Ularitide_Dosage, benefits & legal status
Also known as urodilatin, synthetic urodilatin, ANP (95-126), INN 7107
The clearest demonstration on this site that moving the numbers is not the same as helping the patient.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Ularitide?
Plain language first. The technical label stays, but it never stands alone.Overview
It was infused into a vein for 48 hours in people arriving at hospital with acute heart failure. In a 2,157-patient trial it did everything it was designed to do: blood pressure fell, the wall-stress marker NT-proBNP dropped 47% more than on placebo, and fewer people got worse in the hospital. Cardiovascular deaths were 236 against 225 on placebo. Development stopped.
Ularitide is a synthetic copy of urodilatin, a 32-residue natriuretic peptide made in the kidney from the same precursor protein as ANP. It carries four extra residues on the front of the ANP sequence, acts at the same NPR-A receptor, and raises cyclic GMP to widen blood vessels and push out sodium and water.
What it's used for
Nothing. It was an investigational 48-hour infusion for acute heart failure, never approved anywhere, and nothing further has been reported since the phase 3 trial.
How does Ularitide work?
What it does in the body, and where.The body makes three natriuretic peptides that all push the same way: widen the vessels, pass more sodium and water, take load off the heart. ANP comes from the heart's atria, BNP from the ventricles, CNP mostly from blood vessel lining. Urodilatin is a fourth member, cut from the same gene as ANP but processed in the kidney.
- 01Four extra residues on the front of ANPThe ANP gene makes a long precursor. Cutting it at one point gives the 28-residue ANP that circulates in blood; cutting four residues earlier gives the 32-residue urodilatin found in urine. Same ring, same receptor, a slightly longer tail.
- 02It acts on NPR-A and raises cyclic GMPBinding that receptor switches on an enzyme that makes cyclic GMP inside the cell. Vessels relax, the kidney passes more sodium, and the pressure the failing heart works against drops.
- 03Where the trial came apartEvery measurement moved the right way inside 48 hours. Survival over the following 15 months did not, and the hazard ratio for cardiovascular death was 1.03. The trial was built to test whether easing congestion early changes what happens later, and the answer was no.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
What moved in the first 48 hours
peer-reviewed-human- Human trialFewer people got worse in the hospital: 55 on ularitide against 87 on placebo, at P = 0.005.
- Human trialNT-proBNP, the marker of how hard the heart wall is being stretched, fell 47% more than on placebo, at P < 0.001.
- Human trialHepatic transaminases fell, at P < 0.001, a sign of congestion easing off the liver.
- Human trialLow blood pressure was the cost: 22.4% against 10.1% on placebo. Serum creatinine also rose, at P = 0.005.
What did not move at all
peer-reviewed-human- Human trialCardiovascular deaths: 236 on ularitide (21.7%) against 225 on placebo (21.0%), hazard ratio 1.03 with a 96% confidence interval from 0.85 to 1.25, at P = 0.75, over a median 15 months. The interval is given at 96% rather than the usual 95% because the trial split its error budget across two co-primary endpoints.
- Human trialThe hierarchical clinical composite, the other co-primary endpoint, showed no difference at P = 0.82.
- Human trialReadmission for heart failure at 30 days was 7.1% against 7%, at P = 1. Death or cardiovascular hospitalization at 6 months was 40.7% against 37.2%, at P = 0.1.
- No dataA marker of cardiac microinjury showed no difference either, at P = 0.7. The trial had been designed to test whether protecting the heart early would show up later.
Ularitide is sometimes described as having improved outcomes in acute heart failure. It improved measurements. Both co-primary endpoints missed: cardiovascular death came out at a hazard ratio of 1.03 at P = 0.75, and the clinical composite at P = 0.82. The 47% drop in NT-proBNP and the drop in people worsening in the hospital are real and were statistically significant, and they are the reason the trial is still worth reading, not evidence that the drug helped people live longer. Ularitide and urodilatin are the same molecule. It is not ANP: it is ANP plus four residues, processed in the kidney rather than released from the heart.
The published record
Papers and trials about Ularitide
192 papers tagged human · 110 not reviews or lab · 46 clinical trial publications
4 registered trials · none with posted results
Furthest stage reached: Phase 3, completed, no results posted
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count.
At a glance
Four things to know about Ularitide
Evidence
Investigational
Category
Sexual and hormonal
Common vial
Varies
Half-life
Not quoted here
How much, and do you cycle it?
The range, and whether you take breaks.15 nanograms per kilogram per minute for 48 hours, once, as a single 48-hour infusion. Not applicable Discontinued
A single 48-hour infusion given once at hospital admission. There was never a repeat schedule, and nothing further has been reported since the phase 3 trial.
Not quoted hereNo figure
Natriuretic peptides clear from blood in minutes, and that is why this one was given as a continuous 48-hour infusion rather than as injections. No half-life figure is quoted here because none was read from a primary source.
You can compare this against the whole library to see where it sits.
How is it given?
Dosing context and source notes.Given in hospital from a prepared product, so there is nothing to mix.
Trial dose: 15 ng/kg/min per dose. TRUE-AHF trial record, ClinicalTrials.gov NCT01661634
How do you store it?
Before mixing, and after.Given in a hospital or trial clinic, so the pharmacy stores it.
Ularitide goes into a vein and is prepared by hospital, clinic or trial pharmacy staff, following the product label or the trial protocol. Some products like this are ready-made solutions and others are powders mixed just before use, often with hours rather than weeks of shelf life once prepared. It is not a medicine people store at home.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 28% charged residues, 34% hydrophobic. Water usually sufficient.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- Any use outside a trial: it was never approved anywhere and no product exists
- Anything sold under this name: a sterile hospital infusion cannot be reproduced from a research powder
Stop and get help
- Not applicable outside the closed trial, where the protocol governed stopping for low blood pressure
Common effects
- Low blood pressure, in 22.4% against 10.1% on placebo
- A rise in serum creatinine during the infusion
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Ularitide approved?
And where the numbers on this page come from.No. Ularitide was never approved, and its development has ended. There is no legal route to obtain it as a medicine.
- Approval statusInvestigational
- RouteInto a vein (48-hour infusion)
- Checked24 October 2026
- DoseFrom published clinical trials. Not approved by a regulator for this dose.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesFDA GSRS substance record, ularitide (UNII 740Y5J48Z8)UniProtKB entry P01160, the natriuretic peptides A precursorTRUE-AHF trial record, ClinicalTrials.gov NCT01661634Packer et al., Effect of ularitide on cardiovascular mortality in acute heart failure, New England Journal of Medicine, 2017TRUE-AHF results, presented at the American Heart Association Scientific Sessions, November 2016
What has happened recently
Never approved anywhere, and no further development has been reported since the trial. The phase 3 trial TRUE-AHF (NCT01661634) ran from July 2012 to November 2015 under Cardiorentis, enrolled 2,157 patients at 156 centers in 23 countries, and is recorded as completed. Results were presented at the American Heart Association meeting in November 2016 and published in the New England Journal of Medicine on April 12, 2017. Identity is settled: FDA substance record UNII 740Y5J48Z8 and International Nonproprietary Name number 7107, CAS 115966-23-9.
You can compare this against the whole library, or read how to check a seller.
What else is like Ularitide?
Others in Sexual and hormonal, side by side.If you're weighing Ularitide, it's worth reading Carperitide, Cenderitide, and PT-141 (Bremelanotide) in the same class.
The clearest demonstration on this site that moving the numbers is not the same as helping the patient.
- Dose
- 15 nanograms per kilogram per minute for 48 hours
- How often
- Once, as a single 48-hour infusion
The A in the natriuretic alphabet, and the only one of the three routinely given to patients anywhere. The evidence behind that use is thinner than its 30 years on the market suggest.
- Dose
- 0.1 micrograms per kilogram per minute on the Japanese label; the trial tested 0.02
- How often
- Continuous infusion while in the hospital
A designed chimera rather than a copy of anything the body makes. The engineering is the interesting part.
- Dose
- No established dose
- How often
- Not established
An approved shot that boosts sexual desire through the brain.
- Dose
- 1.75 mg per dose
- How often
- As needed, before activity
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
- How to Read a Peptide COA
What the purity number does and does not tell you, and how to spot an edited report.
- How to Vet a Peptide Vendor
Independent COAs, HPLC purity, and the red flags that mean walk away.
Sources
- FDA GSRS substance record, ularitide (UNII 740Y5J48Z8)(2026)Protein record, 32 residues, one disulfide bond joining cysteines 11 and 27. International Nonproprietary Name 7107, CAS 115966-23-9, formula C145H234N52O44S3. The sequence this record serves has serine and leucine transposed at positions 5 and 6, so the letters on this page come from UniProt instead. The disulfide positions it gives are correct and were used as a check.
- UniProtKB entry P01160, the natriuretic peptides A precursor(2026)Annotates urodilatin as residues 120 to 151 of the 151-residue precursor and ANP as residues 124 to 151, so urodilatin is ANP with four extra residues on the front. A positional read of the sequence confirms residues 120 to 123 are Thr-Ala-Pro-Arg.
- TRUE-AHF trial record, ClinicalTrials.gov NCT01661634(2015)Completed phase 3, 2,157 participants actual, July 2012 to November 2015, sponsor Cardiorentis. Ularitide lyophilizate at 15 ng/kg of body weight per minute for 48 hours. Co-primary endpoints were a hierarchical clinical composite at 6, 24 and 48 hours and freedom from cardiovascular mortality.
- Packer et al., Effect of ularitide on cardiovascular mortality in acute heart failure, New England Journal of Medicine, 2017(2017)Volume 376, pages 1956 to 1964, published online April 12, 2017. Cardiovascular death in 236 of the ularitide group (21.7%) against 225 on placebo (21.0%), hazard ratio 1.03 with a 96% confidence interval of 0.85 to 1.25 at P = 0.75. The 96% level reflects the error budget being split across two co-primary endpoints. The paper concludes that ularitide exerted favorable physiological effects without affecting cardiac troponin levels, and that short-term treatment neither affected the clinical composite nor reduced long-term cardiovascular mortality.
- TRUE-AHF results, presented at the American Heart Association Scientific Sessions, November 2016(2016)The presentation that preceded the paper. Hierarchical composite P = 0.82. Worsening heart failure in the hospital at 48 hours, 55 against 87, P = 0.005. Hypotension 22.4% against 10.1%. NT-proBNP fell 47% against placebo (P < 0.001), hemoglobin rose (P < 0.001), serum creatinine rose (P = 0.005) and hepatic transaminases fell (P < 0.001). This write-up gives the mortality confidence interval as 95%; the published paper gives 96%.
Beyond these, 332 records are indexed. Browse the records