The First Pill That May Dissolve Gout Tophi: What Pozdeutinurad Could Mean for You

The First Pill That May Dissolve Gout Tophi: What Pozdeutinurad Could Mean for You

If you have gout tophi, those hard lumps of uric acid crystals under your skin, you already know the frustration. You take your allopurinol or febuxostat faithfully. Your blood tests show lower uric acid. But the lumps stay. They damage your joints, limit your movement, and remind you every day that gout is still there.

Until now, the only real option for removing tophi was surgery. That may be about to change. A new oral medication called pozdeutinurad (also known as AR882) has just reported Phase 3 trial results showing it can lower uric acid far more effectively than current standard treatments. And in earlier Phase 2 data, it did something no oral drug has ever done before: it actually dissolved tophi in a meaningful number of patients.

What Is Pozdeutinurad and How Does It Work?

Pozdeutinurad is an investigational drug, meaning it is not yet approved by the U.S. Food and Drug Administration (FDA) or any other regulatory body. It belongs to a class of medications called URAT1 inhibitors. To understand why that matters, you need to know how your body handles uric acid.

Most uric acid leaves your body through urine. But your kidneys reabsorb a large portion of it back into your bloodstream through a protein called URAT1 (urate transporter 1). Think of URAT1 as a recycling door. It grabs uric acid from your kidney tubules and pulls it back into circulation. Pozdeutinurad blocks that door, so more uric acid gets flushed out in urine instead of staying in your blood.

This is different from how allopurinol and febuxostat work. Those drugs, known as xanthine oxidase inhibitors, stop your body from producing uric acid in the first place. Pozdeutinurad tackles the other side of the equation: getting rid of the uric acid your body already made.

The drug also uses something called deuteration technology. Without getting too deep into the chemistry, this means the drug molecule has been modified with deuterium, a stable form of hydrogen, to slow down how quickly the body breaks it down. The result is a longer-lasting effect at lower doses, which may translate to fewer side effects.

If you want a deeper dive into how existing medications compare, check out our guide on allopurinol versus febuxostat.

Why Current Treatments Fall Short

Here is a number that might surprise you: somewhere between 30% and 70% of people taking standard urate-lowering therapy still cannot get their serum uric acid (sUA) below the target level of 6 mg/dL. That target matters. Research shows that keeping uric acid below 6 mg/dL prevents new crystal deposits, and going below 4 mg/dL can slowly dissolve existing ones.

The problem is that XO inhibitors only address one side of the equation. They reduce production. But if your kidneys are reabsorbing too much uric acid through URAT1, cutting production alone may not be enough. You are turning down the faucet but the drain is still partly blocked.

This is why some doctors combine an XO inhibitor with a uricosuric drug, one that increases uric acid excretion. But the options have been limited. Probenecid, the oldest uricosuric, has modest efficacy and interacts with many other medications. Lesinurad (brand name Zurampic) was approved by the FDA in 2015 but pulled from the market in 2019 for commercial reasons, not safety ones. Benzbromarone, another uricosuric, was not approved in the United States due to concerns about liver toxicity.

So there is a real gap. People with gout who do not respond to standard therapy have had few places to turn. You can read more about the stages of gout and why tophi form in our guide to gout disease progression.

The Phase 3 REDUCE 2 Results: A Major Step Forward

On May 21, 2026, the Swedish pharmaceutical company Sobi announced top-line results from the REDUCE 2 trial. This was a Phase 3 study, the final stage of testing before a company applies for FDA approval.

The study enrolled 811 adults with gout. Most of them had already tried standard urate-lowering therapy without success. They were randomly assigned to receive either pozdeutinurad 50 mg, pozdeutinurad 75 mg, or a placebo, taken once daily for 12 months. Neither the patients nor the researchers knew who was getting the real drug.

The primary endpoint, the main question the trial was designed to answer, was simple: what percentage of patients achieved sUA below 6 mg/dL at month 6?

The results were striking.

For the 75 mg dose, 69.2% of patients hit the target, compared with only 8.1% on placebo. For the 50 mg dose, 56.6% reached the target. Both results were statistically significant with a p-value less than 0.0001, meaning the odds of this happening by chance are essentially zero.

To put that in perspective: these were patients who had already failed other treatments. Nearly seven out of ten of them got their uric acid under control on the higher dose. That is a meaningful change for people who had run out of options.

Sobi reported that the safety profile was consistent with earlier studies, and the drug was overall well tolerated. Detailed safety data, including specific adverse event rates, will be presented at a scientific congress in the fourth quarter of 2026.

The Tophi Dissolution Data: Why It Matters So Much

The REDUCE 2 results are impressive for uric acid lowering. But what really sets pozdeutinurad apart is the tophi dissolution data from its Phase 2 program, which was presented at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress and the American College of Rheumatology (ACR) 2025 meeting.

In the Phase 2 study, 42 patients with tophaceous gout received pozdeutinurad 75 mg either alone or combined with allopurinol. After 12 months of treatment:

• 43% of patients taking pozdeutinurad alone had at least one tophus completely disappear.
• 57% of patients taking pozdeutinurad combined with allopurinol had at least one tophus completely disappear.
• The total urate crystal burden, measured by imaging, shrank by an average of 17.4 cubic centimeters with monotherapy and 20.1 cubic centimeters with combination therapy.

That last point deserves attention. The researchers could actually see the crystal deposits shrinking on imaging scans over the course of treatment. This was not just a lab number improving. Physical deposits of uric acid were measurably dissolving.

No other oral medication has demonstrated this ability in clinical trials. Injectable uricase drugs like pegloticase (brand name Krystexxa) can reduce tophi, but they require IV infusions in a clinical setting, carry risks of infusion reactions, and are typically reserved for the most severe cases. An oral pill that can achieve similar results would be a fundamentally different treatment option.

You can learn more about what tophi are and why they form in our article on tophi and visible gout lumps.

How Fast Does It Work?

One of the most notable findings from the Phase 2 data is how quickly pozdeutinurad lowered uric acid. At just 6 weeks of treatment, patients on the 75 mg dose saw their sUA drop by 53%. For comparison, patients on febuxostat saw a 39% reduction over the same period, a difference that was statistically significant.

At 3 months, 86% of patients on the 75 mg dose had achieved sUA below 6 mg/dL, compared with 46% of patients taking allopurinol 300 mg.

Speed matters for more than just impatience. The longer uric acid stays elevated, the more crystals accumulate. Rapid, deep reduction creates the conditions needed for existing crystals to start dissolving. Uric acid needs to drop below 4 mg/dL for that process to kick in, and pozdeutinurad’s early data suggests it can get patients there faster than current options.

Safety: What We Know So Far

Any new gout medication faces scrutiny on safety, and for good reason. Febuxostat carries an FDA black box warning for cardiovascular death, although the actual risk is low. Lesinurad was linked to kidney problems. Benzbromarone was not approved in the U.S. due to liver concerns.

Based on the data available so far, pozdeutinurad appears to have a favorable safety profile. In the Phase 2 study, researchers measured serum creatinine, a marker of kidney function, 478 times across all patients. Not a single measurement showed a concerning elevation. No cardiovascular safety signals were detected. No liver enzyme abnormalities were reported.

That said, Phase 2 involved 42 patients. Phase 3 involved over 800 in REDUCE 2 alone, and REDUCE 1 enrolled another 750. The full safety picture will emerge when complete data from both Phase 3 trials is published. Sobi has stated that the safety profile in REDUCE 2 was consistent with Phase 2, which is encouraging.

Common side effects reported in earlier studies included mild stomach upset and headaches. Serious adverse events were rare and occurred at similar rates between the drug and placebo groups.

Who Stands to Benefit the Most?

Pozdeutinurad is being developed specifically for people whose gout is not adequately controlled by existing therapy. That includes:

• People who cannot reach target uric acid levels on allopurinol or febuxostat alone.
• People with tophaceous gout who have visible uric acid deposits.
• People who have tried multiple medications without success.
• People with kidney disease who may have trouble with other urate-lowering drugs, since pozdeutinurad works on URAT1 rather than requiring kidney clearance of the drug itself.

If you also have kidney disease, which frequently coexists with gout, the kidney safety data is particularly relevant. Our article on gout and kidney disease explains why these two conditions are so closely linked.

When Could It Be Available?

Pozdeutinurad is not yet approved. The FDA granted it Fast Track designation, a program designed to speed up the development and review of drugs that address unmet medical needs. But Fast Track does not mean automatic approval.

Here is where things stand:

• REDUCE 2 (the trial in patients who failed standard therapy) reported positive top-line results in May 2026. Full results are expected at a scientific congress in Q4 2026.
• REDUCE 1 (a second Phase 3 trial in a broader gout population) is fully enrolled, with data expected in the second half of 2026.
• If both trials are positive, Sobi plans to submit for regulatory approval. That process typically takes 6 to 10 months for priority review.
• Realistically, if all goes well, the earliest possible approval would be late 2026 or early 2027.

In February 2026, Sobi acquired Arthrosi Therapeutics, the original developer of pozdeutinurad, for $950 million upfront plus up to $550 million in milestone payments. That is a significant investment, and it signals that the company sees real commercial potential in this drug.

What This Means for Your Treatment Right Now

If you are currently struggling to control your gout, pozdeutinurad is not available yet. But the news is still relevant to you for a few reasons.

First, it validates the URAT1 pathway as a viable target. If you have not discussed uricosuric options with your rheumatologist, this might be a good time to ask whether probenecid or combination therapy could help you reach target uric acid levels.

Second, it sets a new benchmark. The fact that 69% of treatment-resistant patients achieved target uric acid levels raises the bar for what patients should expect from their treatment. If your uric acid is not at target, do not settle for “it’s a little better.” Talk to your doctor about escalating or adjusting your regimen.

Third, if you have tophi, this is the first time there is clinical evidence that an oral medication may be able to dissolve them. That does not mean you should wait for pozdeutinurad. Tophi cause joint damage the longer they sit there. But it does mean that more options are coming.

Frequently Asked Questions

Is pozdeutinurad approved by the FDA?

No. Pozdeutinurad is an investigational drug that has not yet been approved by the FDA or any other regulatory authority. It has received FDA Fast Track designation, which speeds up the development and review process, but it still needs to complete its clinical trials and submit a full application before approval can be considered. The earliest realistic approval timeline is late 2026 or early 2027.

How is pozdeutinurad different from allopurinol and febuxostat?

Allopurinol and febuxostat are xanthine oxidase inhibitors, meaning they reduce the production of uric acid. Pozdeutinurad is a URAT1 inhibitor, meaning it blocks the kidneys from reabsorbing uric acid back into the blood. The two approaches address different parts of the uric acid cycle. Some patients may benefit from combining both types of medication, which is what the Phase 2 combination data suggested.

Can pozdeutinurad dissolve tophi that I already have?

Phase 2 data showed that 43% of patients taking pozdeutinurad 75 mg alone and 57% taking it combined with allopurinol had at least one tophus completely disappear after 12 months. Imaging confirmed that the urate crystal deposits shrank measurably. However, these were Phase 2 results from a 42-patient study. The Phase 3 REDUCE 2 trial included tophi reduction as a secondary endpoint, and those detailed results have not yet been published. Full confirmation will come when the complete Phase 3 data is presented.

Will pozdeutinurad work if I have kidney disease?

Early data is encouraging for people with kidney disease. In Phase 2, researchers measured kidney function 478 times and found no concerning elevations in creatinine. Because the drug works by blocking URAT1 in the kidney tubules rather than requiring the kidney to clear the drug itself, it may be suitable for people with reduced kidney function. However, patients with severe kidney disease were largely excluded from early trials, and the full Phase 3 safety data in this population is still pending.

How much will pozdeutinurad cost?

Pricing has not been announced, and no information is available yet about insurance coverage or patient assistance programs. Given that Sobi paid $950 million upfront to acquire the drug and is investing in a large clinical program, it is likely to be priced as a specialty medication. The actual cost to patients will depend on insurance formulary decisions, copay structures, and any patient assistance programs Sobi may establish. This information will become available closer to the drug’s approval date.

Reviewed by the GoutSavvy Editorial Team