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TransformCAH Management

CRENESSITY is the first-ever medication that controls adrenal androgens and enables GC dose reductions, making it a breakthrough for treating classic CAH.1,2

View clinical trial results

MULTIPLE TREATMENT EFFECTS

Control adrenal androgens
Reduce GC doses1-4

CRENESSITY can help you do both by managing androgens differently

CRENESSITY was studied in the largest-ever clinical trial program for a classic CAH treatment. Efficacy in both children and adults was evaluated based on:

  • Reduction in androstenedione levels
  • Reduction in GC doses

Demonstrated safety Profile

Studied in pediatric and adult patients1,3,4

Most common adverse reactions in children taking CRENESSITY were headache, abdominal pain, fatigue, nasal congestion, and epistaxis. Most common adverse reactions in adults taking CRENESSITY were fatigue, headache, dizziness, arthralgia, back pain, decreased appetite, and myalgia.

  • *A total of 3% of children treated with CRENESSITY and no placebo-treated patients discontinued treatment because of adverse reactions of abdominal pain, myalgia, and dizziness. A total of 3% of adults treated with CRENESSITY and no placebo-treated patients discontinued treatment because of adverse reactions of restlessness, apathy, dyspepsia, nausea, and vomiting. One adult discontinued during the randomized phase. Three additional adults and 2 children discontinued after the randomized phase. One additional patient withdrew from CAHtalystTM Pediatric.
100% of children taking CRENESSITY completed their phase 3 trials (28-week).96% of adults taking CRENESSITY completed their phase 3 trials (24-week).

ACCESS SIMPLIFIED

Dedicated support for those prescribed CRENESSITY

Personalized support at every step to ensure timely access, with most patients paying $10 or less a month for CRENESSITY*

  • *Additional terms and conditions apply.
ACTH=adrenocorticotropic hormone; CAH=congenital adrenal hyperplasia; CRF=corticotropin-releasing factor; CRF1=corticotropin-releasing factor type 1; GC=glucocorticoid; MOA=mechanism of action.

REFERENCES

  • Crenessity. Package insert. Neurocrine Biosciences, Inc.
  • Neurocrine Biosciences announces FDA approval of CRENESSITY (crinecerfont), a first-in-class treatment for children and adults with classic congenital adrenal hyperplasia. News release. Neurocrine Biosciences. December 13, 2024. Accessed December 13, 2024. https://neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-announces-fda-approval-crenessitytm
  • Sarafogolu K, Kim MS, Lodish M, et al. Phase 3 trial of crinecerfont in pediatric congenital adrenal hyperplasia. N Engl J Med. 2024;391(6):493-503. doi:10.1056/NEFMoa2404655
  • Auchus RJ, Hamidi O, Pivonello R, et al. Phase 3 trial of crinecerfont in adult congenital adrenal hyperplasia. N Engl J Med. 2024;391(6):504-514. doi:10.1056/NEJMoa2404656

INDICATION

CRENESSITY (crinecerfont) is indicated as adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

CRENESSITY is contraindicated in patients with hypersensitivity to crinecerfont or any excipients of CRENESSITY.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions. A hypersensitivity reaction, including throat tightness, angioedema, and generalized rash, occurred in a subject after 3 days of treatment with CRENESSITY. If a clinically significant hypersensitivity reaction occurs, initiate appropriate therapy and discontinue CRENESSITY.

Risk of Acute Adrenal Insufficiency or Adrenal Crisis with Inadequate Concomitant Glucocorticoid Therapy. Acute adrenal insufficiency or adrenal crisis, which is potentially life-threatening, can occur in patients with underlying adrenal insufficiency who are on inadequate daily glucocorticoid doses, especially in situations associated with increased cortisol need, such as acute intercurrent illness, serious trauma, or surgical procedures. Continue glucocorticoids upon initiation of and during treatment with CRENESSITY. Do not reduce the glucocorticoid dose below the dose required for cortisol replacement. Patients should continue to use stress dosing of glucocorticoids in cases of increased cortisol need.

ADVERSE REACTIONS

In adult patients, the most common adverse reactions (at least 4% for CRENESSITY and greater than placebo) are fatigue, headache, dizziness, arthralgia, back pain, decreased appetite, and myalgia.

In pediatric patients, the most common adverse reactions (at least 4% for CRENESSITY and greater than placebo) are headache, abdominal pain, fatigue, nasal congestion, and epistaxis.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.

Dosage Forms and Strengths:

CRENESSITY is available in 50 mg and 100 mg capsules, and as an oral solution of 50 mg/mL.

Please see full Prescribing Information.