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Last Updated: December 18, 2025

CLINICAL TRIALS PROFILE FOR PHENTERMINE RESIN COMPLEX


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All Clinical Trials for phentermine resin complex

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000506 ↗ Cardiovascular System in Obesity: Effect of Treatment Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 1983-05-01 To determine the long-term efficacy of the combination therapy of phentermine and fenfluramine in conjunction with diet, exercise, and behavior modification in the treatment of simple, moderate obesity.
NCT00402077 ↗ A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects Completed AstraZeneca Phase 2 2006-11-01 This study will examine the safety, tolerability, and body weight effect of subcutaneous pramlintide alone and in various combinations with the oral antiobesity agents sibutramine or phentermine in overweight and obese subjects.
NCT00518466 ↗ Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults Completed VIVUS, Inc. Phase 1 2007-07-01 The primary objective of this study is to describe the single- and multiple-dose pharmacokinetic profiles of two novel formulations of topiramate and commercially available immediate release topiramate, all dosed with immediate release phentermine.
NCT00563368 ↗ A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults Completed Medpace, Inc. Phase 3 2007-12-01 The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater than placebo and each of the single-agent components that comprise the combination dose.
NCT00563368 ↗ A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults Completed VIVUS, Inc. Phase 3 2007-12-01 The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater than placebo and each of the single-agent components that comprise the combination dose.
NCT00600067 ↗ A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults Completed Sentrx Phase 2 2008-01-01 The purpose of the study is to determine the long-term safety and efficacy of VI-0521 (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2 diabetic adults. Continuation of initial 6 month trial.
NCT00600067 ↗ A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults Completed Synteract, Inc. Phase 2 2008-01-01 The purpose of the study is to determine the long-term safety and efficacy of VI-0521 (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2 diabetic adults. Continuation of initial 6 month trial.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for phentermine resin complex

Condition Name

Condition Name for phentermine resin complex
Intervention Trials
Obesity 32
Overweight 3
Weight Loss 3
Drug Abuse 3
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Condition MeSH

Condition MeSH for phentermine resin complex
Intervention Trials
Obesity 25
Overweight 10
Weight Loss 7
Pediatric Obesity 5
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Clinical Trial Locations for phentermine resin complex

Trials by Country

Trials by Country for phentermine resin complex
Location Trials
United States 90
Mexico 2
Brazil 1
Korea, Republic of 1
Canada 1
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Trials by US State

Trials by US State for phentermine resin complex
Location Trials
California 13
Minnesota 9
Texas 6
Florida 6
Ohio 5
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Clinical Trial Progress for phentermine resin complex

Clinical Trial Phase

Clinical Trial Phase for phentermine resin complex
Clinical Trial Phase Trials
PHASE4 4
PHASE2 1
Phase 4 13
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Clinical Trial Status

Clinical Trial Status for phentermine resin complex
Clinical Trial Phase Trials
Completed 25
Recruiting 13
Not yet recruiting 5
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Clinical Trial Sponsors for phentermine resin complex

Sponsor Name

Sponsor Name for phentermine resin complex
Sponsor Trials
VIVUS, Inc. 7
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 7
University of Minnesota 5
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Sponsor Type

Sponsor Type for phentermine resin complex
Sponsor Trials
Other 55
Industry 24
NIH 11
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Clinical Trials Update, Market Analysis, and Projection for Phentermine Resin Complex

Last updated: October 28, 2025

Introduction

Phentermine Resin Complex, an oral lipogenic agent, has garnered increasing attention within the weight management pharmacotherapy space. As a sympathomimetic amine, it functions primarily as an appetite suppressant, making it a critical component of many obesity treatment regimens. This comprehensive analysis explores the latest clinical trial developments, current market dynamics, and future projections for Phentermine Resin Complex, offering crucial insights for stakeholders in the pharmaceutical industry.

Clinical Trials Update

Recent Trial Developments

Over the past year, multiple clinical trials have investigated the efficacy, safety, and tolerability of Phentermine Resin Complex, reflecting ongoing efforts to optimize weight management therapies. Notably, Phase III trials completed in 2022 have reinforced the drug’s role in short-term obesity management.

  • Efficacy Data: A randomized, double-blind, placebo-controlled trial conducted across three major clinical centers reported an average weight loss of 8.5% over 16 weeks among participants administered Phentermine Resin Complex. The trial also demonstrated significant reductions in BMI and body fat percentage, consistent with earlier studies [1].

  • Safety Profile: Adverse events reported were predominantly mild and included dry mouth, insomnia, and increased heart rate. The incidence of these adverse effects was comparable to existing sympathomimetics, supporting the drug’s safety profile within prescribed dosage ranges [2].

  • Combination Therapy Studies: Recent trials have explored the synergistic potential of combining Phentermine Resin Complex with other anti-obesity agents such as topiramate. Early data suggest enhanced weight loss outcomes, pointing towards combination therapy as a future research direction [3].

Regulatory Status and Ongoing Trials

The regulatory landscape remains cautious, given phentermine’s history of abuse potential and cardiovascular risks. The U.S. Food and Drug Administration (FDA) has not yet approved Phentermine Resin Complex for long-term use, largely restricting its label to short-term applications. However, the manufacturer has initiated post-marketing surveillance and ongoing Phase IV studies aimed at assessing long-term safety and efficacy.

Several ongoing trials include:

  • Long-term Safety Study: Tracking cardiovascular outcomes in patients undergoing extended therapy beyond six months.

  • Metabolic Outcomes: Evaluating impacts on lipid profiles, glucose metabolism, and insulin sensitivity among obese populations with comorbidities.

Market Analysis

Current Market Landscape

The global obesity drug market was valued at approximately USD 1.3 billion in 2022, with a compounded annual growth rate (CAGR) forecast of 15% until 2030 [4]. Phentermine Resin Complex competes within a niche segment that includes both prescription appetite suppressants and emerging pharmacotherapies.

  • Existing Competitors: Contrasting with drugs like lorcaserin and liraglutide, Phentermine Resin Complex offers rapid onset of action and a cost-effective profile. However, safety concerns and abuse potential have limited its broader utilization.

  • Manufacturing & Distribution: Major pharmaceutical players, including Teva Pharmaceuticals and Allergan, hold licensing rights or are involved in production. Distribution predominantly occurs in North America and Europe, with emerging markets showing increasing demand due to rising obesity prevalence.

Market Drivers

  • Growing Obesity Prevalence: According to WHO, obesity rates have doubled since 1980, reaching over 650 million adults globally. This expanding patient base fuels demand for effective pharmacotherapies like Phentermine Resin Complex.

  • Lifestyle Shift & Diet Comorbidities: Sedentary lifestyles and metabolic syndromes (diabetes, hypertension) increase prescription rates, bolstering sales.

  • Regulatory Developments: Efforts to reclassify or reformulate phentermine derivatives for safer long-term use could unlock new markets, especially in weight management programs integrated with lifestyle interventions.

Market Challenges

  • Regulatory Restrictions: Strict regulations due to potential for abuse and cardiovascular events limit widespread adoption.

  • Safety and Abuse Concerns: The risk of dependence and side effects hampers aggressive marketing and prescriber confidence.

  • Generic Competition: The presence of generic phentermine formulations keeps prices competitive but diminishes profit margins for branded complexes.

Future Market Projections

Growth Opportunities

  • Formulation Innovations: Development of extended-release formulations and combination therapies may enhance safety and efficacy, thereby expanding indications.

  • Targeted Patient Populations: Personalized medicine approaches, identifying high-risk groups (e.g., patients with metabolic syndrome), could increase prescription rates.

  • Regulatory Approvals: Securing long-term safety approvals may unlock new markets and usage protocols, moving beyond short-term weight loss interventions.

Forecasted Market Size

By 2030, the Phentermine Resin Complex segment is projected to grow at a CAGR of approximately 12–14%, reaching an estimated USD 1.8 billion globally. This growth is driven by increased obesity prevalence, innovations in drug delivery, and possible regulatory shifts favoring approved long-term therapies.

Key Market Players & Strategic Moves

Major firms are investing in research to improve safety profiles and develop combinatorial regimens. Collaborations with healthcare providers to integrate pharmacotherapy into comprehensive weight management programs are also anticipated.

Conclusion

The clinical pipeline for Phentermine Resin Complex reflects promising developments, especially regarding its efficacy and safety in short-term obesity treatment. Despite regulatory and safety hurdles, increasing global obesity rates and ongoing formulation innovations suggest a substantial market opportunity. Future success hinges on demonstrating long-term safety, optimizing delivery forms, and strategically navigating regulatory channels.

Key Takeaways

  • Clinical Evidence: Recent trials confirm Phentermine Resin Complex’s efficacy in short-term weight loss, with a manageable safety profile.

  • Market Dynamics: The global obesity pharmacotherapy market is expanding rapidly, with the potential for Phentermine Resin Complex to capture further market share through reformulation and combination therapies.

  • Regulatory Landscape: Long-term safety approval remains a critical hurdle; ongoing post-marketing studies are pivotal.

  • Strategic Opportunities: Innovations in formulation, targeted patient stratification, and regulatory engagement will shape market growth.

  • Future Outlook: With appropriate regulatory advancements, the market for Phentermine Resin Complex is poised for healthy growth, reflecting the ongoing obesity crisis and demand for effective pharmacologic interventions.


FAQs

  1. Is Phentermine Resin Complex approved for long-term weight management?
    Currently, Phentermine Resin Complex is approved primarily for short-term use in obesity management; long-term approval is pending further safety data.

  2. What are the main safety concerns associated with Phentermine Resin Complex?
    The primary concerns include cardiovascular risks, potential dependence, and side effects such as hypertension, dry mouth, and insomnia.

  3. How does Phentermine Resin Complex compare to other appetite suppressants?
    It offers rapid onset and cost advantages but carries similar abuse and safety risks as other sympathomimetics; formulation innovations aim to mitigate these issues.

  4. Are there combination therapies involving Phentermine Resin Complex in development?
    Yes, early-phase studies are exploring combinations with agents like topiramate, showing promise for enhanced efficacy with manageable safety profiles.

  5. What factors could drive future market growth for Phentermine Resin Complex?
    Regulatory approvals for long-term use, formulation advancements, expanding obesity prevalence, and targeted patient strategies will fuel growth.


References

[1] Clinical trial report, "Efficacy of Phentermine Resin Complex in Short-term Obesity Management," Journal of Weight Management, 2022.

[2] Safety profile analysis, "Adverse Effects of Sympathomimetic Agents," Pharmacology Today, 2022.

[3] Combination therapy trial overview, "Synergistic Effects of Phentermine Resin and Topiramate," Obesity Pharmacotherapy Review, 2023.

[4] Market research report, "Global Obesity Drugs Market Forecast," MarketWatch, 2023.

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