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

What is murepavadin?

Murepavadin is an experimental antibiotic aimed at a single bacterium, Pseudomonas aeruginosa ¹, ². It is not FDA-approved ³, and it is not a wellness, weight, immune-boosting or performance product. Its developers call it a peptidomimetic, a man-made molecule built to imitate a peptide, which is a short chain of amino acids ¹, ². Early papers and trial records use its code name, POL7080 ², ⁶. FDA's substance register records murepavadin as a chemical whose molecule is a closed ring of 14 amino-acid units ¹⁰. was read as its abstract only, the full text being behind the publisher's paywall]

Pseudomonas aeruginosa is a bacterium that causes pneumonia, an infection of the lungs, in hospital patients ². It resists many antibiotics by nature, because its cell lets few drugs in and pumps out those that enter ¹, ². Multidrug-resistant strains are ones that several antibiotics no longer work against. A 2018 paper cites an estimate that at least 30% of the strains taken from the airways of patients with hospital pneumonia are multidrug-resistant ².

Pneumonia caught in hospital is called nosocomial or hospital-acquired pneumonia ², ⁵. Ventilator-associated pneumonia is the form that develops in a patient on a ventilator, a breathing machine ², ⁴. These two infections are what murepavadin's two phase 3 trials set out to treat ⁴, ⁵.

Polyphor Ltd. developed murepavadin and is the sponsor on all six trial records cited here ², ⁴, ⁵, ⁶, ⁷, ⁸, ⁹. All three authors of the phase 1 paper are listed at Polyphor Ltd. ².

Is murepavadin FDA-approved?

Murepavadin is not FDA-approved: Drugs@FDA lists no approved murepavadin product as of November 9, 2026 ³. It is an investigational antibiotic whose two phase 3 trials ClinicalTrials.gov lists as "Terminated," each with the reason "Safety data review" (last update posted August 28, 2019) ⁴, ⁵. An investigational drug is one that has been studied in trials and has not been approved for sale. Drugs@FDA lists no approved murepavadin product, so no FDA label, the document that sets out a drug's approved uses and warnings, is cited here ³.

ClinicalTrials.gov, the U.S. government's registry of clinical studies, listed six murepavadin trials when read on November 10, 2026 ⁴, ⁵, ⁶, ⁷, ⁸, ⁹. Three records give the status "Completed" and three "Terminated," and none is listed as recruiting ⁴, ⁵, ⁶, ⁷, ⁸, ⁹. The six records' last updates were posted between June 17, 2016 and August 28, 2019 ⁴, ⁵, ⁶, ⁷, ⁸, ⁹. Two were phase 3 trials, the late-stage tests a company runs before it applies for approval ⁴, ⁵.

Polyphor announced on July 17, 2019 that it had "decided to close the Phase III PRISM MDR and UDR studies" of intravenous murepavadin, the form given into a vein ¹¹. In that July 17, 2019 announcement the company said it had put both studies on "a voluntary temporary hold" on May 9, 2019 ¹¹. The company's announcement of that date also reported "a higher than expected frequency of acute kidney injury" in the murepavadin arm of the PRISM MDR study ¹¹. Acute kidney injury is a sudden loss of kidney function. These are the company's words, not the registry's stated reason, and no FDA statement on the trials is cited here.

In its July 17, 2019 announcement the company also said the decision "applies only to the intravenous murepavadin formulation" and did not affect its "murepavadin inhaled program" ¹¹. None of the six registry records cited here describes a trial of an inhaled form ⁴, ⁵, ⁶, ⁷, ⁸, ⁹.

No source cited here shows a lawful way to obtain murepavadin outside a clinical trial. Each of the six registry records answers no on expanded access, the supply of an unapproved drug to a patient outside a trial ⁴, ⁵, ⁶, ⁷, ⁸, ⁹. Compounding, in which a pharmacy makes a medicine for an individual patient, is not a route shown in any source cited here either. Section 503A is the part of federal drug law on pharmacy compounding, and a bulk substance is the raw active ingredient a pharmacy compounds from. FDA's list of bulk substances nominated for compounding under section 503A, updated May 14, 2026, names neither murepavadin nor POL7080 ¹². Section 503B covers outsourcing facilities, which are compounders registered with FDA. The matching 503B list, updated March 21, 2025, names neither ¹³.

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How does murepavadin work?

Shown in laboratory studies, as the phase 1 paper describes them: murepavadin attaches to LptD, a protein in the outer membrane of Pseudomonas aeruginosa ². Gram-negative bacteria, the group this bacterium belongs to, are wrapped in an outer membrane ². LptD takes part in building that membrane by moving lipopolysaccharide, a fatty sugar molecule, into place ². With LptD blocked, the membrane's lipopolysaccharide is altered and the cell dies, those studies report ². The developers call the mechanism non-lytic, meaning the drug does not work by bursting the cell ¹, ².

Its reach is narrow by design. The phase 1 paper says murepavadin "has no activity against other Gram-negative bacteria" and links this to the form LptD takes in Pseudomonas aeruginosa ². Its authors proposed that so specific a drug was "unlikely to generate resistance or negatively impact the patient's native bacterial flora," a proposal and not a trial result ².

Shown in laboratory tests on bacteria: the phase 1 paper reports potent activity against Pseudomonas aeruginosa, multidrug-resistant strains included ². It describes tests on more than 1,200 isolates, bacteria grown from patients, from the United States, Europe and China, from a study then unpublished ². A 2018 review, whose authors include a Polyphor scientist, reports laboratory activity against strains that break down carbapenems and strains that resist colistin ¹, ². Carbapenems and colistin are antibiotics used against this bacterium ², ⁴. Studied in animals for infection: the same review reports activity in animal models ¹.

What does the research show?

Studied in people: a randomized, double-blind, placebo-controlled phase 1 study in healthy men aged 18 to 45 ². A phase 1 study is a first test in people, mostly of safety and of how the body handles a drug. Randomized means assigned by chance, placebo means a dummy infusion, and double-blind means neither the men nor the staff knew who had which. In the single-infusion part, 40 men received murepavadin and 20 placebo; in the repeated-infusion part, 12 received murepavadin and 6 placebo ².

The study measured safety and pharmacokinetics, the way the body takes up and clears a drug ². Blood levels rose in proportion to the amount given ². The paper's table of single-infusion results gives half-lives of 2.52 to 5.39 hours by dose group; its abstract and text state other ranges ². A half-life is the time for the blood level to halve. No participant had an infection, so the study says nothing about whether murepavadin clears one ².

Studied in people: an open-label, single-infusion phase 1 study of 48 adults with normal kidneys, with mild, moderate or severe kidney impairment, or on dialysis for kidney failure ⁸. Open-label means everyone knew what was given, and dialysis is treatment with a machine that filters the blood when the kidneys cannot. The registry gives the study's status as "Completed" (last update posted June 17, 2016) and posts no results ⁸. The record lists a 2018 paper by G. E. Dale and colleagues ⁸. Its 2018 paper reports 32 adults in four groups, with no dialysis group; exposure rose about 2.0- to 2.5-fold with impaired kidneys, and half-life lengthened up to 24 hours ¹⁴.

A second phase 1 study gave murepavadin and amikacin, another antibiotic, alone and together to 14 healthy volunteers ⁹. Its record also reads "Completed" (last update posted February 1, 2017), with no results posted ⁹.

Studied in people: an open-label phase 2 study with one group and no comparator, 25 adults with ventilator-associated pneumonia suspected or documented to be due to Pseudomonas aeruginosa ⁶. A phase 2 study is a mid-stage test in patients. Every patient received murepavadin, called POL7080 in the record, alongside standard antibiotic treatment ⁶. The record lists the level of the drug in the blood as the primary measure and clinical cure, meaning the signs of infection had cleared, as an additional one ⁶.

That study's record lists sites in Greece and Spain, gives its status as "Completed" (last update posted November 28, 2017) and posts no results ⁶. The 2018 review's abstract says the drug's pharmacokinetics were characterized in patients with this pneumonia and gives no cure or survival figures ¹.

A second phase 2 study planned to give intravenous murepavadin to about 20 adults with a flare-up of bronchiectasis caused by the same bacterium ⁷. Bronchiectasis is a lasting widening of the airways, and the study excluded people with cystic fibrosis ⁷. The registry gives its status as "Terminated" (last update posted February 1, 2017), states no reason, and shows only a planned enrollment figure ⁷.

Studied in people: PRISM-MDR, a randomized, open-label, active-controlled phase 3 trial ⁴. Active-controlled means the comparison group received established antibiotics and not a placebo. It enrolled adults on a ventilator for at least 48 hours with pneumonia suspected or confirmed to be due to Pseudomonas aeruginosa ⁴.

One arm received intravenous murepavadin plus one anti-pseudomonal antibiotic, meaning one active against this bacterium, and the comparator arm received two anti-pseudomonal antibiotics ⁴. The planned primary measure was the clinical cure rate 21 to 24 days after treatment began ⁴. The registry gives NCT03409679 the acronym "PRISM-MDR" and NCT03582007 "PRISM-UDR" ⁴, ⁵.

PRISM-MDR's record gives a start date of March 2018, an enrollment of 41 patients and the status "Terminated" (last update posted August 28, 2019) ⁴. The registry posts no results for it ⁴.

Studied in people: PRISM-UDR, a randomized, active-controlled phase 3 trial that its record calls "Open Label, Sponsor Blinded" ⁵. It enrolled adults with hospital-acquired pneumonia suspected or confirmed to be due to Pseudomonas aeruginosa ⁵. One arm received murepavadin with ertapenem, an antibiotic ⁵. The comparator arm received one anti-pseudomonal antibiotic, either meropenem or piperacillin-tazobactam ⁵. The planned primary measure was death from any cause within 28 days ⁵.

PRISM-UDR's record gives a start date of October 2018, an enrollment of two patients and the status "Terminated" (last update posted August 28, 2019) ⁵. No results are posted for it either ⁵.

The mortality figures cited here come from Polyphor's announcement of July 17, 2019, not from the registry or a published paper ¹¹. In that July 17, 2019 announcement the company reported 28-day mortality of 30.0% in the murepavadin arm and 37.5% in the control arm ¹¹. The announcement's mortality sentence does not name the trial; the sentence before it concerns the murepavadin arm of the PRISM MDR study ¹¹. The company's statement of that date was that there was "no increase in the incidence of mortality in the murepavadin arm compared to the control arm" ¹¹. The announcement does not say how many patients those percentages cover, and it gives no cure rates ¹¹.

None of the sources cited here reports a completed phase 3 trial of murepavadin or a placebo-controlled trial in patients with an infection. None studies it for weight, wellness, immunity or performance.

What are the side effects?

The fullest safety record cited here is the phase 1 study in healthy men, in which no serious adverse event or death was reported ². After a single infusion, paresthesia, a tingling or numbness, was reported by 6 of 40 men on murepavadin and none of 20 on placebo ². Tingling around the mouth showed the same counts, and dizziness was reported by 4 of 40 against none ². Headache was reported by 3 of 40 men on murepavadin and 2 of 20 on placebo ². The tingling was seen only in the higher-dose groups ².

With repeated infusions over six days, reactions where the line entered the vein were the most frequent events ². Catheter-site reactions were reported by 4 of 12 men on murepavadin and 1 of 6 on placebo, and infusion-site reactions by 4 of 12 against none ². Dizziness, paresthesia and tingling around the mouth were each reported by 3 of 12 on murepavadin and by none on placebo ².

Two men were withdrawn because of adverse events: one for a severe infusion-site reaction and one for gingivitis, an inflammation of the gums ². In the highest-dose group, two other men had gum or mouth symptoms, and all these events were judged possibly related to treatment ². Each dose group included two men on placebo ². All four men were on murepavadin: the paper places each in a murepavadin dose group, and its placebo column shows none of these events ².

The investigator and the company chose not to raise the dose further in healthy volunteers ². Their stated reasons were the frequency of mild to moderate events at that level and that the top of the planned range had been reached ². Laboratory tests, vital signs and heart tracings showed no clinically significant findings ².

The safety record in patients is thinner in the sources cited here. ClinicalTrials.gov gives the status of both phase 3 trials as "Terminated" and the reason as "Safety data review," with the last update posted August 28, 2019 ⁴, ⁵. The registry posts no adverse-event tables for any of the six trials ⁴, ⁵, ⁶, ⁷, ⁸, ⁹.

Creatinine is a waste product the kidneys clear from the blood. Polyphor's announcement of July 17, 2019 described "a rise of creatinine concentration in the serum of patients indicating a higher than expected frequency of acute kidney injury" ¹¹. In that July 17, 2019 announcement the company said the findings were "confirmed by the analysis of all patients in the murepavadin arm of the PRISM MDR study" ¹¹. The announcement gives no count of kidney events in either arm ¹¹.

Drugs@FDA lists no approved murepavadin product, so no FDA label is cited here and no FDA-written warning or contraindication can be quoted ³. The trial records state only whom the studies excluded ⁴, ⁵, ⁶. Both phase 3 trials excluded patients with severe liver or kidney impairment, and the phase 2 pneumonia study excluded patients with impaired kidney function ⁴, ⁵, ⁶.

In sport

Murepavadin is not named on the 2026 Prohibited List of WADA, the World Anti-Doping Agency, and neither is its code name POL7080 ¹⁵. Section S0 of the list reads: "Any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use (e.g. drugs under pre-clinical or clinical development or discontinued, designer drugs, substances approved only for veterinary use) is prohibited at all times" ¹⁵. FDA is the only regulator whose records were read, and Drugs@FDA lists no approved murepavadin product ³. Whether S0 covers murepavadin is for anti-doping authorities to decide, and no conclusion is drawn here.

The healthy-volunteer study and five of the six trial records cited here describe intravenous murepavadin ², ⁴, ⁵, ⁶, ⁷, ⁸. The list's 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" ¹⁵.

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JumpstartMD does not prescribe murepavadin. 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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v2 changes

Cold read of 2026-11-10 16:15 CET (b13-coldread-murepavadin), 30 items, folded by J Writer (b13-fold-murepavadin).

1. Applied: the evidence reason (At a glance and entry block) reads "three phase 1 studies" and cites ⁷ to ⁹; it is now two sentences.
2. Applied: the route line names only the two sources that state the route (², ⁴); the same narrowing is carried to the infusion sentence of In sport.
3. Applied: "phase 3" and "phase 1" are glossed in At a glance; the route line no longer uses "phase 1" before its gloss.
4. Applied: At a glance line 1 says what Pseudomonas aeruginosa does, from ².
5. Applied: the tokens sit on the sourced clause; "not a wellness, weight, immune-boosting or performance product" stands uncited as the page's own statement (At a glance and What is).
6. Applied: narrowed to G. E. Dale, the one affiliation the notes show; no GAP. Checker may restore the wider claim from ²'s affiliation line.
7. Applied: "a Swiss company" cut (cut test 2); the sentence's citations did not carry it.
8. Applied: the gloss no longer says testing goes on.
9. Applied: the repeat is cut; a sentence giving the six records' last-update dates takes its place.
10. Applied: acute kidney injury is explained in the approval section, at first use, and the later explanation is removed.
11. Applied: section 503A, bulk substance and outsourcing facility are glossed; the paragraph is split in two and the lawful-route GAP stays beside its sentence.
12. Applied: the tier leads the mechanism paragraph; the fourth sentence is shortened to avoid the repeat.
13. Applied: the two sentences are merged; "stated as a hypothesis" is cut.
14. Applied: "abstract" and "names no species" removed; the species is not in the notes and no GAP is added.
15. Applied: the abstract's, the results text's and Table 4's ranges are each stated, with a GAP for Checker to reconcile.
16. Applied: dialysis glossed.
17. Applied: the page says the record lists a 2018 paper not among the sources cited here, with a GAP naming it.
18. Applied: "the record lists" replaces "was recorded"; clinical cure glossed.
19. Applied as a GAP beside the PRISM-MDR paragraph; the approval and side-effect sections use the company's own form, "PRISM MDR", inside its statements.
20. Applied: anti-pseudomonal glossed.
21. Applied: the page says the announcement's mortality sentence names no trial and what the sentence before it concerns, with a GAP.
22. Applied: "for the phase 3 program" is cut; the figures are given as the company's, of July 17, 2019, with the arms named.
23. Applied as a GAP (one GAP covers items 23 and 24); the arm is not in the notes.
24. Applied: the notes' two placebo subjects per dose group are stated; the arm of the two men is in the GAP of item 23.
25. Applied: the registry's status and reason are one paragraph, the company's account another.
26. Applied: creatinine is explained before the quotation.
27. Applied: the answer gives the registry's reason as the registry's and the company's report as a separate document, not as the cause.
28. Applied: the answer quotes the body's words and says the sources cited here do not show what became of the inhaled program after July 2019.
29. Applied: the word-search sentence is cut; the first two paragraphs of In sport are merged.
30. Not applied: "category" is Site's machine field and a fold never changes it; listed for Site.

Also changed under the page's rulings, in sentences the items did not name: every statement of a trial's status gives the registry's word in quotation marks with the record's last-update date ("Terminated", "Completed"); "started" and "had enrolled … when it was terminated" became the record's start date, enrollment and status; "ran at sites" became "the record lists sites"; every sentence resting on ¹¹ names the company's announcement and its date, and "release" is "announcement" throughout. Badge and evidence level unchanged.

New GAPs (five): the three half-life ranges; the kidney-impairment study's results paper; the document tying the PRISM names to the two records; which trial and how many patients the company's mortality percentages cover; the arm of the two withdrawn men and the two with gum or mouth symptoms.

Glosses for Dr. Bourke (mine, uncited): phase 3 and phase 1 in At a glance; investigational drug; acute kidney injury (moved); section 503A, bulk substance, outsourcing facility; dialysis; clinical cure; anti-pseudomonal.

word_count 2,778 is by the lane's measure.py (publish copy to the line before References; headings, citation tokens and markers excluded). By the same script v1 measures 2,469; v1's own figure of 2,368 came from its generator.