Unicycive Therapeutics, Inc


Unicycive Therapeutics is dedicated to transforming kidney care through innovative science, a fearless approach to innovation, and a focus on unmet patient needs. They develop novel therapies for kidney diseases, including hyperphosphatemia and acute kidney injury, leveraging proprietary nanoparticle technology and unique mechanisms of action to improve patient adherence and clinical outcomes.

Industries

biotechnology
health-care
health-diagnostics
medical

Nr. of Employees

small (1-50)

Unicycive Therapeutics, Inc

4300 El Camino Real, Suite #210, Los Altos, CA 94022


Patents

Nicorandil derivatives

US-12036211-B2

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Lanthanum carbonate hydroxide, lanthanum oxycarbonate and methods of their manufacture and use

US-11406663-B2

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Lanthanum carbonate hydroxide, lanthanum oxycarbonate and methods of their manufacture and use

US-10350240-B2

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Lanthanum carbonate hydroxide, lanthanum oxycarbonate and methods of their manufacture and use

US-8961917-B2

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Products

Lanthanum‑based nanoparticle oral phosphate binder (oral tablet formulation)

Oral nanoparticle formulation of a lanthanum‑based phosphate binder developed to increase phosphate‑binding capacity while reducing tablet size and daily medication volume; evaluated in preclinical models and early clinical studies for tolerability and PD effect on serum/urine phosphate.

Nicotinamide‑ester mitochondrial KATP activator (oral and IV formulations)

Small‑molecule nicotinamide ester derivative developed to activate mitochondrial ATP‑sensitive potassium channels, modulate mitochondrial permeability transition pore (mPTP) activity, and reduce AKI biomarkers; evaluated in multiple preclinical dosing routes (IV and PO) and in PK/toxicology studies.


Services

Design and conduct of randomized in vivo efficacy studies (rodent AKI, phosphate models), non‑rodent toxicity studies, and associated biomarker and histopathology endpoints.

Execution of Phase I and Phase II studies including dose‑titration, open‑label maintenance periods, safety monitoring, and pharmacodynamic endpoints in patient populations such as maintenance hemodialysis.

Plasma protein binding, transporter and CYP inhibition testing, and LC‑MS/MS metabolite quantification for DDI risk assessment.

Randomized crossover and comparative study designs to establish pharmacodynamic equivalence or improvement versus reference agents and to support regulatory strategy.

Preclinical testing and quantitative modeling of combination therapies (distinct mechanisms) to assess additive versus synergistic effects.

Expertise Areas

  • Preclinical acute kidney injury models and translational biomarkers
  • Development of phosphate‑binding therapeutics and formulation
  • Early‑phase clinical trial design and execution (Phase I/II)
  • Drug‑drug interaction and in vitro transporter/CYP assessment
  • Show More (4)

Key Technologies

  • Nanoparticle oral formulation for phosphate binding
  • Selective mitochondrial KATP activation (nicotinamide ester derivatives)
  • In vivo rodent ischemia‑reperfusion AKI models
  • Metabolic cage urine collection
  • Show More (6)

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