One pill, one niche, one big bet: the doctor‑founder behind Unicycive Therapeutics

Written By Shawn Geddes

By Shawn Geddes

Last updated: February 26, 2025 9:00 am PT

Summary

  • Unicycive Therapeutics, founded in 2016 by nephrologist-turned-entrepreneur Dr. Shalabh Gupta, is betting that a small, focused biotech can move faster than big pharma in kidney disease—an area he argues has been historically overlooked despite a massive global burden.

  • The company’s near-term catalyst is FDA review of its lead candidate, oxylanthanum carbonate (OLC), a phosphate-binder for dialysis patients with hyperphosphatemia that aims to deliver a smaller, more potent, easier-to-take pill to improve adherence and daily quality of life.

  • Unicycive’s broader strategy is a “two shots on goal” kidney pipeline—pairing OLC with UNI-494 (for acute kidney injury/transplant delayed graft function, with Orphan Drug Designation)—and an ambitious plan to commercialize in a tightly defined dialysis market as a small company if approval comes through.

On a winter morning in Davos this February, as the snow-streaked Alps glowed outside a makeshift TV studio, a soft‑spoken nephrologist-turned-entrepreneur in a dark suit leaned into the camera to explain why he had bet his career on one of medicine’s most neglected frontiers: kidney disease.

The man was Dr. Shalabh Gupta, founder, chairman and chief executive of Unicycive Therapeutics, a small California biotechnology company trying to upend how millions of patients on dialysis manage a life‑threatening mineral imbalance in their blood.

In a conference dominated by artificial intelligence, oncology and big‑tech swagger, his message was disarmingly simple: chronic kidney disease is a global crisis hiding in plain sight. And innovation has not kept up.

“We’re not waiting for the future of kidney care,” the company’s mantra goes. “We’re building it.”

Unicycive, founded in 2016, is a minnow in a sea of pharmaceutical giants, yet it has maneuvered into a position where one experimental pill could reshape a market worth billions and influence daily life for some of medicine’s sickest patients. Its lead drug candidate, oxylanthanum carbonate (known internally as OLC) is a phosphate‑binding agent for people with chronic kidney disease on dialysis who struggle with dangerously high phosphorus levels, a condition known as hyperphosphatemia.

The treatment is under review at the Food and Drug Administration, and inside Unicycive’s modest offices, the near‑term goal is stated with almost evangelical clarity: secure approval and get a smaller, more potent, easier‑to‑take pill into the hands of patients who often swallow handfuls of medications every day.

The physician who learned Wall Street’s language

Dr. Gupta, who still sees himself first as a doctor, has had an unusual, winding career: he worked as a practicing physician, then became a Wall Street biotech analyst, then a strategist at Genentech, and later started multiple biotech companies.

Before Unicycive, he founded another company called BioCycive Inc. and later sold it to Sorrento Therapeutics in a deal worth more than $160 million in cash, milestone payments, and royalties. At the time, BioCycive’s main cancer drug was still in the early “IND-enabling” stage—meaning it hadn’t started human trials yet.

That experience, friends and colleagues say, reinforced a belief that nimble, asset‑focused biotech can move faster than many traditional drug developers, especially in overlooked diseases. At Unicycive, he has doubled down on that thesis in nephrology, a specialty he saw lagging far behind fields like cancer in innovation and investor attention.

The company’s own origin story reads less like a triumphant Silicon Valley founding myth and more like a quiet course correction born of frustration. On Unicycive’s website, the narrative begins with a blunt assessment: kidney disease is “an overlooked area” where innovation “lags despite the growing burden of chronic kidney disease.”

Instead of inventing new drugs from the ground up, Unicycive aimed to find promising drugs that were overlooked or left behind and develop them into top-quality treatments. In other words, it looked around the world for compounds that had been shelved, didn’t get enough funding, or were marketed the wrong way.

In 2018, it licensed its first two technologies, OLC and a second candidate called UNI‑494, and set about re‑engineering their clinical and commercial trajectories.

Two shots on goal in kidney care

The choice of targets reflects a kind of brutal triage.

Unicycive is keeping its drug pipeline small and focused on kidney disease, where patients have limited treatment options. For people on dialysis, too much phosphorus isn’t just a lab number—if it isn’t controlled, it can lead to bone problems, heart and blood vessel complications, and earlier death. That’s why patients often need phosphate binders, even though many people find them gritty, large, and hard to tolerate.

In its investor materials and interviews, the company says OLC is meant to grab onto phosphate in the gut more effectively. It uses a lanthanum-based formula that’s supposed to allow smaller pills and a better taste, and the company claims it may work better than current treatments. If that’s true, Unicycive argues patients would be more likely to take it consistently and that could lead to better results.

UNI‑494, meanwhile, targets acute kidney injury and has already received the FDA’s Orphan Drug Designation for preventing delayed graft function in kidney transplant recipients, a serious complication in which the transplanted organ fails to “wake up” promptly after surgery.

Inside Unicycive, that scientific focus is married to a particular philosophy of speed. Company materials describe an organization “built to move faster,” one that prizes lean teams, outsourced infrastructure and a willingness to iterate quickly as new trial data emerge.

Dr. Gupta, in a recent interview, likened each clinical study to a feedback loop, saying that “every opportunity to run a clinical trial has been an invaluable learning experience,” yielding data that refine both the science and how the drug might be used in the clinic.

He said the goal isn’t just to meet the FDA’s requirements, but to stay flexible enough to change the dose, how the drug is marketed, and the sales plan as things change, like if new competitors show up, medical guidelines change, or insurers start expecting something different.

A drug is only half the battle

Yet for all the talk of agility, the path from molecule to market runs through familiar, unforgiving terrain: regulators, investors and an unforgiving capital environment for small‑cap biotech. Unicycive, which Dr. Gupta took public on Nasdaq in July 2021 after founding the company in August 2016, is operating in a sector whipsawed by rising interest rates, clinical missteps and waves of consolidation.

The company presents a straightforward pitch to investors: it has two kidney-focused drug candidates, a clearly defined group of patients, and a target market influenced by big dialysis companies and kidney specialists.

On b2i Digital, a platform that introduces small companies to institutional and retail investors, Unicycive underscores that both of its programs are aimed at “large unmet medical needs” despite their niche‑sounding indications, implicitly asking investors to see under‑served patients as an opportunity rather than a risk.

Dr. Gupta’s own résumé is part of that pitch. Before founding Unicycive, he analyzed pharmaceutical companies as an equity researcher at UBS Investment Bank and covered biotechnology firms at Rodman & Renshaw, now part of HC Wainwright, giving him a front‑row seat to how markets reward or punish drug development decisions.

A stint in commercial strategy at Genentech, long considered a template for integrating science and marketing, exposed him to the intricacies of pricing, access and launch planning for complex therapies.

Those experiences, he has suggested, inform Unicycive’s emphasis on telling a “clear story” to investors, regulators and clinicians, one that connects clinical endpoints to tangible improvements in patients’ daily lives, like needing to swallow fewer pills with every meal.

The mission meets the marketplace

Behind the polished message is a leadership creed he has been articulating with increasing frequency as Unicycive edges closer to a potential first commercial launch.

In a recent essay on Cure, a health‑focused platform, and a separate leadership profile, Dr. Gupta described the mindset that he believes makes or breaks biotech startups: staying aligned around a shared mission, holding steady under pressure and constantly communicating why the work matters.

He frames Unicycive’s culture around under‑served patients, repeatedly highlighting dialysis patients whose quality of life is eroded by treatment regimens that demand dozens of tablets each day, even when they already feel unwell.

“Our focus is on closing urgent gaps in kidney care,” the company declares. “We’re not waiting for the future of kidney care — we’re building it.”

That mission‑driven rhetoric can be hard to separate from the reality that Unicycive, like any biotech, must eventually persuade payers and providers that its products justify their price.

For a small company to compete, experts say it can’t just show its drug works as well as (or better than) others at lowering phosphate levels in the blood. It also has to prove it helps patients stick with treatment and feel better day to day, and that those benefits might eventually lead to fewer hospital stays or other expensive health problems.

In public comments, Dr. Gupta has said Unicycive thinks a small company could launch OLC on its own. He argues that a small, focused sales team and close coordination with dialysis clinics could be enough to win an early slice of the market without having to hand the drug over to a bigger partner right away.

The small-company launch gamble

In a recent YouTube appearance in a series titled “CEOs You Should Know,” Dr. Gupta spoke about Unicycive’s plans “as a small company” to bring its drug to market and reach “as many people as” possible, emphasizing that it had already manufactured commercial‑grade product and was working closely with the FDA to “find the shortest, best possible way to get the drug to the market.”

The comments pointed to a bigger idea: in narrowly focused markets like dialysis, a small biotech with 40 employees can now get closer to patients than it could in the past, partly because sales and marketing can be more targeted and supported by digital tools. But it’s still unclear whether that optimism will hold up once the company has to negotiate with big national dialysis chains and pharmacy benefit managers.

Beyond OLC, Unicycive’s second drug program, UNI-494, shows how Dr. Gupta is aiming the company at key moments in kidney care instead of trying to treat a wide mix of unrelated diseases. The drug is being developed for problems tied to acute kidney injury, including preventing delayed graft function after kidney transplants, where even small early improvements can affect a patient’s health and medical costs for years.

With Orphan Drug Designation in hand and a Phase 1 dose‑ranging safety study in healthy volunteers completed, the asset gives Unicycive a foothold in transplant medicine and the possibility of benefiting from incentives like market exclusivity if it reaches approval.

For investors, it is a second shot on goal; for Dr. Gupta, it is part of a broader attempt to “transform the lives of under‑served patients” across the kidney‑care continuum, from dialysis centers to transplant units.

What the FDA decides next

In Davos, amid panels about algorithmic trading and generative A.I., Dr. Gupta’s remarks at the Forbes AI Summit stood out because they were surprisingly old-school. He talked less about machine learning and more about real patients who can’t tolerate their medications, how to get regulators and companies working toward the same goals so new treatments reach the market faster but still safely, and how he went from working in hospital wards to leading a company in the boardroom.

Unicycive’s “Our Team” page says his career has moved from being a practicing doctor to an equity researcher, then a commercial strategist, and now a repeat entrepreneur, showing how closely medicine, finance, and technology overlap today.

The FDA’s decision on oxylanthanum carbonate will decide whether Unicycive becomes a small kidney-disease company with an approved drug to sell, or another biotech that has to go back and rethink its plans. And even if the FDA says yes, that’s just the start: the company would still need to get insurance coverage, teach doctors about the drug, monitor how it performs in real patients, and prove it can handle the expensive, complicated work of launching and selling a drug in a tightly regulated, budget-focused market.

For the dialysis patients he talks about so often, the stakes are more immediate. The idea is that a new pill could make an already tough daily routine a little easier to live with.

As he left the Davos studio, the cameras turned to the next guest and the conversation shifted back to algorithms and capital flows. For Dr. Gupta, the work was moving to a more prosaic stage: yet another round of investor meetings, regulatory consultations and internal reviews as Unicycive prepares for whatever the FDA decides.

The story he tells, to anyone who will listen, is that in the quiet corners of medicine, in dialysis clinics tucked away from the conference halls and front pages, there is room for a different kind of biotech: smaller, faster, intensely focused on a population that has seldom been at the center of the innovation boom.

Whether that vision will ultimately earn a place not just in Davos or on Wall Street, but in the daily routines of patients fighting to stay alive one treatment at a time, is the question that will define the next chapter of Shalabh Gupta’s experiment in reimagining kidney care.

Further reading

Shawn Geddes
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