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High materiality7/10

Neurocrine Launches Phase 2 Pediatric Trial for Crinecerfont in Under-4 CAH

Jul 1, 2026, 4:12 PM EDT1 sourcesAI-analyzed
Why it may matterVerify against the original reporting

Phase 2 pediatric expansion signals potential longer-term upside if data are favorable, given CRENESSITY’s existing FDA approval and unmet need in under-4 CAH; however, no readouts yet limits near-term impact.

AI summary

What happened, with direct paths to the underlying reporting

Neurocrine Biosciences (NBIX) announced a Phase 2 open-label trial of crinecerfont (CRENESSITY) in children aged 3 months to under 4 years with classic CAH, aiming to expand the approved pediatric indication. The 24-week study will enroll 20 participants to assess safety and PK/PD, with EU studies also progressing. Positive safety signals could support a supplemental NDA to broaden CRENESSITY’s U.S. label.

  • NBIX starts Phase 2 pediatric crinecerfont trial for under-4 CAH.
  • Open-label, single-arm, 24-week study; 20 participants enrolled.
  • FDA Pediatric Written Request supports expanding CRENESSITY to under-4s.
  • EU trial for birth to under-2 CAH reached target enrollment.
  • CRENESSITY approved in 2024; potential label expansion could grow TAM.

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