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

Vasopressin (sold as Vasostrict) is a synthetic copy of the body's antidiuretic hormone, used in intensive care to raise blood pressure in patients whose blood vessels have lost tone despite other treatment. It tightens blood vessels through a pathway independent of the usual catecholamine drugs. The formally approved product has been FDA-approved in the U.S. since 2014 and is given as a continuous intravenous infusion.

At a glance

What it is
Synthetic arginine vasopressin, a vasoconstrictor and antidiuretic hormone
Approved for
Raising blood pressure in adults with vasodilatory (for example septic) shock who remain low despite fluids and catecholamines
Key fact
In the VASST trial, adding vasopressin to norepinephrine did not reduce overall mortality versus norepinephrine alone
Route
Intravenous infusion
Evidence strength
FDA approved

Summary

Vasopressin (Vasostrict) is an FDA-approved hormone used in intensive care to raise blood pressure. Learn how it works, its uses, and side effects.

What is vasopressin?

Vasopressin, sold under the brand Vasostrict, is a synthetic form of arginine vasopressin, the hormone the body releases to conserve water and, at higher levels, to constrict blood vessels. In critical care it is used as a vasopressor, a drug that raises dangerously low blood pressure. Although vasopressin had been used clinically for many years under older marketing arrangements, Vasostrict became the first fully FDA-approved vasopressin injection in 2014.

How does vasopressin work?

Vasopressin raises blood pressure mainly through V1a receptors on the smooth muscle of blood vessels, and it also acts at the kidney's V2 receptors. The table below compares the two.

Study findings for Vasopressin
Receptor Where it sits Effect of activation
V1aSmooth muscle of blood vesselsTriggers the vessel wall to contract, increasing systemic vascular resistance and blood pressure
V2KidneyPromotes water reabsorption, its antidiuretic effect

Importantly, this blood-pressure action works through a different signaling pathway than the catecholamine vasopressors such as norepinephrine, so vasopressin can add blood-pressure support when those drugs alone are not enough, including in states where their receptors have become less responsive.

In vasodilatory shock, such as septic shock, the blood vessels are pathologically relaxed, and vasopressin helps restore tone. The evidence shows it supports blood pressure but does not necessarily improve survival: in the VASST trial, adding low-dose vasopressin to norepinephrine did not reduce 28-day mortality compared with norepinephrine alone, though a subgroup with less severe shock showed possible benefit. It is used to maintain pressure and reduce the dose of other vasopressors.

Is it FDA-approved?

Editor’s note

Status: Yes. Vasopressin injection (Vasostrict) received full FDA approval in 2014 to raise blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. It is given as a continuous intravenous infusion in a monitored setting.

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

Yes. Vasopressin injection (Vasostrict) received full FDA approval in 2014 to raise blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. It is given as a continuous intravenous infusion in a monitored setting.

What is vasopressin prescribed for?

Vasopressin is used to increase blood pressure in adults with vasodilatory shock, such as septic or post-cardiotomy shock, who are not responding adequately to fluid resuscitation and catecholamine vasopressors. It is an intensive-care medication, not an outpatient treatment.

What are the side effects?

According to the prescribing information, common side effects include:

  • Decreased cardiac output
  • Slowed heart rate or arrhythmia

More serious considerations include:

  • Reduced blood flow to the heart, gut, fingers, toes, or skin, which can cause tissue damage
  • Low blood sodium
  • Tissue injury if the infusion leaks out of the vein

Sources: FDA prescribing information for Vasostrict; the VASST trial (Russell et al., The New England Journal of Medicine, 2008, DOI: 10.1056/NEJMoa067373), indexed on PubMed. This document is educational and does not constitute medical advice.

Registered human trials

0 registered human trials on ClinicalTrials.gov that we reviewed

Sources

  1. [1]
  2. [2]

    approval

    Primary drugs.com

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