Lanthanum carbonate

Unicycive Therapeutics Reaches Alignment with the FDA on Path to File New Drug Application for Oxylanthanum Carbonate (OLC)

Retrieved on: 
Monday, October 23, 2023
Type, FDA, Element, Trial of the century, Food, Agency, CMC, MD, OLC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Lanthanum carbonate, Chronic kidney disease, Dialysis, Clinical trial, File, LOS, Kidney disease, NDA, CKD, Safety, Therapy, Chemistry, Patient, Pharmaceutical industry

LOS ALTOS, Calif., Oct. 23, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced the Company has reached alignment with the U.S. Food and Drug Administration (FDA) on the path forward for Oxylanthanum Carbonate (OLC) and on the overall package requirements to file a New Drug Application.

Key Points: 
  • As reported in June, in the pre-NDA package shared with the FDA, the Agency requested clinical data in patients to proceed with the filing.
  • As a reminder, Unicycive intends to file the OLC NDA utilizing the 505(b)(2) regulatory pathway to reference the currently approved drug, Fosrenol®.
  • In the Type C meeting, plans were confirmed with the FDA for the pivotal clinical trial.
  • “The alignment with the FDA includes all elements of our planned NDA package including clinical, preclinical, and CMC requirements.

Unicycive Announces Acceptance of Three Abstracts for Presentation at the National Kidney Foundation’s Spring Clinical Meetings

Retrieved on: 
Monday, January 23, 2023
Food, Kidney disease, Kidney, NFK, Lanthanum carbonate, Risk, Chronic kidney disease, Kidney failure, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, LOS, 2021 Essex County Council election, DDI, Therapy, National Kidney Foundation, Pharmaceutical industry

LOS ALTOS, Calif., Jan. 23, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that three abstracts have been accepted for presentation at the National Kidney Foundation’s (NFK) upcoming Spring Clinical Meetings taking place in Austin, Texas from April 11-15, 2023.

Key Points: 
  • LOS ALTOS, Calif., Jan. 23, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that three abstracts have been accepted for presentation at the National Kidney Foundation’s (NFK) upcoming Spring Clinical Meetings taking place in Austin, Texas from April 11-15, 2023.
  • “With the recently announced results of our successful bioequivalence study of Renazorb compared to Fosrenol®, we expect to file a New Drug Application with the U.S. Food and Drug Administration (FDA) in mid-2023.
  • These data provide further evidence of the benefits of Renazorb as a powerful phosphate binder and highlight its enhanced product profile, which is expected to improve medication compliance and, thereby, improve outcomes and quality-of-life for chronic kidney disease patients with hyperphosphatemia.”
    “We are very encouraged by the UNI-494 data to be presented as it should underscore the prodrug’s potential to be reno-protective and to have low risk of DDI, both of which are important findings for this product candidate as a promising therapeutic for acute kidney disease, a condition for which there are currently no FDA approved therapies,” added Dr. Gupta.
  • Fosrenol is a registered trademark of Shire International Licensing BV.

Unicycive Announces Acceptance of Four Abstracts for Presentation at the World Congress of Nephrology 2023

Retrieved on: 
Thursday, January 5, 2023
Partnership, Phosphate binder, Food, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Lanthanum carbonate, Pharmacokinetics, Acute kidney injury, Hyperphosphatemia, Trial of the century, LOS, Kidney disease, 2021 Essex County Council election, Patient, Nicorandil, International Society, Nephrology, WCN, Congress, Phosphate, Pharmaceutical industry

LOS ALTOS, Calif., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that four abstracts have been accepted for presentation at the upcoming International Society of Nephrology’s World Congress of Nephrology 2023 meeting taking place in Bangkok, Thailand from March 30 – April 2, 2023.

Key Points: 
  • LOS ALTOS, Calif., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that four abstracts have been accepted for presentation at the upcoming International Society of Nephrology’s World Congress of Nephrology 2023 meeting taking place in Bangkok, Thailand from March 30 – April 2, 2023.
  • “With our recently announced successful bioequivalence study of Renazorb compared to Fosrenol®, we are looking forward to filing a New Drug Application with the U.S. Food and Drug Administration in mid-2023.
  • These data provide further evidence of the benefits of Renazorb as a powerful phosphate binder and highlight its enhanced product profile, which is expected to improve medication compliance and, thereby, improve outcomes and quality-of-life for patients.”
    “The exposure of these favorable data before an audience of international nephrologists should further expand awareness of the advantages of Renazorb to treat hyperphosphatemia and should bolster our positioning in any potential partnership or licensing discussions,” added Dr. Gupta.
  • Fosrenol is a registered trademark of Shire International Licensing BV.

Unicycive Achieves Primary Endpoint in Pivotal Bioequivalence Study of Renazorb

Retrieved on: 
Wednesday, December 28, 2022
Chronic kidney disease, Dialysis, Food, Therapy, NDA, Hyperphosphatemia, LOS, CKD, Kidney disease, Tablet, Patient, Particle-size distribution, Confidence interval, FDA, BE, Food and Drug Administration, Phosphorus, LS, Pharmaceutical industry, PD, Lanthanum carbonate

LOS ALTOS, Calif., Dec. 28, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the primary endpoint was met in the Company’s pivotal bioequivalence (BE) study comparing Renazorb to Fosrenol®. 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.

Key Points: 
  • 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.
  • If approved, Renazorb may dramatically reduce the pill burden that patients endure with currently available medications.
  • Today's positive results are from a randomized, open-label, two-way crossover BE study to establish PD BE between Renazorb and Fosrenol.
  • The study design, including the dose, primary endpoint, and sample size, was reviewed, and aligned by the FDA before the initiation of the study.

Unicycive Reports Key Findings from Independent Renal Dietitian Survey

Retrieved on: 
Tuesday, July 26, 2022
Renal osteodystrophy, Osteoporosis, ESRD, Diabetes, Absorption, Kidney disease, Kidney, GLOBE, CKD, Intelligence, Mortality, Acute kidney injury, Dialysis, Cardiovascular disease, Fracture, Compliance, Hyperphosphatemia, Bone pain, Atherosclerosis, Chronic kidney disease, Risk, Therapy, SHPT, Biotechnology, Artery, Company, Gastrointestinal tract, Patient, Nasdaq, Bone disease, Hypertension, Pharmacotherapy, LOS, Lanthanum carbonate, Pharmaceutical industry, Rastogi

LOS ALTOS, Calif., July 26, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced the results from an independent survey of renal dietitians conducted by Spherix Global Insights, an independent business intelligence firm that leverages its own independent data and expertise to provide strategic guidance. The survey canvassed 100 U.S. renal dietitians regarding a variety of topics related to the treatment of their chronic kidney disease and dialysis patients.

Key Points: 
  • The survey canvassed 100 U.S. renal dietitians regarding a variety of topics related to the treatment of their chronic kidney disease and dialysis patients.
  • Key findings from the Spherix survey:
    As renal dietitians indicate they have high influence on brand selection for phosphate binders, the results of this survey are an important barometer that further support the potential for Renazorb to be the phosphate binder of choice, said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive.
  • The Unicycive team is preparing to capitalize on this substantial opportunity by offering patients and providers an attractive treatment alternative.
  • Unicycive is conducting important market research to inform its brand and market access strategy and comprehensive launch plan for Renazorb.

Unicycive Reports Key Findings from Market Research with Nephrologists

Retrieved on: 
Wednesday, July 20, 2022
Renal osteodystrophy, Osteoporosis, ESRD, Diabetes, Trademark, Absorption, Kidney disease, Kidney, GLOBE, CKD, Mortality, Acute kidney injury, U.S. Securities and Exchange Commission, Dialysis, Calcium, Research, Fracture, Cardiovascular disease, Compliance, Hyperphosphatemia, Bone pain, Private Securities Litigation Reform Act, Chronic kidney disease, Atherosclerosis, Risk, Failure, Therapy, Safety, COVID-19, Strategic management, SHPT, Nephrology, Biotechnology, Artery, MBA, FDA, Company, Security (finance), Gastrointestinal tract, Patient, Nasdaq, Bone disease, Coronavirus, Hypertension, Sevelamer, Face, LLC, Pharmacotherapy, LOS, Lanthanum carbonate, Pharmaceutical industry, Genzyme, Rastogi

LOS ALTOS, Calif., July 20, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced the results from a primary market research study conducted on behalf of the company by Reason Research, LLC. The study was a discrete-choice model (“conjoint”) analysis in which 100 US-based nephrologists were presented with various phosphate binder attributes, including efficacy, safety/tolerability, pill burden, composition (calcium or non-calcium based), and dose form (chewable or swallowed), in a trade-off methodology to determine comparative prescribing preferences for currently available phosphate binders and Renazorb®, Unicycive’s product under development.

Key Points: 
  • Key findings from the research:
    Nephrologists estimate that they will prescribe Renazorb (pending FDA approval) for a market-leading 34% of their dialysis patients requiring phosphate binder therapy.
  • This market research with nephrologists, the predominant prescribers of phosphate binders, provides strong validation for our belief in the best-in-class potential of the Renazorb product profile, said Doug Jermasek, MBA, Executive Vice President, Corporate Strategy at Unicycive.
  • These survey results give us further confidence in the significant market opportunity for Renazorb.
  • Unicycive is conducting important market research to inform its brand and market access strategy and comprehensive launch plan for Renazorb.

Unicycive Initiates Pivotal Clinical Bioequivalence Study of Renazorb to Treat Hyperphosphatemia

Retrieved on: 
Thursday, June 2, 2022
Osteoporosis, Absorption, Company, SHPT, Biotechnology, Bone pain, Food, Gastrointestinal tract, Renal osteodystrophy, Artery, Dialysis, Kidney, Hyperphosphatemia, Nasdaq, Chronic kidney disease, Acute kidney injury, Therapy, FDA, Cardiovascular disease, Patient, GLOBE, Pharmacotherapy, Mortality, Risk, Diabetes, Trial of the century, Fracture, Compliance, Kidney disease, Atherosclerosis, Clinical trial, LOS, CKD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Bone disease, Hypertension, ESRD, Pharmaceutical industry, Lanthanum carbonate, Rastogi

LOS ALTOS, Calif., June 02, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.(Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease today announced the initiation of its pivotal clinical bioequivalence (BE) study of Renazorb (lanthanum dioxycarbonate.)

Key Points: 
  • LOS ALTOS, Calif., June 02, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.(Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease today announced the initiation of its pivotal clinical bioequivalence (BE) study of Renazorb (lanthanum dioxycarbonate.)
  • Renazorb is a novel phosphate binding agent utilizing proprietary nanoparticle technology that is being developed by Unicycive for the treatment of hyperphosphatemia.
  • The study is a randomized, open label, two-way crossover BE study to establish pharmacodynamic bioequivalence between Renazorb and Fosrenol.
  • The Renazorb program is supported by a previously completed clinical trial that studied Renazorb in 32 healthy volunteers.

Unicycive Announces Full Year 2021 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 31, 2022
Chronic kidney disease, Disease, Company, National Kidney Foundation, Therapy, NASDAQ, Acute kidney injury, Investigational New Drug, Trial of the century, Particle-size distribution, Kidney, BE, Biotechnology, Program, Research, LOS, European Renal Association – European Dialysis and Transplant Association, Kidney disease, NKF, Food, Poster, 2021 Essex County Council election, Drug discovery, New Drug Application, Safety, Contract research organization, Hyperphosphatemia, Nasdaq, CKD, Type, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, GLOBE, CRO, NDA, FDA, Insurance, Patient, Pharmaceutical industry, Animal, Cryptocurrency, Lanthanum carbonate

LOS ALTOS, Calif., March 31, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the full year ended December 31, 2021 and provided a business update.

Key Points: 
  • LOS ALTOS, Calif., March 31, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.(Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the full year ended December 31, 2021 and provided a business update.
  • The primary endpoint of the study is LS mean change in urinary phosphate excretion from baseline to the evaluation period.
  • The Unicycive team is preparing to capitalize on this substantial opportunity by offering patients and providers an attractive treatment alternative.
  • Unicycive is conducting important market research to inform its brand and market access strategy and comprehensive launch plan for Renazorb.