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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TWICE-DAILY
ORAL DOSING
GC down-titration

CRENESSITY dosing varies by age and weight1

Age and
body weight		Recommended
dosage
Adults (18 and older)
and children weighing ≥55 kg		Capsules: 100 mg twice daily
(200 mg per day)
Children weighing 20 to <55 kgCapsules or oral solution:
50 mg twice daily (100 mg per day)
Children weighing 10 to <20 kgOral solution:
25 mg twice daily (50 mg per day)

CRENESSITY is a CYP3A4 substrate¹

  • CRENESSITY dose should be when coadministered with a strong or moderate CYP3A4 inducer1
  • Please refer to the full Prescribing Information for full dosing information and additional considerations for patients taking CYP3A4 inducers or inhibitors

CRENESSITY does not address cortisol deficiency. Patients prescribed CRENESSITY should continue taking GCs.1

CRENESSITY should be used alongside GC therapy and has no contraindications with any specific GC used in the treatment of CAH.

Around-the-clock ACTH and androgen reduction

When comparing doses, twice-daily dosing led to the greatest reduction of androstenedione.3*

*

A phase 2 study compared 50 mg once daily, 100 mg once daily, and 100 mg twice daily. Main outcomes included change from baseline to day 14 in ACTH, 17-OHP, androstenedione, and testosterone. 100 mg twice daily led to the greatest reductions.3

A pharmacokinetic profile that supports twice-daily dosing1

Following oral administration, the time to reach maximum CRENESSITY plasma concentration is

4 hours1

The effective half-life of
CRENESSITY is approximately

14 hours1

Efficacy and safety outcomes in the phase 3 trials are based on twice-daily dosing.1

CRENESSITY administration

  • CRENESSITY should be taken twice a day1

    CRENESSITY must be taken with morning and evening meals, but fat and calorie count does not need to be considered. CRENESSITY exposure was similiar with food intake ranging from 150 (eg, a glass of whole milk) to 350 calories.

    CRENESSITY dosing can be timed with GC doses.

  • CRENESSITY is available as capsules1

    Capsules should be swallowed whole with liquid and not opened, chewed, or broken.

  • CRENESSITY is available as an oral solution1

    Oral solution should not be diluted and should be taken with an oral syringe.

Approximately 70% of pediatric patients rated the oral solution as easy or very easy to take.

of pediatric patients rated the oral solution as easy or very easy to take (n=35).5

Patients aged 6-17 years rated ease of administration on a 5-option scale ranging from very difficult to very easy.5

Support your patients taking CRENESSITY through GC down‑titration

Tailor the process to each patient’s clinical picture6

When reducing GCs, preparation and communication are key. Patients may experience withdrawal symptoms—especially with faster reductions—but these symptoms typically improve within a few weeks to a month. Setting expectations early can help maintain adherence to both CRENESSITY and the broader treatment plan. Discuss common symptoms of GC withdrawal.5

CRENESSITY does not address cortisol deficiency. Patients prescribed CRENESSITY should continue taking GCs.1

Consider mineralocorticoid support during GC down-titration

Some GCs—especially hydrocortisone—have mineralocorticoid effects. As GC doses are lowered, mineralocorticoid activity may also decrease. This can increase the need for fludrocortisone supplementation.7

To guide mineralocorticoid adjustments, monitor8,9:

  • Plasma renin levels
  • Blood pressure
  • Electrolyte levels
GC dose reductions in clinical trialsStress dosing considerations

Every patient’s experience is different. Encourage ongoing dialogue as you adjust GC dosing alongside CRENESSITY treatment.6

ACCESS SIMPLIFIED

Dedicated team of Care Coordinators

The Neurocrine Access Support program provides patients a dedicated Care Coordinator as a central point of contact from initiation through their entire treatment journey.

Discover Access Support

Actor portrayals.

Efficacy

Review outcomes from CRENESSITY clinical trials.

Get in Touch

Sign up to schedule a call or visit with a Neurocrine representative.

Support

Explore information and resources for prescribing CRENESSITY.

PeerConnect

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

17-OHP=17-hydroxyprogesterone; ACTH=adrenocorticotropic hormone; CAH=congenital adrenal hyperplasia; CYP3A4=cytochrome P450 3A4; GC=glucocorticoid; ULN=upper limit of normal.

REFERENCES

  • Crenessity. Package insert. Neurocrine Biosciences, Inc.
  • 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
  • Auchus RJ, Sarafoglou K, Fechner PY, et al. Crinecerfont lowers elevated hormone markers in adults with 21-hydroxylase deficiency congenital adrenal hyperplasia. J Clin Endocrinol Metab. 2022;107(3):801-812. doi:10.1210/clinem/dgab749
  • Auchus RJ, Sarafoglou K, Geffner ME et al. Evaluation of potential drug-drug interactions with crinecerfont. Poster presented at: Endocrine Society Annual Meeting; July 12-15, 2025; San Francisco, CA.
  • Data on file. Neurocrine Biosciences, Inc.
  • Beuschlein F, Else T, Bancos I, et al. European Society of Endocrinology and Endocrine Society Joint Clinical Guideline: Diagnosis and therapy of glucocorticoid-induced adrenal insufficiency. Clin Endocrinol Metab. 2024;109(7):1657-1683. doi:10.1210/clinem/dgae250
  • Lang K, Quinkler M, Kienitz T. Mineralocorticoid replacement therapy in salt-wasting congenital adrenal hyperplasia. Clin Endocrinol (Oxf). 2024;101(4):346-358. doi:10.1111/cen.14959
  • Bancos I, Kim H, Cheng HK, et al. Glucocorticoid therapy in classic congenital adrenal hyperplasia: traditional and new treatment paradigms. Expert Rev Endocrinol Metab. 2025;20(1):33-49. doi:10.1080/17446651.2025.2450423
  • 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
  • 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/NEJMoa2404655
  • Adrenal Insufficiency: Identification and Management. London: National Institute for Health and Care Excellence (NICE); August 28, 2024.
  • Hospital for Sick Children. Stress dosing or illness dosing for adrenal insufficiency. SickKids. Accessed July 21, 2025. https://www.sickkids.ca/siteassets/care--services/clinical-departments/endocrinology/stress-dosing-illness-dosing.pdf
  • Mushtaq T, Ali SR, Boulos N, et al. Emergency and perioperative management of adrenal insufficiency in children and young people: British Society for Paediatric Endocrinology and Diabetes consensus guidance. Arch Dis Child. 2023;108(11):871-878. doi:10.1136/archdischild-2022-325156
  • Tschaidse L, Wimmer S, Nowotny HF, et al. Frequency of stress dosing and adrenal crisis in paediatric and adult patients with congenital adrenal hyperplasia: a prospective study. Eur J Endocrinol. 2024;190(4):275-283. doi:10.1093/ejendo/lvae023

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.