Paulex Bio is a biopharmaceutical company on a mission to eliminate the root cause of diabetes. Because for us, this is about more than science. It is about the families who wake up every day facing the relentless burden of this disease. That human reality fuels everything we do.
Paulex Bio stands at the threshold of what could be a transformative breakthrough for type 1 and type 2 diabetes: beta cell regeneration through an oral medicine designed to eliminate the root cause of diabetes.
Our leadership team has a proven track record of delivering breakthrough therapies for serious unmet needs—including FDA-approved treatments like TZIELD®.
We're developing an oral medicine designed to regenerate pancreatic islet beta cells and restore the body's natural insulin production.
Diabetes is a lifelong, high-burden disease with severe complications and shortened life expectancy. The need for a transformative solution has never been greater.
Our Ph1b trial aims to deliver proof-of-concept and clinical evidence for beta cell mass restoration and insulin normalization.
*TZIELD® is a registered trademark of Sanofi Group.
Paulex Bio was born from both a scientific breakthrough and a bold ambition: to create a world without diabetes. From the very beginning, the company’s co-founders, Dr. Miguel Sanjuan and Dr. Francisco Leon, partnered with world-leading researchers at the Icahn School of Medicine at Mount Sinai to translate groundbreaking biology into a first-in-class oral therapy for diabetes—moving innovation decisively from bench to bedside.
The scientific roots of Paulex extend back more than a decade to a landmark discovery at Mount Sinai: the identification of a novel regulator of human beta cell proliferation. This finding challenged long-held assumptions that adult beta cells could not meaningfully regenerate, opening an entirely new therapeutic paradigm for restoring insulin-producing cells.
Drs. Sanjuan and Leon, together with Paulex’s leadership team, bring decades of experience advancing transformative therapies for type 1 diabetes. Their work achieved global recognition with the FDA approval and launch of TZIELD® in 2022—the first disease-modifying therapy for type 1 diabetes.
In 2024, the convergence of pioneering regenerative science and seasoned drug-development leadership led to the founding of Paulex Bio. Today, Paulex is advancing this mission to its next chapter—harnessing regenerative biology to fundamentally redefine what is possible for people living with diabetes.
Paulex Bio was named in honor of Paula and Alex—the niece and nephew of our co-founder—both of whom live with type 1 diabetes. Their daily experiences give a deeply personal meaning to our work and serve as a constant reminder of what is at stake.
What began as a personal connection has grown into a much broader purpose. The challenges faced by Paula and Alex are shared by millions of people worldwide, and their stories reinforce our commitment to pursue solutions that can scale far beyond any single family. At Paulex, we are driven to translate personal motivation into global impact—advancing a functional cure that has the potential to transform the lives of millions living with diabetes.
Paulex Bio’s highly experienced management and development team brings extensive experience in delivering novel therapies for unmet needs, including diabetes. Our team collectively has over 50+ years in advancing therapies for diabetes, making our team uniquely positioned to drive the mission of preventing, treating, and ultimately curing this burdensome disease.
Our co-founder and key executives made a significant impact on Type 1 diabetes beginning in 2016. Today, we are taking their mission to the new level.
