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Talphera, Inc.: Advances in Renal Therapy at AKI & CRRT 2026

Talphera, Inc., a specialty pharmaceutical firm headquartered in San Mateo, California, operates at the forefront of developing groundbreaking therapies designed for medically supervised environments. Recently, the company made headlines by announcing that it had two significant abstracts accepted for presentation at the upcoming 31st Annual International Conference on Advances in Critical Care Nephrology (AKI & CRRT 2026), which is set to take place from March 29 to April 2, 2026, in San Diego, California.

Overview of Presentations

The first presentation, titled "A Randomized, Placebo-Controlled, 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 of Bleeding," will be presented by Kayla Adler on March 29. It will delve into the NEPHRO-CRRT study design that is currently enrolling participants. This clinical trial is particularly important due to the significant medical need for effective regional anticoagulants, especially for patients who are unable to tolerate heparin or are at increased risk of bleeding.

Nafamostat, a key ingredient in Talphera's Niyad formulation, has been used outside the United States for over three decades and is proposed as a potential solution to fill this existing gap in treatment with its safety profile and effectiveness. With the NEPHRO-CRRT study, Talphera aims to evaluate nafamostat's safety and efficacy rigorously.

Discussion of Nafamostat

The second poster will focus on "In Vivo Assessment Of Nafamostat, A Novel Regional Anticoagulant In a Porcine Model AKI And CKRT," also presented by Kayla Adler, on March 30. This poster will cover the pharmacokinetics of nafamostat and its impacts on post-filter and systemic Activated Clotting Time (ACT) across various membrane types when tested in a porcine model. This innovative research highlights how administering the compound pre-filter leads to over 95% removal by a hemofilter, ensuring minimal systemic exposure. The ultimate goal is to find an optimal post-filter ACT to maintain necessary anticoagulation during CRRT while minimizing systemic effects.

Dr. Shakil Aslam, Chief Medical Officer of Talphera, expressed excitement about these upcoming presentations, noting that the potential approval of nafamostat as the first regional anticoagulant sanctioned by the U.S. FDA could significantly change the landscape for continuous renal replacement therapy. Existing anticoagulants currently in use have their share of complications, making nafamostat an exciting candidate given its recent advancements in regulatory status.

The NEPHRO-CRRT Study

The NEPHRO CRRT Study has received central Institutional Review Board (IRB) approval. It is designed as a forward-looking, double-blind trial targeting a total enrollment of 70 adult patients across up to 14 U.S. hospital ICUs. The study aims to evaluate the efficacy of Niyad compared to placebo over the initial 24 hours by measuring the mean post-filter activated clotting time. Key secondary endpoints of the trial include dialysis effectiveness based on urea concentration in fluids and monitoring the frequency of filter changes and transfusions over 72 hours, making the trial comprehensive in its approach.

About Talphera, Inc.

Founded with a mission to lead in the development of innovative medical therapies, Talphera, Inc. is committed to improving patient outcomes in critical settings. Its flagship product, Niyad, has garnered attention for its unique formulation of nafamostat, which has exhibited broad-spectrum capabilities as a serine protease inhibitor with anticoagulant properties.

In a clinical landscape where effective treatments for renal replacement therapy are vital, Talphera’s studies bring hope for new standards of care for patients requiring continuous renal replacement therapy. As preparations for AKI & CRRT 2026 unfold, the medical community eagerly anticipates further advancements highlighted in Talphera’s presentations, signaling progress in the high-stakes field of critical care nephrology.

For more information about Talphera, Inc. and its innovative research, visit www.talphera.com.