Phase 3 Trial Of Crenessity (Crinecerfont) In Pediatric Congenital Adrenal Hyperplasia
The U.S. Food and Drug Administration (FDA) has approved Crenessity™ (crinecerfont) as an adjunctive treatment to glucocorticoid therapy for adults and children aged four years and older with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency.
This approval marks the first new treatment option for CAH in over seven decades.
Mechanism Of Action Of Crenessity
Developed by Neurocrine Biosciences, Crenessity is a first-in-class selective corticotropin-releasing factor type 1 (CRF1) receptor antagonist.
It works by reducing excessive adrenocorticotropic hormone (ACTH) secretion, thereby decreasing the overproduction of adrenal androgens—a hallmark of CAH.
This mechanism allows patients to maintain hormonal balance while potentially reducing the need for high-dose glucocorticoids, which are associated with significant long-term side effects.
The FDA’s approval was based on two randomized, double-blind, placebo-controlled trials involving 182 adults and 103 children with classic CAH.
Patient Pilot Studies
In the adult study, participants receiving Crenessity achieved a 27% reduction in daily glucocorticoid dose while maintaining control of androgen levels, compared to a 10% reduction in the placebo group.
In the pediatric trial, children treated with Crenessity reduced their glucocorticoid dose by 18%, whereas those on placebo experienced an almost 6% increase.
“This approval represents a significant advancement for individuals living with classic CAH,” said Kyle Gano, Chief Executive Officer of Neurocrine Biosciences. “
Crenessity offers a novel approach to managing this challenging condition, providing patients with a new option to achieve hormonal balance while potentially minimizing the adverse effects associated with long-term glucocorticoid use.”
Possibility Of Crenessity
Crenessity will be available in both capsule and oral solution formulations, catering to the needs of both adult and pediatric patients. Neurocrine Biosciences has partnered with PANTHERx Rare Specialty Pharmacy to distribute the medication, ensuring broad access across the United States.
The FDA granted Crenessity multiple designations, including Fast Track, Breakthrough Therapy, Orphan Drug, and Priority Review, underscoring the therapy’s potential to address an unmet medical need in the CAH patient population.
With an estimated 30,000 individuals affected by classic CAH in the U.S., the introduction of Crenessity is poised to significantly impact the standard of care for this rare endocrine disorder.
About CRENESSITY™
CRENESSITY™ is a potent and selective, oral corticotropin-releasing factor type 1 receptor (CRF1) antagonist developed to reduce and control excess adrenocorticotropic hormone (ACTH) and adrenal androgens through a non-glucocorticoid (GC) mechanism for the treatment of classic congenital adrenal hyperplasia (CAH).
Antagonism of CRF receptors in the pituitary has been shown to decrease ACTH levels, which in turn decreases the production of adrenal androgens and potentially the symptoms associated with CAH.
The robust clinical study data demonstrate that lowering adrenal androgen levels with CRENESSITY enables lower, more physiologic dosing of GCs to replace missing cortisol.
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