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crinecerfont

Generic: CRINECERFONT·Brand: CRENESSITY, Crenessity

crinecerfont: developed by 1 company · 2 clinical trials tracked · 2 FDA decisions.

crinecerfont evidence translation

What we can confirm

2 FDA records · 2 tracked trials

What it means

Source-backed records connect crinecerfont to NBIX; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could crinecerfont → NBIX affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (1)
Clinical Trials (2)

A Phase 2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Crinecerfont in Pediatric Participants 3 Months to <4 Years of Age With Classic Congenital Adrenal Hyperplasia

NCT07536269·Phase 2·NBIX
Not yet recruiting

Primary endpoint: Number of Participants With Treatment-emergent Adverse Events (TEAE)

Interventionalopen20 targetStarted 2026-04Completion 2028-03Neurocrine Biosciences

A Phase 2, Open-Label Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Pharmacodynamics of Crinecerfont in Pediatric Subjects 0 to <2 Years of Age With Congenital Adrenal Hyperplasia

NCT07187375·Phase 2·NBIX
Active, not recruiting

Primary endpoint: Plasma Concentration of Crinecerfont

Interventionalopen7 enrolledStarted 2025-09Completion 2029-103 sites · GermanyNeurocrine Switzerland GmbH
FDA Decisions2 records
NDA218808Type 1 - New Molecular EntityOrphan DrugPriorityOralCapsule
NDA218820Type 3 - New Dosage FormOrphan DrugPriorityOralSolution

Frequently asked questions

Who is developing crinecerfont?

crinecerfont is being developed by NEUROCRINE BIOSCIENCES INC.

How many clinical trials involve crinecerfont?

BioSniper tracks 2 clinical trials involving crinecerfont.

What is crinecerfont's latest FDA decision?

The most recent tracked FDA decision for crinecerfont is Approval, dated December 13, 2024.