Unicycive Therapeutics
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2016-01-01
- Employees
- 14
- Market Cap
- -
- Website
- http://www.unicycive.com
- Introduction
Unicycive Therapeutics, Inc. engages in the development of treatment for kidney diseases. Its products include UNI-494, Renazorb, and UNI-220. The company was founded by Shalabh Gupta on August 18, 2016 and is headquartered in Los Altos, CA.
Clinical Trials
1
Trial Phases
1 Phases
Drug Approvals
0
Drug Approvals
No drug approvals found
This company may not have drug approvals in our database
Clinical Trials
Distribution across different clinical trial phases (1 trials with phase data)• Click on a phase to view related trials
A Study to Assess the Tolerability of Oxylanthanum Carbonate in Patients With Chronic Kidney Disease on Dialysis
- Conditions
- Chronic Kidney Disease Requiring Chronic Dialysis
- Interventions
- First Posted Date
- 2024-01-23
- Last Posted Date
- 2024-06-24
- Lead Sponsor
- Unicycive Therapeutics, Inc
- Target Recruit Count
- 106
- Registration Number
- NCT06218290
- Locations
- 🇺🇸
US Renal Care, San Antonio, Texas, United States
🇺🇸Clinical Advancement Center, PLLC, San Antonio, Texas, United States
News
FDA Publishes Over 200 Drug Rejection Letters in Historic Transparency Initiative
The FDA published more than 200 Complete Response Letters (CRLs) from 2020-2024 for drug applications that were initially rejected but later approved, marking a significant step toward increased regulatory transparency.
FDA Manufacturing Issues Delay Unicycive's Kidney Disease Drug Approval Process
The FDA has identified manufacturing deficiencies at a third-party vendor for Unicycive Therapeutics' oxylanthanum carbonate, an investigational oral phosphate binder for kidney disease patients on dialysis.
Unicycive and ORIC Pharmaceuticals Receive Buy Ratings Based on Promising Clinical Data
Unicycive Therapeutics' OLC shows promise in treating hyperphosphatemia by reducing pill burden and adverse events, potentially gaining FDA approval by June 2025.
FDA Accepts Unicycive's NDA for Oxylanthanum Carbonate to Treat Hyperphosphatemia in CKD Patients
The FDA has accepted Unicycive Therapeutics' New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) with a PDUFA target action date of June 28, 2025.
Unicycive's OLC Receives FDA Acceptance for Hyperphosphatemia Treatment
Unicycive's New Drug Application for oxylanthanum carbonate (OLC) has been accepted by the FDA, with a PDUFA target action date set for June 28, 2025.
Unicycive's Hyperphosphatemia Drug, Oxylanthanum Carbonate, Awaits FDA Decision in June
Unicycive Therapeutics' oxylanthanum carbonate (OLC) is under FDA review for treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.
FDA Accepts Unicycive's NDA for Oxylanthanum Carbonate in CKD Patients on Dialysis
The FDA has accepted Unicycive Therapeutics' New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.
Unicycive's OLC Receives FDA Acceptance for Hyperphosphatemia NDA
The FDA has accepted Unicycive Therapeutics' New Drug Application for Oxylanthanum Carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients on dialysis.
FDA Accepts Unicycive's Oxylanthanum Carbonate (OLC) Application for Hyperphosphatemia Treatment
The FDA has accepted Unicycive Therapeutics' NDA for Oxylanthanum Carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients on dialysis.
FDA Accepts Unicycive's NDA for Oxylanthanum Carbonate to Treat Hyperphosphatemia in CKD Patients on Dialysis
The FDA has accepted Unicycive Therapeutics' NDA for Oxylanthanum Carbonate (OLC) with a PDUFA target action date of June 28, 2025.