Sold as Crenessity. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 2 applications for Crinecerfont (sold as Crenessity), first approved Dec 13, 2024, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Crenessity | Part D | $5.1M | New | 25 |
| Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Crinecerfont in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Who Are Less Than 4 Years OldCongenital Adrenal Hyperplasia · Neurocrine Switzerland GmbH | Phase 2 | Recruiting | Apr 17, 2026 |
| Pharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Less Than 2 Years OldCongenital Adrenal Hyperplasia · Neurocrine Switzerland GmbH | Phase 2 | Active, not recruiting | Sep 23, 2025 |
| Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)Congenital Adrenal Hyperplasia · Neurocrine Biosciences | Phase 3 | Active, not recruiting | Mar 19, 2021 |
| Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal HyperplasiaCongenital Adrenal Hyperplasia · Neurocrine Biosciences | Phase 3 | Active, not recruiting | Jul 29, 2020 |
| Dec 13, 2024 | CrenessityNDA 218808 · New molecular entity | Neurocrine | 0 | Marketed |
| Dec 13, 2024 | CrenessityNDA 218820 · New dosage form | Neurocrine | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
