🇺🇸 Lerochol in United States

FDA authorised Lerochol on 12 December 2025

Marketing authorisations

FDA — authorised 12 December 2025

  • Application: BLA761427
  • Marketing authorisation holder: LIB THERAPEUTICS, INC.
  • Local brand name: LEROCHOL
  • Indication: INJECTABLE — INJECTION
  • Status: approved

The FDA approved Lerochol, a new molecular entity, on 12 December 2025. The marketing authorisation was granted to LIB THERAPEUTICS, INC. under the standard expedited pathway. The indication for which Lerochol was approved is not specified in the available information.

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FDA

  • Marketing authorisation holder: LIB THERAPEUTICS, INC.
  • Status: approved

Lerochol in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Metabolic approved in United States

Frequently asked questions

Is Lerochol approved in United States?

Yes. FDA authorised it on 12 December 2025; FDA has authorised it.

Who is the marketing authorisation holder for Lerochol in United States?

LIB THERAPEUTICS, INC. holds the US marketing authorisation.