Unicycive Therapeutics

What Unicycive Therapeutics does

Unicycive Therapeutics, Inc. is a clinical-stage biopharmaceutical company founded in 2016 by Dr. Shalabh Gupta and headquartered in Mountain View, California, that develops therapies for kidney diseases with high unmet medical need. The company is publicly traded on NASDAQ under the ticker UNCY (IPO July 2021) and operates with approximately 11-50 employees. Unicycive is led by a team with deep renal and commercial experience, including EVP Corporate Strategy Douglas Jermasek, who previously drove sales of Renvela as standard-of-care at Genzyme's renal franchise.

Unicycive's pipeline comprises two investigational assets, both in-licensed. The lead program, Oxylanthanum Carbonate (OLC), is a next-generation lanthanum-based phosphate binder that uses proprietary nanoparticle technology to deliver lanthanum in a smaller, swallowable tablet, reportedly enabling approximately a 4x reduction in daily pill volume versus the most-prescribed phosphate binder. OLC is being developed under the FDA 505(b)(2) pathway for hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. The second program, UNI-494, is a novel nicotinamide ester derivative and selective mitochondrial ATP-sensitive potassium channel (KATP) activator being developed for acute kidney injury (AKI) and prevention of Delayed Graft Function (DGF) following kidney transplantation; it holds FDA orphan drug designation for DGF. The OLC and UNI-494 technologies were licensed from Spectrum Pharmaceuticals and Sphaera Pharma, respectively.

Unicycive has not yet received marketing approval for any product and does not generate product revenue. Operations are funded primarily through public equity financings (e.g., a ~$50M raise in March 2024 led by Great Point Partners and Octagon Capital). As of May 11, 2026 the company reported approximately $57.1M in unaudited cash, projected to fund operations into 2027, against a full-year 2025 net loss of $26.6M. The FDA accepted the original OLC NDA in November 2024, issued a Complete Response Letter in June 2025 citing third-party manufacturing deficiencies (without questioning clinical safety or efficacy), and issued a second CRL in June 2026 reiterating the same manufacturing issues. The company is preparing for a potential Q3 2026 commercial launch of OLC contingent on FDA action, with go-to-market planned through standard pharmaceutical wholesale distribution to dialysis providers and nephrology practices.

Name

Unicycive Therapeutics

Legal name

Unicycive Therapeutics, Inc.

Website

https://unicycive.com

Company type

Public

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

Unicycive Therapeutics is a clinical-stage biopharmaceutical company developing in-licensed therapies for kidney diseases, including a nanoparticle-based phosphate binder (OLC) for dialysis patients and a mitochondrial KATP activator (UNI-494) for acute kidney injury.

Ownership category

akta.pro rank

Product category

Nephrology Pharmaceuticals

akta.pro primary industry

Renal Care Ancillaries (Anemia Management Devices, Phosphate Binder Support, Nutrition Monitoring) (HLAHAKAK)

akta.pro secondary industries

Acute Kidney Injury (AKI) & Hospital Nephrology (Inpatient Consults) (HLAKAHAI), Renal Transplant Medicine (Pre/Post-Transplant Care) (HLAKAHAD)

Keywords

• Nephrology therapeutics
• Phosphate binding agents
• Acute kidney injury treatment
• Chronic kidney disease drugs
• Kidney transplant therapy

Headquarters

HQ city

Los Altos

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Pharmaceutical Product Sales: Once approved, Unicycive plans to generate revenue through the sale of oxylanthanum carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients on dialysis. The company is preparing for potential commercial launch in Q3 2026.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Unicycive Therapeutics is a clinical-stage biopharmaceutical company developing two investigational therapies for kidney disease. Oxylanthanum Carbonate (OLC) is a next-generation lanthanum-based phosphate binder using proprietary nanoparticle technology for hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a selective mitochondrial KATP channel activator being developed for acute kidney injury and prevention of delayed graft function in kidney transplant patients.

Product overview

Unicycive Therapeutics is a clinical-stage biotechnology company developing therapies for kidney diseases. Its pipeline consists of two investigational products: Oxylanthanum Carbonate (OLC), a next-generation phosphate binder for hyperphosphatemia in chronic kidney disease patients on dialysis, and UNI-494, a novel mitochondrial potassium channel activator for acute kidney injury. OLC utilizes proprietary nanoparticle technology to deliver lanthanum with reduced pill burden, while UNI-494 is being developed as a potential first-in-class treatment for AKI.

Differentiator

Problem solved

Functional benefit

Products and services

• Oxylanthanum Carbonate (OLC) A next-generation lanthanum-based phosphate binding agent using proprietary nanoparticle technology, in development for treating hyperphosphatemia in chronic kidney disease patients on dialysis. Delivers lanthanum in a smaller swallowable tablet offering a 4x reduction in daily pill burden by volume compared to existing phosphate binders.
• UNI-494 A novel nicotinamide ester derivative and selective mitochondrial ATP-sensitive potassium channel (KATP) activator in development for acute kidney injury (AKI) and prevention of delayed graft function (DGF) in kidney transplant patients. Designed as a potential first-in-class therapy addressing an unmet need where no FDA-approved AKI treatments exist.

Quantifiable outcome

• OLC demonstrated >90% of patients achieved serum phosphate ≤5.5 mg/dL by end of titration in clinical trials
• +2 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Scale indicators4 records

Recent moves7 records

Expansion highlights4 records

Direct peers

• Akebia Therapeutics: Markets Auryxia (ferric citrate) for hyperphosphatemia in CKD patients on dialysis, directly competing with Unicycive's OLC in the same patient population and prescriber base. Akebia also resulted from the merger with Keryx Biopharmaceuticals, where Unicycive's EVP Jermasek previously held senior leadership.
• Ardelyx: Develops and commercializes tenapanor (Xphozah) for hyperphosphatemia in CKD patients on dialysis, directly competing with OLC in the same phosphate-binder market. Both companies are small clinical/commercial-stage renal-focused biotechs pursuing differentiated mechanisms.

Broad incumbents

• Vifor Pharma: Established renal-focused pharmaceutical company with a portfolio including phosphate binders (Velphoro, Feraccru) and other nephrology products. Vifor competes directly with OLC in the hyperphosphatemia market as a larger, established incumbent with global distribution.
• Fresenius Medical Care: Largest dialysis services provider globally and a key channel for phosphate binders. Controls the prescribing environment where OLC must win formulary access, making it both a potential partner and a powerful gatekeeper competitor.
• DaVita: Second-largest US dialysis provider and primary channel for phosphate binders. Like Fresenius, represents both a critical commercialization partner and a competitive gatekeeper for OLC uptake in the CKD-on-dialysis patient population.
• AMAG Pharmaceuticals: Specialty pharmaceutical company with renal-relevant products (e.g., Ferumoxytol iron therapy) and a focus on women's health. Represents a comparable specialty pharma commercial model in adjacent renal therapeutic categories.
• OPKO Health: Diversified healthcare company with renal-relevant products including Rayaldee (calcifediol) for secondary hyperparathyroidism in CKD. Comparable as a broader player with overlapping nephrology therapeutic adjacencies.

Emerging players

• Chinook Therapeutics: Clinical-stage nephrology-focused biotech developing treatments for rare kidney diseases (now part of Novartis). Comparable as a similarly-sized, kidney-focused development-stage company pursuing high-unmet-need indications with limited competition.
• Shield Therapeutics: Specialty pharmaceutical company developing and commercializing iron-based therapies with relevance to the renal anemia space. Comparable as a small, focused company commercializing differentiated therapeutics in adjacent renal indications.
• Travere Therapeutics: Rare disease biopharma with kidney-related assets (including sparsentan for FSGS/IgA nephropathy). Comparable as a similarly-sized commercial/specialty renal company pursuing differentiated therapies in underserved nephrology indications.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/unicycive
• YouTubeyoutube.com/@UnicyciveTherapeutics/featured
• Facebookfacebook.com/unicycive
• LinkedInlinkedin.com/company/unicycive
• Instagraminstagram.com/unicycive

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds4 records

Investors10 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Unicycive Therapeutics