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 and longest-ever clinical trial program for a classic CAH treatment.1-7

This most extensive patient cohort to date included 285 pediatric and adult patients, with open-label treatment for 233 patients extending up to 2 years and beyond for most.1,6-8

CAHtalyst® Pediatric:
Personalized GC Dose Reduction1,6,9

  • 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?
  • Question 3: Does long-term treatment with CRENESSITY improve clinical outcomes?

CAHtalyst® Adult:
Protocolized GC Dose Reduction1,7,10

  • 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?
  • Question 3: Does long-term treatment with CRENESSITY improve clinical outcomes?
  • 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?
  • Question 3: Does long-term treatment with CRENESSITY improve clinical outcomes?
  • 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?
  • Question 3: Does long-term treatment with CRENESSITY improve clinical outcomes?

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

The 28-week, randomized, double-blind, placebo-controlled phase 3 trial addressed questions 1 and 2 below, while the open-label and open-label extension periods addressed question 31,3,6,9,11:

Question 1

Question 2

Question 3

Androstenedione reduction was evaluated
at week 4 while GCs remained steady.
GC dose reduction (while maintaining or improving
) was evaluated at week 28.
Study design included a 28-week, randomized, double-blind, placebo-controlled phase 3 trial and open-label phases.
2:1 randomization
Open-label period
(months 7-12)Open-label
extension (ongoing)
  • 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 0.1,9

Baseline characteristics were representative of the CAH population and highlight challenges of effectively treating CAH1,8,9,11

Baseline
  • aPlus-minus values are means ± SD.
  • bIn hydrocortisone equivalent dose.9
  • cPrednisone, prednisolone, or methylprednisolone.8
  • 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).9
  • 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).9
  • fPercentages based on male patients who had ultrasonography at baseline (31 taking CRENESSITY, 15 taking placebo).9
  • gPercentages based on female patients (34 taking CRENESSITY, 16 taking placebo).12
Baseline characteristics were well balanced between the 2 groups.9

CAHtalyst® Adult

Explore the efficacy and safety data for adult patients.

Dosing

Review the dosing and administration information for CRENESSITY.

GC Dosing Calculators

Access these calculators to help navigate GC dosing and down titration when treating with CRENESSITY.

Get in Touch

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PeerConnect

Connect with colleagues who treat CAH to consult, collaborate, or transition care.

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

REFERENCES

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).

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.