Nesiritide: evidence, FDA status and research

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Nesiritide was marketed in the 2000s as a modern hormone-based treatment for acute heart failure, replacing older drips.

Studies say

The largest heart failure drug trial of its era showed nesiritide neither helped nor clearly harmed, which is why its use faded and its approval is now mostly of historical interest.

Why grade B. Nesiritide was approved on short-term symptom trials, but the definitive outcome trial, ASCEND-HF with 7,141 patients, found no reduction in death or heart failure readmission and only a small, non-significant improvement in breathlessness. The approval exists, but the evidence for a meaningful clinical benefit is weak, which keeps it at B. ¹

FDA. Approved in 2001 as Natrecor for acutely decompensated heart failure with shortness of breath at rest or with minimal activity. The product is now listed as discontinued in the United States, and the FDA has stated the discontinuation was not for safety or effectiveness reasons. ¹

Written from 1 cited sources. Fact-checked 2026-10-27: 13 claims checked, 0 corrected. Last refreshed 2026-10-27. Not physician reviewed.

Evidence checklist

Randomised controlled trial ASCEND-HF, placebo-controlledyes
Human study over 100 people ASCEND-HF 7,141 patientsyes
More than one research group One large trial citedno information
Clinical outcomes, not surrogate markers Death and readmission: no effectyes
Human safety data beyond case reports Low blood pressure; kidney worry not borne outyes

Drawn from the cited studies below. A dash means the sources give no information.

What it is

Nesiritide is a recombinant version of human B-type natriuretic peptide (BNP), the hormone the heart's ventricles release when they are stretched by too much fluid. Doctors measure BNP in blood tests to diagnose heart failure; nesiritide is the same molecule given as an intravenous infusion to treat it. ¹

Scios, later part of Johnson & Johnson, won approval in 2001 for patients hospitalized with acute heart failure who were short of breath at rest. For a few years it was widely used in US hospitals. After the ASCEND-HF results and earlier safety concerns, use dropped sharply and the product was eventually withdrawn from the market. ¹

How it works

BNP binds to natriuretic peptide receptors on blood vessels and in the kidney. The effect is to dilate veins and arteries, lower the pressure the heart pumps against, and encourage the kidney to shed sodium and water. In theory this relieves congestion faster and more gently than loop diuretics alone. The trials tested whether that theory translated into patients feeling or doing better. ¹

What human research shows

ASCEND-HF randomized 7,141 patients hospitalized with acute decompensated heart failure to nesiritide or placebo infusion added to standard care. The two primary endpoints were self-reported dyspnea at 6 and 24 hours and the combination of death or heart failure rehospitalization within 30 days. Nesiritide produced a small improvement in dyspnea that did not meet the trial's pre-specified threshold for significance, and had no effect on the 30-day death or readmission rate. ¹

The trial also addressed two earlier worries. Pooled analyses from the mid-2000s had suggested nesiritide might worsen kidney function and increase mortality. ASCEND-HF found no increase in worsening renal function and no increase in deaths. It did find more hypotension, in roughly one in four patients compared with one in six on placebo. The authors concluded nesiritide could not be recommended for routine use. ¹

Study	Model	Finding
ASCEND-HF	Humans, n=7,141 with acute decompensated heart failure, randomized double-blind placebo-controlled	No reduction in death or heart failure rehospitalization at 30 days, a small non-significant dyspnea improvement, and more hypotension; no excess kidney injury or mortality. ¹
ASCEND-HF safety outcomes	Humans, same 7,141-patient trial, pre-specified safety analyses	Hypotension was more frequent on nesiritide than placebo, while worsening renal function and 30-day mortality did not differ. ¹

Safety

The main adverse effect is low blood pressure, which was significantly more common than placebo in ASCEND-HF and is the expected consequence of a vasodilator. Headache, nausea and dizziness were reported in earlier trials. The feared effects on kidney function and mortality were not borne out in the large trial. Because the product is discontinued, there is no current post-marketing surveillance. ¹

Questions for your clinician

Is nesiritide still available, and is it right for my heart failure?
What treatments have better evidence for my symptoms?
What blood pressure monitoring would I need?

Questions people ask

Is nesiritide still used?

Rarely, if at all, in the United States. The product is listed as discontinued, and after ASCEND-HF most heart failure guidelines stopped recommending it for routine use. Loop diuretics and, where needed, nitrates remain the standard for congestion. ¹

Was nesiritide dangerous?

The large trial did not show excess deaths or kidney injury, which answered the concerns raised in the mid-2000s. What it did show was more low blood pressure and no clear benefit, so the risk-benefit balance was unfavorable because there was not much benefit to weigh. ¹

What is the difference between BNP and nesiritide?

None at the molecular level: nesiritide is recombinant human BNP. BNP measured in a blood test is a diagnostic marker released by a struggling heart; nesiritide was the same peptide infused as a drug. ¹

Citations

O'Connor 2011, N Engl J Med: effect of nesiritide in patients with acute decompensated heart failure (ASCEND-HF) doi.org