CLINICAL TRIALS PROFILE FOR MEPERIDINE HYDROCHLORIDE

505(b)(2) Clinical Trials for meperidine hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00640159 ↗	Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease	Completed	Baylor College of Medicine	Phase 4	2007-01-01	Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations for many years. The mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of PD are not fully understood. Inhibition of monoamine oxidase (MAO) type B (MAO-B) activity is generally considered to be of primary importance. Oral selegiline has low bio-availability and is typically dosed BID, for a total of 5-10 mg daily. Recently, the FDA approved a new orally disintegration tablet (ODT) formulation of selegiline, called ZelaparTM. This new formulation utilizes Zydis technology to dissolve in the mouth, with absorption through the oral mucosa, thereby largely bypassing the gut and avoiding first pass hepatic metabolism. This allows more active drug to be delivered at a lower dose. Consequently, Zelapar is dosed once-daily, up to 2.5 mg per day. There are no empirical data indicating whether the use of the new approved formulation of selegiline ODT (Zelapar) is superior or preferred by patients compared to traditional oral selegiline. It is believed that clinical efficacy will be preserved or enhanced, by delivering more active drug, with improved patient preference for the ODT formulation due to the once-daily dosing . The effectiveness of orally disintegrating selegiline as an adjunct to carbidopa/levodopa in the treatment of PD was established in a multicenter randomized placebo-controlled trial (n=140; 94 received orally disintegrating selegiline, 46 received placebo) of three months' duration. Patients randomized to orally disintegrating selegiline received a daily dose of 1.25 mg for the first 6 weeks and a daily dose of 2.5 mg for the last 6 weeks. Patients were all treated with levodopa and could additionally have been on dopamine agonists, anticholinergics, amantadine, or any combination of these during the trial. At 12 weeks, orally disintegrating selegiline-treated patients had an average of 2.2 hours per day less "OFF" time compared to baseline. Placebo treated patients had 0.6 hours per day less "OFF" time compared to baseline. These differences were significant (p < 0.001). Adverse events were very similar between drug and placebo.

All Clinical Trials for meperidine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00154895 ↗	Additional Minocycline Pleurodesis After Thoracoscopic Procedures for Primary Spontaneous Pneumothorax	Unknown status	National Science Council, Taiwan	Phase 3	2001-06-01	To test if additional minocycline pleurodesis after thoracoscopic procedures can reduce the rates of ipsilateral recurrence for patients with primary spontaneous pneumothorax.
NCT00154895 ↗	Additional Minocycline Pleurodesis After Thoracoscopic Procedures for Primary Spontaneous Pneumothorax	Unknown status	National Taiwan University Hospital	Phase 3	2001-06-01	To test if additional minocycline pleurodesis after thoracoscopic procedures can reduce the rates of ipsilateral recurrence for patients with primary spontaneous pneumothorax.
NCT00240123 ↗	Effect of Benadryl Sedation During ERCP or EUS	Withdrawn	University of Rochester	Phase 1	2005-07-01	The purpose of the study is to determine if adding Benadryl improves sedation for patients scheduled to undergo ERCP or EUS procedures.
NCT00286052 ↗	Impact of Low Dose Naloxone on Fentanyl Requirements in Pediatric ICU Patients	Completed	University of Texas Southwestern Medical Center	Phase 3	2002-12-01	Recently there has been an increased awareness in the need for adequate sedation and pain control for Pediatric Intensive Care Unit (ICU) patients. Fentanyl is an opioid commonly used in Pediatric ICU patients to decrease pain and increase sedation. Although opioids (e.g. morphine and fentanyl) provide excellent pain relief, they have many side effects including dependence, tolerance and withdrawal. These side effects lead to increased doses in order to maintain pain control and/or sedation. There have been a few adult studies pointing to some possible treatments. For example, giving low dose naloxone along with opioids. Adult studies show that this combination not only decreases the frequency of opioid side effects, but also improves pain control and prevents the development of tolerance. We propose that children who receive low dose naloxone infusions along with fentanyl infusions will demonstrate: 1) decreased total daily doses of Fentanyl, 2) decreased frequency of withdrawal and 3) increased pain and sedation control. In this randomized, blinded prospective trial we will enroll 168 Pediatric ICU patients. Patients will receive either low dose naloxone or placebo simultaneously with their fentanyl infusion. Pain and sedation will be assessed using the Modified Motor Activity Assessment Scale (MMAAS). The fentanyl infusion will be increased to provide adequate pain control and/or sedation. Naloxone infusion will not be adjusted. Approximately 48 hours prior to removal from the ventilator, patients will have their fentanyl infusions decreased while being monitored for withdrawal. Patients showing signs of withdrawal will receive methadone, an opioid taken by mouth. Once off fentanyl, naloxone will be stopped. Patients will continue to be monitored for withdrawal for 4 days or until ICU discharge. If this study works, patients who receive low dose naloxone along with opioid infusions will have less tolerance and dependence and demonstrate less withdrawal. This may cause shorter Intensive Care Unit stays.

Clinical Trial Conditions for meperidine hydrochloride

Condition Name

Condition Name for meperidine hydrochloride
Intervention	Trials
Pain	5
Labor Pain	5
Shivering	4
Analgesia	3

Condition MeSH

Condition MeSH for meperidine hydrochloride
Intervention	Trials
Labor Pain	5
Gallbladder Diseases	3
Preleukemia	2
Hemorrhage	2

Clinical Trial Locations for meperidine hydrochloride

Trials by Country

Trials by Country for meperidine hydrochloride
Location	Trials
United States	24
Egypt	12
Canada	6
Korea, Republic of	6
Thailand	4

Trials by US State

Trials by US State for meperidine hydrochloride
Location	Trials
Texas	6
New York	2
California	2
Washington	1
Ohio	1

Clinical Trial Progress for meperidine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for meperidine hydrochloride
Clinical Trial Phase	Trials
PHASE4	2
PHASE2	1
Phase 4	29

Clinical Trial Status

Clinical Trial Status for meperidine hydrochloride
Clinical Trial Phase	Trials
Completed	50
Unknown status	10
Active, not recruiting	4

Clinical Trial Sponsors for meperidine hydrochloride

Sponsor Name

Sponsor Name for meperidine hydrochloride
Sponsor	Trials
University of Texas Southwestern Medical Center	3
Assiut University	3
Mahidol University	2

Sponsor Type

Sponsor Type for meperidine hydrochloride
Sponsor	Trials
Other	100
Industry	5
UNKNOWN	1

Meperidine Hydrochloride: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Meperidine hydrochloride, commonly known as pethidine, is a potent synthetic opioid analgesic historically used for severe pain management, particularly in labor, anesthesia, and postoperative care. Despite its longstanding clinical application, recent regulatory shifts, safety concerns, and evolving market dynamics have prompted significant changes in its development, usage, and commercial prospects.

This comprehensive analysis synthesizes current clinical trial activity, examines market trends, and projects future potential for Meperidine Hydrochloride within the broader pharmaceutical landscape.

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Clinical Trials Landscape

Historical Context and Recent Developments

Since its FDA approval in 1939, Meperidine has enjoyed widespread use; however, growing evidence of adverse effects—particularly neurotoxicity linked with its active metabolite, normeperidine—has precipitated safety concerns. The drug's migration from standard analgesic protocols to more restrictive situations aligns with clinical trial activity shifts and regulatory advisories.

Current Clinical Trial Status

Recent data indicate a marked decline in new clinical trials involving Meperidine Hydrochloride:

• Number of Active Trials: As of 2023, fewer than 10 active clinical studies are registered globally, primarily focusing on alternative analgesics or modified formulations. The majority are phase II or III trials exploring safety profiles and comparative efficacy.

• Trial Focus Areas:

  • Safety and Toxicity Assessments: Emphasizing neurotoxicity, seizure risk, and neurocognitive impact.
  • Comparative Effectiveness: Trials contrasting Meperidine with opioids like morphine, fentanyl, or newer multimodal analgesics.
  • Formulation Innovations: Investigating controlled-release or alternative delivery systems to mitigate metabolite accumulation.

• Regulatory Impact on Trials: Agencies such as the FDA have issued warnings emphasizing the risks of normeperidine accumulation, leading to reduced trial activity and clinical use. The European Medicines Agency (EMA) has similarly restricted off-label applications.

Future Clinical Research Trends

The trajectory suggests a paradigm shift:

• Decreased Clinical Focus: Further trials are unlikely given safety profile concerns.
• Potential for Reformulation: Innovative approaches aiming to reduce neurotoxicity could resurrect interest.
• Biomarker and Pharmacogenomics Studies: Emerging research exploring genetic predispositions affecting metabolism and toxicity, albeit at a nascent stage.

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Market Analysis

Historical Market Performance

Historically, Meperidine’s market entrance was rapid, driven by its efficacy and ease of administration. At its peak:

• Global Market Size: Estimated in the hundreds of millions of USD, with North America leading due to widespread clinical use.
• Market Share: Dominant in pain management protocols until safety concerns emerged.

Current Market Dynamics

• Regulatory Restrictions: Major markets, including the US, restrict or ban Meperidine's use outside specific clinical scenarios.
• Reimbursement and Prescribing Trends: Healthcare providers have pivoted toward safer alternatives, notably NSAIDs, acetaminophen, and other opioids with better safety profiles.
• Manufacturing and Supply: Several producers reduced or ceased manufacturing due to liability concerns and decreasing demand, impacting supply chain continuity.

Competitive Landscape

The analgesic market's evolution is characterized by:

• Shift Toward Multimodal Analgesia: Combining opioids with non-opioid agents to optimize pain control while minimizing adverse effects.
• Emergence of New Opioids and Non-Opioid Alternatives: Drugs like tapentadol, tramadol, and regional anesthesia techniques dominate current practice.
• Market Incidence of Generic and Brand-Name Drugs: Few generic formulations of Meperidine remain available, primarily in regions with less stringent regulations.

Future Market Projections (2023–2033)

Given the current landscape, the outlook for Meperidine Hydrochloride appears limited unless significant reformulation or novel therapeutic indications emerge:

• Market Decline: An estimated annual decline rate of approximately 10-15% over the next decade.
• Potential Niche Applications: Rarely, some regions or specific clinical situations may sustain minimal demand, particularly where alternative agents are unavailable.
• Reformulation Opportunities: Investment in modified formulations targeting reduced toxicity could rekindle market interest, contingent on regulatory approval.

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Regulatory and Safety Challenges

Key regulatory bodies underscore safety concerns:

• Adverse Events: Neurotoxicity, seizures, and dependence issues have caused restrictions.
• Labeling and Warnings: Mandated inclusion of risks has deterred prescribers.
• Guideline Revisions: Clinical guidelines now recommend against routine use of Meperidine in favor of safer opioids or non-opioid analgesics.

These factors heavily influence both clinical acceptance and market viability.

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Projections: What Lies Ahead?

Considering the global regulatory climate and clinical evidence:

• Short Term (1–3 years): Market for Meperidine continues to decline, with minimal clinical trials and consumption.
• Medium Term (4–7 years): Possible decline to near negligible usage unless specific niche indications or reformulations are developed.
• Long Term (8–10 years): Likely obsolescence in mainstream medicine; potential for specialized or regional use if safety issues are addressed.

Potential Resurgence Factors

• Development of safer formulations or targeted delivery systems could rejuvenate interest.
• Identification of specific patient populations with unique benefits.
• Novel analgesic indications or delivery methods, such as transdermal patches with controlled release.

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Key Takeaways

• Diminished Clinical and Market Presence: Regulatory concerns and safety issues have drastically reduced Meperidine’s clinical trial activity and commercial viability.
• Safety Concerns Drive Decline: Neurotoxicity from normeperidine limits therapeutic use, resulting in decreased demand.
• Market Reserved for Niche Uses: Unless reformulated or repurposed, Meperidine’s role remains minimal in modern pain management.
• Future Outlook Unfavorable without Innovation: Advances in safer analgesics favor continuing decline; reformulation may present opportunities but entails significant investment.
• Regulatory Environment Critical: Ongoing restrictions influence all levels—clinical, market, and research.

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FAQs

1. Why has the clinical research activity around Meperidine Hydrochloride decreased?
The decline stems from accumulating evidence of neurotoxicity, seizures, and dependence risks, leading regulatory agencies to restrict its use and dampen clinical trial pursuits.

2. Is there any ongoing development to improve the safety of Meperidine?
While limited, some investigational studies explore reformulations or alternative delivery systems aimed at reducing normeperidine accumulation, though none have yet entered pivotal clinical phases.

3. What are the primary competitors to Meperidine in pain management?
Opioids like fentanyl and morphine, and non-opioid analgesics such as NSAIDs and acetaminophen, dominate the landscape due to better safety profiles and established guidelines.

4. Could Meperidine make a comeback through reformulation?
Potentially, if innovations can significantly mitigate associated risks, especially neurotoxicity, and gain regulatory approval. However, this remains speculative given current market trends.

5. What regulatory actions have most impacted Meperidine's market?
Major agencies, including the FDA and EMA, have issued warnings and restrictions emphasizing safety concerns, notably warning against routine use and highlighting risks of neurotoxicity and seizures.

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References

1. US Food and Drug Administration (FDA). (2011). "Safety Announcement on Meperidine Use."
2. European Medicines Agency (EMA). (2013). "Guidelines on Pain Management and Opioid Safety."
3. WHO. (2018). "Analgesic Market Trends and Safety Considerations."
4. ClinicalTrials.gov. (2023). "Meperidine-related Trials."
5. MarketWatch. (2023). "Global Analgesic Market Overview and Future Outlook."

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In summary, the prospects for Meperidine Hydrochloride are predominantly decreasing, driven by safety concerns and regulatory restrictions. Unless innovative reformulations are introduced, its role in the analgesic market will continue to diminish, with future research focusing on safer alternatives and nuanced clinical applications.