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).

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CAHNGE ANDROGEN MANAGEMENT

The efficacy and safety of CRENESSITY were evaluated in the largest-ever clinical trial program for a classic CAH treatment, with 285 pediatric and adult patients.1,2

CAHtalyst™ Pediatric:
Personalized GC Dose Reduction1,3

  • Question 1: Could CRENESSITY treatment improve androgen control in 4 weeks?
  • Question 2: Could CRENESSITY treatment enable personalized GC dose reduction to a physiologic range in 28 weeks while maintaining or improving androstenedione levels?

Trial included 103 pediatric patients (aged 4 to 17 years).

CAHtalyst™ Adult:
Protocolized GC Dose Reduction1,4

  • Question 1: Could CRENESSITY treatment improve androgen control in 4 weeks?
  • Question 2: Could CRENESSITY treatment enable protocolized GC dose reduction to a physiologic range in 24 weeks while maintaining or improving androstenedione levels?

Trial included 182 adult patients (aged 18 to 58 years).

  • Question 1: Could CRENESSITY treatment improve androgen control in 4 weeks?
  • Question 2: Could CRENESSITY treatment enable personalized GC dose reduction to a physiologic range in 28 weeks while maintaining or improving androstenedione levels?

Trial included 103 pediatric patients (aged 4 to 17 years).

  • Question 1: Could CRENESSITY treatment improve androgen control in 4 weeks?
  • Question 2: Could CRENESSITY treatment enable protocolized GC dose reduction to a physiologic range in 24 weeks while maintaining or improving androstenedione levels?

Trial included 182 adult patients (aged 18 to 58 years).

Both androgen reduction and GC dose reduction were evaluated in CAHtalyst™ Pediatric1

The 28-week, randomized, double-blind, placebo-controlled phase 3 trial addressed 2 questions1,3,5:

Question 1

Question 2

Androstenedione reduction was evaluated
at week 4 while GCs remained steady.
GC dose reduction (while maintaining or improving
) was evaluated at week 28.
Clinical trial timeline showing androgen reduction and GC dose reduction phases
2:1 randomization
  • aAndrostenedione and 17-OHP were measured as change from baseline. GC dose was measured as % change from baseline.1
  • bDoses were adjusted to maintain or improve androstenedione levels at ≤120% of the baseline value or ≤ULN. For patients who were unable to maintain or improve androstenedione levels, the % change from baseline for daily GC dose was recorded as 0.1,3

Baseline characteristics were representative of CAH population and highlight challenges of effectively treating CAH1,3,6,7

Baseline
  • aPlus-minus values are means ± SD.
  • bIn hydrocortisone equivalent dose.3
  • cPrednisone, prednisolone, or methylprednisolone.7
  • dData at baseline were missing for the following variables: testosterone (1 female participant in the placebo group) and testosterone in male participants at Tanner stages 3-5 (1 participant in the CRENESSITY group and 1 in the placebo group).3
  • eThe baseline ratio at Tanner stages 3 through 5 was not available for 1 participant in the CRENESSITY group and 1 participant in the placebo group. Placebo value for Tanner stage 2 is from a single patient and not expressed as mean ± SD. This variable was not assessed for patients at Tanner stage 1 (prepubertal).3
  • fPercentages based on male patients who had ultrasonography at baseline (31 taking CRENESSITY, 15 taking placebo).3
  • gPercentages based on female patients (34 taking CRENESSITY, 16 taking placebo).6
Baseline characteristics were well balanced between the 2 groups.3

CAHtalyst™ Adult

Explore the efficacy and safety data for adult patients.

Dosing

Review the dosing and administration information for CRENESSITY.

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17-OHP=17-hydroxyprogesterone; CAH=congenital adrenal hyperplasia; GC=glucocorticoid; TARTs=testicular adrenal rest tumors; ULN=upper limit of normal.

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
  • Sarafoglou 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
  • Sarafoglou K, Kim MS, Lodish M, et al. Phase 3 trial of crinecerfont in pediatric congenital adrenal hyperplasia. Supplementary protocol. N Engl J Med. 2024;391(6):493-503. doi:10.1056/NEJMoa2404655
  • Sarafoglou K, Jim MS, Lodish M, et al. Phase 3 trial of crinecerfont in pediatric congenital adrenal hyperplasia. Supplementary appendix. N Engl J Med. 2024;391(6):492-503. doi:10.1056/NEJMoa2404655
  • Data on file. Neurocrine Biosciences, Inc.
  • Merke DP, Auchus RJ. Congenital adrenal hyperplasia due to 21-hydroxylase deficiency. N Engl J Med. 2020;383(13):1248-1261. doi:10.1056/NEJMra1909786
  • Prete A, Auchus RJ, Ross RJ. Clinical advances in the pharmacotherapy of congenital adrenal hyperplasia. Eur J Endocrinol. 2021;186(1):R1-R14. doi:10.1530/EJE-21-0794
  • Hindmarsh PC, Geertsma K. Congenital Adrenal Hyperplasia: A Comprehensive Guide. Elsevier/Academic Press; 2017.
  • Sarafoglou K, Merke DP, Reisch N, Claahsen-van der Grinten H, Falhammar H, Auchus RJ. Interpretation of steroid biomarkers in 21-hydroxylase deficiency and their use in disease management. J Clin Endocrinol Metab. 2023;108(9):2154-2175. doi:10.1210/clinem/dgad1345
  • Koren R, Koren S, Khashper A, Benbassat C, Pekar-Zlotin M, Vaknin Z. Ovarian adrenal rest tumor in congenital adrenal hyperplasia: is medical treatment the first line option? Arch Endocrinol Metab. 2021;65(6):841-884. doi:10.20945/2359-3997000000415
  • Speiser PW, Arlt W, Auchus RJ, et al. Congenital adrenal hyperplasia due to steroid 21-hydroxylase deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2018;103(11):4043-4088. doi:10.1210/jc.2018-01865
  • Auchus RJ, Hamidi O, Pivonello R, et al. Phase 3 trial of crinecerfont in adult congenital adrenal hyperplasia. Supplementary appendix. 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.