🇺🇸 Phase I in United States

Phase I (Phase I) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Phase I in other countries

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

Frequently asked questions

Is Phase I approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Phase I in United States?

KK Women's and Children's Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.