Ularitide

Also known as: urodilatin

Not FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA
Randomized controlled trials 34 of 281 publications on PubMed
Registered clinical trials 4 0 active
Adverse event reports 0 0 classified as serious
  • Ularitide is not an FDA-approved drug: Drugs@FDA has no record of it.
  • PubMed lists 281 publications mentioning it, including 34 randomized controlled trials and 72 animal-only studies.
  • ClinicalTrials.gov lists 4 registered studies testing it (0 active).
  • FDA’s adverse event system (FAERS) has no reports mentioning it.

Research topics

  • Atrial Natriuretic Factor 136
  • Diuretics 52
  • Heart Failure 42
  • Cyclic GMP 40
  • Kidney 39
  • Natriuretic Peptide, Brain 31
  • Sodium 27
  • Natriuresis 24
  • Receptors, Atrial Natriuretic Factor 24
  • Blood Pressure 21

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

No application found in Drugs@FDA, FDA's database of approved drugs.

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 281
  • Human (MeSH) 189
  • Animal only 72
  • Clinical trials 46
  • Randomized controlled trials 34
  • Systematic reviews & meta-analyses 1
  • Case reports 3
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
4
Active
0
With posted results
0

Conditions studied

  • Cirrhosis, Liver 1
  • Ascites Hepatic 1
  • Acute Decompensated Heart Failure 1
  • Renal Dysfunction 1
  • Acute Renal Failure 1
  • Mortality 1
  • Heart Failure, Congestive 1
Study Status Phase Start
Refractory Ascites in Patients With Liver Cirrhosis, and the Potential Treatment With 48 Hours Infusion of Ularitide.
NCT04311489 University of Aarhus
Terminated Phase 2 August 1, 2020
Efficacy and Safety of Ularitide for the Treatment of Acute Decompensated Heart Failure
NCT01661634 Cardiorentis
Completed Phase 3 Jul 2012
Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol
NCT00390624 Rocky Mountain Cancer Centers
Completed Phase 2 Jul 2003
A Study of Ularitide in the Treatment of Subjects With Acute Decompensated Heart Failure
NCT00487799 Facet Biotech
Withdrawn Phase 1 —

All 4 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

No FAERS reports mention this peptide.

Source: FDA FAERS · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.