Renazorb™

Promising innovation to address a persistent problem

RENAZORB™ (lanthanum dioxycarbonate) is an unapproved investigational new drug being developed under FDA’s 505(b)(2) regulatory procedure. If approved, Renazorb, will share the same product label and prescribing information as the reference-listed drug (RLD) Fosrenol (lanthanum carbonate) with the exception that Renazorb tablets are smaller in size and swallowed whole with water and not chewed.

THE UNMET NEED IN HYPERPHOSPHATEMIA

Despite the availability of 6 FDA-approved phosphate binders, hyperphosphatemia remains uncontrolled in an estimated 75% of US dialysis patients.1

Representative Sample of US Dialysis Patients
Serum Phosphorus (3-month average).

THE DAILY BURDEN FOR PATIENTS

The daily pill burden of maintenance dialysis patients is among the highest across various chronic disease states including HIV/AIDS, diabetes mellitus, and congestive heart failure.2

  • 19 pills per day (median)
  • 49% of pill burden from phosphate binders
  • Higher pill burden was independently associated with lower quality of life scores (HR-QOL)
  • 62% of patients are non-adherent (self-reported)
Unmet Needs in Treatment of Hyperphosphatemia with Phosphate Binders (Unaided)3

In a survey of 100 US-based nephrologists:

  • Lower pill burden/better patient compliance
  • Greater efficacy
  • Fewer side effects
  • Once daily dosing / not taken with meal
  • Other
  • New MOA
  • Lower cost / better coverage
  • None

A POTENTIAL SOLUTION

Through its proprietary nanoparticle technology, UNICYCIVE has harnessed the phosphate binding potency of lanthanum to reduce the number and size of pills that patients must take to control hyperphosphatemia3*

  • pill
  • pill
  • pill
  • pill
  • pill
  • pill
  • pill
  • pill
  • pill

Renvela®

sevelamer carbonate 800mg

  • pill
  • pill
  • pill

Renazorb™

lanthanum dioxycarbonate 1,000mg

*Average daily dose of Renvela and Fosrenol (lanthanum carbonate) from dailymed.nlm.nih.gov. Expected average daily dose of Renazorb based on bioequivalence to Fosrenol. Product images are proportionally sized.

If approved, Renazorb™ may offer patients a 4-fold reduction in daily pill burden (by volume) compared to Renvela® (sevelamer carbonate)—currently the most prescribed phosphate binder.3

References: 1. US-DOPPS Practice Monitor, May 2021; http://www.dopps.org/DPM 2. Chiu YW, Teitelbaum I, Misra M, et al. Pill burden, adherence, hyperphosphatemia, and quality of life in maintenance dialysis patients. Clin J Am Soc Nephrol. 2009 Jun;4(6):1089-96. 3. Data on file. Unicycive Therapeutics, Inc; 2022.