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Label indication CRENESSITY is 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 (CAH) . CRENESSITY 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… FDA label
Also known as NBI-74788, Crenessity
Crinecerfont · 6 trials · 2 indications
Blood serum samples were collected for the analysis of serum androstenedione concentrations. Least square (LS) mean and standard error (SE) were calculated using analysis of covariance (ANCOVA) model.
Least square (LS) mean and standard error (SE) were calculated using analysis of covariance (ANCOVA) model.
Percent changes in 17-OHP were assessed through the collection of samples from 0700 hours to 1000 hours (morning window) both prior to study drug administration (i.e., baseline) and after 14 days of study drug dosing. The 2 samples collected during this morning window at each visit were averaged and used to determine the percent change from baseline.
Percent changes in 17-OHP were assessed through the collection of samples from 0600 hours to 1000 hours both prior to study drug administration (i.e., at baseline) and after 14 days of study drug dosing. The 3 samples collected during this morning window at each visit were averaged and used to determine the percent change from baseline.
| Arm | Type | Description |
|---|---|---|
| Crinecerfont | EXPERIMENTAL | Crinecerfont solution or capsule, administered orally, twice daily for 28 weeks during the placebo-controlled treatment period, followed by active treatment with crinecerfont for at least 24 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo solution or capsule, administered orally, twice daily for 28 weeks, followed by active treatment with crinecerfont for at least 24 weeks. |
| Crinecerfont 50 milligrams (mg) Twice Daily (BID) | EXPERIMENTAL | Crinecerfont administered orally for 14 consecutive days. |
| Cohort 1 (50 mg QHS) | EXPERIMENTAL | NBI-74788 50 mg once daily at bedtime (QHS) administered orally for 14 consecutive days. |
| Cohort 2 (100 mg QHS) | EXPERIMENTAL | NBI-74788 100 mg once daily at bedtime (QHS) administered orally for 14 consecutive days. |
| Cohort 3 (100 mg QPM) | EXPERIMENTAL | NBI-74788 100 mg once daily in the evening (QPM) administered orally for 14 consecutive days. |
| Cohort 4 (100 mg BID) | EXPERIMENTAL | NBI-74788 100 mg twice daily (BID) administered orally for 14 consecutive days. |
| Name | Type | Description |
|---|---|---|
| Crinecerfont | DRUG | CRF type 1 receptor antagonist |
| Placebo | DRUG | Non-active dosage form |
| NBI-74788 | DRUG | Capsule, administered daily. |
Inclusion Criteria: * Be willing and able to adhere to the study procedures, including all requirements at the study center, and return for the follow-up visit. * Have a medically confirmed diagnosis of classic CAH due to 21-hydroxylase deficiency. * Be on a stable steroid regimen. * Have elevated ...
Crinecerfont is being developed for the treatment of congenital adrenal hyperplasia (CAH), an endocrine condition. It is being studied in both classic pediatric CAH and adult CAH, including in children less than 4 years old. It has not been approved by the FDA and remains in clinical development.
Crinecerfont targets CRHR1, the corticotropin-releasing hormone receptor 1. It acts as an antagonist at this receptor. By blocking CRHR1, the drug is designed to reduce the signaling that drives excess ACTH production in congenital adrenal hyperplasia.
Crinecerfont is being developed by Neurocrine Biosciences, Inc., which trades on the Nasdaq under the ticker NBIX. Neurocrine is the sponsor of the clinical program evaluating the drug in congenital adrenal hyperplasia.
Crinecerfont is in clinical development, with Phase 2 and Phase 3 trials ongoing. It is investigational and has not been approved by the FDA. The FDA has granted it Breakthrough Therapy, Fast Track, and Rare Pediatric Disease designations for congenital adrenal hyperplasia.
Crinecerfont is being studied in four trials. These include NCT07536269 and NCT07187375 in children under 4 and under 2 years old, plus the Phase 3 CAHtalyst Pediatric study NCT04806451 and the Phase 3 adult study NCT04490915. Total enrollment across these trials is 312 participants.
No. Crinecerfont is the drug, while CAHtalyst is the name of the clinical trial program evaluating it. The CAHtalyst Pediatric Study is registered as NCT04806451, and a separate Phase 3 registration study in adults is registered as NCT04490915.