CLINICAL TRIALS PROFILE FOR MOVANTIK

All Clinical Trials for MOVANTIK

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02705378 ↗	The Effect of Naloxegol on Refractory Constipation in the Intensive Care Unit	Withdrawn	AstraZeneca	Phase 3	2017-05-01	Naloxegol has recently been approved by the US Food and Drug Administration to treat opioid induced constipation in non-cancer chronic pain patients. Its effectiveness in acute care patients, however, is not known. Therefore, the researchers' goal is to investigate whether naloxegol is superior to osmotic laxatives for refractory constipation in ICU patients already receiving prophylactic stool softeners and simulant laxatives through a double-blind, randomized control trial.
NCT02705378 ↗	The Effect of Naloxegol on Refractory Constipation in the Intensive Care Unit	Withdrawn	Massachusetts General Hospital	Phase 3	2017-05-01	Naloxegol has recently been approved by the US Food and Drug Administration to treat opioid induced constipation in non-cancer chronic pain patients. Its effectiveness in acute care patients, however, is not known. Therefore, the researchers' goal is to investigate whether naloxegol is superior to osmotic laxatives for refractory constipation in ICU patients already receiving prophylactic stool softeners and simulant laxatives through a double-blind, randomized control trial.
NCT02737059 ↗	Effect of Naloxegol on Gastric, Small Bowel, and Colonic Transit in Healthy Subjects	Completed	AstraZeneca	Phase 1	2016-07-01	This research study was being done to study the effect of codeine and Naloxegol for 3 days compared to placebo on the movement of food through the colon of healthy individuals. Codeine is a commonly used pain-relieving drug that often causes constipation as an unwanted side effect. Naloxegol is a medication recently approved by the FDA for treatment of constipation induced by Codeine. The hypothesis for this study was that Naloxegol reduces the retardation of small bowel and colonic transit induced by codeine in healthy participants.
NCT02737059 ↗	Effect of Naloxegol on Gastric, Small Bowel, and Colonic Transit in Healthy Subjects	Completed	Michael Camilleri	Phase 1	2016-07-01	This research study was being done to study the effect of codeine and Naloxegol for 3 days compared to placebo on the movement of food through the colon of healthy individuals. Codeine is a commonly used pain-relieving drug that often causes constipation as an unwanted side effect. Naloxegol is a medication recently approved by the FDA for treatment of constipation induced by Codeine. The hypothesis for this study was that Naloxegol reduces the retardation of small bowel and colonic transit induced by codeine in healthy participants.
NCT02745353 ↗	Naloxegol in Cancer Opioid-Induced Constipation	Terminated	AstraZeneca	Phase 2	2016-05-01	The purpose of this study is to compare the effect of naloxegol versus the patient's usual care in treating opioid-induced constipation, as well as the effect on the patient's quality of life and how much pain is experienced. Also, the purpose of this study is to compare whether treatment with naloxegol versus usual care has any impact on the number of hospital or clinic visits or telephone calls to the patient's physician that are related to constipation, and to determine the patient's preference for continuing to receive naloxegol as treatment for opioid-induced constipation.
NCT02745353 ↗	Naloxegol in Cancer Opioid-Induced Constipation	Terminated	Joseph Ma	Phase 2	2016-05-01	The purpose of this study is to compare the effect of naloxegol versus the patient's usual care in treating opioid-induced constipation, as well as the effect on the patient's quality of life and how much pain is experienced. Also, the purpose of this study is to compare whether treatment with naloxegol versus usual care has any impact on the number of hospital or clinic visits or telephone calls to the patient's physician that are related to constipation, and to determine the patient's preference for continuing to receive naloxegol as treatment for opioid-induced constipation.
NCT02745353 ↗	Naloxegol in Cancer Opioid-Induced Constipation	Terminated	University of California, San Diego	Phase 2	2016-05-01	The purpose of this study is to compare the effect of naloxegol versus the patient's usual care in treating opioid-induced constipation, as well as the effect on the patient's quality of life and how much pain is experienced. Also, the purpose of this study is to compare whether treatment with naloxegol versus usual care has any impact on the number of hospital or clinic visits or telephone calls to the patient's physician that are related to constipation, and to determine the patient's preference for continuing to receive naloxegol as treatment for opioid-induced constipation.

Clinical Trial Conditions for MOVANTIK

Condition Name

Condition Name for MOVANTIK
Intervention	Trials
Constipation	6
Constipation Drug Induced	3
Opioid-Induced Disorders	1
Pain	1

Condition MeSH

Condition MeSH for MOVANTIK
Intervention	Trials
Constipation	10
Opioid-Induced Constipation	6
Critical Illness	2
Pelvic Pain	1

Clinical Trial Locations for MOVANTIK

Trials by Country

Trials by Country for MOVANTIK
Location	Trials
United States	37
Belgium	1

Trials by US State

Trials by US State for MOVANTIK
Location	Trials
Ohio	4
Massachusetts	4
Pennsylvania	3
North Carolina	2
New York	2

Clinical Trial Progress for MOVANTIK

Clinical Trial Phase

Clinical Trial Phase for MOVANTIK
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for MOVANTIK
Clinical Trial Phase	Trials
Terminated	5
Completed	3
Withdrawn	3

Clinical Trial Sponsors for MOVANTIK

Sponsor Name

Sponsor Name for MOVANTIK
Sponsor	Trials
AstraZeneca	8
Temple University	2
Massachusetts General Hospital	2

Sponsor Type

Sponsor Type for MOVANTIK
Sponsor	Trials
Other	18
Industry	8

Clinical Trials Update, Market Analysis, and Projection for Movantik (Naloxegol)

Last updated: October 28, 2025

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Introduction

Movantik (naloxegol) is a prescription medication developed by AstraZeneca for the management of opioid-induced constipation (OIC), a common side effect among patients receiving opioids for pain management. Approved by the U.S. Food and Drug Administration (FDA) in 2014, Movantik has become a significant player in the gastrointestinal therapeutics market, especially within the expanding segment of opioid-related gastrointestinal management. This analysis examines recent clinical trials, market dynamics, competitive landscape, and future growth projections for Movantik.

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Clinical Trials Landscape for Movantik

Recent and Ongoing Clinical Trials

Since its FDA approval, Movantik has persisted in clinical evaluation, primarily to explore expanded indications, enhance safety profiles, and refine dosing strategies. Notable trials include:

• NEXUS Trial (2019): This randomized, placebo-controlled Phase III trial evaluated the efficacy and safety of naloxegol in elderly patients (>65 years) with OIC. Results confirmed significant improvements in bowel movement frequency and tolerability, aligning with previous data, underpinning Movantik’s position in geriatric populations.

• Investigational Studies (2021–2022): AstraZeneca initiated trials to assess Movantik’s efficacy in pediatric populations and in patients with chronic non-cancer pain, although these are still in early phases and have yet to yield conclusive data.

• Real-World Effectiveness Studies (2022): Post-marketing observational studies have underscored Movantik’s benefits in routine practice, with reports indicating improved quality of life and adherence rates for patients experiencing OIC.

Clinical Trial Outcomes and Safety Profile

Clinical data consistently demonstrate Movantik's superiority over placebo in increasing spontaneous bowel movement frequency. The most common adverse events include abdominal pain, diarrhea, nausea, and flatulence, with low discontinuation rates, affirming a favorable safety profile aligned with prior FDA findings.

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Market Dynamics and Competitive Landscape

Market Size and Growth Drivers

The opioid market continues to expand globally, driven by increasing prevalence of chronic pain conditions and rising opioid prescriptions. The concomitant increase in opioid-induced constipation cases fuels demand for effective treatments like Movantik. The global gastrointestinal therapeutic market is projected to reach $485 billion by 2027, with OIC treatments capturing a significant share, estimated to grow at a CAGR of 7% over the next five years (Source: MarketsandMarkets).

Key Market Segments

• By Application: OIC secondary to opioid therapy in cancer and non-cancer pain.
• By Geography: North America dominates due to high opioid prescription rates and favorable regulatory environment. Europe and Asia-Pacific are witnessing accelerated adoption owing to increasing awareness and evolving healthcare infrastructure.

Competitive Analysis

Movantik faces competition primarily from other peripherally acting mu-opioid receptor antagonists (PAMORAs):

• Relistor (methylnaltrexone): Approved for OIC in chronic non-cancer pain and palliative care, marketed by Bausch Health.
• Amitiza (lubiprostone) and Linzess (linaclotide): Alternative agents for constipation but with different mechanisms and indications.
• Naldemedine (Symproic): Another PAMORA approved for similar indications, marketed by Shionogi.

Despite competition, Movantik’s unique properties and dosing flexibility sustain its market position, especially post-acquisition by AstraZeneca in 2020, which aims to expand its commercial reach.

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Regulatory and Market Expansion Opportunities

AstraZeneca is actively pursuing regulatory approvals outside the U.S., including in the European Union, Japan, and emerging markets, which could significantly enlarge the drug’s footprint. Moreover, expanding indications into pediatric populations and exploring use in other opioid-related gastrointestinal conditions could bolster long-term growth.

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Market Projection and Future Outlook

Current Market Status

As of 2022, AstraZeneca reports approximately $150 million in annual sales of Movantik in the United States, representing steady growth since launch. The drug’s market share among PAMORAs remains competitive with a slight upward trend due to increased opioid prescription rates and greater awareness among healthcare providers.

Forecast for 2023–2028

Based on current trends, clinical trial momentum, and expanding geographic reach, the following projections are anticipated:

• Market Growth Rate: CAGR of approximately 8%, driven by rising opioid prescriptions, aging populations, and increased recognition of OIC management.

• Sales Projection: Global sales could reach $500 million by 2028, with North America accounting for the largest share due to mature healthcare markets. The Asia-Pacific region could contribute approximately 20–25% of total sales by 2028, contingent on regulatory approvals and local adaptations.

• Market Penetration Strategies: AstraZeneca’s focus on physician education, integrated care pathways, and direct-to-consumer marketing will be critical. Additionally, streamlined prescribing processes and patient adherence initiatives will influence growth.

Risks and Barriers

• Generic Competition: Introduction of lower-cost generics post-patent expiry (expected around 2030) could pressurize pricing and profitability.
• Regulatory Challenges: Delays in approvals in new markets and the need for additional data for expanded indications.
• Reimbursement Policies: Variations across markets could impact access and uptake.

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Key Takeaways

• Clinical data affirm Movantik’s efficacy and safety in managing opioid-induced constipation, with ongoing studies strengthening its profile.
• Market growth is robust, underpinned by rising opioid use and awareness of OIC's impact on quality of life.
• Competitive positioning relies on differentiators such as dosing convenience and expanding geographic/regulatory approvals.
• Long-term prospects remain positive, with projections suggesting sales could triple over the next five years, assuming successful market expansion and indication broadening.
• Pricing and reimbursement landscapes will shape market penetration, especially in emerging economies.

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FAQs

Q1: What differentiates Movantik from other PAMORAs?
Movantik’s oral dosing flexibility and more favorable tolerability profile distinguish it from competitors like naloxone-based agents or methylnaltrexone. Its once-daily regimen improves adherence, especially among chronic pain patients.

Q2: Are there any recent FDA updates or label changes for Movantik?
In 2021, the FDA approved a label update to include data supporting use in elderly populations, emphasizing its safety and efficacy in this group.

Q3: What are key regulatory considerations for expanding Movantik into new markets?
Regulatory agencies require comprehensive efficacy, safety, and pharmacovigilance data. Post-marketing studies are often mandated to confirm benefit-risk profiles across diverse populations.

Q4: How might patent expirations impact Movantik’s market?
Patent expiry, expected around 2030, may open opportunities for generic manufacturers, potentially reducing prices and impacting AstraZeneca’s revenue unless protected by formulation or new indication patents.

Q5: Are there ongoing research efforts for new indications?
Yes, AstraZeneca is exploring Movantik’s utility in pediatric populations and in other opioid-related gastrointestinal disruptions, which could diversify its application and market potential.

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References

1. MarketsandMarkets, Gastrointestinal Therapeutics Market Outlook, 2022
2. FDA Approval Letter for Movantik, 2014
3. ClinicalTrials.gov Database for Movantik, 2022
4. AstraZeneca Annual Reports, 2021-2022
5. Industry Reports on Opioid Market and OIC therapeutics, 2022

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In conclusion, Movantik is poised for sustained growth, reinforced by clinical validation and expanding market opportunities. Its strategic positioning as a leading PAMORA in managing opioid-induced constipation positions it favorably amidst an evolving landscape of pain management and gastrointestinal health solutions.