Crinecerfont

Crinecerfont is a selective corticotropin-releasing factor (CRF) type 1 receptor antagonist. Crinecerfont blocks the binding of CRF to CRF type 1 receptors in the pituitary but not CRF type 2 receptors.

• CRENESSITY 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) . CRENESSITY is a corticotropin-releasing factor type 1 receptor antagonist 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).

• CRENESSITY is contraindicated in patients with hypersensitivity to crinecerfont or any excipients of CRENESSITY. Reactions have included throat tightness, angioedema, and generalized rash [see Warnings and Precautions ( 5.1 )] .contraindicated

Continue glucocorticoid replacement therapy for adrenal insufficiency associated with CAH. ( 2.1 ) Adults : 100 mg orally, twice daily with a meal in the morning and evening. ( 2.2 ) Pediatric Patients (4 years of age and older ) : Weight-based dosage orally, twice daily with a meal in the morning and evening. ( 2.2 ) See Full Prescribing Information for complete dosage and administration information. 2.1 Important Administration Information Patients receiving CRENESSITY should continue glucocorticoid replacement therapy for the adrenal insufficiency associated with congenital adrenal hyperplasia (see Warning and Precautions ( 5.2 ) . Androstenedione levels can be assessed beginning four weeks after CRENESSITY initiation to inform reduction in glucocorticoid dosage as clinically indicated. Do not reduce the glucocorticoid dosage below that required for replacement therapy. 2.2 Recommended Dosage and Administration Recommended Dosage for Adults The recommended CRENESSITY dosage for adults is 100 mg orally, twice daily with a meal in the morning and evening [see Clinical Pharmacology ( 12.3 )] . Recommended Dosage for Pediatric Patients 4 Years of Age and Older The recommended CRENESSITY dosage for pediatric patients 4 years of age and older is weight-based and administered orally, twice daily with a meal in the morning and evening (see Table 1 ) [see Clinical Pharmacology ( 12.3 )] .

Hypersensitivity Reactions: Include throat tightness, angioedema, and generalized rash. If clinically significant hypersensitivity occurs, initiate appropriate therapy and discontinue CRENESSITY. ( 5.1 ) Risk of Acute Adrenal Insufficiency or Adrenal Crisis with Inadequate Concomitant Glucocorticoid Therapy: Continue glucocorticoids upon initiation of and during treatment with CRENESSITY. Do not reduce the glucocorticoid dose below the dose required for cortisol replacement. Any adjustment of daily glucocorticoid dosage after initiation of CRENESSITY should be performed under the supervision of a health care provider. Use glucocorticoid stress doses in cases of increased cortisol need (e.g., acute intercurrent illness, serious trauma, surgical procedures). ( 5.2 ) 5.1 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. 5. 2 Risk of Acute Adrenal Insufficiency or Adrenal Crisis w ith Inadequate Concomitant Glucocorticoid Therapy Continue glucocorticoids upon initiation of and during treatment with CRENESSITY. Do not reduce the glucocorticoid dose below the dose required for cortisol replacement.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Risk of Acute Adrenal Insufficiency or Adrenal Crisis with Inadequate Concomitant Glucocorticoid Therapy [see Warnings and Precautions ( 5.2 )] Adults: Most common adverse reactions (at least 4% for CRENESSITY and greater than placebo) are fatigue, headache, dizziness, arthralgia, back pain, decreased appetite, and myalgia. ( 6.1 ) Pediatric Patients: Most common adverse reactions (at least 4% for CRENESSITY and greater than placebo) are headache, abdominal pain, fatigue, nasal congestion, and epistaxis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Neurocrine Biosciences, Inc. at 877-641-3461 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults with Congenital Adrenal Hyperplasia ( CAH) The safety of CRENESSITY in adults was assessed in Study 1, a randomized, double-blind, placebo-controlled study of 182 adults aged 18 to 58 years with classic CAH due to 21-hydroxylase deficiency. A total of 122 subjects received CRENESSITY 100 mg twice daily and 59 subjects received placebo twice daily for up to 24 weeks [see Clinical Studies ( 14.1 )] .

8.1 Pregnancy Risk Summary Available data from reports of pregnancy in clinical trials with CRENESSITY are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. No developmental toxicity was observed in rats at 4-fold higher than human exposure at the maximum recommended human dose (MRHD) based on area under the concentration-time curve (AUC). Crinecerfont was associated with a low incidence of poly-malformations (craniofacial defects) in rabbits at 2-fold higher than human exposure at the MRHD. In a pre- and postnatal developmental toxicity study, no developmental toxicity was observed in rats at 4-fold higher than human exposure at the MRHD ( see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. If CRENESSITY is administered during pregnancy, or if a patient becomes pregnant while receiving CRENESSITY, health care providers should report exposure to CRENESSITY by calling 1-855-CRNSITY (1-855-276-7489).

Metabolism

Crinecerfont maximum plasma concentration (C max ) and area under the time concentration curve (AUC 0-24 hours ) increases dose-proportionally over the approved recommended dosage range. Upon twice daily dosing, steady state conditions are achieved in approximately 7 days with an accumulation ratio of 1.4.

• Dec 13, 2024NDANDA218808Neurocrine
• Dec 13, 2024NDANDA218820Neurocrine

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Crenessity, Capsule, 25 mg (NDC 70370-5025-1)To be discontinued
  Sponsor: Neurocrine Biosciences, Inc.
  Updated Apr 28, 2026

1. 1Headache2415%
2. 2Fatigue2113%
3. 3Epistaxis159.3%
4. 4Dizziness106.2%
5. 5Drug Ineffective106.2%
6. 6Nausea106.2%
7. 7Weight Decreased106.2%
8. 817-hydroxyprogesterone Increased95.6%
9. 9Laboratory Test Abnormal74.3%
10. 10Therapeutic Response Unexpected74.3%
11. 11Vomiting74.3%
12. 12Blood Androstenedione Increased63.7%
13. 13Suicidal Ideation63.7%
14. 14Arthralgia53.1%
15. 15Abdominal Pain42.5%

The 6 most recently updated of 6 ClinicalTrials.gov registrations naming Crinecerfont as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia
  Active not recruiting · Phase 3 · Interventional · 182 enrolled · Neurocrine Biosciences
  NCT04490915updated 2026-05-11
• Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Crinecerfont in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Who Are Less Than 4 Years Old
  Not yet recruiting · Phase 2 · Interventional · 20 enrolled · Neurocrine Biosciences
  NCT07536269updated 2026-04-17
• Pharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Less Than 2 Years Old
  Recruiting · Phase 2 · Interventional · 6 enrolled · Neurocrine Biosciences
  NCT07187375updated 2026-03-20
• Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)
  Active not recruiting · Phase 3 · Interventional · 103 enrolled · Neurocrine Biosciences
  NCT04806451updated 2025-02-05
• Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 (Crinecerfont) in Pediatric Participants With Congenital Adrenal Hyperplasia
  Completed · Phase 2 · Interventional · 8 enrolled · Neurocrine Biosciences
  NCT04045145updated 2024-07-18
• Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal Hyperplasia
  Completed · Phase 2 · Interventional · 18 enrolled · Neurocrine Biosciences
  NCT03525886updated 2022-05-03

Frequently asked questions

How does Crinecerfont work?

Crinecerfont is a selective corticotropin-releasing factor (CRF) type 1 receptor antagonist. Crinecerfont blocks the binding of CRF to CRF type 1 receptors in the pituitary but not CRF type 2 receptors.

What is Crinecerfont used for?

According to FDA labeling, Crinecerfont carries indications including: CRENESSITY 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) . CRENESSITY is a corticotropin-releasing factor type 1 receptor antagonist 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).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Crinecerfont?

Crinecerfont is classified as Corticotropin-releasing Factor Type 1 Receptor Antagonist, Corticotropin-releasing Factor Type 1 Receptor Antagonists, Pituitary Hormone Receptor Antagonists, Corticotropin Releasing Hormone Alteration, Decreased Adrenocorticotropic Hormone Secretion.

What are the brand names for Crinecerfont?

Crinecerfont is marketed under brand names including Crenessity.

What are the contraindications for Crinecerfont?

Crinecerfont labeling lists contraindications including: CRENESSITY is contraindicated in patients with hypersensitivity to crinecerfont or any excipients of CRENESSITY. Reactions have included throat tightness, angioedema, and generalized rash [see Warnings and Precautions ( 5.1 )] .. Always consult the full prescribing information and a clinician.