Drugs / Oxylanthanum Carbonate
Oxylanthanum Carbonate
also known as
Dilanthanum dioxycarbonate · Lanthanum oxycarbonate · Renazorb · RZB 012 · RZB-014 · SPI-014 · UNI-014
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | hyperphosphatemia | 2026-09-29 | “today announced the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), the Company’s investigational oral phosphate binder” unicycive.com ↗ |
| Rejected (CRL) | US (FDA) | — | hyperphosphatemia | 2026-06-30 | “received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the resubmitted New Drug Application (NDA) for oxylanthanum carbonate (OLC)” unicycive.com ↗ |
| Filed | US (FDA) | — | hyperphosphatemia | 2025-12-29 | “resubmitted its 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for oxylanthanum carbonate (OLC)” unicycive.com ↗ |
| Filed | US (FDA) | — | hyperphosphatemia | 2024-09-03 | “the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Oxylanthanum Carbonate (OLC)” unicycive.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT06218290 | Dec 2023 → May 2024 | end stage renal failure | Unicycive Therapeutics, Inc | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT01560884 Comparator | Apr → Sep 2012 | — | Spectrum Pharmaceuticals, Inc | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 24
| Date | Issuer | Release |
|---|---|---|
| 2026-06-30 | Unicycive Therapeutics, Inc | Regulatory Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted Oxylanthanum Carbonate (OLC) New Drug Application (NDA) unicycive.com ↗
Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the resubmitted New Drug Application (NDA) for oxylanthanum carbonate (OLC) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. |
| 2026-01-29 | Unicycive Therapeutics, Inc | Regulatory UPDATE - Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission unicycive.com ↗
Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC) |
| 2026-01-29 | Unicycive Therapeutics, Inc | Regulatory Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission unicycive.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC) |
| 2025-12-29 | Unicycive Therapeutics, Inc | Regulatory Unicycive Therapeutics Announces Resubmission of New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) unicycive.com ↗
The NDA for OLC was resubmitted based on continued progress by the original third-party manufacturing vendor in resolving FDA-cited deficiencies and demonstrating inspection readiness. |
| 2025-10-30 | Unicycive Therapeutics, Inc | Results Unicycive Therapeutics Announces Upcoming Presentation of New Data Reinforcing the Potential of Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia at the American Society of Nephrology Kidney Week 2025 Conference unicycive.com ↗
Analysis of the data from the open-label pivotal trial of oxylanthanum carbonate (OLC) highlights that pill burden was significantly reduced in terms of both pill volume (7x) and pill count (2x) from pre-trial phosphate binder therapy |
| 2025-10-28 | Unicycive Therapeutics, Inc | Regulatory Unicycive Therapeutics Provides Update from FDA Type A Meeting and Expects to Resubmit OLC NDA Before Year-End unicycive.com ↗
The Type A FDA meeting was held to discuss the resolution of the single deficiency identified in the CRL related to the compliance status of a third-party manufacturing vendor. |
| 2025-07-24 | Unicycive Therapeutics, Inc | Results Unicycive Therapeutics Announces the Publication of Oxylanthanum Carbonate Pivotal Trial Data in Clinical Journal of the American Society of Nephrology unicycive.com ↗
OLC was well tolerated and enabled serum phosphate control in >90% of patients with a low pill burden (two-thirds of patients receiving three or fewer tablets/day). |
| 2025-06-30 | Unicycive Therapeutics, Inc | Regulatory Unicycive Therapeutics Announces Receipt of Complete Response Letter for Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis unicycive.com ↗
Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has issued a CRL for its New Drug Application (NDA) for OLC to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. |
| 2025-06-10 | Unicycive Therapeutics, Inc | Regulatory Unicycive Provides Update on New Drug Application for Oxylanthanum Carbonate to Treat Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis unicycive.com ↗
The FDA communicated to the Company that it had identified deficiencies in cGMP compliance at a third-party manufacturing vendor (one of its CDMO's third-party subcontractors and not its Drug Substance vendor) following an FDA inspection. |
| 2025-04-10 | Unicycive Therapeutics, Inc | Results Unicycive Presents New Patient-Level Data Underscoring Challenges Faced with Current Phosphate Binders and Highlighting the Potential of Oxylanthanum Carbonate to Address Barriers to Adherence for Patients with Hyperphosphatemia on Dialysis unicycive.com ↗
Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced new patient-reported outcomes data from its pivotal Phase 2 study of OLC as well as from a new survey conducted by the National Kidney Foundation (NKF) with sponsorship from Unicycive. |
| 2025-02-20 | Unicycive Therapeutics, Inc | Results Unicycive Therapeutics Announces the Publication of Preclinical Data on Synergies Between Oxylanthanum Carbonate and Tenapanor in American Society of Nephrology Journal Kidney360 unicycive.com ↗
Data demonstrated sizeable reductions in urinary phosphate excretion (a proxy for intestinal phosphate absorption) in response to both OLC monotherapy and the combination of OLC with tenapanor. |
| 2025-01-07 | Unicycive Therapeutics, Inc | Results Unicycive Therapeutics Announces Publication of Positive Oxylanthanum Carbonate (OLC) Dose Escalation Data in Clinical and Translational Science unicycive.com ↗ |
| 2024-12-17 | Unicycive Therapeutics, Inc | Results Unicycive Therapeutics Announces Publication of Oxylanthanum Carbonate (OLC) Positive Bioequivalence Data in Clinical Therapeutics unicycive.com ↗
In the study, OLC was well tolerated and demonstrated bioequivalence to lanthanum carbonate (LC). |
| 2024-11-13 | Unicycive Therapeutics, Inc | Regulatory Unicycive Announces Third Quarter 2024 Financial Results and Provides Business Update unicycive.com ↗ |
| 2024-11-11 | Unicycive Therapeutics, Inc | Regulatory Unicycive Therapeutics Announces U.S. FDA Acceptance of the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis unicycive.com ↗
Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) and has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025. |
| 2024-10-28 | Unicycive Therapeutics, Inc | Results Unicycive Therapeutics Delivers Multiple Poster Presentations Highlighting Development Progress on Oxylanthanum Carbonate (OLC) and UNI-494 at the American Society of Nephrology (ASN) Kidney Week 2024 unicycive.com ↗
We were excited to present our positive pivotal clinical trial data demonstrating that OLC enabled adequate control of serum phosphate in more than 90% of patients with chronic kidney disease (CKD) on dialysis who entered the maintenance phase of the trial. |
| 2024-09-03 | Unicycive Therapeutics, Inc | Regulatory Unicycive Therapeutics Announces Submission of the New Drug Application (NDA) to the U.S. FDA for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis unicycive.com ↗ |
| 2024-07-10 | Unicycive Therapeutics, Inc | Results Unicycive Therapeutics Announces Initial Positive Patient Satisfaction Findings from Pivotal Clinical Trial of Oxylanthanum Carbonate (OLC) unicycive.com ↗
Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the initial results from the patient reported outcome survey conducted during the UNI-OLC-201 pivotal clinical trial. |
| 2024-06-25 | Unicycive Therapeutics, Inc | Results Unicycive Therapeutics Achieves Study Objective in Oxylanthanum Carbonate (OLC) Pivotal Clinical Trial unicycive.com ↗
Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced positive results from the Oxylanthanum Carbonate (OLC) UNI-OLC-201 pivotal clinical trial with regard to both safety and tolerability endpoints. |
| 2024-05-28 | Unicycive Therapeutics, Inc | Results Unicycive Therapeutics Delivers Multiple Presentations on Oxylanthanum Carbonate (OLC) and UNI-494 at the European Renal Association Congress unicycive.com ↗
For OLC, we presented data showcasing the potent phosphate lowering capacity of OLC, which was three-fold greater than that of tenapanor in an established preclinical model of CKD. |
| 2024-05-15 | Unicycive Therapeutics, Inc | Results Unicycive Therapeutics Presents Bioequivalence Data on Oxylanthanum Carbonate (OLC) at the National Kidney Foundation Spring Clinical Meeting unicycive.com ↗
Our data confirms that OLC is bioequivalent to lanthanum carbonate (LC) by showing similar outcomes in both groups with respect to mean change in urinary phosphate excretion. |
| 2023-07-18 | Unicycive Therapeutics, Inc | Results Unicycive Therapeutics Announces Publication of Positive Comparison of Oxylanthanum Carbonate to Commercially Available Phosphate Binders in the American Journal of Nephrology unicycive.com ↗ |
| 2023-06-29 | Unicycive Therapeutics, Inc | Regulatory Unicycive Therapeutics Provides Regulatory Update on Lanthanum Dioxycarbonate Program unicycive.com ↗
Based on the review of this information, the FDA has asked the Company to provide additional information, including risk assessment and clinical data, to evaluate the tolerability of LDC in patients with chronic kidney disease on dialysis. |
| 2022-12-28 | Unicycive Therapeutics, Inc | Results Unicycive Achieves Primary Endpoint in Pivotal Bioequivalence Study of Renazorb unicycive.com ↗
Based on the topline results, pharmacodynamic (PD) BE of Renazorb to Fosrenol was established and met the regulatory criteria for PD BE in the healthy volunteer BE study. |
All press releases naming this drug 39 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Oxylanthanum Carbonate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06218290 ↗ |
| Known as | Dilanthanum dioxycarbonate | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068411 ↗ |
| Known as | Lanthanum oxycarbonate | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068411 ↗ |
| Known as | Renazorb | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01560884 ↗ |
| Known as | RZB 012 | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068411 ↗ |
| Known as | RZB-014 | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068411 ↗ |
| Known as | SPI-014 | “The purpose of this trial is to study safety, tolerability, and phosphate binding capacity of Renazorb (SPI-014) in healthy volunteers before conducting trials in patients with...” NCT01560884 ↗ |
| Known as | UNI-014 | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068411 ↗ |
| Modality | Small molecule | — CHEMBL6068411 ↗ |
| Route | Oral | “orally administered oxylanthanum carbonate” PMID 39617673 ↗ Nov 2024 |