Is lutetium Lu-177 vipivotide tetraxetan FDA-approved, and what does the research show?

What is lutetium Lu-177 vipivotide tetraxetan?

Lutetium Lu-177 vipivotide tetraxetan is a radioactive drug for prostate cancer, sold under the brand name Pluvicto ¹. Its label calls it "a radioligand therapeutic agent" ¹. A ligand is a molecule that binds a target. In the label's words, the drug is "a PSMA-binding ligand bound to a DOTA chelator radiolabeled with lutetium-177" ¹. A chelator is a chemical cage that holds a metal atom, here the radioactive lutetium-177.

PSMA stands for prostate-specific membrane antigen, a protein in the cell membrane that "is expressed in prostate cancer" ¹. The label does not use the word peptide for the drug ¹. The 2021 trial paper calls it 177Lu-PSMA-617 ³.

Pluvicto is not a wellness, weight-loss or performance product. It is a cancer treatment given into a vein, and the label calls it a radiopharmaceutical, a radioactive drug ¹. The label says such drugs "should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radiopharmaceuticals" ¹. A government agency that licenses the use of radioactive drugs must have approved that training ¹.

Is lutetium Lu-177 vipivotide tetraxetan FDA-approved?

Yes, as a prescription cancer drug. FDA approved Pluvicto on March 23, 2022, under NDA 215833, an application held by Novartis ². Its marketing status is "Prescription" as of November 9, 2026, the date of the Drugs@FDA record's data ².

The label, revised in July 2026, lists two uses ¹. Both are for adults whose prostate cancer is metastatic, meaning it has spread, and PSMA-positive ¹. The first is "in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer" ¹. Androgens are male hormones such as testosterone, and an ARPI is a drug that blocks their signaling. The ARPIs the label names are abiraterone, apalutamide, enzalutamide and darolutamide ¹.

The second use is "for the treatment of adult patients with PSMA-positive metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer who have been treated with ARPI therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy" ¹. Taxanes are one class of chemotherapy drugs.

The label does not define "naïve or -sensitive" or "resistant" ¹. Its trials show the difference. PSMAddition, the label's trial in mAPMN/S cancer, admitted patients who had received no more than 45 days of hormone treatment for metastatic disease ¹. PSMAfore, a trial in mAPMR cancer, enrolled patients with a "castrate level of serum/plasma testosterone" whose cancer had "progressed only once on an ARPI" ¹. The 2021 paper on another of the label's trials, VISION, calls its patients' condition "metastatic castration-resistant prostate cancer" ³.

FDA's July 31, 2026 approval notice says mAPMN/S cancer was "previously referred to as metastatic hormone-sensitive prostate cancer" ⁴. FDA's March 2025 letter calls the second use's cancer "metastatic castration-resistant prostate cancer (mCRPC)" ⁵.

A scan decides who is eligible. The label says to select patients with "LOCAMETZ or another approved PSMA positron emission tomography (PET) product based on PSMA expression in tumors" ¹. A PET scan shows where a radioactive tracer collects in the body, here a tracer that binds PSMA.

Drugs@FDA lists two later supplements to the application classed "Efficacy," approved March 28, 2025, and July 31, 2026 ². The label marks its first use as a recent major change ¹. FDA's March 28, 2025 letter says that supplement extended the second use to patients for whom delaying taxane chemotherapy is judged appropriate, based on PSMAfore ⁵. The July 31, 2026 supplement added the first use, with an ARPI ⁶.

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How does lutetium Lu-177 vipivotide tetraxetan work?

The account is the label's, for an approved drug ¹. The drug has two parts: a piece that binds PSMA, and the radioactive atom lutetium-177, which the label calls the "active moiety" ¹. Once the drug binds, "the beta-minus emission from lutetium-177 delivers radiation to PSMA-expressing cells, as well as to surrounding cells, and induces DNA damage which can lead to cell death" ¹. Beta-minus emission is the radiation lutetium-177 gives off as it decays ¹.

That radiation travels a short way. The label puts its maximum reach in tissue at "approximately 2 mm" and its mean reach at 0.67 mm ¹. Lutetium-177 has a physical half-life of 6.647 days, the time in which half of its radioactivity decays away ¹. The label's decay table shows 48.2 percent remaining after 7 days and 4.4 percent after 30 days ¹.

The drug reaches healthy tissue too. Radiation doses to the organs were estimated in 29 patients from one trial, VISION ¹. The organs with the highest absorbed doses were the "lacrimal glands, salivary glands, large intestine (left and right colon), kidneys, and urinary bladder wall" ¹. The lacrimal glands, which make tears, have a mean in the label's table of 2.1 gray per gigabecquerel, against 0.037 for the body as a whole ¹. A gray is a unit of absorbed radiation, and a gigabecquerel is a unit of the radioactivity given.

The body clears the drug mainly through the kidneys ¹. Its terminal elimination half-life, the time for half of it to leave the blood late in clearance, is 41.6 hours ¹. The label says the link between exposure and benefit has "not been fully characterized" ¹.

What does the research show?

The drug is FDA-approved, and its label describes three randomized trials ¹, ². Randomized means that chance decided each patient's treatment. All three were open-label, so patients and doctors knew who received the drug ¹. All three required at least one tumor that took up a PSMA tracer on a PET scan more than normal liver did ¹.

Studied in people after hormone drugs and chemotherapy: VISION, a phase 3 trial, the last stage before approval, randomized 831 of the 1,179 patients screened ³. Their castration-resistant cancer had been treated with at least one ARPI and one or two taxane regimens ³, ¹. The trial assigned 551 patients to the drug plus best standard of care and 280 to standard care alone ¹. Standard care excluded chemotherapy, immunotherapy, investigational drugs and radium-223, another radioactive treatment ³.

Overall survival, the time patients lived after randomization, had a median of 15.3 months with the drug and 11.3 months without it ³, ¹. The hazard ratio for death was 0.62, with a 95 percent confidence interval of 0.52 to 0.74 ³, ¹. A hazard ratio below 1 means fewer events over time in the treated arm, and the interval is the range in which the true figure plausibly lies. By the label's analysis, 343 of 551 patients (62 percent) and 187 of 280 (67 percent) had died ¹.

The paper also reports imaging-based progression-free survival, the time until scans show the cancer growing or the patient dies ³. In the paper's 581-patient analysis set for this measure, its median was 8.7 months with the drug and 3.4 months without ³. The hazard ratio was 0.40 (99.2 percent confidence interval, 0.29 to 0.57) ³. The label adds a caution about that result: "Interpretation of the magnitude of the rPFS effect was limited due to a high degree of censoring from early drop out in the control arm" ¹. Its abbreviation rPFS stands for radiographic progression-free survival ¹.

Among patients whose tumors could be measured, 91 of 184 (49 percent) responded in the drug arm and 1 of 64 (1.6 percent) in the control arm ¹. A response means the tumors shrank or disappeared on scans. The paper reports a median follow-up of 20.9 months ³. It reports that "quality of life was not adversely affected," and that Endocyte, a Novartis company, funded the trial ³.

Studied in people after a hormone drug, with chemotherapy delayed: PSMAfore enrolled patients with progressive, PSMA-positive mAPMR cancer that had progressed once on an ARPI ¹. Their doctors judged it appropriate to delay taxane chemotherapy ¹. The trial randomized 234 patients to the drug and 234 to a change of ARPI ¹. Median radiographic progression-free survival was 9.3 months with the drug and 5.6 months with the changed ARPI ¹. The hazard ratio was 0.41 (95 percent confidence interval, 0.29 to 0.56) ¹.

Overall survival in PSMAfore did not differ to a statistically significant degree ¹. The medians were 24.5 and 23.1 months, with a hazard ratio of 0.91 (95 percent confidence interval, 0.72 to 1.14) ¹. Of the patients assigned to a change of ARPI, 141 (60 percent) crossed over to the drug after their cancer progressed ¹. Among patients with measurable disease, 35 of 72 (49 percent) responded to the drug and 10 of 72 (14 percent) to the changed ARPI ¹.

Studied in people earlier in the disease, with a hormone drug: PSMAddition enrolled patients with PSMA-positive mAPMN/S cancer ¹. It randomized 572 to the drug in combination with an ARPI and 572 to an ARPI alone ¹. Cancer progressed on scans, or the patient died, in 139 patients (24 percent) in the combination arm and 172 (30 percent) on an ARPI alone ¹. The hazard ratio was 0.72 (95 percent confidence interval, 0.58 to 0.90) ¹. The median was not estimable in either arm, and survival is not yet known: "The OS data were immature, and a total of 291 patients (25%) had died across both study arms" ¹.

The label reports weight only as a side effect, in patients with metastatic prostate cancer ¹. In VISION, "weight decreased" was recorded in 11 percent of 529 patients on the drug plus standard care and 10 percent of 205 on standard care alone ¹. Decreased appetite was recorded in 21 percent and 15 percent ¹.

No trial in the label studied the drug for weight, wellness or performance, or in people without prostate cancer ¹. The label states: "The safety and efficacy of PLUVICTO have not been established in females" ¹. It says of children that safety and effectiveness "have not been established" ¹.

What are the side effects?

The label lists no contraindications: the section reads "None" ¹. It carries five warnings: radiation exposure, myelosuppression (the bone marrow making too few blood cells), kidney toxicity, harm to an unborn child, and infertility ¹.

On radiation, the label says the drug "contributes to a patient’s overall long-term cumulative radiation exposure," which "is associated with an increased risk for cancer" ¹. It tells clinicians to give patients precautions "to minimize radiation exposure to others" after each administration ¹. Three are "Limit close contact (less than 3 feet) with others for 2 days or with children and pregnant women for 7 days," "Refrain from sexual activity for 7 days," and "Sleep in a separate room from others for 3 days, from children for 7 days, or from pregnant women for 15 days" ¹. The same section says to "Ensure patients increase oral fluid intake and advise patients to void as often as possible to reduce bladder radiation" ¹. To void is to urinate.

The label warns that the drug "can cause severe and life-threatening myelosuppression, including anemia, thrombocytopenia, leukopenia, and neutropenia" ¹. The four terms name shortages of red cells, platelets and white cells.

The label grades reactions by the Common Terminology Criteria for Adverse Events ¹. Grades 3 and 4 are the more severe grades on that scale. In VISION, Grade 3 or 4 drops in hemoglobin occurred in 15 percent of the drug arm and 7 percent of the control arm ¹. For platelets the figures were 9 percent and 2.5 percent ¹.

The label records deaths in VISION's drug arm: "Two deaths (0.4%) occurred due to intracranial hemorrhage and subdural hematoma in association with thrombocytopenia, one death (0.2%) occurred due to sepsis and concurrent neutropenia, and one death (0.2%) occurred due to bone marrow failure" ¹. In PSMAfore, one patient who received the drug died of bone marrow failure during long-term follow-up ¹.

The label says the drug "can cause severe renal toxicity," renal meaning of the kidneys ¹. Grade 3 or 4 acute kidney injury occurred in 3.4 percent of drug-treated patients in VISION, 1.3 percent in PSMAfore and 1.6 percent in PSMAddition ¹. Patients with mild to moderate kidney impairment "may be at greater risk of toxicity," and the drug has not been studied in severe impairment ¹.

Across the three trials, 1,320 patients received the drug ¹. Their most common reactions, laboratory changes included, were decreased lymphocytes (86 percent), decreased hemoglobin (68 percent) and fatigue (51 percent) ¹. Dry mouth (46 percent), decreased neutrophils (35 percent) and nausea (35 percent) followed ¹. Lymphocytes and neutrophils are types of white blood cell. Dry mouth was far more frequent with the drug: 39 percent against 1 percent in VISION, 61 against 2.6 in PSMAfore, and 46 against 3.7 in PSMAddition ¹.

Serious adverse reactions occurred in 37 percent of drug-treated patients in VISION, 20 percent in PSMAfore and 32 percent in PSMAddition ¹. Fatal adverse reactions occurred in 3 percent, 1.8 percent and 2.7 percent ¹. The label gives no control-arm figures for those two measures ¹. The VISION paper reports adverse events of grade 3 or above in 52.7 percent of the drug arm and 38.0 percent of the control arm ³. In PSMAddition, serious adverse reactions occurred in 43 percent of patients aged 75 or older and 29 percent of younger patients ¹.

The label says the drug "can cause fetal harm" ¹. It tells clinicians to advise "males with female partners of reproductive potential to use effective contraception during treatment with PLUVICTO and for 14 weeks after the last dose" ¹. It also warns that the drug "may cause infertility in males," which may be "temporary or permanent" ¹. Cancer-causing potential has not been tested in studies, and the label notes that "radiation is a carcinogen and mutagen" ¹.

In sport

Lutetium Lu-177 vipivotide tetraxetan is not named on WADA's 2026 Prohibited List ⁷. WADA is the World Anti-Doping Agency, and its list names no radioligand or radiopharmaceutical in any section ⁷. The drug is given into a vein ¹. WADA's method rule 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" ⁷.

What JumpstartMD offers

JumpstartMD does not prescribe lutetium Lu-177 vipivotide tetraxetan. 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.