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
Chronic Pain	1
Influenza, Human	1
Substance-Related Disorders	1
Substance Withdrawal Syndrome	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

Last updated: June 10, 2026

BENEMID (probenecid) clinical trials update, market analysis, and projection

Executive summary: BENEMID is a brand of probenecid (uric-acid reabsorption inhibitor). BENEMID is a long-established, small-molecule medicine with an essentially mature market profile in the US and other major markets. Current activity is dominated by (1) label-expansion and limited investigator-led studies rather than pivotal, late-stage registrational trials; (2) ongoing evidence-generation in gout and off-label uses (including urate handling in specialized populations) rather than brand-new mechanisms; and (3) pricing and supply competition as generic probenecid is widely available. As a result, near-term commercial upside for the brand is generally tied to payer contracting, channel stability, and use-specific niches, not to a clear “pipeline-to-launch” curve.

What clinical trials exist for BENEMID (probenecid) right now?

Are there active Phase 3 trials for probenecid/BENEMID?

No clear, brand-specific Phase 3 registrational program is evident in the public clinical-trials record set for “BENEMID” in 2024-2026. The probenecid evidence base has largely transitioned to:

• older pivotal efficacy history for gout/hyperuricemia indications (historical),
• post-marketing comparative or mechanistic studies,
• smaller trials focused on pharmacokinetics (PK), drug-drug interactions (DDIs), renal transport and urate handling biomarkers, and use in specialized therapeutic contexts.

What kinds of trials are most common for probenecid today?

Current trial patterns for probenecid typically focus on:

• PK and DDI readouts (timing to reach steady-state concentrations of co-administered drugs; effect on renal clearance).
• Urate handling endpoints (serum urate changes, fractional excretion of urate, renal transport biomarkers).
• Clinical outcomes in gout flares or chronic management settings using standard endpoints (time to symptom improvement, flare frequency), usually in smaller designs.

How does probenecid’s trial activity differ from modern small-molecule urate-lowering drugs?

Compared with newer entrants in gout and hyperuricemia (for example, agents targeting uric acid production or urate transport with longer-lived pharmacology), probenecid’s ongoing studies are less likely to be designed for label expansion via large, global Phase 3 trials. The market has already been saturated by generic probenecid and by newer urate-lowering therapies, which shifts incentives away from brand-level Phase 3 investment.

What is the Orange Book status of BENEMID (probenecid) in the US?

BENEMID is not typically the entry point for contemporary exclusivity disputes. In the US, probenecid’s primary active ingredient is long off patent for most practical purposes, and generic versions have broad availability.

What matters for “Orange Book status” operationally:

• If probenecid has listed patents in the Orange Book, they are typically older and not blocking generic supply in routine practice.
• Competitive outcomes are more influenced by formulation scale-up, supply chain, distribution contracts, and payer economics than by a continuing exclusivity stack.

When does BENEMID (probenecid) lose exclusivity, and what risks remain for brand supply?

Exclusivity timeline

• Regulatory exclusivity for a legacy small molecule like probenecid is generally exhausted.
• The practical “exclusivity” constraint today is not patent expiry, it is product-level manufacturability and contracting.

What supply or lifecycle risks can affect BENEMID revenue even after exclusivity?

• Generic substitution at pharmacy level driven by PBM formularies.
• Narrow channel differentiation (if BENEMID is priced at or above generics).
• Shortages or manufacturing constraints that can temporarily lift brand share, but typically do not create sustainable long-term market expansion.

How big is the BENEMID (probenecid) market today, and who buys it?

Market structure

The US probenecid market is characterized by:

• generic availability at low-cost price points,
• prescriber use patterns concentrated in gout/hyperuricemia and specific clinician preferences,
• substitution driven by formularies and pricing, not by innovation-led switching.

What segments drive utilization?

• Gout patients who are managed with urate-lowering strategies and in whom probenecid is considered appropriate.
• Clinician-specific practice where probenecid is used due to experience, cost coverage, or patient-specific renal considerations.
• Off-label or niche uses where PK modulation of co-administered therapies may matter.

Competitive set

The competitive landscape includes:

• Allopurinol and febuxostat (urate production inhibition)
• Uricosurics beyond probenecid (where available through modern formulations or dosing)
• Biologic and newer urate-related agents in specific payer contexts
• Generic probenecid products that directly compete with BENEMID

How does BENEMID (probenecid) compare with modern gout drugs in efficacy and adoption?

Efficacy and clinical positioning

Probenecid’s clinical positioning is typically:

• slower or more constrained in practical use versus some modern options,
• sensitive to renal function and patient selection criteria (as with uricosurics generally),
• chosen when cost coverage and patient factors favor older uricosuric approaches.

Adoption drivers

• Cost and formulary access favor generics.
• Newer agents capture growth when they offer easier initiation, fewer contraindication issues, or better adherence profiles.

Net effect on BENEMID

BENEMID’s competitive edge is limited by:

• generics of the same API,
• limited differentiated clinical value relative to newer urate-lowering alternatives,
• payer preference for lower net-cost options.

What patent estate protects probenecid/BENEMID, and how strong is it?

Patent estate overview

For BENEMID/probenecid, the relevant IP landscape has shifted to:

• older patents that have mostly expired,
• potential downstream patents around specific formulations or methods (if any remain),
• and limited room for new enforcement that would materially block generics.

Litigation and Paragraph IV relevance

Because generic probenecid is already widely available, Paragraph IV-driven litigation is generally not a current primary driver of BENEMID market positioning. The brand’s risk is typically economic substitution rather than legal blocking.

What manufacturing and IP barriers could stop generic entry for BENEMID?

The barriers for probenecid are generally:

• standard CMC scale-up and bioequivalence compliance,
• no meaningful API-level monopoly,
• packaging and distribution constraints rather than IP.

Net: barrier level is typically “low” for a legacy small molecule once generics are established.

What FDA regulatory milestones matter for BENEMID and probenecid?

Label and safety monitoring

Key FDA relevance is operational:

• label language around use in gout/hyperuricemia,
• renal considerations and contraindication warnings,
• monitoring requirements for urate control and urinalysis when indicated.

Pathway implications

Probenecid is typically supported via generic pathways rather than new NDA development. Brand-specific FDA milestones are therefore limited.

Clinical trials update: what is the near-term pipeline signal for probenecid?

Near-term pipeline signal for probenecid is best characterized as evidence maintenance, not as a credible late-stage launch pathway. Clinical trial activity is more likely to:

• refine dosing/monitoring,
• quantify PK/DDIs with co-therapies,
• evaluate urate handling physiology in specific patient categories,
• or address observational outcomes and pragmatic endpoints.

For market projection, this means the pipeline does not create a new commercialization curve for BENEMID. Revenue evolution is dominated by price, contracting, and generic competition.

Market analysis and projection for BENEMID (probenecid): base case through 2028

Base case (most likely)

• US growth is flat-to-low in unit terms with potential modest volume stability depending on payer coverage.
• Revenue declines are plausible in nominal terms if BENEMID prices remain higher than generic probenecid net pricing.
• Any share change is likely driven by contract cycles, not by trial-driven label expansion.

Upside scenario

• BENEMID captures temporary share if generics face supply disruptions.
• Payer contracting increases coverage or reduces out-of-pocket friction.
• Limited niche label usage expands in specific subpopulations, but this is unlikely to produce a step-change without a clear Phase 3 outcome and regulatory label expansion.

Downside scenario

• Further generic price erosion reduces net revenue per tablet.
• Reduced formulary placement shrinks channel penetration.
• Supply stabilization problems shift patient flow to lower-cost competitors when availability returns.

What commercial metrics should track BENEMID performance?

Monitor:

• script volume for probenecid-containing products by channel,
• average net price (ANP) and gap to closest generics,
• formulary tier placement shifts,
• claims trends for gout and uricosuric use categories,
• inventory and shortage indicators for probenecid tablets.

Key Takeaways

• BENEMID (probenecid) is a legacy urate-lowering medicine with mature market dynamics and minimal brand-level innovation-driven growth.
• Clinical trial activity is more consistent with mechanistic, PK/DDI, and smaller evidence-generation studies than with large registrational Phase 3 programs.
• Market trajectory is mainly determined by generic competition, payer contracts, and price erosion, not by pipeline catalysts.
• Near-term projections through 2028 are best framed as flat-to-declining nominal revenue with unit stability as the base case.

FAQs

1. Are there any new FDA approvals or label expansions for probenecid/BENEMID in 2024-2026?
2. Does probenecid have current clinical trials for urate transporter biomarkers (fractional excretion of urate)?
3. What drug-drug interactions are most clinically relevant for probenecid use in gout?
4. How do payer formularies typically position probenecid versus allopurinol and febuxostat?
5. What generic probenecid brands compete most directly with BENEMID by coverage tier?

References

1. ClinicalTrials.gov. Probenecid search results (accessed 2026-06-11).
2. FDA Orange Book (Drugs@FDA and Orange Book patent/exclusivity listings for probenecid/BENEMID) (accessed 2026-06-11).