Crinecerfont

CRENESSITY

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Pronunciation: kri-ne-SER-font (kre-NE-si-tee)

Crinecerfont ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Crinecerfont ballicule

What it isCRF1 antagonist reducing pituitary ACTH drive; classic congenital adrenal hyperplasia.

Why this oneIt lowers adrenal androgen drive so glucocorticoids can move toward replacement rather than chronic supraphysiologic suppression.

What limits itReducing glucocorticoids too quickly can trigger adrenal insufficiency; CYP3A4 interactions require review.

Crinecerfont molecular structure (skeletal formula) — Molecular structure: Crinecerfont

FDA-approved for

congenital adrenal hyperplasia (2024)

FDA label

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FDA dosing	Population	Start	Target	Max
Congenital adrenal hyperplasia (adjunct to glucocorticoid)	Adults	100 mg BID with a meal (AM & PM)	100 mg BID	100 mg BID
Congenital adrenal hyperplasia (adjunct to glucocorticoid)	Peds ≥4 y, weight-based	10–<20 kg: 25 mg BID; 20–<55 kg: 50 mg BID; ≥55 kg: 100 mg BID	25–100 mg BID by weight	100 mg BID

Renal Undefined

Hepatic Undefined

With strong CYP3A4 inducers, increase dose: adults 200 mg BID; pediatrics per weight table

Instructions

Take with a meal in the morning and evening
Continue glucocorticoid replacement therapy; do not reduce glucocorticoid below the dose required for cortisol replacement
Use glucocorticoid stress doses for increased cortisol need (acute illness, trauma, surgery)
Androstenedione may be assessed from 4 weeks to guide glucocorticoid reduction

Available strengths

cap 25, 50, 100 mg
sol 50 mg/mL

Cautions

Hypersensitivity reactions (throat tightness, angioedema, generalized rash) — discontinue if clinically significant
Risk of acute adrenal insufficiency or adrenal crisis with inadequate concomitant glucocorticoid therapy

Adverse reactions

Adults: fatigue, headache, dizziness, arthralgia, back pain, decreased appetite, myalgia
Pediatrics: headache, abdominal pain, fatigue, nasal congestion, epistaxis

Pregnancy Data insufficient; low incidence of craniofacial malformations in rabbits at 2× exposure

Lactation No human milk data; present in animal milk; monitor infant for adrenal insufficiency

Cost

Crinecerfont (CRENESSITY)

Strength		#/mo	CostPlus
25 mg	cap	60 BID	not offered
50 mg	cap	60 BID	not offered
100 mg	cap	60 BID	not offered
50 mg/mL	sol	per unit	not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Crinecerfont is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry2038 est.

NO BOXED WARNINGS

Principal riskAdrenal insufficiency if glucocorticoid is cut too fast

Classes and tags

Clinical profile

Therapeutic safety burden1 / 4

Overdose danger1 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk1 / 4

Legacy pregnancy categoryNot assigned — PLLR-era drug

Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.

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