Crenessity FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 16, 2024.
FDA Approved: Yes (First approved December 13, 2024)
Brand name: Crenessity
Generic name: crinecerfont
Dosage form: Capsules and Oral Solution
Company: Neurocrine Biosciences, Inc.
Treatment for: Congenital Adrenal Hyperplasia
Crenessity (crinecerfont) is a corticotropin-releasing factor type 1 receptor antagonist indicated as adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia.
- Congenital adrenal hyperplasia (CAH) is a rare genetic condition that affects the adrenal glands. Most cases of CAH are caused by variants of the CYP21A2 gene that leads to deficiency of the enzyme 21-hydroxylase (21-OH), resulting in a decrease in cortisol biosynthesis. People with classic CAH do not produce enough cortisol and produce too many androgens. Historically, exogenous glucocorticoids have been used to correct the endogenous cortisol deficiency, but high doses are required to also reduce the excess levels of androgens.
- Crenessity is a selective corticotropin-releasing factor (CRF) type 1 receptor antagonist that works by blocking the binding of CRF to CRF type 1 receptors to inhibit adrenocorticotropic hormone (ACTH) secretion from the pituitary, thereby reducing ACTH-mediated adrenal androgen production. By reducing excessive adrenal androgen production, Crenessity reduces the amount of glucocorticoid treatment needed.
- FDA approval of Crenessity was supported by data from the CAHtalyst clinical programs which demonstrated a significant decrease in androstenedione levels compared to placebo, which in turn enabled significant glucocorticoid dose reductions.
- Crenessity is administered orally, twice daily.
- Warnings and precautions associated with Crenessity include hypersensitivity reactions, and the risk of acute adrenal insufficiency or adrenal crisis with inadequate concomitant glucocorticoid therapy.
- Common adverse reactions in adult patients include fatigue, headache, dizziness, arthralgia, back pain, decreased appetite, and myalgia.
Common adverse reactions in pediatric patients include headache, abdominal pain, fatigue, nasal congestion, and epistaxis.
Development timeline for Crenessity
| Date | Article |
|---|---|
| Dec 15, 2024 | Approval FDA Approves Crenessity (crinecerfont) for the Treatment of Children and Adults with Classic Congenital Adrenal Hyperplasia |
Further information
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