Company Profile: Unicycive Therapeutics, Inc.

Core Mission and Strategic Approach

Unicycive operates with a mission to transform the lives of underserved renal patients through the discovery and delivery of new therapies with high efficiency. The company's strategy centers on a "fast-to-market" model, often utilizing the FDA?s 505(b)(2) regulatory pathway. This allows Unicycive to develop improved versions of previously approved drugs, significantly reducing the time and cost associated with traditional drug development while offering "best-in-class" potential for patient compliance and efficacy.

Targeted Therapeutic Areas

• Hyperphosphatemia: A condition characterized by abnormally high levels of phosphate in the blood, affecting nearly all patients with End-Stage Renal Disease (ESRD) on dialysis.
• Acute Kidney Injury (AKI): A sudden episode of kidney failure or kidney damage that happens within a few hours or a few days, often leading to a buildup of waste products in the blood.

Products and Pipeline

Unicycive?s value proposition lies in its late-stage and mid-stage pipeline, designed to solve specific burdens of care, such as "pill burden" in dialysis patients.

1. Oxylanthanum Carbonate (OLC) / Renazorb

Oxylanthanum Carbonate (also known as Renazorb) is the company's lead investigational product. It is a next-generation, non-aluminum, non-calcium phosphate binder utilized to treat hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.

• Pill Burden Reduction: Current standard-of-care phosphate binders often require patients to take up to 12 large tablets daily. OLC utilizes proprietary nanoparticle technology to deliver high potency in a significantly smaller volume. Clinical data suggests OLC could reduce the daily pill volume by over 80%.
• Patient Convenience: Unlike the reference drug Fosrenol (lanthanum carbonate), which must be chewed, OLC tablets are small and designed to be swallowed whole with water.
• Regulatory Status: As of January 2026, Unicycive has resubmitted its New Drug Application (NDA) to the FDA. The company is anticipating potential approval and commercial launch in the first half of 2026.

2. UNI-494

UNI-494 is a patent-protected new chemical entity (NCE) currently in clinical development for the treatment of conditions related to Acute Kidney Injury (AKI).

• Mechanism of Action: UNI-494 is a prodrug of nicorandil. It is designed to protect kidney function by targeting mitochondrial dysfunction. By opening mitochondrial ATP-sensitive potassium (mitoKATP) channels, it helps reduce oxidative stress and prevents the opening of the mitochondrial permeability transition pore (mPTP), which is a key driver of cell death in AKI.
• Clinical Development: The drug has successfully completed a Phase 1 study in healthy volunteers and is progressing into patient trials to evaluate its efficacy in preventing delayed graft function (DGF) in kidney transplant recipients and other AKI-related conditions.

Services and Partnerships

As a clinical-stage biotech, Unicycive does not yet offer direct healthcare services but operates through a robust network of strategic and commercial partnerships:

• Manufacturing and Supply: The company utilizes specialized Contract Manufacturing Organizations (CMOs) to produce its nanoparticle-based drug candidates at commercial scale.
• Global Licensing: Unicycive has secured several high-value international partnerships to ensure global access to OLC:
  • Lee's Pharmaceutical: Exclusive rights for Mainland China, Hong Kong, and parts of Southeast Asia.
  • Lotus Pharmaceutical: Exclusive development and commercialization rights in the Republic of Korea.
• Clinical Research: Partnerships with top-tier Contract Research Organizations (CROs), such as Syneos Health, facilitate the execution of complex clinical trials across multiple global sites.

Financial and Market Position

Unicycive is publicly traded on the NASDAQ under the symbol UNCY. The company has successfully raised significant capital through healthcare-focused institutional investors to fund the commercial launch of OLC. The hyperphosphatemia market is estimated to be over $2.5 billion globally, with a substantial portion of that opportunity located in the United States, where over 500,000 patients require daily phosphate binder therapy.

Leadership Team

• Shalabh Gupta, M.D.: Founder, President, and CEO.
• Douglas Jermasek: Executive Vice President, Corporate Strategy (formerly of Genzyme and Akebia).
• John Townsend, CPA: Chief Financial Officer.