Version July 2025
Congenital adrenal hyperplasia, classic:
Note: Continue same glucocorticoid replacement when crinecerfont is initiated. During crinecerfont therapy, do not reduce glucocorticoid dose below the minimum dose required for cortisol replacement.
Oral: 100 mg twice daily with meals.
Missed doses: Administer missed dose as soon as possible (even if it is soon before the next scheduled dose), then resume regular dosing schedule.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
eGFR ≥44 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer’s labeling.
eGFR <44 mL/minute/1.73 m2: Use is not recommended.
End-stage kidney disease: Use is not recommended.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
(For additional information see "Crinecerfont: Pediatric drug information")
Congenital adrenal hyperplasia, classic:
Note: Continue same glucocorticoid replacement when crinecerfont is initiated. During crinecerfont therapy, glucocorticoid dose may be reduced based on androstenedione levels, but do not reduce glucocorticoid dose below the minimum dose required for cortisol replacement.
Children ≥4 years and Adolescents:
10 to <20 kg: Oral: 25 mg twice daily.
20 to <55 kg: Oral: 50 mg twice daily.
≥55 kg: Oral: 100 mg twice daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling. Not recommended for use in severe kidney impairment or end-stage kidney disease (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults unless otherwise noted.
>10%:
Gastrointestinal: Abdominal pain (children, adolescents: 13%)
Hematologic & oncologic: Decreased neutrophils (children, adolescents, adults: 14% to 37%)
Nervous system: Fatigue (children, adolescents: 7%; adults: 25%), headache (children, adolescents, adults: 16% to 25%)
1% to 10%:
Gastrointestinal: Decreased appetite (4%)
Nervous system: Dizziness (8%)
Neuromuscular & skeletal: Arthralgia (7%), back pain (6%), myalgia (4%)
Respiratory: Epistaxis (children, adolescents: 4%), nasal congestion (children, adolescents: 7%)
Frequency not defined:
Gastrointestinal: Dyspepsia, nausea, vomiting
Hypersensitivity: Hypersensitivity reaction (including angioedema)
Nervous system: Apathy, restlessness, suicidal ideation (children, adolescents, adults)
Hypersensitivity to crinecerfont or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity: Hypersensitivity reactions, including throat tightness, angioedema, and generalized rash, have occurred with crinecerfont.
Disease-related concerns:
• Adrenal crisis: Acute adrenal insufficiency or adrenal crisis, which can potentially be fatal or life-threatening, may occur in patients with underlying adrenal insufficiency who are on inadequate daily glucocorticoid doses, especially in situations associated with increased cortisol need (eg, acute illness, trauma, surgical procedures). Any adjustment of daily glucocorticoid dosage after initiation of crinecerfont should be performed under the supervision of a health care provider. Use glucocorticoid stress doses in case of increased cortisol need.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Crenessity: 50 mg, 100 mg
Solution, Oral:
Crenessity: 50 mg/mL (30 mL) [contains saccharin; orange flavor]
No
Capsules (Crenessity Oral)
50 mg (per each): $766.66
100 mg (per each): $766.66
Solution (Crenessity Oral)
50 mg/mL (per mL): $766.66
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral: Administer with morning and evening meals. If dosage adjustments are required which necessitate administration of 2 unequal doses each day, administer the higher dose in the evening.
Oral: Administer with meals in the morning and the evening. If dosage adjustments are required which necessitate administration of two unequal doses each day, administer the higher dose in the evening.
Capsules: Swallow whole.
Oral solution: Use accurate measuring device (calibrated oral syringe) for administration.
Missed doses: Administer missed dose as soon as possible (even if it is soon before the next scheduled dose), then resume regular dosing schedule.
Congenital adrenal hyperplasia, classic: Adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients ≥4 years of age with classic congenital adrenal hyperplasia.
Substrate of CYP2B6 (Minor), CYP2C19 (Minor), CYP2C8 (Minor), CYP3A4 (Major with inducers), CYP3A4 (Minor with inhibitors); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
CYP3A4 Inducers (Moderate): May decrease serum concentration of Crinecerfont. Management: Double the evening dose of crinecerfont and continue the morning dose unchanged during coadministration with moderate CYP3A4 inducers. See full interaction monograph for details. Risk D: Consider Therapy Modification
CYP3A4 Inducers (Strong): May decrease serum concentration of Crinecerfont. Management: Double the morning and evening doses of crinecerfont during coadministration with strong CYP3A4 inducers. See full interaction monograph for details. Risk D: Consider Therapy Modification
When administered with a high-fat meal (800 to 1,000 calories, 50% fat), Cmax and AUC increased 4.9-fold and 3.3-fold (respectively) for the oral capsule, and 8.6-fold and 8.3-fold (respectively) for the oral solution when compared to administration under fasting conditions. Management: Administer with meals.
Adverse events were observed in animal reproduction studies when rabbits were administered crinecerfont in doses 2-fold higher than the recommended human exposure (based on AUC). Adverse events were not observed when pregnant rats were administered crinecerfont in doses 4-fold higher than the maximum human exposure.
Data collection to monitor pregnancy and infant outcomes following exposure to crinecerfont is ongoing. Health care providers are encouraged to report patients exposed to crinecerfont during pregnancy (855-276-7489).
It is not known if crinecerfont is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Monitor infants exposed to crinecerfont via breast milk for signs of adrenal insufficiency (eg, weakness, decreased feeding, weight loss).
Administer with morning and evening meals.
Androstenedione levels starting 4 weeks after initiation (to inform glucocorticoid dose reduction as clinically indicated).
Crinecerfont is a selective corticotropin-releasing factor (CRF) type 1 receptor antagonist. Crinecerfont binding to CRF type 1 receptors inhibits adrenocorticotropic hormone (ACTH) secretion from the pituitary, thereby reducing ACTH-mediated adrenal androgen production.
Distribution: Vd: Adults: 852 L.
Protein binding: ≥99.9%.
Metabolism: Hepatic, primarily by CYP3A4 and to a lesser extent by CYP2B6; may also have minor contributions from CYP2C8 and CYP2C19.
Half-life elimination: ~14 hours.
Time to peak: 4 hours.
Excretion: Feces (~47.3% [2.7% as unchanged drug]); urine (2%).
Clearance: 3.5 L/hour.
