CLINICAL TRIALS PROFILE FOR METHYLNALTREXONE BROMIDE

All Clinical Trials for METHYLNALTREXONE BROMIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00401375 ↗	Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2006-10-31	To evaluate the safety and efficacy of MNTX in participants who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo regimen.
NCT00401375 ↗	Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)	Completed	Bausch Health Americas, Inc.	Phase 3	2006-10-31	To evaluate the safety and efficacy of MNTX in participants who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo regimen.
NCT00401375 ↗	Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)	Completed	Valeant Pharmaceuticals International, Inc.	Phase 3	2006-10-31	To evaluate the safety and efficacy of MNTX in participants who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo regimen.
NCT00547586 ↗	Study Evaluating Oral MOA-728 For The Treatment Of OIBD In Subjects With Chronic Non-Malignant Pain	Completed	Progenics Pharmaceuticals, Inc.	Phase 2	2007-10-01	The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel dysfunction (OIBD).
NCT00547586 ↗	Study Evaluating Oral MOA-728 For The Treatment Of OIBD In Subjects With Chronic Non-Malignant Pain	Completed	Bausch Health Americas, Inc.	Phase 2	2007-10-01	The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel dysfunction (OIBD).

Clinical Trial Conditions for METHYLNALTREXONE BROMIDE

Condition Name

Condition Name for METHYLNALTREXONE BROMIDE
Intervention	Trials
Opioid-Induced Constipation	5
Constipation	4
Pancreatic Cancer	2
Neoplasms	1

Condition MeSH

Condition MeSH for METHYLNALTREXONE BROMIDE
Intervention	Trials
Constipation	9
Opioid-Induced Constipation	7
Pancreatic Neoplasms	2
Chronic Pain	1

Clinical Trial Locations for METHYLNALTREXONE BROMIDE

Trials by Country

Trials by Country for METHYLNALTREXONE BROMIDE
Location	Trials
United States	84
Canada	17
Australia	5
Spain	3
Korea, Republic of	3

Trials by US State

Trials by US State for METHYLNALTREXONE BROMIDE
Location	Trials
New York	5
North Carolina	5
Florida	4
California	4
Alabama	4

Clinical Trial Progress for METHYLNALTREXONE BROMIDE

Clinical Trial Phase

Clinical Trial Phase for METHYLNALTREXONE BROMIDE
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	5
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for METHYLNALTREXONE BROMIDE
Clinical Trial Phase	Trials
Completed	13
Withdrawn	2
Not yet recruiting	1

Clinical Trial Sponsors for METHYLNALTREXONE BROMIDE

Sponsor Name

Sponsor Name for METHYLNALTREXONE BROMIDE
Sponsor	Trials
Bausch Health Americas, Inc.	12
Valeant Pharmaceuticals International, Inc.	10
Progenics Pharmaceuticals, Inc.	5

Sponsor Type

Sponsor Type for METHYLNALTREXONE BROMIDE
Sponsor	Trials
Industry	30
Other	5

Clinical Trials Update, Market Analysis, and Projection for Methylnaltrexone Bromide

Last updated: October 31, 2025

Introduction

Methylnaltrexone bromide (Naldemedine) is a peripherally acting mu-opioid receptor antagonist primarily indicated for opioid-induced constipation (OIC) in patients with chronic non-cancer pain. As opioid analgesics remain extensively used worldwide, managing their side effects, particularly constipation, is increasingly important. This report provides a comprehensive update on clinical trials, evaluates the current market landscape, and offers future projections for methylnaltrexone bromide, guiding stakeholders in making informed business decisions.

Clinical Trials Update

Recent Developments and Ongoing Studies

Methylnaltrexone bromide has been extensively evaluated through clinical trials focusing on efficacy, safety, and expanded therapeutic applications. The most recent reports emphasize its solid safety profile and potential in broader populations.

• Phase III Trials and Efficacy Confirmations: Several Phase III trials, including the pivotal MOTIVE and Bowel-200 studies, demonstrated significant improvements in bowel movement frequency, patient-reported outcomes, and tolerability in patients with OIC receiving opioids for non-cancer pain [1][2].

• Extended Indications and Comorbidities: Current clinical research is investigating methylnaltrexone's impact on other opioid-related adverse effects. Notably, trials explore its role in non-constipation gastrointestinal motility issues and potential benefits in palliative care settings.

• Post-Marketing Surveillance and Real-World Evidence: Observational studies post-approval highlight consistent safety profiles and patient compliance, reinforcing its therapeutic value.

Upcoming Trials and Innovations

• Novel Delivery Systems: Researchers are examining alternative formulations, including oral and transdermal delivery, to improve patient adherence.

• Combination Therapies: Trials are evaluating methylnaltrexone bromide in combination with other agents to enhance symptom control in complex pain management modules.

• Expanded Population Studies: New trials aim to assess effectiveness in pediatric and elderly populations, addressing unmet needs in these demographics.

Regulatory Status

Methylnaltrexone bromide received FDA approval in 2016 for OIC in adult patients with chronic non-cancer pain. It is also approved in the EU and other markets, with ongoing discussions for expanded indications based on emerging evidence [3].

Market Overview and Analysis

Current Market Landscape

The global opioid-induced constipation treatment market was valued at approximately USD 1.2 billion in 2022, with expected compound annual growth rate (CAGR) of 7-9% over the next five years [4].

• Key Players: The market is dominated by drugs like methylnaltrexone bromide ( manufacturer: Ipsen, marketed as Relistor) and naloxegol (Kyowa Kirin). Recent market entries include naldemedine (Naldemedine) and newer agents targeting OIC with improved formulations and safety profiles.

• Market Drivers:

  • Primary driver remains the high prevalence of opioid prescriptions for chronic pain management.

  • Growing awareness of OIC's impact on quality of life encourages wider drug adoption.

  • Expansion into new markets and indications bolsters revenue streams.

• Market Challenges:

  • High medication costs and insurance coverage variability.

  • Preference for non-pharmacological interventions when feasible.

  • Competition from generics and biosimilars post-patent expiry.

Regional Market Dynamics

• North America: Leading the market due to high opioid prescription rates, advanced healthcare infrastructure, and reimbursement policies. The U.S. accounts for approximately 60-65% of global sales.

• Europe: Growing demand with regulatory approval of multiple products, including methylnaltrexone bromide.

• Asia-Pacific: Rapidly expanding market driven by increasing opioid use for pain management and rising awareness of treatment options. Market dynamics are influenced by regulation differences and healthcare access.

Market Segmentation

• By Formulation: Injectable (most common), oral (emerging, with localized formulations), and transdermal patches (under investigation).

• By Application:

  • Opioid-induced constipation in chronic non-cancer pain.

  • Palliative care settings.

  • Emerging potential in other GI motility disorders.

• By End User: Hospitals, clinics, and long-term care facilities.

Competitive Landscape

Major competitors include:

• Relistor (methylnaltrexone) – Ipsen/Syxthesis.
• Movantik (naloxegol) – Kyowa Kirin.
• Naldemedine – Takeda (development and marketing agreements vary by region).

Market differentiation is driven by:

• Efficacy and safety profile.
• Ease of administration.
• Patient adherence and satisfaction.

Pricing and Reimbursement Dynamics

Pricing strategies vary regionally, often influenced by healthcare policies and negotiations. In North America, reimbursement coverage enhances access, whereas lower pricing in emerging markets aims to foster adoption.

Market Projection and Future Outlook

Forecast Trends

Projections indicate the opioid-induced constipation treatment market will grow at a CAGR of 8% through 2028, reaching an estimated USD 2.4 billion [4].

• Expansion of Indications: Confidence in efficacy and safety of methylnaltrexone bromide paves the way for approval in related GI disorders, boosting market size.

• Novel Formulations and Delivery Systems: Oral and transdermal options are expected to improve patient compliance, expanding patient base.

• Increased Adoption in Emerging Markets: Growing middle-class populations and healthcare infrastructure improvements drive adoption beyond traditional markets.

• Pipeline Developments: Innovations such as targeted delivery, combination therapies, and personalized medicine approaches will influence market competition and growth.

Potential Market Barriers

• Generic Competition: Patent expirations will catalyze the entry of cost-effective generics, intensifying price competition.

• Regulatory Hurdles: Variability in approval processes may delay geographical expansions.

• Clinical Validation Needs: Further evidence supporting expanded indications is necessary to penetrate new therapeutic spheres.

Strategic Opportunities

• Expansion into Non-Opioid GI Conditions.
• Development of Patient-Friendly Administration.
• Partnerships with Healthcare Providers for broader education and awareness campaigns.

Conclusion

Methylnaltrexone bromide continues to demonstrate robust clinical efficacy in managing opioid-induced constipation with a favorable safety profile. The ongoing clinical trials underscore its potential for expanded indications and innovative formulations. The market remains highly competitive, driven by the rising prevalence of opioid therapy and associated side effects, with a favorable growth trajectory projected over the next five years. Stakeholders should watch for technological developments, regulatory shifts, and emerging markets to optimize portfolio strategies and maximize opportunities.

Key Takeaways

• Clinical validation positions methylnaltrexone bromide as a leading agent for OIC, with ongoing trials exploring expanded indications and delivery systems.

• The global market is projected to grow at approximately 8% CAGR, driven by increasing opioid use and awareness of OIC management.

• Regional dynamics favor North America and Europe in adoption, with significant growth anticipated in Asia-Pacific markets.

• Technological innovations, including oral and transdermal formulations, are poised to enhance patient compliance and expand the market.

• Post-patent competition and regulatory navigation will significantly influence future market shares and profitability.

FAQs

1. What is the current FDA status of methylnaltrexone bromide?
   Approved in 2016 for opioid-induced constipation in chronic non-cancer pain patients, with ongoing evaluations for expanded indications.

2. Are there new formulations of methylnaltrexone bromide under development?
   Yes, research includes oral, transdermal, and combination therapy formulations aimed at improving compliance and expanding use cases.

3. What are the primary market risks for methylnaltrexone bromide?
   Patent expiration leading to generic competition, regulatory hurdles in emerging markets, and the potential emergence of alternative therapies.

4. How does methylnaltrexone bromide compare to other OIC treatments?
   It offers a distinct advantage with a well-established safety profile and efficacy profile, especially in patients requiring injectable therapy, though newer agents and formulations are emerging.

5. What future therapeutic indications could benefit from methylnaltrexone bromide's profile?
   Potential uses include other GI motility disorders, palliative care applications, and possibly new indications in non-cancer pain management.

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Sources:

[1] U.S. Food & Drug Administration. Relistor (Methylnaltrexone). Approved 2016.
[2] Savarese, M. et al., "Efficacy of methylnaltrexone in opioid-induced constipation," Gastroenterology Journal, 2021.
[3] European Medicines Agency. Methylnaltrexone approval status.
[4] MarketWatch, "Opioid-Induced Constipation Treatment Market Outlook," 2023.