🇺🇸 Forzinity in United States

FDA authorised Forzinity on 19 September 2025

Marketing authorisations

FDA — authorised 19 September 2025

  • Application: NDA215244
  • Marketing authorisation holder: STEALTH BIOTHERAPS
  • Local brand name: FORZINITY
  • Indication: SOLUTION — SUBCUTANEOUS
  • Status: approved

The FDA approved Forzinity, a new molecular entity, for marketing in the United States on 19 September 2025. The application number is NDA215244. Forzinity is indicated for a specific medical condition, but the exact indication is not specified in the available data. The marketing authorisation holder is STEALTH BIOTHERAPS.

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FDA

  • Marketing authorisation holder: STEALTH BIOTHERAPS
  • Status: approved

Forzinity in other countries

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

Other Cardiovascular approved in United States

Frequently asked questions

Is Forzinity approved in United States?

Yes. FDA authorised it on 19 September 2025; FDA has authorised it.

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

STEALTH BIOTHERAPS holds the US marketing authorisation.