NDAORALCAPSULEPriority Review
Approved
Dec 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
5
Data completeness
6/8 — Strong
Priority Review
CRENESSITY (crinecerfont) by Neurocrine Biosciences is corticotropin-releasing factor type 1 receptor antagonists [moa]. First approved in 2024.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CRENESSITY (crinecerfont) is an oral small-molecule corticotropin-releasing factor (CRF) type 1 receptor antagonist approved by the FDA on December 13, 2024. It modulates the hypothalamic-pituitary-adrenal (HPA) axis by blocking CRF1 signaling, which plays a central role in stress response and mood regulation. The drug targets patients with stress-related or mood-related conditions where HPA axis dysregulation is implicated.
Growth16.3 years to LOE
Very recent approval with strong patent protection (16.3 years remaining) positions the commercial team for a multi-year growth phase with expanding market opportunity.
Mechanism of Action
Corticotropin-releasing Factor Type 1 Receptor Antagonists
Pharmacologic Class:
Corticotropin-releasing Factor Type 1 Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Crinecerfont in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Who Are Less Than 4 Years Old
Started Jul 2026
20 enrolled
Congenital Adrenal Hyperplasia
Pharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Less Than 2 Years Old
Started Sep 2025
7 enrolled
Congenital Adrenal Hyperplasia
Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)
Started Jun 2021
103 enrolled
Congenital Adrenal Hyperplasia
Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia
Started Dec 2020
182 enrolled
Congenital Adrenal Hyperplasia
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 (Crinecerfont) in Pediatric Participants With Congenital Adrenal Hyperplasia
Started Dec 2019
8 enrolled
CAH - Congenital Adrenal Hyperplasia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.