Renazorb (lanthanum dioxycarbonate) / Unicycive, Assertio - LARVOL DELTA

MEDICATION VOLUME COMPARISON TO BIND PHOSPHATE (ERA-EDTA 2023) - " Five phosphate binders were assessed: ferric citrate (210 mg ferric iron), calcium acetate (667 mg calcium acetate), lanthanum carbonate (500 and 1,000 mg lanthanum), sevelamer carbonate (800 mg sevelamer carbonate), and lanthanum dioxycarbonate (500 and 1,000 mg lanthanum). The study found that lanthanum dioxycarbonate had the lowest volume to bind the same amount of phosphate compared to other binders.With a low medication volume and high phosphate binding capacity, lanthanum dioxycarbonate, a novel investigational nanotechnology product, can be a welcoming choice for patients to manage their hyperphosphatemia. The drug's decreased pill size (making it easy to swallow) and its tolerability have the potential to increase medication adherence and improve phosphate control."

Cardiovascular • Chronic Kidney Disease • Metabolic Disorders • Nephrology • Renal Disease

High Phosphate Binding Capacity of Lanthanum Dioxycarbonate With a Low Medication Volume: Comparison With Commercially Available Phosphate Binders. (PubMed, Am J Nephrol) - "Lanthanum dioxycarbonate has the lowest daily phosphate binder dose volume and the smallest volume required to bind 1 g of phosphate compared to all other commercially available phosphate binders. A randomized trial that compares gastrointestinal tolerability across binders would be warranted to demonstrate acceptability and adherence in the target population. ."

Journal • Chronic Kidney Disease • Gastrointestinal Disorder • Nephrology • Renal Disease

Binder Weight to Bind 1 Gram of Phosphate (NKF-SCM 2023) - "This study evaluated the medication weight of various phosphate binders to bind 1 gram of phosphorus.Methods The daily dose weights and weight required to bind 1 g phosphate for lanthanum dioxycarbonate, sucroferric oxyhydroxide, calcium acetate, lanthanum carbonate, ferric citrate, and sevelamer carbonate were calculated. Lanthanum dioxycarbonate and sevelamer carbonate had the lowest (11.7 g) and highest weight (76.2 g) required to bind 1 g of phosphate, respectively.Conclusion Due to its low daily medication weight and high phosphate binding capacity, lanthanum dioxycarbonate, a novel investigational nanotechnology product, may be a welcome choice for patients to manage their hyperphosphatemia. The drug's smaller size and tolerability have the potential to increase medication adherence and phosphate control."

Cardiovascular • Chronic Kidney Disease • Metabolic Disorders • Nephrology • Renal Disease

IN-VIVO PHOSPHATE REDUCTION: LANTHANUM DIOXYCARBONATE VS LANTHANUM CARBONATE TETRAHYDRATE (ISN-WCN 2023) - "Figure 1: Mean Urine Phosphate Excretion/Day View Large Image Figure Viewer Download Hi-res image Download (PPT) Conclusions Similar to LCTH, LDC was effective on day 1 in lowering P levels and maintaining low P levels. These results suggest that per amount of active elemental lanthanum, LDC has similar efficacy as LCTH while having a potentially smaller pill size that is swallowed with water, which may improve patient QoL."

Preclinical • Metabolic Disorders • Nephrology • Renal Disease

DAILY MEDICATION VOLUME OF PHOSPHATE BINDER THERAPIES (ISN-WCN 2023) - "Methods The daily dose volumes for lanthanum dioxycarbonate (RENAZORB TM ), sucroferric oxyhydroxide, calcium acetate, lanthanum carbonate, ferric citrate, and sevelamer carbonate were calculated. Conclusions Due to its low daily dose volume, lanthanum dioxycarbonate, a novel investigational nanotechnology product, may be a welcome choice for patients to manage their hyperphosphatemia. The drug’s improved size (making it easy to swallow) and tolerability have the potential to increase medication adherence and phosphate control."

Cardiovascular • Chronic Kidney Disease • Metabolic Disorders • Nephrology • Renal Disease

LANTHANUM DIOXYCARBONATE EFFECTIVELY REDUCES URINARY PHOSPHATE EXCRETION IN HEALTHY VOLUNTEERS (ISN-WCN 2023) - "Currently available 3000 mg/day lanthanum carbonate effectively reduces urinary P excretion by 236-468 mg/day.6 Lanthanum dioxycarbonate, RENAZORB(LDC), is a novel nanotechnology product that combines lanthanum, which has the highest binding capacity vs. other P binders,7 with a potentially smaller pill size that is swallowed with water rather than chewed. It was well tolerated, with minimal systemic absorption of lanthanum. LDC may be a welcome choice for patients as it is effective and is a small swallowable pill."

Clinical • Metabolic Disorders • Nephrology • Renal Disease

"$UNCY Unicycive Achieves Primary Endpoint in Pivotal Bioequivalence Study of Renazorb https://t.co/dhcZ5CDFpk" (@stock_titan)

Daily Medication Volume of Phosphate Binder Therapies (KIDNEY WEEK 2022) - "Methods The daily dose volumes for lanthanum dioxycarbonate (RENAZORB TM ), sucroferric oxyhydroxide, calcium acetate, lanthanum carbonate, ferric citrate, and sevelamer carbonate were calculated. Conclusion Lanthanum dioxycarbonate, a novel investigational nanotechnology product, may be a welcome choice for patients to manage their hyperphosphatemia. Improved size (easily swallowed) and tolerability have the potential to increase medication adherence and phosphate control."

Cardiovascular • Chronic Kidney Disease • Metabolic Disorders • Nephrology • Renal Disease

Novel Phosphate Binder Lanthanum Dioxycarbonate Does Not Demonstrate Clastogenic or Mutagenic Potential (KIDNEY WEEK 2022) - "These data support that LDC is safe and should be tested in the target population of patients with ESKD on dialysis with hyperphosphatemia. If approved, LDC would offer a small, swallowable phosphate binder option that could improve patient quality of life and potentially adherence."

Metabolic Disorders • Nephrology • Renal Disease

Lanthanum Dioxycarbonate Effectively Reduces Urinary Phosphate Excretion in Healthy Volunteers (KIDNEY WEEK 2022) - "Currently available 3000 mg/day lanthanum carbonate effectively reduces urinary P excretion by 236-468 mg/day. It was well tolerated. LDC may be a welcome choice for patients as it is effective and is a small swallowable pill."

Clinical • Metabolic Disorders • Nephrology • Renal Disease

"$UNCY Unicycive Initiates Pivotal Clinical Bioequivalence Study of Renazorb to Treat Hyperphosphatemia https://t.co/pp0elfEAPB" (@stock_titan)

Clinical • Metabolic Disorders • Nephrology • Renal Disease

Fast and High Phosphate Reduction With Lanthanum Dioxycarbonate Versus Selevamer In In-Vivo Study (ERA-EDTA 2022) - "FIGURE 1: Urine Phosphate Excretion/Day: LDC versus SVH. FIGURE 1: Urine Phosphate Excretion/Day: LDC versus SVH."

Preclinical • Chronic Kidney Disease • Metabolic Disorders • Nephrology • Renal Disease

Lanthanum Dioxycarbonate is Safe in Rats (ERA-EDTA 2022) - "These results suggest lanthanum dioxycarbonate may be a suitable candidate for further development. Potential benefits of LDC may include reduced pill burden and ease of dose administration (smaller easy-to-swallow versus chewable), which collectively has potential to enhance patient adherence, improve treatment outcomes and enhance QoL."

Preclinical • Chronic Kidney Disease • Metabolic Disorders • Nephrology • Renal Disease

Lanthanum Dioxycarbonate Is Safe in Dogs (NKF-SCM 2022) - "These results suggest lanthanum dioxycarbonate may be a suitable candidate for further development. Potential benefits of LDC may include reduced pill burden and ease of dose administration (swallow vs chewable), which collectively has potential to enhance patient adherence, improved treatment outcomes, and enhanced QoL."

Chronic Kidney Disease • Metabolic Disorders • Nephrology • Renal Disease

Lanthanum Dioxycarbonate Effectively Reduces Phosphate in Healthy Volunteers (NKF-SCM 2022) - "Currently available 3000mg/day lanthanum carbonate effectively reduces urinary P excretion by 236-468mg/day6. It was well tolerated. LDC may be a welcome choice for patients as it is effective and is a small swallowable pill."

Clinical • Metabolic Disorders • Nephrology • Renal Disease

"$UNCY Unicycive Therapeutics Receives Confirmatory Guidance on Renazorb Regulatory Pathway https://t.co/x2wOP7nNW5" (@stock_titan)

Unicycive Therapeutics Acquires Renazorb (Lanthanum Dioxycarbonate) from Spectrum Pharmaceuticals for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease (PRNewswire) - "Unicycive Therapeutics...announced it has entered a licensing agreement with Spectrum Pharmaceuticals for Renazorb (lanthanum dioxycarbonate), a late-stage asset for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD)….Under the terms of the asset purchase agreement, Unicycive has acquired global rights for Renazorb and all its trademark and associated patents, and Spectrum has received an equity interest in Unicycive along with milestone and royalty payments."

Licensing / partnership • Chronic Kidney Disease • Renal Disease

Reducing Pill Burden of Phosphate Binders Has the Potential to Improve Patient Adherence (KIDNEY WEEK 2019) - "Phase 1 data for lanthanum dioxycarbonate1, suggest comparable urinary excretion of phosphate to published data for lanthanum carbonate...Kidney Week 2013, Atlanta, GA, Nov 5-10 Dosages of selected phosphate binders required to reach a phosphorous binder equivalent dose (PBED)...St Peter, LD Wazny, E Weinhandl et al. Drugs, 2017, 77:1155-1186FundingCommercial Support"

Clinical