FDA approves Ozempic for chronic kidney disease in type 2 diabetes

The U.S. Food and Drug Administration approved Ozempic (semaglutide) injection on January 28, 2025, to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease) and death from cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD) ^[3]. Novo Nordisk said the decision makes Ozempic the only GLP-1 receptor agonist with a kidney outcomes indication, and the most broadly indicated drug in its class ^[3].

The approval adds a third use to Ozempic's label. The drug was first approved in December 2017 to improve blood sugar in adults with type 2 diabetes alongside diet and exercise, and in January 2020 it gained an indication to reduce major cardiovascular events in adults with type 2 diabetes and known heart disease ^[1][3]. The prescribing information now states the drug is indicated "to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease" ^[5].

What the FLOW trial showed

The approval rests on FLOW, an international, randomized, double-blind, placebo-controlled phase 3b kidney outcomes trial ^[3]. It enrolled 3,533 adults with type 2 diabetes and CKD — 1,767 assigned to Ozempic and 1,766 to placebo — across 28 countries and roughly 400 sites, starting in 2019 ^[3][4].

Participants received once-weekly semaglutide 1 mg or placebo on top of standard care ^[3]. The primary endpoint was a composite: a sustained drop in eGFR of 50% or more, sustained eGFR below 15 mL/min/1.73 m2, chronic renal replacement therapy (such as dialysis), renal death, and cardiovascular death ^[3].

Ozempic cut that composite risk by a statistically significant 24% compared with placebo, which Novo Nordisk described as a 4.9% absolute risk reduction at three years ^[3]. An independent data monitoring committee recommended stopping the trial early after it met pre-specified efficacy criteria, following a median 3.4 years of follow-up ^[3].

One note on the numbers: the company's release attributes the 4.9% absolute reduction to the full composite endpoint ^[3], while a trade publication's summary described "a nearly 5% risk decrease for CVD-related death at 3 years" ^[4]. The prescribing information and company release support the composite reading ^[3][5].

CKD affects about 37 million U.S. adults, and roughly 40% of people with type 2 diabetes also have CKD, according to figures cited by Novo Nordisk ^[3]. Diabetes is the leading cause of CKD and kidney failure ^[3].

Why it matters for patients

For adults who have both type 2 diabetes and chronic kidney disease, the change means the kidney benefit is now printed on the FDA-approved label rather than being an off-label inference from trial data. Labeled indications often influence what insurers will cover and what clinicians feel comfortable prescribing.

The indication applies to Ozempic injection, not to every semaglutide product. Ozempic tablets and Wegovy do not carry the kidney indication; Wegovy is approved for weight reduction, cardiovascular risk reduction in obesity or overweight, and noncirrhotic MASH ^[1]. Novo Nordisk has said its semaglutide products "are not interchangeable and should not be used outside of their approved indications" ^[3].

The trial tested the 1 mg weekly dose, and the label's dosing section reflects that for this use ^[3][5]. Risks did not change with the new indication: Ozempic carries a boxed warning for thyroid C-cell tumors seen in rodents and is contraindicated in people with a personal or family history of medullary thyroid carcinoma or MEN 2 ^[5]. Labeled warnings include acute pancreatitis, diabetic retinopathy complications, hypoglycemia when combined with insulin or insulin secretagogues, severe gastrointestinal reactions, gallbladder disease, pulmonary aspiration under anesthesia, and — notably for kidney patients — acute kidney injury caused by dehydration from vomiting or diarrhea ^[1][5]. The most common side effects reported in 5% or more of patients are nausea, vomiting, diarrhea, abdominal pain and constipation ^[1].

What happens next

Later semaglutide milestones did not extend the kidney indication. Novo Nordisk lowered the self-pay price of Ozempic to $499 per month in August 2025 and announced a further U.S. list price cut in February 2026 ^[1]. Ozempic tablets were approved January 30, 2026 for type 2 diabetes and cardiovascular risk reduction only ^[1]. Whether other GLP-1 drugs will seek kidney indications is not addressed in these sources.