🇺🇸 Aceclidin in United States

FDA authorised Aceclidin on 31 July 2025

Marketing authorisation

FDA — authorised 31 July 2025

  • Application: NDA218585
  • Marketing authorisation holder: LENZ THERAP
  • Indication: Type 1 - New Molecular Entity
  • Status: approved

The FDA approved Aceclidin, a new molecular entity, for marketing in the United States. The approval was granted to LENZ THERAP on July 31, 2025, through the standard expedited pathway. The application number for this approval is NDA218585.

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Aceclidin in other countries

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

Other Neuroscience approved in United States

Frequently asked questions

Is Aceclidin approved in United States?

Yes. FDA authorised it on 31 July 2025.

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

LENZ THERAP holds the US marketing authorisation.