Fortrea’s Phase 3 Study on AP301: A Potential Game-Changer for Hyperphosphatemia Treatment

Fortrea Holdings Inc. ((FTRE)) announced an update on their ongoing clinical study.

Fortrea Holdings Inc. is collaborating with Alebund Pharmaceuticals on a Phase 3 clinical study titled A Randomized, Double-Blind, Multi-Regional, Phase 3 Study to Evaluate the Efficacy and Safety of AP301 on Serum Phosphorus Control in Chronic Kidney Disease Patients Receiving Maintenance Dialysis With Hyperphosphatemia. The study aims to determine the effectiveness of AP301, an iron-based phosphate binder, in reducing blood phosphate levels in patients undergoing dialysis due to chronic kidney disease. The significance of this study lies in its potential to improve the quality of life for patients with hyperphosphatemia.

The intervention being tested is AP301, a drug designed to lower blood phosphate levels. It is administered orally three times a day at varying doses, depending on the patient’s needs. The study also includes a low-dose version of AP301 to serve as a comparator.

This study is interventional, with a randomized allocation and a parallel intervention model. It employs quadruple masking, meaning that the participant, care provider, investigator, and outcomes assessor are all blinded to the treatment. The primary purpose of the study is treatment-focused.

The study began on March 19, 2025, and is currently recruiting participants. The last update was submitted on August 8, 2025. These dates are crucial as they indicate the study’s progress and the timeline for potential results.

The outcome of this study could significantly impact Fortrea Holdings Inc.’s stock performance and investor sentiment, particularly if AP301 proves effective. Success in this trial could position Fortrea favorably against competitors in the pharmaceutical industry focused on kidney disease treatments.

The study is ongoing, with further details available on the ClinicalTrials portal.