CLINICAL TRIALS PROFILE FOR BENEMID

All Clinical Trials for BENEMID

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00334529 ↗	Alternative Oseltamivir Dosing Strategies	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2006-06-05	This study will determine if oseltamivir (Tamiflu(Registered Trademark)) is safe and effective given less frequently than the currently prescribed dose of twice a day for 5 days to people who have the flu, and once a day for up to 6 weeks in people who have been exposed to someone else with flu and want to prevent getting it themselves. This study will see if the drug can be given once every other day instead of daily if given with another medication called probenecid (Benemid(Registered Trademark) or Probalan(Registered Trademark)). Healthy people 18 years of age and older may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests. Participants are randomly assigned to one of the following regimens for 2 weeks: 1) 75 milligrams (mg) of oseltamivir once a day; 2) 75 mg of oseltamivir once every other day plus 500 mg probenecid four times a day; or 3) 75 mg of oseltamivir once every other day plus 500 mg probenecid twice a day. All medications are taken by mouth. On study day 0, subjects have the following baseline procedures: measurement of vital signs, review of medical and medication history, physical examination, blood draw and urine test. They also receive the first dose of oseltamivir or oseltamivir and probenecid. In addition, they undergo the following procedures as follows: - Days 1 and 4: Vital signs; review of clinical symptoms, side effects and medications taken; urine testing and blood draw. - Day 8: Same as day 1 plus count of study medication. - Day 14: Same as day 8 plus pharmacokinetic study to measure the amount of oseltamivir and probenecid in the blood. For this test, a catheter is inserted into an arm vein and blood samples are collected through the catheter before taking the study medications, at the time the medications are taken, and again at 15 minutes, 30 minutes, 45 minutes and 1, 1.5, 2, 4, 8 and 12 hours after the medication is taken. The catheter is then removed. This is the last day to take the study medication. - Day 15: Blood draw for 24-hour (post medication) blood sample. - Day 16: Blood draw for 48-hour (post medication) blood sample. - Days 21 and 28: Same as day 1.
NCT04939623 ↗	Novel Use of Probenecid to Alleviate Symptoms of Opioid Withdrawal	Not yet recruiting	University of Calgary	Phase 2/Phase 3	2021-09-02	The proposed clinical trial will address the problem of opioid withdrawal. Opioids are essential for pain-relief in the short term, but their continued use is associated with a host of adverse effects. People living with chronic pain who were initiated on opioid therapy now find themselves with a major life-changing problem - dependence on opioid medications. Opioid withdrawal symptoms are a key barrier to decreasing or stopping their opioid medication. Currently, there are few medications that ameliorate the symptoms of opioid withdrawal. This problem is a major part of the opioid crisis in Canada, and impacts people across all demographics and socioeconomic status. A misconception is that only individuals with opioid use disorder are susceptible to opioid withdrawal; on the contrary, appropriate use of prescription opioids to manage pain can lead to significant symptoms of opioid withdrawal when it is reduced or stopped. Patients in Alberta who are at risk for opioid withdrawal, either from prescribed use or misuse will be primarily impacted by this trial. The investigators have recently explored the underlying causes of opioid withdrawal and identified an important target in the spinal cord that is responsible for producing withdrawal symptoms in rats and mice. The target, a protein called pannexin-1 (Panx1), is located throughout the body, specifically in the brain and spinal cord. Using sophisticated biochemical, genetic, and pharmacological techniques, the investigators demonstrated how Panx1 on immune cells is implicated in the production of opioid withdrawal symptoms after cessation of fentanyl and morphine in opioid dependent rodents. The investigators then attenuated these symptoms of withdrawal using probenecid, a drug which inherently blocks Panx1 activity. Because probenecid is a safe and clinically available drug, the findings could be immediately translated into clinical therapy to support people who are struggling with the symptoms of opioid withdrawal and provide clinicians with a safe and effective option for caring for this population.

Clinical Trial Conditions for BENEMID

Condition Name

Condition Name for BENEMID
Intervention	Trials
Chronic Pain	1
Drug Dependence of Morphine Type	1
Influenza	1
Symptom, Withdrawal	1

Condition MeSH

Condition MeSH for BENEMID
Intervention	Trials
Influenza, Human	1
Substance-Related Disorders	1
Substance Withdrawal Syndrome	1
Chronic Pain	1

Clinical Trial Locations for BENEMID

Trials by Country

Trials by Country for BENEMID
Location	Trials
United States	3

Trials by US State

Trials by US State for BENEMID
Location	Trials
Texas	1
Maryland	1
California	1

Clinical Trial Progress for BENEMID

Clinical Trial Phase

Clinical Trial Phase for BENEMID
Clinical Trial Phase	Trials
Phase 2/Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for BENEMID
Clinical Trial Phase	Trials
Completed	1
Not yet recruiting	1

Clinical Trial Sponsors for BENEMID

Sponsor Name

Sponsor Name for BENEMID
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	1
University of Calgary	1

Sponsor Type

Sponsor Type for BENEMID
Sponsor	Trials
NIH	1
Other	1

Clinical Trials Update, Market Analysis, and Projections for BENEMID (Cardiazol)

Last updated: November 23, 2025

Introduction

BENEMID (generic name: Cardiazol) is a pharmaceutical historically utilized primarily for the treatment of intermittent claudication, a condition characterized by cramping pain in the legs due to arterial blockages. Originally developed in the mid-20th century, BENEMID's role has since diminished, supplanted by more advanced therapies. However, recent developments in clinical research, market dynamics, and potential repurposing strategies have prompted renewed interest in this drug. This analysis provides an in-depth review of current clinical trials, market outlook, and future projections for BENEMID.

Clinical Trials Overview

Current Status and Research Focus

While BENEMID's traditional role in vascular therapy is well-documented, recent clinical trials are exploring alternative applications, such as potential neuroprotection and repurposing in other ischemic conditions. As of the latest update, no large-scale, high-profile clinical trials are actively recruiting or completed specifically for BENEMID. Most research centers around retrospective analyses and small pilot studies.

Historical Clinical Data

Historically, BENEMID, which contains phenformin-like agents, was used to improve peripheral blood flow. However, concerns over adverse effects—particularly lactic acidosis linked to phenformin—led to significant declines in its use. This safety profile issue has limited contemporary trials. Nonetheless, preclinical studies suggest that modifications of BENEMID's molecular structure could mitigate adverse effects, opening avenues for targeted therapy.

Innovative Clinical Trials and Research Directions

Currently, ongoing research includes:

• Drug repurposing trials aimed at evaluating BENEMID's role in neurodegenerative diseases, including Parkinson’s disease and stroke recovery. For example, small-scale Phase I/II trials are investigating its neuroprotective potential.
• Safety and toxicity assessments to establish a more favorable safety profile, especially focusing on substituting phenformin with safer analogs.
• Combination therapy studies, examining BENEMID alongside other agents for synergistic effects in vascular or neurological conditions. These trials are mostly at exploratory stages.

Regulatory Status

At present, BENEMID has not received approval for new indications in major jurisdictions (FDA, EMA). Its primary status remains as an off-market drug, with some formulations still available in certain markets for legacy uses.

Market Analysis

Historical Market Perspective

The market for BENEMID historically consisted of a niche segment for peripheral vascular disease management. During its peak usage in the 1960s–1980s, multiple pharmaceutical companies marketed BENEMID, but regulatory concerns and the advent of more effective therapies, such as PDE inhibitors and endovascular interventions, led to market decline.

Current Market Landscape

Today, the market for similar drugs is fragmented:

• Vasodilators and Intermittent Claudication Drugs: The primary treatment options include cilostazol, pentoxifylline, and supervised exercise programs.
• Niche and Off-Label Uses: Limited, mainly in regions with regulatory leniency or for legacy practitioners maintaining older protocols.

The overall market value for drugs treating peripheral arterial disease (PAD) is projected to grow at a CAGR of approximately 5-7% over the next five years, driven by aging populations and increased PAD diagnosis [1]. However, BENEMID itself constitutes a minor share of this market due to its outdated status.

Emerging Opportunities and Challenges

Potential re-entry into the market hinges on:

• Rebranding as a repurposed or modified agent with improved safety.
• Regulatory approval for new indications, particularly neuroprotection or circulatory support.
• Patent opportunities for new formulations or delivery systems.

Challenges include safety concerns—especially lactic acidosis—and stiff regulatory requirements. Conversely, the growing interest in drug repurposing presents opportunities for niche positioning if safety and efficacy can be validated.

Competitive Landscape

The competitive landscape lacks direct equivalents to BENEMID but features:

• Established drugs such as cilostazol with proven efficacy.
• Novel agents in development targeting ischemic conditions.
• Innovative therapies like gene therapy and advanced endovascular hardware.

Given this environment, BENEMID’s future would depend on positioning within the niche of drug repurposing, emphasizing safety improvements and expanding indications.

Market Projections and Future Outlook

Short-term (1–3 years)

• Limited clinical trial activity on the horizon.
• No significant regulatory approvals expected without new safety data.
• Potential for small-scale research grants aimed at exploring the drug’s neuroprotective capacity.

Medium-term (4–7 years)

• Possible emergence of pharmacological reformulations, especially if early-phase trials suggest safety and efficacy.
• Market growth driven by renewed interest in drug repurposing and the aging demographics increasing PAD and neurodegenerative cases.
• Strategic partnerships between biotech firms and academic institutions centered on BENEMID analogs.

Long-term (8+ years)

• Conditional approval for new indications if safety and efficacy are demonstrated convincingly.
• Entry into niche markets as a secondary agent for specific ischemic or neurodegenerative conditions.
• Commercial viability tied to successful reformulation, patent protection, and targeted marketing.

Concluding Remarks

BENEMID remains a historically significant agent dulled by safety concerns. Nonetheless, the evolving landscape of pharmaceutical research offers potential avenues for repositioning, especially in neuroprotection and ischemic therapies. To capitalize on this, stakeholders must prioritize safety profiling, innovative formulation, and targeted clinical development.

Key Takeaways

• Current clinical research on BENEMID is limited, emphasizing small-scale studies and safety assessments aimed at drug repurposing.
• Market prospects are constrained by safety issues, but the growing burden of PAD and neurodegenerative diseases presents niche opportunities.
• Innovation in formulations and indications could revive BENEMID's commercial relevance, provided safety concerns are adequately addressed.
• Strategic collaborations and early-phase clinical trials are essential for advancing BENEMID’s repositioning prospects.
• Regulatory pathways may be challenging but feasible if evidence supports improved safety profiles and novel indications.

FAQs

1. What is the primary historical use of BENEMID?
   BENEMID was primarily used to treat intermittent claudication by improving peripheral blood flow in patients with peripheral arterial disease.

2. Why has BENEMID's clinical use declined?
   Its decline is due to safety concerns, especially lactic acidosis linked to phenformin-like compounds, leading to regulatory restrictions.

3. Are there ongoing clinical trials for BENEMID?
   Existing clinical trials are limited, mostly exploratory studies assessing its repurposing potential for neuroprotection and other ischemic conditions.

4. Could BENEMID be repositioned for modern therapeutic use?
   Yes, particularly if formulations can mitigate safety risks. Early-stage research suggests potential in neuroprotection and stroke recovery.

5. What is the future market outlook for BENEMID?
   The market remains niche, with growth contingent on successful reformulations, new indications, and positive clinical trial outcomes.

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Sources

[1] GlobalData Healthcare, "Peripheral Arterial Disease Market Analysis," 2022.