Crinecerfont

Last updated

Crinecerfont
Crinecerfont.svg
Clinical data
Trade names Crenessity
Other namesSSR-125543, NBI-74788
AHFS/Drugs.com Crenessity
License data
Routes of
administration 		By mouth
Drug class Corticotropin-releasing factor type 1 receptor antagonist
ATC code
  • None
Legal status
Legal status
Identifiers
  • 4-(2-Chloro-4-methoxy-5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-N-prop-2-ynyl-1,3-thiazol-2-amine
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
CompTox Dashboard (EPA)
Chemical and physical data
Formula C27H28ClFN2OS
Molar mass 483.04 g·mol−1
3D model (JSmol)
  • FC1=CC(=CC=C1C)C(N(C2=NC(C=3C=C(C(OC)=CC3Cl)C)=C(S2)C)CC#C)CC4CC4
  • InChI=1S/C27H28ClFN2OS/c1-6-11-31(24(13-19-8-9-19)20-10-7-16(2)23(29)14-20)27-30-26(18(4)33-27)21-12-17(3)25(32-5)15-22(21)28/h1,7,10,12,14-15,19,24H,8-9,11,13H2,2-5H3/t24-/m0/s1
  • Key:IEAKXXNRGSLYTQ-DEOSSOPVSA-N

Crinecerfont, sold under the brand name Crenessity, is a medication used for the treatment of congenital adrenal hyperplasia. [1] It is a corticotropin-releasing factor type 1 receptor (CRF1R) antagonist developed to treat classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency (21OHD). [1] It is taken by mouth. [1]

Contents

The most common side effects of crinecerfont in adults include fatigue, dizziness, and arthralgia (joint pain). [2] For children, the most common side effects include headache, abdominal pain, and fatigue. [2]

Crinecerfont was approved for medical use in the United States in December 2024. [2] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4]

Medical uses

Crinecerfont is indicated as adjunctive treatment to glucocorticoid replacement to control androgens in people four years of age and older with classic congenital adrenal hyperplasia. [1] [2]

Adverse effects

The US Food and Drug Administration prescription label for crinecerfont has a warning for acute adrenal insufficiency or adrenal crisis. [2]

History

Crinecerfont's approval is based on two randomized, double-blind, placebo-controlled trials in 182 adults and 103 children with classic congenital adrenal hyperplasia. [2] In the first trial, 122 adults received crinecerfont twice daily and 60 received placebo twice daily for 24 weeks. [2] After the first four weeks of the trial, the glucocorticoid dose was reduced to replacement levels, then adjusted based on levels of androstenedione, an androgen hormone. [2] The primary measure of efficacy was the change from baseline in the total glucocorticoid daily dose while maintaining androstenedione control at the end of the trial. [2] The group that received crinecerfont reduced their daily glucocorticoid dose by 27% while maintaining control of androstenedione levels, compared to a 10% daily glucocorticoid dose reduction in the group that received placebo. [2]

In the second trial, 69 children received crinecerfont twice daily and 34 received placebo twice daily for 28 weeks. [2] The primary measure of efficacy was the change from baseline in serum androstenedione at week four. [2] The group that received crinecerfont experienced a statistically significant reduction from baseline in serum androstenedione, compared to an average increase from baseline in the placebo group. [2] At the end of the trial, children assigned to crinecerfont were able to reduce their daily glucocorticoid dose by 18% while maintaining control of androstenedione levels compared to an almost 6% daily glucocorticoid dose increase in children assigned to placebo. [2]

The US Food and Drug Administration (FDA) granted the application for crinecerfont fast track, breakthrough therapy, orphan drug, and priority review designations. [2] The FDA granted the approval of Crenessity to Neurocrine Biosciences, Inc. [2]

Society and culture

Crinecerfont was approved for medical use in the United States in December 2024. [1] [2] [5]

Names

Crinecerfont is the international nonproprietary name. [6]

Crinecerfont is sold under the brand name Crenessity. [1]

References

  1. 1 2 3 4 5 6 7 "Crenessity- crinecerfont; capsule Crenessity- crinecerfont solution". DailyMed. 1 December 2024. Retrieved 25 January 2025.
  2. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 "FDA Approves New Treatment for Congenital Adrenal Hyperplasia". U.S. Food and Drug Administration (FDA) (Press release). 1 October 2024. Archived from the original on 13 December 2024. Retrieved 16 December 2024.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  3. ↑ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Archived from the original on 19 April 2024. Retrieved 20 December 2024.
  4. ↑ New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.
  5. ↑ "Neurocrine Biosciences Announces FDA Approval of Crenessity (crinecerfont), a First-in-Class Treatment for Children and Adults With Classic Congenital Adrenal Hyperplasia" (Press release). Neurocrine Biosciences. 13 December 2024. Retrieved 16 December 2024– via PR Newswire.
  6. ↑ World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82". WHO Drug Information. 33 (3). hdl: 10665/330879 .

Further reading

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