A Multicenter, Multidose, Study to Assess the Tolerability and Pharmacokinetics of Oxylanthanum Carbonate at Clinically Effective Doses in Patients With Chronic Kidney Disease on Dialysis

The goal of this clinical study is to test the tolerability of oxylanthanum carbonate (OLC) in patients with chronic kidney disease on hemodialysis and have hyperphosphatemia (too much phosphorus in their blood). The main question it aims to answer is whether patients taking OLC for hyperphosphatemia are able to tolerate the drug.
Participants will continue with their scheduled dialysis treatments and replace their current phosphate binder drug with OLC.

Start Date15 Dec 2023

Sponsor / Collaborator

Unicycive Therapeutics, Inc.

100 Clinical Results associated with Oxylanthanum Carbonate

100 Translational Medicine associated with Oxylanthanum Carbonate

100 Patents (Medical) associated with Oxylanthanum Carbonate

Literatures (Medical) associated with Oxylanthanum Carbonate

01 Mar 2025·Kidney360

Combination Oxylanthanum Carbonate and Tenapanor Lowers Urinary Phosphate Excretion in Rats

Article

Author: Chertow, Glenn M. ; Medicherla, Satya ; Reddy, Guru ; Gupta, Shalabh ; Gupta, Pramod

Key Points

Combination therapy with oxylanthanum carbonate+tenapanor led to greater reductions in urinary phosphate excretion than either drug alone.

We demonstrated dose-dependent and sizable reductions in urinary phosphate excretion in response to oxylanthanum carbonate monotherapy.

BackgroundThis study evaluated the combined effects of oxylanthanum carbonate (OLC), an investigational phosphate binder, and tenapanor, an approved sodium/hydrogen exchanger 3 inhibitor that reduces paracellular phosphate absorption, on urinary phosphate excretion in rats on a high-phosphorus diet.MethodsSixty-four male Sprague Dawley rats were randomized into eight groups: vehicle; tenapanor (0.15 mg/kg) only; OLC (0.75%, 1.5%, and 3%) only; and combination OLC (0.75%, 1.5%, and 3%)+tenapanor (0.15 mg/kg). Vehicle and tenapanor were dosed orally twice per day, whereas OLC was incorporated into diets. We collected 24-hour urine samples to measure urinary phosphate excretion, a proxy for intestinal phosphate absorption efficiency. Primary analyses compared pooled results in the three OLC dose groups.ResultsIn the tenapanor 0.15 mg/kg group, mean urinary phosphate excretion from days 9 to 11 was 8.5 mg/d (12.5%) lower compared with the vehicle group. In the OLC-alone groups, mean urinary phosphate excretion (pooled across the 0.75%, 1.5%, and 3% OLC dose groups) was 12.1 mg/d (17.7%) lower compared with the vehicle group. Compared with vehicle, urinary phosphate excretion was 28.1 mg/d (41.3%) lower in the combination OLC+tenapanor groups (P = 0.016). Bliss model of independence assessing the statistical significance between observed and predicted results indicated that combination OLC+tenapanor was synergistic (P = 0.009 for 0.75% OLC+tenapanor and P = 0.010 for 1.5% OLC+tenapanor).ConclusionsWe demonstrated sizable reductions in urinary phosphate excretion in response to OLC monotherapy and the most pronounced reductions in urinary phosphate excretion when using OLC in combination with tenapanor.

01 Jan 2025·Clinical Therapeutics

Two-Way Randomized Crossover Study to Establish Pharmacodynamic Bioequivalence Between Oxylanthanum Carbonate and Lanthanum Carbonate

Article

Author: Reddy, Guru ; Mathur, Vandana ; Hasal, Steve ; Walker, Michael ; Gupta, Shalabh

PURPOSEPhosphate binders (PB) are integral to hyperphosphatemia management in patients with end-stage kidney disease. PB efficacy is adversely affected by nonadherence and limited phosphate-binding capacity relative to dietary intake. Oxylanthanum carbonate is an investigational novel nanotechnology product that combines lanthanum, which has the highest binding capacity of available PBs, with a smaller pill size that is swallowed with water rather than chewed. This study's objective was to demonstrate the pharmacodynamic equivalence of orally administered oxylanthanum carbonate to lanthanum carbonate (LC) in healthy subjects.METHODSIn this phase one, single-center, randomized, open-label study, healthy subjects were treated with oxylanthanum carbonate swallowable tablets 1000 mg three times/day and LC chewable tablets 1000 mg three times/day in a two-way crossover design. The primary pharmacodynamic variable was the least squares mean (LSM) change in urinary phosphate excretion from baseline to the evaluation period (Days 1-4 of treatment).FINDINGSA total of 80 subjects were randomized and 75 received all doses. The LSM change in urinary phosphate excretion from Baseline to the Evaluation (Treatment) Period was similar for both oxylanthanum carbonate (-320.4 mg/day [90% CI: -349.7, -291.0]) and LC (-324.0 mg/day [90% CI: -353.3, -294.7]); the between-group LSM difference was 3.6 [90% CI: -37.8, 45.1] mg/day. Both drugs were well tolerated with an equal incidence of adverse events.IMPLICATIONSThus, oxylanthanum carbonate was bioequivalent to LC in healthy subjects and well tolerated. Oral oxylanthanum carbonate may provide an option for patients with chronic kidney disease and hyperphosphatemia for whom chewing tablets is disliked, inconvenient, or difficult.CLINICAL TRIAL REGISTRATION NUMBERNCT06218290.

01 Jan 2025·Clinical and Translational Science

Safety and Phosphate‐Binding Capacity of Oxylanthanum Carbonate in Healthy Volunteers

Article

Author: Khare, Atul ; Pergola, Pablo E. ; Hasal, Steve J. ; Finn, William F. ; Joy, Melanie S. ; Gupta, Pramod ; Reddy, Guru ; Garsd, Armando

ABSTRACTDespite the widespread use of currently available serum phosphate management options, elevated serum phosphate is common in patients with end‐stage kidney disease on dialysis. Characteristics of currently available phosphate binders that lead to poor patient experiences such as large drug volume size of required daily medication (e.g., many large tablets) and adverse gastrointestinal effects may decrease compliance to labeled dosing instructions, thus decreasing their efficacy. Oxylanthanum carbonate is a new molecule yielding the same phosphate‐binding capacity as lanthanum carbonate, but in a much smaller drug volume and tablet size. It is formulated as small tablets that can be easily swallowed. In a double‐blind dose‐escalation phase 1 study, healthy volunteers (n = 32) were randomly divided into four treatment arms and randomly assigned to receive oxylanthanum carbonate tablets or a placebo over a period of 4 days to evaluate safety, urinary and fecal excretion of phosphorus, and pharmacokinetics. Each treatment arm evaluated a different dose of oxylanthanum carbonate: 500, 1000, 1500, or 2000 mg three times a day (TID). The study drug was well‐tolerated. Oxylanthanum carbonate effectively decreased dietary phosphorus absorption, demonstrated by decreased urinary phosphorus excretion and increased fecal phosphorus excretion. Systemic absorption of oxylanthanum carbonate was minimal, with lanthanum serum concentration values below the level of quantification (0.500 ng/mL) in all subjects receiving 500 mg TID and did not exceed 0.7 ng/mL at other doses. Future studies should evaluate and confirm the ability of oxylanthanum carbonate to reduce pill burden and improve dose administration, patient tolerability, adherence, and treatment outcomes.Trial Registration:ClinicalTrials.gov identifier: NCT01560884

News (Medical) associated with Oxylanthanum Carbonate

13 Nov 2024

·www.echemi.com

New Drug OLC Could Revolutionize CKD Treatment, Countdown to US FDA Approval!

Shilpa Medicare, a leading integrated pharmaceutical group, today announced its CDMO partner, Unicycive Therapeutics, Inc. Has successfully had the U.S. Food and Drug Administration (USFDA) accept a New Drug Application (NDA) for lanthanum oxycarbonate (OLC). This important advance marks a major breakthrough for Unicycive in the field of treating chronic kidney disease (CKD) hyperphosphatemia. The USFDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025. If the OLC is eventually approved by the USFDA, it will be a significant boon for dialysis treated CKD hyperphosphatemia patients. Currently, these patients face an onerous treatment regimen that often requires taking up to 12 pills a day. The introduction of OLC is expected to significantly improve the treatment burden for patients as it requires a lower pill burden in terms of the number and size of pills per dose. In addition, OLC pills are designed to swallow rather than chew, increasing patient convenience and compliance. Chronic kidney disease (CKD) is a serious health condition characterized by a gradual loss of kidney function over time. The kidneys play a vital role in filtering waste and excess fluid from the blood, regulating blood pressure, balancing electrolytes, and producing hormones that affect red blood cell production and calcium metabolism. When kidney function declines, waste can build up in the body, leading to a range of serious health complications. Unicycive has entered into a long-term manufacturing contract with Shilpa, ensuring that OLC will be available on a commercial scale once approved by the U.S. Food and Drug Administration. Unicycive's NDA is currently under review and is expected to commercialize and launch an OLC in the U.S. market in the second half of 2025. Shilpa Medicare not only has a strong presence in oncology and non-oncology apis, peptides, polymers, differentiated finished dosage formulations, but also offers a wide range of formulations including oral dispersion membranes and transdermal patches. In addition, Shilpa has a well-crafted portfolio of biological products. To support its broad reach, Shilpa Medicare also provides end-to-end CDMO services to pharmaceutical companies worldwide, and its strong R&D and manufacturing capabilities are strongly supported by four R&D departments and seven manufacturing facilities.

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperphosphatemia	NDA/BLA	United States	Unicycive Therapeutics, Inc.	-
Chronic Kidney Diseases	Phase 2	United States	Unicycive Therapeutics, Inc.	15 Dec 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06218290 (UNI-OLC-201, Company_Website) Manual	Phase 2	Hyperphosphatemia	86	OXYLANTHANUM CARBONATE	(vqglshehyp) = yrqaeeejwh yibqznzqhr (vwielnolub ) View more	Positive	25 Jun 2024

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