American Society of Nephrology Annual Meeting nephrology news and issues logo ByJill Rollet Fact checked byRichard Smith Investigational phosphate-binding agent lowers pill size, number
November 06, 2025 2 min read Add topic to email alerts
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Share Key takeaways: More than 90% of patients with hyperphosphatemia reached serum phosphate less than 5.5 mg/dL. Pills were seven times smaller, and patients took half the number compared with their pretrial medications. HOUSTON — Patients with hyperphosphatemia taking an investigational phosphate-binding agent achieved clinical targets with lower pill burden, according to pivotal trial data presented at ASN Kidney Week.
The medication, oxylanthanum carbonate (OLC; Unicycive Therapeutics), is “a next-generation lanthanum-based phosphate-binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis,” according to the company website.
NNI1125Gupta_JR_KW_IG5 Data derived from Gupta S, et al. TH-PO0506. Presented at: ASN Kidney Week; Nov. 5-9, 2025; Houston gupta_ig Shalabh Gupta “The main takeaway message is that the pill burden matters, and pill burden with OLC is substantially better,” Shalabh Gupta, MD, founder, CEO, president and chairman of Unicycive Therapeutics, told Healio.
In an open-label, single-arm trial, Gupta and colleagues administered OLC to 72 patients with CKD on dialysis (mean age, 62 years; 54.7% men). Patients had mean serum phosphate levels between 4 mg/dL and 7 mg/dL in the 8 weeks preceding the trial. Before the trial, 52.3% of patients were prescribed sevelamer carbonate, 19.8% calcium acetate, 15.1% ferric citrate and 14% sucroferric oxyhydroxide. After a 3-week washout period, OLC doses were titrated for up to 6 weeks followed by a 4-week maintenance period.
At the end of the titration period, 91% of patients had a serum phosphate level less than 5.5 mg/dL, up from 59% before titration.
“Saying it differently, 41% of patients were not able to achieve their target serum phosphate level no matter what their physician did, no matter what drug they were on, no matter what doses they were on, and that 41% inability to achieve true target serum phosphate level went down to 9%,” Gupta said.
Before the study, patients were taking a mean of 8.3 pills per day with a volume of 9.3 cm3. After titration, mean pill burden was 3.8 per day with a volume of 1.3 cm3. OLC pills are the size of a baby aspirin, according to Gupta.
“This is a patient population [in which] 69%, to be precise, were being managed with three pills or less [per day],” Gupta said. “In fact, there are close to 15% patients that were being managed by one pill or two pills a day, so it is a very potent drug.”
Two patients experienced a severe adverse event — one with upper abdominal pain and one with diarrhea, according to the researchers.
Gupta said Unicycive Therapeutics is planning to submit OLC for FDA approval by the end of the year with a decision expected in the first half of 2026.. my emphasis
For more information: Shalabh Gupta, MD, can be reached at info@unicycive.com.
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