Regulatory status

Status at a glance

503A compounding status

Not nominated

We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.

Status recorded · FDA source document

FDA approval
An FDA-approved product contains this peptide
503B outsourcing
Not determined
Anti-doping (WADA)
Not on the WADA Prohibited List
DEA schedule
Not a controlled substance

About peptide status

Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.

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Status as of

Key takeaway

Nesiritide (sold as Natrecor) is a laboratory-made copy of B-type natriuretic peptide, a hormone the heart releases when it is under strain, developed as an intravenous treatment for acute heart failure. It relaxes blood vessels and lowers heart-filling pressures, but a large trial later found it did not reduce death or rehospitalization. As of 2026 it has been FDA-approved in the U.S. since 2001, though it has largely been withdrawn from the market.

At a glance

What it is
Recombinant human B-type natriuretic peptide (BNP), a vasodilator
Approved for
Acute decompensated heart failure with shortness of breath at rest or minimal activity
Key fact
In the large ASCEND-HF trial it did not improve survival or rehospitalization and had only a small effect on symptoms
Route
Intravenous
Evidence strength
FDA-approved (discontinued)

Summary

Nesiritide is a lab-made copy of the heart hormone BNP, approved for acute heart failure. See how it works, what trials found, and its side effects.

What is nesiritide?

Nesiritide, sold under the brand Natrecor, is a recombinant form of human B-type natriuretic peptide (BNP), a hormone normally released by the heart's ventricles when they are stretched by excess pressure or volume. The drug was designed to amplify that natural signal in acute heart failure, promoting vessel relaxation and fluid removal. It was approved in the United States in 2001 and has since been largely withdrawn from the market for commercial reasons.

How does nesiritide work?

Nesiritide reproduces the 32-amino-acid sequence of human BNP and binds the natriuretic peptide receptor-A, raising the second messenger cyclic GMP in blood-vessel walls. This relaxes both arteries and veins, lowering the pressure the heart has to pump against and the pressure filling it (reflected as a lower pulmonary capillary wedge pressure). It also promotes sodium and water excretion by the kidney and dampens the renin-angiotensin-aldosterone system.

Those effects improve the hemodynamics of acute heart failure, but the two key trials reached different results:

Study findings for Nesiritide
Trial Findings
VMAC, the earlier trialNesiritide lowered filling pressure more than nitroglycerin or placebo and improved breathing at 3 hours
ASCEND-HF, the larger later trialOnly a small, non-significant effect on dyspnea and no benefit on 30-day death or rehospitalization, while increasing episodes of low blood pressure

That gap between short-term hemodynamics and hard outcomes is the central story of the drug.

Is it FDA-approved?

Editor’s note

Status: Yes. Nesiritide was approved by the FDA in 2001 for acute decompensated heart failure in patients with shortness of breath at rest or with minimal activity. After the neutral ASCEND-HF results and shifting practice, the product was largely withdrawn from the U.S. market, so its approval is now mainly of historical interest.

Category: FDA-approved · Primary body area: Heart & blood

Yes. Nesiritide was approved by the FDA in 2001 for acute decompensated heart failure in patients with shortness of breath at rest or with minimal activity. After the neutral ASCEND-HF results and shifting practice, the product was largely withdrawn from the U.S. market, so its approval is now mainly of historical interest.

What is nesiritide prescribed for?

Nesiritide was prescribed for intravenous treatment of acute decompensated heart failure to relieve shortness of breath, given in a monitored hospital setting. In current practice it is rarely used, both because of the ASCEND-HF findings and because the product has been largely withdrawn.

What are the side effects?

Common side effects include:

  • Low blood pressure, which can be symptomatic or prolonged
  • Headache
  • Nausea

More serious considerations include:

  • Significant hypotension, the main safety concern
  • Slowed heart rate
  • Earlier concerns about worsening kidney function, which were not confirmed in ASCEND-HF

Sources: FDA prescribing information for Natrecor; the VMAC trial (2002) and O'Connor et al. (2011), the ASCEND-HF trial. PubMed-indexed studies are cited by DOI where used. This article is for educational purposes only and is not medical advice.

Registered human trials

2 registered human trials on ClinicalTrials.gov that we reviewed

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