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 Sep 2025·Clinical Journal of the American Society of Nephrology

A Phase 2 Clinical Trial of Oxylanthanum Carbonate in Patients Receiving Maintenance Hemodialysis with Hyperphosphatemia

Article

Author: Pergola, Pablo E. ; Block, Geoffrey A. ; Chertow, Glenn M. ; Block, Martha ; Hasal, Steven J. ; Gupta, Shalabh ; Reddy, Guru ; Mourya, Sanjay

Key Points:

Oxylanthanum carbonate (OLC) was well tolerated with fewer than 10% of patients stopping treatment due to side effects.More than 90% of patients with hyperphosphatemia taking OLC achieved effective phosphate control.Two thirds of patients required three or fewer OLC tablets per day to control serum phosphate.

Background:

In patients with kidney failure receiving maintenance dialysis, hyperphosphatemia is managed by dietary phosphate restriction and the provision of phosphate binders. Oxylanthanum carbonate (OLC) is a phosphate binder in development with high potency and formulated in a small pill swallowed whole.

Methods:

We conducted a phase 2, open-label, single-arm, multicenter trial in adult patients receiving maintenance hemodialysis with hyperphosphatemia. The primary objective was to evaluate the tolerability of OLC at clinically effective doses with a goal serum phosphate (sP) concentration ≤5.5 mg/dl. The trial included washout, titration, and maintenance periods. Eligible patients had sP ≥4.0 and ≤7.0 mg/dl for at least 8 weeks before screening while receiving thrice weekly hemodialysis and a stable phosphate binder regimen. Patients started titration when sP was >5.5 mg/dl and entered maintenance once sP was ≤5.5 mg/dl. The starting dose of OLC during titration was 1500 mg/d (500 mg thrice daily). We assessed tolerability on the basis of the incidence of discontinuations due to treatment-related adverse events (TRAEs).

Results:

Eighty-six patients were treated with OLC during the study. At screening, sP was ≤5.5 mg/dl in 51 (59%) patients. Seventy-eight (91%) patients entered maintenance, and 71 (91%) patients achieved sP ≤5.5 mg/dl on a median OLC dose of 500 mg three times a day. The most common TRAEs were gastrointestinal and included diarrhea (9%) and vomiting (6%); all other TRAEs were reported in <5% of patients. Three (4%) patients discontinued drug due to TRAEs. Minimal to no systemic absorption of lanthanum was observed after administration of OLC 1000 mg thrice daily.

Conclusions:

In this open-label phase 2 trial, OLC was well tolerated and enabled sP control in >90% of patients with a low pill burden (two thirds of patients receiving three or fewer tablets/day).

Clinical Trial registry name and registration number::

NCT06218290.

01 Sep 2025·PROTEIN SCIENCE

Structural and functional insights into the selective inhibition of mutant tau aggregation by purpurin and oleocanthal in frontotemporal dementia

Article

Author: Lukáš Malina ; Viswanath Das ; Ihor Kozlov ; Patricie Skoupilová ; Alladi Charanraj Goud ; Sudeep Roy

Abstract:

Tau aggregation driven by microtubule‐associated protein tau (MAPT) mutations is central to frontotemporal dementia pathology, yet no disease‐modifying therapies effectively target mutant tau. Here, we identify purpurin (PUR) and oleocanthal (OLC) as selective inhibitors of mutant tau aggregation using peptide models spanning the R2R3 interface. Biophysical and cellular assays demonstrated that both compounds more effectively inhibit the aggregation of mutant tau peptides compared to wild‐type, with PUR preferentially targeting V287I and N279K variants, and OLC showing broader inhibitory activity. Surface plasmon resonance and docking analyses revealed more stable interactions and lower binding free energies with mutant tau, consistent with their enhanced inhibitory effects. Computational studies using monomeric and fibrillar tau structures supported the mutation‐specific binding profiles of PUR and OLC. Atomic force microscopy and confocal imaging confirmed reduced fibril formation, while post‐transduction treatment assays showed that both compounds significantly suppressed intracellular tau propagation. Additionally, OLC reduced tau phosphorylation and oligomerization in SY5Y‐TauP301L‐EGFP cells expressing mutant tau. These findings highlight the potential of PUR and OLC as structurally distinct, mutation‐targeted inhibitors of tau aggregation and propagation, providing a rationale for their further development as candidate therapeutics for frontotemporal dementia.

26 Aug 2025·ACS Omega

Targeting Diabetic Complications through Oleuropein-Mediated Enzyme Modulation: A Chemical Biology Study in the Human-Relevant Model Psammomys obesus

Article

Author: Boudhrioua, Nourhène ; Ben Chaouacha-Chekir, Rafika ; Zekri, Sami ; Haffani, Yosr Z. ; Feki, Moncef ; Torkhani, Montassar ; Rejeb, Ahmed ; Fouzai, Chaker ; Darmoul, Dalila ; Ben Halim, Nizar

This study investigates the therapeutic potential of oleuropein-rich olive leaf extract (OLE) and pure oleuropein compound (OLC) in mitigating diabetes-induced organ damage using Psammomys obesus, a well-established model for metabolic syndrome. Despite the rising global burden of diabetes and associated complications, effective interventions targeting multiorgan dysfunction remain limited. Oleuropein, a polyphenolic compound with documented antioxidant and anti-inflammatory properties, was administered orally at 1 mg/kg body weight over 7 months to six experimental groups subjected to high- or low-calorie diets to simulate diabetic and control conditions. Results demonstrated that the OLE and OLC significantly reduced kidney weight, preserved renal and hepatic histological architecture, and prevented diabetes-associated body weight and muscle mass loss. Biochemical analyses revealed normalization of erythrocyte biomarkers, including reduced activities of aldose reductase (AR) and sorbitol dehydrogenase (SDH), key enzymes in the polyol pathway linked to diabetic pathology. Antioxidant efficacy was evident through restored levels of malondialdehyde (MDA), superoxide dismutase (SOD), and catalase in retina and erythrocytes. Notably, vascular protection was observed via modulation of vascular endothelial growth factor (VEGF) expression and localization, supported by retinal flat mount analysis showing improved vascular integrity. These benefits were mechanistically tied to oleuropein's capacity to suppress oxidative stress and inhibit polyol pathway hyperactivation. This research establishes oleuropein as a dual-action nutraceutical and pharmaceutical agent, offering both preventive and therapeutic strategies for diabetes-related complications. The use of P. obesus underscores its translational relevance in metabolic syndrome research, positioning oleuropein as a promising candidate for further clinical exploration in diabetes management.

News (Medical) associated with Oxylanthanum Carbonate

29 Dec 2025

·endpoints.news

ASK Pharm makes China rights deal; Unicycive resubmits kidney drug after CRL

Plus, news about Harbour BioMed, Omeros, Gilead, Repare Therapeutics, Vaccinex and Foresee Pharmaceuticals. 💵 ASK Pharm nabs China rights to pan-RAS inhibitor: ASK Pharm, also known as Jiangsu Aosaikang Pharmaceutical, will pay US and China-based biotech Adlai Nortye $20 million in upfront and near-term payments in a deal worth up to $230 million total. In exchange, ASK Pharm gets rights to the pan-RAS (ON) inhibitor AN9025 in mainland China, Hong Kong and Macao. — Lei Lei Wu 📑 Unicycive heads back to FDA with kidney disease drug: The California biotech has resubmitted its drug, known as oxylanthanum carbonate, to the FDA for the treatment of elevated levels of phosphate in patients with chronic kidney disease. The FDA rejected the drug in June over manufacturing problems. — Lei Lei Wu 🤝Harbour BioMed inks radionuclide deal: The 9-year-old biotech will work with Yantai Lannacheng Biotechnology to develop new radionuclide drug conjugates. The companies didn’t reveal the financial terms of the long-term deal . But a couple weeks prior, Harbour BioMed announced a separate partnership with Bristol Myers Squibb that will give the biotech $90 million upfront. — Nicole DeFeudis 💉 FDA approves Omeros’ Yartemlea : The Seattle-based biotech said Yartemlea (narsoplimab) is the first approved therapy for hematopoietic stem cell transplant-associated thrombotic microangiopathy, or a serious blood-clotting complication. Omeros did not disclose pricing in a Wednesday press release. It anticipates an approval decision by the European Medicines Agency in mid-2026. — Andy Dunn 💰 Gilead to acquire Repare Therapeutics’ cancer drug: The pharma giant has paid $25 million upfront to acquire the clinical-stage drug, a polymerase theta ATPase inhibitor called RP-3467 that’s currently in a Phase 1 trial. Gilead will pay an additional $5 million “upon completion of specified technology transfer activities,” according to a Dec. 24 press release. That cash is expected to boost the payout to shareholders of Repare, which agreed in November to be acquired by the privately held nonprofit biotech XenoTherapeutics. — Andy Dunn 🧠 Vaccinex gets $60 million for Alzheimer’s work: The funding, which comes from an entity established by an existing investor, will allow Vaccinex to run an enlarged Phase 2b study for its drug candidate pepinemab. In return, the investment entity will get half of future proceeds from a development partner or licensee of pepinemab for neurological indications and 25% of proceeds related to other indications. — Nicole DeFeudis 💉 Foresee’s Phase 3 success in kids experiencing early puberty: The Taiwan- and US-based company’s drug, called leuprolide mesylate, is a GnRH agonist that was tested as a twice-yearly injection in children with a condition called central precocious puberty. The company says it plans to discuss submitting a new drug application by mid-2026. Foresee most recently won approval for leuprolide mesylate at a different dosing strength and interval to treat advanced prostate cancer, which is marketed as Camcevi. — Andy Dunn

Drug ApprovalPhase 1Phase 2AcquisitionPhase 3

10 Oct 2025

·www.prnewswire.com

UNCY LAWSUIT ALERT: Levi & Korsinsky Notifies Unicycive Therapeutics, Inc. Investors of a Class Action Lawsuit and Upcoming Deadline

NEW YORK, Oct. 10, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Unicycive Therapeutics, Inc. ("Unicycive Therapeutics, Inc." or the "Company") (NASDAQ: UNCY) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Unicycive Therapeutics, Inc. investors who were adversely affected by alleged securities fraud between March 29, 2024 and June 27, 2025. Follow the link below to get more information and be contacted by a member of our team: UNCY investors may also contact Joseph E. Levi, Esq. via email at [email protected] or by telephone at (212) 363-7500. CASE DETAILS: The filed complaint alleges that defendants made false statements and/or concealed that: (i) Unicycive's readiness and ability to satisfy the FDA's manufacturing compliance requirements was overstated; (ii) the oxylanthanum carbonate new drug application's regulatory prospects were likewise overstated; and (iii) as a result, defendants' public statements were materially false and misleading at all relevant times. WHAT'S NEXT? If you suffered a loss in Unicycive Therapeutics, Inc. during the relevant time frame, you have until October 14, 2025 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. NO COST TO YOU: If you are a class member, you may be entitled to compensation without payment of any out-of-pocket costs or fees. There is no cost or obligation to participate. WHY LEVI & KORSINSKY: Over the past 20 years, the team at Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. Our firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States. CONTACT: Levi & Korsinsky, LLP Joseph E. Levi, Esq. Ed Korsinsky, Esq. 33 Whitehall Street, 17th Floor New York, NY 10004 [email protected] Tel: (212) 363-7500 Fax: (212) 363-7171 SOURCE Levi & Korsinsky, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Patent Infringement

19 Sep 2025

·www.prnewswire.com

Shareholders that lost money on Unicycive Therapeutics, Inc.(UNCY) should contact Levi & Korsinsky about pending Class Action - UNCY

NEW YORK, Sept. 19, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Unicycive Therapeutics, Inc. ("Unicycive Therapeutics, Inc." or the "Company") (NASDAQ: UNCY) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Unicycive Therapeutics, Inc. investors who were adversely affected by alleged securities fraud between March 29, 2024 and June 27, 2025. Follow the link below to get more information and be contacted by a member of our team: UNCY investors may also contact Joseph E. Levi, Esq. via email at [email protected] or by telephone at (212) 363-7500. CASE DETAILS: The filed complaint alleges that defendants made false statements and/or concealed that: (i) Unicycive's readiness and ability to satisfy the FDA's manufacturing compliance requirements was overstated; (ii) the oxylanthanum carbonate new drug application's regulatory prospects were likewise overstated; and (iii) as a result, defendants' public statements were materially false and misleading at all relevant times. WHAT'S NEXT? If you suffered a loss in Unicycive Therapeutics, Inc. during the relevant time frame, you have until October 14, 2025 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. NO COST TO YOU: If you are a class member, you may be entitled to compensation without payment of any out-of-pocket costs or fees. There is no cost or obligation to participate. WHY LEVI & KORSINSKY: Over the past 20 years, the team at Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. Our firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States. CONTACT: Levi & Korsinsky, LLP Joseph E. Levi, Esq. Ed Korsinsky, Esq. 33 Whitehall Street, 17th Floor New York, NY 10004 [email protected] Tel: (212) 363-7500 Fax: (212) 363-7171 SOURCE Levi & Korsinsky, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Patent Infringement

100 Deals associated with Oxylanthanum Carbonate

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperphosphatemia	NDA/BLA	United States	Unicycive Therapeutics, Inc.	29 Jan 2026
Chronic Kidney Diseases	Phase 2	United States	Unicycive Therapeutics, Inc.	15 Dec 2023

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06218290 (Pubmed \| Clin J Am Soc Nephrol)	Phase 2	Hyperphosphatemia	86	Oxylanthanum Carbonate	odvcnhgrtg(vvkquhrhli) = tektktqhxv vfhprzcdkc (adtxezgbli )	Positive	14 Jul 2025
NCT06218290 (UNI-OLC-201, Company_Website) Manual	Phase 2	Hyperphosphatemia	86	OXYLANTHANUM CARBONATE	uudwmqmdvg(llhweyrtff) = abqwnbgqtd hlsmoxwyhy (sadvhfbtbz ) View more	Positive	25 Jun 2024

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