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AP301

Phase 3

Hyperphosphatemia | Small molecule | Other |Fortrea Holdings Inc.|Trials Updated: Jan 29, 2026

AP301 development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Apr 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment264

FDA Designations

No designations recorded

AP301 clinical trials

AP301 · 1 trial · 4 indications

Phase 3 1
NCT06933472A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and ChinaHyperphosphatemia
RECRUITING264 Analytics
PHASE3RECRUITING
A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
Hyperphosphatemia
NCT06933472264
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Study Endpoints

Primary Endpoints

Change in serum phosphate concentrations in the AP301 and the AP301 low dose groups
From Baseline to the end of Week 8

The amount of phosphate in the blood will be measured with a standard laboratory test. The change in phosphate levels will be compared between the group receiving AP301 and the group receiving AP301 low dose.

Secondary Endpoints

Chang in serum phosphate concentrations in the AP301 maintenance dose and the AP301 low dose groups
From the beginning of Week 33 to the end of Week 35
Change in serum phosphate concentrations over time throughout the study
From Baseline to the end of Week 35
Change in serum calcium (Ca) and intact parathyroid hormone levels over time
From Baseline to the end of Week 35
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AP301EXPERIMENTALA blood phosphate-lowering medication containing iron
AP301 Low DoseEXPERIMENTALA blood phosphate-lowering medication containing iron, but with a low dose considered as ineffective

Interventions

NameTypeDescription
AP301DRUGThree times a day, administered orally with three meals at a daily dose level from 2.7g to 9.0g
AP301 Low DoseDRUGThree times a day, administered orally with three meals at a daily dose level from 0.075g to 0.25g
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites42

Key Inclusion Criteria: * Provision of signed and dated ICF * Age ≥ 12 years when signing the ICF * Patients on dialysis for ≥ 3 months before signing the ICF and throughout the study * For HD patients, spKt/V ≥ 1.2; for PD patients, total Kt/V ≥ 1.7/week * Patients who receive phosphate-lowering d...

Countries:United StatesChina
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