What was Rexulti’s last clinical trial phase?
Rexulti (brexpiprazole) is an antipsychotic that reached late-stage testing before approval. The most advanced clinical development phase for Rexulti was Phase 3, which is typically the final phase used to support regulatory approval. The product’s regulatory submissions relied on those Phase 3 efficacy and safety data.
Was Rexulti studied in Phase 4 after approval?
Yes. Like most approved prescription drugs, Rexulti has been studied further in the post-approval setting through additional clinical studies (often categorized as Phase 4 or other post-marketing research). These can include ongoing safety monitoring, real-world effectiveness, and additional indications depending on what regulators and the manufacturer require.
What does “last clinical phase” mean for FDA approval timing?
For drug development and labeling, the “last clinical phase” usually refers to the latest numbered phase in the pre-approval program, which for Rexulti is Phase 3. After that, additional studies continue, but they generally do not replace the Phase 3 data used for initial approval.
Are there specific Rexulti trials you want identified?
If you tell me whether you mean:
- the last Phase 3 program (and the indication it supported), or
- the last post-marketing study type (Phase 4 / label-required studies),
I can narrow it to the specific trial names and dates. Also, if you share a link or the exact label/indication you’re looking at, I can align the answer to that context.
Sources: None provided in your prompt.