Talphera, Inc. ((TLPH)) announced an update on their ongoing clinical study.
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Study Overview: Talphera, Inc. is conducting a clinical study titled ‘A Randomized, Placebo-controlled, Double-blind, Multi-center Study of the Safety and Efficacy of Niyad in Patients Undergoing Continuous Renal Replacement Therapy (CRRT) Who Cannot Tolerate Heparin or Are at a Higher Risk for Bleeding.’ The study aims to evaluate the safety and efficacy of Niyad, a nafamostat mesylate, as an anticoagulant for patients with acute kidney injury undergoing CRRT, who are unable to use heparin or have a higher bleeding risk.
Intervention/Treatment: The study tests Niyad, an experimental nafamostat mesylate infusion, against a placebo of 0.9% saline. Niyad is intended to safely manage anticoagulation in CRRT patients at risk of bleeding.
Study Design: This is a randomized, placebo-controlled, double-blind study with a parallel intervention model. It involves quadruple masking, meaning participants, care providers, investigators, and outcomes assessors are unaware of the treatment allocations. The primary purpose is treatment-focused.
Study Timeline: The study began on November 21, 2023, with the latest update submitted on October 13, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates for stakeholders.
Market Implications: This study could significantly impact Talphera, Inc.’s stock performance by potentially positioning Niyad as a leading anticoagulant option for CRRT patients. If successful, it could enhance investor confidence and influence industry dynamics, especially among competitors focusing on renal therapies.
The study is currently ongoing, with further details available on the ClinicalTrials portal.