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Crinecerfont · 5 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.
| 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. |
| Name | Type | Description |
|---|---|---|
| Crinecerfont | DRUG | CRF type 1 receptor antagonist |
| Placebo | DRUG | Non-active dosage form |
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 an investigational small molecule being developed for the treatment of Congenital Adrenal Hyperplasia (CAH), a group of inherited endocrine disorders. It is being studied in both adult and pediatric populations, including patients less than 2 years old, to address the underlying hormonal imbalances associated with the condition.
Crinecerfont is being developed by Neurocrine Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol NBIX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Congenital Adrenal Hyperplasia.
Crinecerfont is in Phase 2 and Phase 3 clinical trials. It has completed a Phase 2 study in pediatric participants and is currently in two Phase 3 registration studies for adults and children with Congenital Adrenal Hyperplasia. The drug is investigational and has not been approved by regulatory authorities.
Crinecerfont is being studied in four clinical trials. These include NCT04045145 (completed Phase 2 in pediatrics), NCT04490915 (Phase 3 in adults), NCT04806451 (Phase 3 in pediatrics), and NCT07187375 (Phase 2 in children under 2 years old). All trials are evaluating the drug for Congenital Adrenal Hyperplasia.
Crinecerfont has received several FDA designations, including Breakthrough Therapy, Fast Track, Rare Pediatric Disease, Priority Review, and Orphan Drug. These designations are intended to expedite the development and review of the drug for Congenital Adrenal Hyperplasia, reflecting the serious nature of the condition.
Yes, Crinecerfont is also known as NBI-74788. The completed Phase 2 trial NCT04045145 used the name NBI-74788 in its title, confirming that both names refer to the same investigational drug being developed by Neurocrine Biosciences for Congenital Adrenal Hyperplasia.