal surgeries globally drives the demand for alvimopan to manage postoperative ileus.
  • Growing Awareness of Opioid-Induced Complications: Enhanced recovery protocols and increased awareness of opioid-induced gastrointestinal side effects are key drivers.
  • Improved Healthcare Facilities: Advances in healthcare infrastructure worldwide contribute to the growing market for alvimopan[5].

Market Restraints

  • Strict Regulations and Approval Processes: The pharmaceutical industry faces stringent regulatory requirements, which can slow market growth.
  • Associated Side Effects: The risk of adverse events, although manageable, can impact market acceptance and patient compliance[5].

Market Opportunities

  • R&D Initiatives: Ongoing research and development to explore additional therapeutic applications of alvimopan offer potential for market expansion.
  • Investments in Healthcare Infrastructure: Increasing investments in public and private healthcare infrastructure can further boost the market[5].

Market Dynamics and Competitive Landscape

Porter's Five Forces Analysis

Understanding the competitive landscape using Porter's Five Forces framework is crucial for businesses operating in the alvimopan market. This framework helps assess the power dynamics, evaluate competitive positioning, and identify strategic opportunities. Key players in the market include Adolor Corporation, GlaxoSmithKline, Hikma Pharmaceuticals PLC, and Merck & Co., Inc.[2].

Leading Vendors and Innovations

Companies like Adolor Corporation and GlaxoSmithKline are at the forefront of developing and commercializing alvimopan. These companies are involved in extensive clinical studies and collaborative efforts to expand the drug's therapeutic applications and improve patient outcomes[3].

Projections and Future Outlook

Market Growth Projections

The alvimopan market is expected to continue growing, driven by the increasing need for effective management of postoperative ileus and opioid-induced gastrointestinal side effects. The projected CAGR of 5.23% indicates a steady and significant growth trajectory up to 2030[2].

Strategic Recommendations

For success in the alvimopan market, companies should focus on:

  • Navigating Regulatory Landscapes: Ensuring compliance with stringent regulations while demonstrating safety and efficacy.
  • Tailored Marketing Strategies: Developing strategies that highlight the clinical benefits and cost savings associated with alvimopan.
  • R&D and Innovation: Continuously exploring new therapeutic applications and improving the drug's profile to address emerging needs[5].

Key Takeaways

  • Alvimopan significantly accelerates gastrointestinal recovery and reduces postoperative ileus in patients undergoing bowel resection surgeries.
  • The drug is effective in managing opioid-induced gastrointestinal side effects without compromising analgesia.
  • The market for alvimopan is growing, driven by increasing surgical procedures and awareness of opioid-induced complications.
  • Key challenges include strict regulations and the risk of adverse events.
  • Future growth is expected, with a projected CAGR of 5.23% up to 2030.

FAQs

What is alvimopan used for?

Alvimopan is used to accelerate gastrointestinal recovery following bowel resection surgeries and to manage postoperative ileus and opioid-induced gastrointestinal side effects.

What are the key benefits of alvimopan in clinical trials?

Alvimopan has been shown to accelerate GI recovery, reduce postoperative ileus, and decrease hospital stay lengths. It also improves health-related quality of life (HRQOL) in patients with opioid-induced gastrointestinal symptoms.

What are the common adverse events associated with alvimopan?

Common adverse events include abdominal pain, nausea, and diarrhea, with an increased frequency at higher doses.

Who are the key players in the alvimopan market?

Key players include Adolor Corporation, GlaxoSmithKline, Hikma Pharmaceuticals PLC, and Merck & Co., Inc.

What is the projected market size for alvimopan by 2030?

The alvimopan market is projected to reach USD 8.87 billion by 2030, growing at a CAGR of 5.23%.

Sources

  1. JAMA Surgery: "Gastrointestinal Tract Recovery in Patients Undergoing Bowel Resection: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3b Trial"[1].
  2. GII Research: "Alvimopan Market by Therapeutic Application, End User, and Geography - Global Forecast to 2030"[2].
  3. Biospace: "GlaxoSmithKline And Adolor Corporation Present Positive Results From Phase 2 Clinical Study Of Alvimopan (Entereg)"[3].
  4. CINJ: "Alvimopan Provides Additional Improvement in Outcomes and Cost Savings in Enhanced Recovery Colorectal Surgery"[4].
  5. Research and Markets: "Alvimopan Market Size, Competitors & Forecast to 2030"[5].

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.