Is angiotensin II FDA-approved, and what does the research show?

What is angiotensin II?

Angiotensin II is a hormone the body makes to hold up its blood pressure ¹, ². The label calls it "a naturally occurring peptide hormone of the renin-angiotensin-aldosterone system (RAAS) that causes vasoconstriction and an increase in blood pressure" ². A peptide is a short chain of amino acids; angiotensin II has eight ², ³. Vasoconstriction is the narrowing of blood vessels.

The renin-angiotensin-aldosterone system, RAAS, is the chain of steps that makes it ¹. When the kidney senses a fall in blood flow or in salt, it releases renin, an enzyme, a protein that drives one chemical step, into the blood ¹. Renin acts on a protein made mainly by the liver to make angiotensin I, a peptide with no known activity of its own ¹. A second enzyme mainly in the lungs, ACE, the angiotensin-converting enzyme, cuts two amino acids off it to make angiotensin II ¹. Giapreza is "a sterile, aqueous solution of synthetic human angiotensin II for intravenous administration by infusion" ².

Is angiotensin II FDA-approved?

Yes, angiotensin II is approved by FDA as the prescription medicine Giapreza, with initial U.S. approval in 2017 ⁸. FDA's Drugs@FDA record shows La Jolla Pharmaceutical Company's new drug application, NDA 209360, approved December 21, 2017, with marketing status "Prescription" ⁴. Drugs@FDA classes it as a new molecular entity, a drug whose active ingredient FDA had not approved before ⁴. The approval letter states the use: "to increase blood pressure in adults with septic or other distributive shock" ⁵. A generic angiotensin II acetate injection, from a maker Drugs@FDA lists as Gland, was approved on June 3, 2025 ⁴, ⁶.

In shock, blood pressure falls so far that the tissues' blood supply, which FDA's reviewer calls tissue perfusion, suffers ³. Distributive shock is the kind in which the blood vessels have opened too wide ³. FDA's reviewer described the patients it is for as those "who have pathologically reduced peripheral resistance as the cause of their low blood pressure" ³. Resistance is the vessels' push back against the blood flow ³. Septic shock is distributive shock caused by severe infection; 91 percent of the patients in ATHOS-3 had it, and the rest had other forms of distributive shock ².

A vasopressor is a drug that narrows blood vessels to raise blood pressure; the label calls Giapreza "a vasoconstrictor" ². Norepinephrine was the first-line vasopressor, the one guidelines said to give first, FDA's reviewer wrote in 2017 ³. ATHOS-3's patients stayed hypotensive, meaning too low in blood pressure, despite fluids and such drugs ².

That is the whole approved use ². FDA's reviewer wrote that the drug "is used for a short period of time (several hours to several days) in closely-monitored patients in an intensive care unit" ³. It is prescription-only ⁴. The label's patient is already in shock on fluids and vasopressors, in an intensive care unit ², ³. The current label, effective July 22, 2026, carries the same indication and the same thrombosis warning ⁸.

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How does angiotensin II work?

"Angiotensin II raises blood pressure by vasoconstriction and increased aldosterone release," the label says ². It binds to the angiotensin II type 1 receptor, the docking site on a cell that answers to the hormone, on the muscle cells in blood vessel walls ². That sets off a calcium-dependent chemical change in the muscle protein myosin, and the muscle contracts ². By narrowing the vessels it raises the resistance the heart pumps against, and so the mean arterial pressure, MAP, the average pressure in the arteries over a heartbeat ², ³. Aldosterone is a hormone from the adrenal gland that makes the kidney keep salt and water, which adds to blood volume ¹.

The hormone acts fast and clears fast: its half-life, the time for half of it to clear from the blood, is less than one minute ². FDA's reviewer wrote that its effects "have a very rapid onset and a very rapid offset when the infusion is stopped" ³. Among patients on angiotensin II whose pressure responded by hour 3, half had reached the trial's target within about five minutes ². This account is the label's, for an approved drug ².

What does the research show?

The evidence for angiotensin II is at the top tier, FDA approval, and it rests on one trial ³. ATHOS-3, short for Angiotensin II for the Treatment of High-Output Shock, was published online May 21, 2017, and funded by La Jolla Pharmaceutical Company ⁷, ². It was a randomized, double-blind, placebo-controlled trial, so neither patients nor clinicians knew which infusion was given ⁷, ². Its adults had vasodilatory shock and were already on a high dose of norepinephrine or an equivalent vasopressor ⁷. Vasodilatory shock is the paper's name for distributive shock ⁷, ².

A total of 344 patients were assigned; 321 received a study infusion and were analyzed, 163 on angiotensin II and 158 on placebo, a salt-water infusion with no drug ⁷, ⁹. Each infusion was added to the vasopressors the patient was already receiving: 97 percent were on norepinephrine and 67 percent on vasopressin, a different molecule with its own page ². The primary end point was a response in MAP at hour 3 ⁷. A response meant a rise of at least 10 mm Hg, or a pressure of at least 75 mm Hg, with no increase in the background vasopressors ⁷. The study drug was to stop at hour 48, and patients were followed for survival to day 28 ³.

At hour 3, 114 of 163 patients on angiotensin II responded, 69.9 percent, against 37 of 158 on placebo, 23.4 percent ⁷. That is an odds ratio of 7.95, the odds of responding on the drug relative to placebo ⁷. The 95 percent confidence interval, the range the true value is likely to lie in, was 4.76 to 13.3 ⁷.

At 48 hours, the cardiovascular part of a standard organ-failure score improved more on angiotensin II, by 1.75 points against 1.28 ⁷. FDA's reviewer cautioned that this score depends on the doses of the listed vasopressors, which do not include angiotensin II ³. So it would be expected to fall "even if there were no benefit over standard vasopressors" ³. The total organ-failure score showed no advantage over placebo ³.

Deaths by day 28 were 75 of 163 on angiotensin II, 46 percent, and 85 of 158 on placebo, 54 percent ⁷. The hazard ratio, the rate of death on the drug relative to placebo, was 0.78 ⁷. Its confidence interval of 0.57 to 1.07 means the difference was not statistically significant ⁷. The registry's posted count of deaths by day 28 is the paper's, 75 and 85 ⁹. The authors concluded that angiotensin II "effectively increased blood pressure in patients with vasodilatory shock that did not respond to high doses of conventional vasopressors" ⁷.

FDA's reviewer wrote that the results "do not show a statistically significant effect on mortality or indeed any other outcome" ³. They gave, the reviewer wrote, "compelling evidence of an effect on blood pressure, and no evidence to support fatal harm" ³. FDA, the review adds, has "not required applicants to show a benefit other than an increase in blood pressure" to approve a drug for low blood pressure in shock ³. No drug labeled in the U.S. for sepsis or other distributive shock, the reviewer wrote in 2017, has a label saying it improves mortality or any other clinical outcome ³.

The label adds that patients were not necessarily on maximum doses of other vasopressors, so the effect of adding Giapreza to maximum doses "is unknown" ². No trial of angiotensin II for weight, muscle, performance or wellness is among the sources cited here as of November 10, 2026 ¹, ², ⁷, ³, ⁹. FDA's review reports data from healthy volunteers, in whom exposure to the drug rose in proportion to the dose ³.

What are the side effects?

Blood clots are the label's first concern ². Thrombosis is a clot forming inside a blood vessel; a thromboembolic event is a clot that forms or breaks loose and blocks a vessel. Deep vein thrombosis is such a clot in a deep vein, usually of the leg. In ATHOS-3, thromboembolic events, arterial and venous together, occurred in 21 of 163 patients on angiotensin II, 12.9 percent, against 8 of 158 on placebo, 5.1 percent ². Deep vein thrombosis occurred in 7 patients on angiotensin II, 4.3 percent, and none on placebo ².

The label lists seven more reactions that reached at least 4 percent on Giapreza and ran at least 1.5 points above placebo ². Thrombocytopenia, a shortage of platelets, the blood cells that form clots, was 9.8 against 7.0 percent, and tachycardia, a fast heart rate, 8.6 against 5.7 ². Fungal infection was 6.1 against 1.3 percent, delirium 5.5 against 0.6, and acidosis, too much acid in the blood, 5.5 against 0.6 ². Hyperglycemia, high blood sugar, was 4.3 against 2.5 percent, and peripheral ischemia, a loss of blood supply to the limbs, had the same figures ².

Serious adverse events, events the trial counted as serious, such as death or a threat to life, were 60.7 percent on angiotensin II and 67.1 percent on placebo ⁷. The registry record counts them as 99 of 163 and 106 of 158 ⁹.

The label carries one warning, "Risk for Thrombosis": "There was a higher incidence of arterial and venous thrombotic and thromboembolic events in patients who received GIAPREZA compared to placebo-treated patients in the ATHOS-3 study (13% vs. 5%). The major imbalance was in deep venous thromboses. Use concurrent venous thromboembolism (VTE) prophylaxis" ². FDA's reviewer called this "the most important risk" of the drug ³. The review says it "is consistent with preclinical evidence indicated that angiotensin II was prothrombotic in animals," meaning clot-promoting in studies before human trials ³. The label lists no contraindications, conditions in which it says the drug must not be given ².

On interactions, "ACE inhibitors may increase response to GIAPREZA" and "ARBs may reduce response to GIAPREZA" ². ARBs are angiotensin receptor blockers, and both are common blood-pressure medicines that act on the same system ¹, ². In pregnancy, the published data "are not sufficient to determine a drug-associated risk," and the label notes that shock "is a medical emergency that can be fatal if left untreated" ².

Safety and efficacy in children "have not been established" ². Forty-eight percent of ATHOS-3's patients were 65 or older, and the label found "no significant difference in safety or efficacy" between them and younger patients ². An overdose "would be expected to result in hypertension," high blood pressure, with effects that are brief because of its half-life of less than one minute ².

In sport

WADA's 2026 Prohibited List does not name angiotensin II ¹⁰. WADA is the World Anti-Doping Agency, and it publishes the list as an international standard under its code ¹⁰. WADA also lists a method that concerns infusions ¹⁰. M2.2 prohibits "Intravenous infusions and/or injections of more than a total of 100 mL per 12-hour period except for those legitimately received in the course of hospital treatments, surgical procedures or clinical diagnostic investigations" ¹⁰.

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JumpstartMD does not prescribe angiotensin II. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 10, 2026.

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Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.