🇺🇸 Palsonify in United States

FDA authorised Palsonify on 25 September 2025

Marketing authorisations

FDA — authorised 25 September 2025

Application: NDA219070
Marketing authorisation holder: CRINETICS
Local brand name: PALSONIFY
Indication: TABLET — ORAL
Status: approved

The FDA approved Palsonify, a new molecular entity, on 25 September 2025. The marketing authorisation was granted to CRINETICS under standard expedited pathway. Palsonify is indicated for a specific medical condition, but the exact indication is not specified in the available data.

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FDA

Marketing authorisation holder: CRINETICS
Status: approved

Palsonify 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 Palsonify approved in United States?

Yes. FDA authorised it on 25 September 2025; FDA has authorised it.

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

CRINETICS holds the US marketing authorisation.