Crenessity (crinecerfont)

Neurocrine describes Crenessity as the first and only classic CAH treatment that directly reduces excess ACTH and adrenal androgen production. It is used together with, not instead of, hydrocortisone or other glucocorticoid replacement.

In classic CAH, a missing adrenal enzyme (most often 21-hydroxylase) means the body cannot make enough cortisol. The pituitary gland responds by releasing more ACTH, the hormone that tells the adrenal glands to work harder, and much of that extra push ends up as androgens. Standard care uses steroid doses above normal replacement levels to hold ACTH down, and long-term high-dose steroids carry their own risks such as weight gain, diabetes and bone loss^[4]. Crinecerfont blocks the CRF1 receptor in the pituitary, the switch that the brain hormone CRF uses to trigger ACTH release. With less ACTH, the adrenal glands make fewer androgens, so steroid doses can move closer to normal replacement, although steroids are still needed because crinecerfont does not replace cortisol^[1].

Crenessity has no boxed warning. It must not be used by anyone allergic to crinecerfont or its ingredients; one trial participant developed throat tightness, swelling of the face or tongue (angioedema) and a widespread rash after 3 days. The key warning is that steroid replacement must continue: adrenal crisis, a life-threatening shortage of cortisol, can happen if the steroid dose is cut too far, especially during illness, injury or surgery. In the adult trial, adrenal crisis occurred in 1.6% of people on Crenessity against 0% on placebo, and none occurred in the children's trial. The most common side effects in adults, against placebo, were fatigue (25% against 15%), headache (16% against 15%), dizziness (8% against 3%), joint pain (7% against 0%), back pain (6% against 3%), decreased appetite (4% against 2%) and muscle pain (4% against 3%). In children they were headache (25% against 6%), stomach pain (13% against 0%), fatigue (7% against 0%), stuffy nose (7% against 3%) and nosebleeds (4% against 0%). Suicidal thoughts without a plan were reported by 2.5% of adults on Crenessity against 1.7% on placebo, and by 6% of children against 0%. Neutrophil counts (a type of white blood cell) below 2,000 per microliter were more common on Crenessity, in 14% of adults against 5% and 37% of children against 16%. About 3% of people on Crenessity in each trial stopped because of side effects, against none on placebo^[1].

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Approved as an add-on to steroid replacement for classic CAH in adults and children 4 years and older. Safety and effectiveness below age 4 have not been established. The adult trial enrolled people 18 to 58 years old with CAH from 21-hydroxylase deficiency, and no one 65 or older was studied. Not recommended with severe kidney impairment or end-stage kidney disease.

Source: Neurocrine Access Support for Crenessity

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Approval rested on 2 placebo-controlled Phase 3 trials called CAHtalyst. In the adult trial (NCT04490915), 182 adults with classic CAH took 100 mg twice daily or placebo for 24 weeks. After 4 weeks on an unchanged steroid dose, androstenedione (a key adrenal androgen) fell by 299 ng/dL on Crenessity and rose by 46 ng/dL on placebo. By week 24, while keeping androstenedione controlled, people on Crenessity had cut their daily steroid dose by 27% against 10% on placebo, and 63% reached a normal replacement-level steroid dose against 18% on placebo. In the pediatric trial (NCT04806451), 103 children aged 4 to 17 took a weight-based dose or placebo for 28 weeks. At week 4, androstenedione fell by 197 ng/dL on Crenessity and rose by 71 ng/dL on placebo, and by week 28 the daily steroid dose had fallen 18% on Crenessity while it rose 6% on placebo^[1]. Both trials were published in the New England Journal of Medicine in 2024^[5][6].

Neurocrine Biosciences developed crinecerfont under the code NBI-74788^[7]. The FDA approved it as Crenessity capsules and oral solution on December 13, 2024 for classic CAH in adults and children 4 years and older, under priority review and with orphan status, and granted Neurocrine a rare pediatric disease priority review voucher^[2][3]. Neurocrine said it was the first new treatment available to the classic CAH community in 70 years and that it would be dispensed through the specialty pharmacy PANTHERx Rare^[4]. The open-label extension parts of both CAHtalyst trials are still running, with completion estimated for August 2027 on ClinicalTrials.gov^[7]. The current label, updated in September 2026, adds a 25 mg capsule and a dose for children weighing 10 kg to under 20 kg^[1].