One Pill, One Niche, One Big Bet: The Doctor‑Founder Behind Unicycive Therapeutics

Written By Shawn Geddes

By Shawn Geddes

Last updated: February 25, 2025 1:35 pm PT

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.

For Dr. Gupta, who still identifies first as a physician, that ambition is the culmination of an unusually zigzagging career: attending doctor, Wall Street biotech analyst, Genentech strategist, then repeat biotech founder. Before Unicycive, he built and sold another company, BioCycive Inc., whose oncology pipeline targeting the HIF‑1 alpha pathway was acquired by Sorrento Therapeutics in a deal valued at more than $160 million in cash, milestones and royalties when its lead drug was still in the “IND‑enabling” stage, just before human trials. 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.” Rather than chase brand‑new drug concepts from scratch, Unicycive set out to “identify undervalued assets and turn them into best‑in‑class therapies,” essentially scanning the global scientific landscape for promising compounds that had been shelved, under‑resourced or simply mispositioned. 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.

The choice of targets reflects a kind of brutal triage. Unicycive’s pipeline is deliberately narrow and firmly rooted in kidney pathology, where the stakes are high and the patients few tools. For dialysis patients, excess phosphorus is more than a lab abnormality; left unchecked, it contributes to bone disease, cardiovascular complications and early death, forcing patients to rely on phosphate binders that many find chalky, bulky and difficult to tolerate. OLC, as described in investor materials and interviews, is designed to bind phosphate more efficiently in the gut, using a lanthanum‑based formulation that allows for smaller pill size, improved palatability and what the company says is a more potent profile than existing therapies, factors that it argues could translate into better adherence and better outcomes. 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. The aim, he suggested, is not only to hit regulatory endpoints but to remain nimble enough to adjust dosing, positioning and commercial plans as the landscape shifts, whether because of new competitors, revised guidelines or evolving payer expectations.

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 pitches itself to investors through a simple proposition: two kidney‑focused assets, a clearly defined patient population and an addressable market shaped by large dialysis providers and specialist nephrologists. 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.

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. Phosphate binders, while clinically important, live in a world of formularies, step‑therapy protocols and contracts with dialysis chains and integrated health systems. For a small company to compete, experts say, it must demonstrate not only non‑inferiority or superiority in controlling serum phosphate, but also meaningful advantages in adherence and quality‑of‑life metrics that might, in time, reduce hospitalizations or other costly complications. In public comments, Dr. Gupta has suggested that Unicycive sees an opening for a “small company” to launch OLC itself, arguing that a focused field force and tight alignment with dialysis centers could be enough to carve out a foothold without immediately surrendering the asset to a larger partner.

If that sounds audacious, it is also a bet on changing power dynamics in drug commercialization. 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 agency to “find the shortest, best possible way to get the drug to the market.” The comments hinted at a broader belief: that in tightly defined specialty markets like dialysis, the distance between a 40‑person biotech and the end patient has shrunk, thanks in part to more targeted commercial models and digital engagement. Whether that optimism will survive the glare of real‑world negotiations with national dialysis providers and pharmacy benefit managers remains an open question.

Beyond OLC, Unicycive’s second program, UNI‑494, underscores how Dr. Gupta is positioning the company at critical junctures in kidney care rather than chasing diffuse indications. The molecule is being developed for conditions related to acute kidney injury, including the prevention of delayed graft function in kidney transplant patients, where even modest improvements in early graft performance can ripple through years of health outcomes and costs. 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.

In Davos, amid panels about algorithmic trading and generative A.I., Dr. Gupta’s remarks at the Forbes AI Summit stood out for another reason: they were almost stubbornly analog. He spoke less about machine‑learning pipelines and more about patients struggling to tolerate their medications, about aligning incentives so regulators and companies move in lockstep to bring new therapies to market quickly but safely, and about the personal journey from hospital wards to boardrooms. On Unicycive’s own “Our Team” page, the company describes his career as “devoted to healthcare,” spanning work as an attending physician, equity researcher, commercial strategist and now serial entrepreneur, a progression that mirrors the increasingly interdependent worlds of medicine, finance and technology.

Still, the test that now looms before him is not about crafting a narrative but delivering results. The FDA’s decision on oxylanthanum carbonate will determine whether Unicycive becomes a rare nephrology upstart with a marketed product or joins the long list of development‑stage companies forced back to the drawing board. Even a positive ruling will be only the beginning of a longer, less glamorous slog: negotiating coverage, educating clinicians, tracking real‑world safety and effectiveness, and, perhaps most difficult, proving that a small company can sustain the logistical and financial demands of a commercial launch in a highly regulated, cost‑conscious sector. For the dialysis patients he speaks about so often, the stakes are more immediate. The hope is that a new pill might make a grueling regimen just a little easier to bear.

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
Next

A Punchline Like a Trapdoor: The Strange Genius of PBF