Unicycive Therapeutics is a biopharmaceutical company that develops novel therapies for kidney diseases, including chronic kidney disease (CKD) and acute kidney injury (AKI). Pulse 2.0 interviewed Unicycive Therapeutics founder and CEO Dr. Shalabh Gupta, MD, to gain a deeper understanding of the company.
Dr. Gupta’s Background
Could you tell me more about your background? Dr. Gupta said:
“I was born in Uttar Pradesh and grew up in Kanpur. This is where my curiosity and love for science took root thanks in large part to my father, a physician who showed me firsthand how much of a difference compassionate care can make.”
“As I got older, I saw how much healthcare quality and access to advanced technologies could vary depending on where you lived, which motivated me to move to the U.S. to study. I earned my Master’s in Public Administration from NYU, focusing on Health Care Finance and Management, and completed my medical training at NYU Grossman School of Medicine in Physical Medicine and Rehabilitation.”
“Eventually, I found myself on Wall Street, working as an analyst while still practicing medicine on weekends and holidays. That unusual mix of experiences led me to start Unicycive Therapeutics—where I’ve been focused on using innovation and technology to develop treatments that truly make a difference in people’s lives.”
Formation Of The Company
How did the idea for the company come together? Dr. Gupta shared:
“I started Unicycive in 2016 with a simple but powerful goal: to make a real difference in the lives of people living with kidney disease. Compared to fields like oncology, where innovation is constant, nephrology has fallen behind—leaving patients with limited options. I saw an opportunity for a smaller, more agile company to step in and address some of the most urgent, unmet needs.”
“We listened closely to nephrologists’ biggest concerns, then identified and acquired two drug candidates with real, near-term potential to solve those challenges. This led to the development of Oxylanthanum Carbonate (OLC), a treatment that reflects what Unicycive is all about: advancing care for chronic kidney disease and improving patient outcomes.”
Favorite Memory
What has been your favorite memory working for the company so far? Dr. Gupta reflected:
“One of my favorite memories is the day I acquired the drug—loading nearly 40 kilograms into the backseat of my car and driving it back to our office. Looking back now, it’s incredible to see how far we’ve come. From those early days to where we are today, our team has worked tirelessly to develop this into a potential best-in-class treatment for patients. It’s inspiring and a constant reminder of what’s possible through teamwork, persistence, and unwavering belief in our mission.”
Core Products
What are the company’s core products and features? Dr. Gupta explained:
“Unicycive’s lead programs focus on addressing critical unmet needs in nephrology, especially for people living with CKD. Our primary drug candidate, OLC, is a novel phosphate binder developed to treat hyperphosphatemia in CKD patients—particularly those undergoing dialysis.”
“What sets OLC apart is its small tablet size, lower pill burden, and ease of swallowing—key factors that can improve adherence and help patients achieve better phosphate control. It’s a promising solution to a long-standing challenge in kidney care.”
Challenges Faced
What challenges have Dr. Gupta and the team face in building the company? Dr. Gupta acknowledged:
“One of the biggest challenges in the early days of Unicycive was sharpening our value proposition—figuring out where our product could make the biggest difference and how to bring it to market in the near-term. With OLC, we saw a clear opportunity to raise the standard of care for hyperphosphatemia in CKD patients, but we still needed healthcare providers, investors, and other stakeholders to see that potential too.”
“Tackling challenges like this comes down to three core principles:
Always tell a clear story: Whether it’s engaging with investors, regulators, or the broader medical community, we continually refine how we communicate OLC’s value and the difference it can have on patients.
Build the strongest team possible: Advancing a drug from development to commercialization requires people who understand both science and the business. We focus on attracting top talent who can take our work to the next level.
Keep moving the product and company forward: Approval isn’t the finish line. We’re always looking for ways to improve, optimize, and expand the drug’s potential, while also strengthening the company behind it.
These principles aren’t static—they evolve with us. But they’ve been essential to helping Unicycive grow and navigate the complexity of a competitive, highly regulated space.”
Evolution Of The Company’s Technology
How has the company’s technology evolved since launching? Dr. Gupta noted:
“The company’s development path has significantly evolved since launch. Initially, we were planning to follow the 505(b)(1) pathway, but we later shifted to the 505(b)(2) pathway, which allowed us to pursue a more expedited approval process, including a fast-track option. This change required us to think differently than our predecessor company, especially in terms of how we approach drug development.”
“As we’ve moved forward, every opportunity to run a clinical trial has been an invaluable learning experience. We’ve gained critical data that not only informs our current strategy but also helps us understand how to use the drug more effectively in the future. This continuous feedback loop has allowed us to refine our approach and stay focused on the long-term success of the drug.”
“Additionally, as we navigate the changing regulatory environment and fast-track pathways, it’s crucial to keep understanding and engaging with all stakeholders, including patients, healthcare providers, and regulators, to ensure that our technology evolves in ways that meet their needs and expectations.”
Significant Milestones
What have been some of the company’s most significant milestones? Dr. Gupta cited:
“Since our founding, Unicycive has achieved several important milestones, all of which have been instrumental in shaping the company’s journey and positioning it for success in the nephrology space.”
“One of the company’s significant milestones was initially acquiring two drugs from other companies. This strategic move allowed us to immediately build on existing compounds with the potential to address critical gaps in kidney disease treatment. By acquiring these drugs, we could leverage their development into solutions that address unmet needs in hyperphosphatemia and CKD, positioning the company as a unique player in a relatively stagnant field.”
“Another key milestone was assembling a team of talented individuals who believe in the company’s mission and vision. At Unicycive, we’ve created a small but mighty team—a group of people passionate about making a real difference in the lives of CKD patients. None of this is possible alone; we need a team that brings expertise, energy, and dedication to our goals. The company’s culture fosters collaboration, trust, and innovation.”
Customer Success Stories
When asking Dr. Gupta about customer success stories, he highlighted:
“We take a patient-centered approach to phosphate management. Unicycive’s comprehensive strategy focuses on understanding and addressing the day-to-day obstacles dialysis patients face. Our team worked closely with clinicians to bridge knowledge gaps surrounding dietary phosphorus and explored innovative therapies that reduced pill size and dosing frequency without sacrificing the efficacy required for optimal phosphate control.”
“OLC’s innovative approach led to a significant improvement in both clinical outcomes and patient satisfaction. Patients reported a noticeable reduction in treatment-related anxiety, as the smaller pills and simplified dosing allowed for a more convenient and less disruptive treatment experience. The new therapy also fostered stronger patient-clinician relationships, as healthcare providers saw firsthand the benefits of addressing patient concerns with more personalized and empathetic care.”
“By improving the ease of adherence and reducing the stigma associated with taking medication in public, OLC’s solutions gave dialysis patients the freedom to engage in normal social eating, a key aspect of their overall well-being.”
“For more information on recent patient success stories please read more here and preclinical data here.”
Differentiation From The Competition
What differentiates the company from its competition? Dr. Gupta affirmed:
“While there are six approved drugs on the market for treating hyperphosphatemia in CKD patients, there are still major challenges that existing treatments fail to address. We’ve identified it as the problem of the 3 Ps:
Potency: Patients have to take 12-15 pills per day to control their serum phosphorus
Pill burden: Many of the treatments require patients to chew large, chalky pills that are difficult to consume.
Palatability: Unpleasant taste due to the presence of metal in the pills.
How OLC is different:
More potent: Patients need fewer daily pills—just one per meal (three per day) instead of 12-15.
Less pill burden: Unlike bulky phosphate binders, OLC is small and easy to swallow.
Better palatability: OLC dissolves in water within 30 seconds, making it more convenient and eliminating the bad taste associated with other binders.
By addressing these real patient pain points, Unicycive offers a more effective, patient-friendly alternative that improves compliance and quality of life.”
Future Company Goals
What are some of the future company goals? Dr. Gupta concluded:
“Unicycive’s future goals are to advance our pipeline, particularly with OLC, which we are working hard to bring to market.”
“Unicycive’s primary near-term goal is to secure FDA approval. This would be a critical milestone for the company and enable us to offer patients a more effective, patient-friendly treatment for hyperphosphatemia, which remains inadequately controlled with existing therapies. OLC’s small pill size, improved palatability, and potent formula are all key differentiators that we believe will significantly impact patient adherence and overall health outcomes.”
“Securing FDA approval would validate OLC’s efficacy and safety and position Unicycive as a leader in addressing gaps in the nephrology market. It would also mark the beginning of an exciting new chapter in the company’s growth and expansion, allowing us to bring innovative, near-term solutions to a field that has been in need of innovation for years.”
