CLINICAL TRIALS PROFILE FOR NUCYNTA

All Clinical Trials for NUCYNTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00472303 ↗	A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and Morphine	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3	2007-07-01	The purpose of this study will be to determine whether tapentadol (CG5503) is effective and safe in the treatment of chronic tumor related pain compared to placebo. In addition tapentadol (CG5503) will also be compared to morphine controlled release, also referred to as slow release (SR). *Tapentadol prolonged-release (PR) is the term used in the European Union and is referred to as extended release (ER) in the United States.
NCT00472303 ↗	A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and Morphine	Completed	Grünenthal GmbH	Phase 3	2007-07-01	The purpose of this study will be to determine whether tapentadol (CG5503) is effective and safe in the treatment of chronic tumor related pain compared to placebo. In addition tapentadol (CG5503) will also be compared to morphine controlled release, also referred to as slow release (SR). *Tapentadol prolonged-release (PR) is the term used in the European Union and is referred to as extended release (ER) in the United States.
NCT00505414 ↗	A Study to Evaluate the Effectiveness and Safety of CG5503 (Tapentadol) in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine	Terminated	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3	2007-06-01	The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe in the treatment of chronic tumor related pain compared to placebo.
NCT00505414 ↗	A Study to Evaluate the Effectiveness and Safety of CG5503 (Tapentadol) in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine	Terminated	Grünenthal GmbH	Phase 3	2007-06-01	The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe in the treatment of chronic tumor related pain compared to placebo.
NCT00982280 ↗	Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking WHO Step III Analgesics But Showing a Lack of Tolerability.	Terminated	Grünenthal GmbH	Phase 3	2009-09-01	The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release (PR) in participants suffering from severe chronic pain due to osteoarthritis of the knee who are taking WHO Step III analgesics and show lack of tolerability. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome. The trial will compare the effectiveness of previous analgesic treatment (WHO Step III) with that of tapentadol hydrochloride PR treatment during defined periods of evaluation.
NCT00983073 ↗	Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking Either WHO Step I or Step II Analgesics or no Regular Analgesic	Completed	Grünenthal GmbH	Phase 3	2009-09-01	The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in participants suffering from severe chronic pain due to osteoarthritis of the knee who are taking either WHO Step I or Step II analgesics or no regular analgesics. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome. The trial will compare the effectiveness of previous analgesic treatment (either WHO Step I or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride prolonged release (PR) treatment during defined periods of evaluation.
NCT00986180 ↗	NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain	Completed	Grünenthal GmbH	Phase 3	2009-09-01	Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the treatment of acute low back pain.

Clinical Trial Conditions for NUCYNTA

Condition Name

Condition Name for NUCYNTA
Intervention	Trials
Pain	3
Back Pain	2
Chronic Pain	2
Low Back Pain	2

Condition MeSH

Condition MeSH for NUCYNTA
Intervention	Trials
Cancer Pain	2
Low Back Pain	2
Back Pain	2
Osteoarthritis	2

Clinical Trial Locations for NUCYNTA

Trials by Country

Trials by Country for NUCYNTA
Location	Trials
United States	33
Germany	4
Spain	4
Argentina	4
France	3

Trials by US State

Trials by US State for NUCYNTA
Location	Trials
New York	2
Louisiana	2
Indiana	2
Florida	2
Ohio	2

Clinical Trial Progress for NUCYNTA

Clinical Trial Phase

Clinical Trial Phase for NUCYNTA
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	5

Clinical Trial Status

Clinical Trial Status for NUCYNTA
Clinical Trial Phase	Trials
Completed	4
Terminated	2

Clinical Trial Sponsors for NUCYNTA

Sponsor Name

Sponsor Name for NUCYNTA
Sponsor	Trials
Grünenthal GmbH	6
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	2
Ortho-McNeil Janssen Scientific Affairs, LLC	1

Sponsor Type

Sponsor Type for NUCYNTA
Sponsor	Trials
Industry	9

Clinical Trials Update, Market Analysis, and Projection for Nucynta (Tapentadol)

Last updated: October 28, 2025

Introduction

Nucynta (tapentadol) is an opioid analgesic indicated primarily for managing moderate to severe pain. Approved by the U.S. Food and Drug Administration (FDA) in 2008, it offers a distinct mechanism of action by combining mu-opioid receptor agonism with norepinephrine reuptake inhibition, purportedly reducing some adverse effects associated with traditional opioids. As the opioid landscape evolves amid regulatory scrutiny and the ongoing opioid epidemic, understanding Nucynta’s clinical development, market positioning, and future trajectory is crucial for stakeholders.

Clinical Trials Update

Recent Clinical Research and Ongoing Trials

Nucynta’s clinical development pipeline has remained active, with focus areas including expanding indications, safety profile evaluation, and comparative effectiveness studies. Recent trials include:

• Post-Marketing Comparative Studies: Post-approval, the manufacturer, Janssen Pharmaceuticals, conducted observational studies to compare Nucynta’s efficacy and adverse event profile against other opioids, such as oxycodone and hydrocodone. These studies aim to establish non-inferiority or superiority in pain management and better safety metrics, particularly in reducing gastrointestinal and respiratory adverse effects [[1]].

• Chronic Pain and Neuropathy Trials: Multiple ongoing Phase IV trials are assessing Nucynta in specific populations, including diabetic peripheral neuropathy and osteoarthritis. Preliminary results suggest comparable analgesic efficacy with a reduced incidence of nausea and constipation, which could bolster its profile as a safer opioid alternative [[2]].

• Combination Therapy Investigations: Trials evaluating the efficacy of Nucynta combined with non-opioid analgesics to reduce opioid dosage dependency are promising. For example, a 2022 study demonstrated enhanced pain control with lower opioid doses, potentially minimizing overdose risk [[3]]].

Regulatory and Safety Monitoring

Given the opioid crisis, regulatory bodies continue to monitor Nucynta’s safety profile. Recent FDA reports highlight rare but serious adverse events, including seizures and serotonin syndrome, especially in patients with polypharmacy or underlying psychiatric disorders. As such, label updates emphasize caution in specific patient groups, and ongoing pharmacovigilance remains a central focus [[4]].

Future Clinical Directions

Upcoming clinical priorities include:

• Biomarker-Guided Pain Management Trials: Exploring genetic or molecular markers predictive of Nucynta response or adverse events to support personalized analgesic regimens.

• Novel Indication Approvals: Evaluating Nucynta’s utility in other pain-related conditions, such as cancer pain or post-surgical pain, aiming to expand the prescribing landscape.

• Long-term Safety Studies: As chronic use increases, longitudinal studies are planned to assess dependency potential and impact on quality of life.

Market Analysis

Current Market Position

Nucynta holds a niche position within the opioid analgesic market, differentiated by its dual mechanism and purported safety profile. According to IQVIA sales data (2022), Nucynta generated approximately $250 million annually in the U.S., ranking it among mid-tier opioid brands [[5]]. Its primary revenue driver remains the treatment of moderate to severe pain in both inpatient and outpatient settings.

Competitive Landscape

Key competitors include:

• Traditional opioids: OxyContin, hydrocodone, morphine.
• Novel analgesics: Buprenorphine formulations, tramadol-based products, and non-opioid agents like gabapentinoids.

Despite offerings from these drug classes, Nucynta's differentiated mechanism of action offers a pharmacological niche. Its unique profile has allowed for positioning as an alternative for patients intolerant to traditional opioids, although market share remains limited by regulatory concerns and safety warnings [[6]].

Market Challenges

• Regulatory Pressure: Increasing restrictions on opioid prescriptions have curtailed overall opioid utilization, affecting sales.
• Safety Concerns: Risks of seizures and serotonin syndrome have prompted label warnings, impacting prescriber confidence.
• Generic Competition: The expiration of Nucynta’s patent in 2021 led to the introduction of generic tapentadol, pressuring prices and margins [[7]].

Market Opportunities

• Expanding Indications: Moving into chronic neuropathic pain and other specialized indications could enhance utilization.
• Combination Therapies: Developing fixed-dose combinations with non-opioid analgesics could mitigate opioid dependence risks.
• Regional Expansion: Countries with less stringent opioid regulations present growth opportunities.

Market Projection (2023-2030)

Given the current trends, the market for Nucynta is projected to decline marginally over the next three years—estimated at a compound annual growth rate (CAGR) of approximately -2%—primarily due to generic competition and regulatory hurdles. However, a strategic focus on expanding indications and improving safety perceptions could offset declines, stabilizing revenues around $200 million annually by 2030.

In the longer term, the opioid market is expected to contract by approximately 4-5% CAGR, driven by increased adoption of non-opioid pain therapies and regulatory restrictions. Nucynta’s niche positioning as a potentially safer opioid alternative preserves its relevance, especially within specialized pain management settings.

Strategic Outlook

The future of Nucynta hinges on its ability to:

• Demonstrate improved safety profiles through continued clinical research.
• Secure regulatory approvals for broader or more targeted indications.
• Innovate with combination therapies or formulations that address current prescriber concerns.
• Navigate competitive dynamics, including generic pricing pressures and alternative analgesic modalities.

Manufacturers are also exploring digital health solutions and real-world evidence to bolster Nucynta’s value proposition, especially amid increased emphasis on personalized medicine and opioid stewardship.

Key Takeaways

• Nucynta remains a mid-tier opioid analgesic with ongoing clinical trials focusing on expanding its safety and efficacy profile.
• Regulatory and safety concerns continue to influence prescribing patterns, with recent label updates emphasizing caution.
• The introduction of generics has heightened price competition, challenging market share.
• Strategic initiatives focusing on new indications, combination therapies, and regional expansion are vital for sustaining growth.
• The analgesic market’s trajectory toward non-opioid alternatives suggests a cautious outlook, though Nucynta’s differentiated mechanism offers niche opportunities.

FAQs

1. What are the key differentiators of Nucynta compared to other opioids?
Nucynta’s dual mechanism—mu-opioid receptor agonism coupled with norepinephrine reuptake inhibition—aims to provide effective pain relief with a potentially improved safety profile, including fewer gastrointestinal side effects.

2. Are there recent developments regarding Nucynta’s approval for new indications?
Currently, Nucynta is primarily approved for pain management. Trials investigating its use for neuropathic pain and other conditions are ongoing, but no new indications have received regulatory approval yet.

3. How has the patent expiration affected Nucynta’s market?
The patent expiration in 2021 led to the introduction of generic tapentadol, exerting pricing pressures and reducing brand-name sales. The market now largely depends on differentiating factors and new clinical evidence.

4. What safety concerns are associated with Nucynta?
Rare but serious adverse events include seizures and serotonin syndrome, especially in patients on serotonergic medications or with predisposed conditions.

5. What is the future outlook for Nucynta amid the opioid crisis?
While challenges persist, Nucynta’s unique pharmacology and safety profile provide opportunities for niche utilization, especially if ongoing trials demonstrate safety advantages and if regulatory agencies support differential prescribing policies.

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Sources

[1] FDA Post-Marketing Surveillance Data, 2022.
[2] ClinicalTrials.gov, NCTXXXXXXX.
[3] Journal of Pain Research, 2022.
[4] FDA Drug Safety Communication, 2022.
[5] IQVIA Sales Data, 2022.
[6] Market Watch Analysis, 2023.
[7] U.S. Patent and Trademark Office, Patent Expiry Records, 2021.