Q1 2025 Recap: Nephrology News and Updates

The first quarter of 2025 saw significant advancements in the nephrology landscape, including major regulatory approvals and updates, notable clinical trial readouts, and historic advances in xenotransplantation.

The US Food and Drug Administration (FDA) was hard at work for the first few months of the year, approving semaglutide for reducing kidney and cardiovascular complications in patients with type 2 diabetes and chronic kidney disease (CKD) and giving the green light to an expanded indication for furosemide injection (Furoscix) in CKD. Paired with forward movement for therapies in lupus nephritis, focal segmental glomerulosclerosis (FSGS), and IgA nephropathy (IgAN), Q1 was a busy time in renal drug development.

Meanwhile, groundbreaking steps in xenotransplantation—including the FDA's clearance of a first-of-its-kind gene-edited kidney trial—suggest the future of kidney transplant and an end to the organ donor shortage crisis may be closer than ever.

Here's a look at the top nephrology news from Q1 of 2025:

Q1 Regulatory Updates in Nephrology

FDA Approves Semaglutide (Ozempic) for Type 2 Diabetes, Chronic Kidney Disease

The year began with a notable FDA approval for Novo Nordisk’s semaglutide (Ozempic) to reduce the risk of kidney disease worsening, kidney failure, and death due to cardiovascular disease in adults with type 2 diabetes and CKD.

The decision was based on results from the phase 3b FLOW kidney outcomes trial demonstrating semaglutide’s statistically significant and superior 24% relative risk reduction of kidney disease worsening, end-stage kidney disease, and death due to cardiovascular disease compared with placebo when added to standard of care.

Related: Understanding Semaglutide for Diabetes and CKD, with Pranav Garimella, MBBS, MPH

FDA Approves Furosemide Injection (Furoscix) for Edema in CKD

In the second approval of Q1, the FDA approved scPharmaceuticals’ supplemental New Drug Application (sNDA) for furosemide (Furoscix), expanding its indication to include the treatment of edema, including congestion, fluid overload, or hypervolemia, in adult patients with CKD.

FDA Accepts Obinutuzumab (Gazyva/Gazyvaro) sBLA for Lupus Nephritis

On March 5, 2025, Roche announced the FDA acceptance of the company’s supplemental Biologics License Application (sBLA) for obinutuzumab (Gazyva/Gazyvaro) for the treatment of lupus nephritis, supported by positive results from the phase 3 REGENCY study demonstrating improved complete renal response with obinutuzumab plus standard therapy. A decision on approval is expected by October 2025.

Travere Therapeutics Submits sNDA for Sparsentan (Filspari) in FSGS

Travere Therapeutics announced the submission of a supplemental New Drug Application (sNDA) to the FDA seeking priority review for traditional approval of sparsentan (Filspari) for the treatment of FSGS. Announced on March 17, 2025, the submission was supported by results from the phase 3 DUPLEX study and the phase 2 DUET study.

Otsuka Files BLA for Sibeprenlimab for IgA Nephropathy

Ending Q1 on a high note, on March 31, 2025, Otsuka Pharmaceutical announced the filing of a Biologics License Application (BLA) with the FDA for sibeprenlimab in adults with IgAN, supported by results from the phase 2 ENVISION and the phase 3 VISIONARY clinical trials.

Renal Trials

Monlunabant Misses Primary Endpoint in Phase 2 Diabetic Kidney Disease Trial

Novo Nordisk announced the completion of a phase 2 trial of monlunabant, formerly INV-202, in patients with diabetic kidney disease in a 2024 financial report. The trial, which missed its primary endpoint for urine albumin-creatinine ratio improvement, investigated the efficacy and safety of a once-daily 10 mg and 25 mg dose of monlunabant, a small molecule oral cannabinoid receptor 1 inverse agonist, compared with placebo in 254 people with diabetic kidney disease for 16 weeks.

Tonix Announces Positive Topline Phase 1 Data for TNX-1500

Following positive topline data from its phase 1, single ascending dose trial of TNX-1500 in healthy participants, Tonix Pharmaceuticals announced plans to discuss safety, tolerability, pharmacokinetics, and pharmacodynamics results with the FDA in an end-of-phase 1 meeting. Pending alignment with the FDA, the company plans to pursue a phase 2 study of TNX-1500 in kidney transplant recipients.

REGENCY: Obinutuzumab Proves Efficacy in Lupus Nephritis

Prior to the FDA acceptance of Roche’s sBLA for obinutuzumab in lupus nephritis, results from the phase 3 REGENCY trial were published and showed use of obinutuzumab was superior to standard of care therapy alone for achieving a complete renal response. In addition, results also indicated use of obinutuzumab was associated with a statistically significant and clinically meaningful improvement in markers of disease activity and inflammation.

Advancements in Xenotransplant

FDA Clears First Xenotransplant Trial for Gene-Edited Kidneys

On February 3, 2025, the FDA cleared United Therapeutics’ Investigational New Drug application to initiate a clinical study of the company’s investigational UKidney™ derived from a 10 gene-edited source pig. The study is expected to enroll an initial cohort of 6 patients with end-stage renal disease, expanding to up to 50 participants, and is intended to support a Biologics License Application with the FDA. The first xenotransplant in the trial is expected to be performed around mid-year 2025.

Second Xenotransplant with Gene-Edited Pig Kidney Performed at Mass General

Just days later, on February 7, 2025, Massachusetts General Hospital announced the successful completion of its second transplant of a pig kidney with 69 genomic edits provided by eGenesis into a 66-year-old male patient who had been on dialysis for more than 2 years due to end-stage kidney disease.

In March 2024, Massachusetts General Hospital became the first hospital in the world to transplant a genetically edited pig kidney into a living human. The latest 2.5-hour xenotransplant procedure was performed under the US Food and Drug Administration Expanded Access Protocol granted in December 2024, which is planned to support 2 additional xenotransplants this year.