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Oxylanthanum Carbonate

Phase 2

Chronic Kidney Disease Requiring Chronic Dialysis | Small molecule | Nephrology |Unicycive Therapeutics, Inc.|Last Updated: Jun 24, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment106
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06218290A Study to Assess the Tolerability of Oxylanthanum Carbonate in Patients With Chronic Kidney Disease on DialysisPHASE2 COMPLETED 106Dec 15, 2023May 29, 2024Jun 24, 20247 United States
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Study Endpoints
Primary Endpoints
Incidence of treatment-related AEs leading to study drug discontinuation during the Maintenance Period.
4 weeks

Tolerability of clinically effective doses of OLC as assessed by the incidence of treatment-related AEs leading to study drug discontinuation during the Maintenance Period.

Secondary Endpoints
Adverse Drug Reactions
up to 10 weeks
Maximum Plasma Concentration (Cmax) of Lanthanum
up to 10 weeks
Area Under the Concentration-Time Curve (AUC) of Lanthanum
up to 10 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
All PatientsEXPERIMENTALAll patients with chronic kidney disease with hyperphosphatemia
Interventions
NameTypeDescription
Oxylanthanum CarbonateDRUGPhosphate Binder to Reduce Hyperphosphatemia
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Patient must be ≥18 years of age. 2. Patient must be willing and capable of giving written Informed Consent, adhering to dosing and visit schedules, and meeting all study requirements. 3. Patient must be willing and able to swallow whole tablets. 4. Patient has chronic kidney...

Countries:United States
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