Is Murepavadin legal in the US?
No. It is not approved, and development has stopped.
Not approved by the FDA for any use. Murepavadin is an investigational antibiotic; Polyphor stopped its two phase 3 trials of the intravenous form in 2019 after excess kidney injury. An inhaled formulation for cystic fibrosis lung infection was later developed by Spexis with Cystic Fibrosis Foundation funding, but the foundation now lists that program as discontinued, with no active development.
No. Its intravenous phase 3 trials were closed in 2019 for kidney toxicity. No murepavadin product has been approved. The inhaled form is also listed as discontinued. 345
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Citations
- Martin-Loeches 2018, Expert Rev Anti Infect Ther: Murepavadin, a new antibiotic class in the pipeline doi.org
- Wach 2018, Antimicrob Agents Chemother: pharmacokinetics and safety of intravenous murepavadin in healthy adults, single and multiple ascending doses doi.org
- Polyphor press release, May 2019: enrollment halted in the phase 3 PRISM trials of murepavadin biospace.com
- Polyphor press release, July 2019: phase 3 PRISM studies of intravenous murepavadin closed biospace.com
- Cystic Fibrosis Foundation: inhaled murepavadin pipeline entry (discontinued) apps.cff.org
Reference information only, not medical advice. Drawn from the Murepavadin article, fact-checked against the cited sources. No dosing anywhere on this site.