Innovative therapeutic development solutions

FAQs

Frequently Asked Questions About Unicycive

Chronic Kidney Disease (CKD) FAQ

What is chronic kidney disease (CKD)?

Chronic kidney disease (CKD) is a long-term condition in which the kidneys gradually lose their ability to properly filter waste and excess fluids from the blood. As kidney function declines, patients may develop complications including cardiovascular disease, anemia, bone disorders, and electrolyte imbalances.1-4

What causes chronic kidney disease?

CKD is commonly caused by diabetes and high blood pressure, although other medical conditions may also contribute to kidney damage over time. As CKD progresses, many patients eventually require dialysis to support kidney function.1-3

What are the common complications of CKD?

Common complications of CKD include elevated phosphorus levels (hyperphosphatemia), cardiovascular disease, bone disease, and vascular calcification. Hyperphosphatemia has been associated with increased morbidity and mortality in dialysis patients.1,5-8

When do CKD patients typically require dialysis?

Patients with advanced or end-stage chronic kidney disease (ESRD) may require dialysis when their kidneys can no longer adequately remove waste products and maintain fluid and electrolyte balance.2,3,9

Hyperphosphatemia FAQ

What is hyperphosphatemia?

Hyperphosphatemia is a condition characterized by elevated phosphate levels in the blood. It occurs frequently in patients with chronic kidney disease on dialysis because damaged kidneys are unable to effectively remove excess phosphorus from the body. 6,10

Why is phosphorus control important in dialysis patients?

Elevated phosphorus levels are associated with cardiovascular disease, vascular calcification, bone disease, hospitalization, and increased mortality in dialysis patients. Clinical guidelines recommend lowering phosphate levels toward the normal range.6,10

What causes elevated phosphorus levels in CKD patients?

As kidney function declines, the kidneys lose their ability to remove the phosphorus we get from our diets efficiently. This can lead to phosphorus accumulation in the blood, particularly in patients with advanced CKD or those requiring dialysis.10

How is hyperphosphatemia treated?

Treatment for hyperphosphatemia typically includes limiting phosphorus in diet and oral phosphate-binding medications taken with meals to reduce phosphorus absorption. Despite multiple approved therapies, many dialysis patients continue to struggle with phosphorus control and treatment adherence due to pill burden and tolerability challenges.10,11

Dialysis Patient FAQ

What is dialysis?

Dialysis is a treatment that removes waste products and excess fluids from the blood when the kidneys can no longer do so adequately, to replicate kidney function.12

Why do dialysis patients need phosphate management?

Dialysis patients often experience elevated phosphorus levels because dialysis alone may not adequately remove dietary phosphate. Managing phosphorus is important to help reduce the risk of cardiovascular and bone-related complications.10

What dietary restrictions are common for dialysis patients?

Dialysis patients are often advised to limit foods high in phosphorus and follow individualized dietary guidance from their healthcare team. Dietary management is commonly part of a treatment plan along with phosphate-binding medications.5,10

What should dialysis patients discuss with their nephrologist?

Patients on dialysis may want to discuss phosphorus management, medication options, dietary recommendations, treatment adherence, and overall kidney health with their nephrologist or healthcare provider, to understand treatment options for their condition and lifestyle.

Product / Therapy FAQ

What is oxylanthanum carbonate (OLC)?

Oxylanthanum carbonate (OLC) is an investigational oral phosphate binder being developed by Unicycive Therapeutics for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis.13 To learn more visit the OLC page.

How may OLC differ from currently available phosphate binders?

OLC utilizes proprietary nanoparticle technology designed to reduce pill burden by lowering the number and size of pills patients may need to take compared with currently available phosphate binders.14

Is OLC approved in the United States?

OLC is currently an investigational therapy and has not yet received FDA approval. In January 2026, the FDA accepted the company’s NDA resubmission and assigned a PDUFA target action date of June 29, 2026.15

Company FAQ

What is Unicycive Therapeutics’ area of focus?

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases, including therapies for hyperphosphatemia and acute kidney injury.16

What differentiates Unicycive’s approach to kidney disease treatment?

Unicycive is focused on developing therapies designed to address some of the biggest unmet needs in kidney disease care, including reducing treatment burden and improving patient adherence.16,17

Does Unicycive have additional pipeline programs?

Yes. In addition to OLC, Unicycive is developing UNI-494, an investigational therapy intended for conditions related to acute kidney injury and delayed graft function in kidney transplant patients.18,19 To learn more visit the UNI-494 page.

Where can investors and healthcare professionals learn more?

Additional company, pipeline, and investor information is available through the Unicycive Investor Relations website.

References:
  1. Chronic kidney disease (CKD). National Kidney Foundation. Updated September 11, 2023. Accessed May 27, 2026. https://www.kidney.org/kidney-topics/chronic-kidney-disease-ckd
  2. Chronic kidney disease basics. Centers for Disease Control and Prevention (CDC). Updated May 15, 2024. Accessed May 27, 2026. https://www.cdc.gov/kidney-disease/about/index.html
  3. Chronic kidney disease (CKD). National Institute of Diabetes and Digestive and Kidney Diseases. Updated October 2016. Accessed May 27, 2026. https://www.niddk.nih.gov/health-information/kidney-disease/chronic-kidney-disease-ckd
  4. Dhondup T, Qian Q. Acid-case and electrolyte disorders in patients with and without chronic kidney disease: an update. Kidney Diseases. 2017;3:136–14.
  5. Phosphorus and your CKD diet. National Kidney Foundation. Updated July 16, 2024. Accessed May 27, 2026. https://www.kidney.org/kidney-topics/phosphorus-and-your-ckd-diet
  6. High phosphorus (hyperphosphatemia). American Kidney Fund. Updated March 6, 2024. Accessed May 27, 2026. https://www.kidneyfund.org/living-kidney-disease/health-problems-caused-kidney-disease/high-phosphorus-hyperphosphatemia
  7. CKD-Mineral and Bone Disorder (CKD-MBD). Kidney Disease: Improving Global Outcomes (KDIGO). Accessed May 27, 2026. https://kdigo.org/guidelines/ckd-mbd/
  8. Rout P, Jialal I. Hyperphosphatemia. In: StatPearls. Treasure Island, FL: StatPearls Publishing; 2026. Updated June 12, 2023. Accessed June 1, 2026. https://www.ncbi.nlm.nih.gov/books/NBK551586/
  9. Kidney Failure. National Kidney Foundation. Updated September 5, 2023. Accessed June 2, 2026. https://www.kidney.org/kidney-topics/kidney-failure
  10. High phosphorus (hyperphosphatemia). National Kidney Foundation. Updated December 6, 2024. Accessed June 3, 2026. https://www.kidney.org/kidney-topics/high-phosphorus-hyperphosphatemia
  11. Hill Gallant KM, Jermasek D, Oppenheimer B, Doss S. Phosphate binder compliance study in patients with end-stage kidney disease. J Nephrol Dialysis Med. 2025;6(3):1-8.
  12. Hemodialysis. National Kidney Foundation. Updated April 26, 2024. Accessed May 27, 2026. https://www.kidney.org/kidney-topics/hemodialysis
  13. A study to assess the tolerability of oxylanthanum carbonate in patients with chronic kidney disease on dialysis. ClinicalTrials.gov. Updated June 24, 2025. Accessed May 27, 2026. https://clinicaltrials.gov/study/NCT06218290?term=Oxylanthanum%20Carbonate&viewType=Card&rank=1
  14. Block GA, Chertow GM, Reddy G, et al. A phase 2 clinical trial of oxylanthanum carbonate in patients receiving maintenance hemodialysis with hyperphosphatemia. Clin J Am Soc Nephrol. 2025;20(9):1259-1267.
  15. Unicycive Therapeutics, Inc. UPDATE — Unicycive Therapeutics announces FDA acceptance of oxylanthanum carbonate (OLC) new drug application (NDA) resubmission [press release]. Los Altos, CA: Unicycive Therapeutics, Inc.; January 29, 2026. Accessed June 3, 2026. https://ir.unicycive.com/news/detail/118/update—unicycive-therapeutics-announces-fda-acceptance-of
  16. Unicycive Therapeutics, Inc. Our focus on kidney health. Unicycive Therapeutics website. Updated May 20, 2026. Accessed June 3, 2026. https://unicycive.com/our-focus/
  17. Unicycive Therapeutics, Inc. Oxylanthanum carbonate (OLC). Unicycive Therapeutics website. Updated May 19, 2026. Accessed June 3, 2026. https://unicycive.com/olc/
  18. Unicycive Therapeutics, Inc. Unicycive Therapeutics announces orphan drug designation granted for UNI-494 by the U.S. Food and Drug Administration for the prevention of delayed graft function in kidney transplant patients [press release]. Los Altos, CA: Unicycive Therapeutics, Inc.; March 4, 2024. Accessed June 3, 2026. https://ir.unicycive.com/news/detail/62/unicycive-therapeutics-announces-orphan-drug-designation
  19. Unicycive Therapeutics, Inc. Therapeutic pipeline. Unicycive Therapeutics website. Accessed June 3, 2026. https://unicycive.com/pipeline/