Crenessity

(Crinecerfont)

Phase 3Small molecule

Neurocrine Biosciences

Crenessity is one of 18 small molecule programs targeting Congenital Adrenal Hyperplasia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Congenital Adrenal HyperplasiaActive, not recruiting

Congenital Adrenal HyperplasiaPhase 3

Active, not recruiting

Competition

Competitive Landscape

27 competitors in Congenital Adrenal Hyperplasia

#DrugCompanyPhaseTrials

Florinef

Alnylam Pharmaceuticals

Phase 3

2 2

Femara

Novartis

Phase 3

1 3

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Phase 3

6 4

Eulexin

SSchering-Plough

Phase 3

1 5

Decadron

AAspen Global Incorporated

Phase 2

1 6

Teslac

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

1 7

Lu AF95245

Lundbeck

Phase 2

1 8

Crenessity

Neurocrine Biosciences

Phase 3

4 9

Zytiga

Johnson & Johnson

Phase 1

2 10

Chronocort

NNeurocrine UK Limited

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 3Active, not recruiting

Congenital Adrenal Hyperplasia

NCT04490915

Phase 3Active, not recruiting

Congenital Adrenal Hyperplasia

NCT04806451

Q4 2029

Phase 2Recruiting

Congenital Adrenal Hyperplasia

NCT07187375

Clinical

Trials by Indication[1]

Congenital Adrenal Hyperplasia4 trials

Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia

Active, not recruiting· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 3·NCT04490915·182 enrolled

Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)

Active, not recruiting· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 3·NCT04806451·103 enrolled

Pharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Less Than 2 Years Old

Recruiting· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 2·NCT07187375·6 enrolled

Show 1 more trial

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 (Crinecerfont) in Pediatric Participants With Congenital Adrenal Hyperplasia

Completed· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 2·NCT04045145·8 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 13, 2024

CRENESSITY

NDA NDA218808

Dec 13, 2024

CRENESSITY

NDA NDA218820

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Crinecerfont. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Crinecerfont compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Crinecerfont. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA218808). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Crenessity. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Neurocrine Biosciences company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Neurocrine Biosciences

Patent Landscape[5]

Patent Cliff

Jan 21, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10905690Jan 21, 2035

11311544Jan 21, 2035

11730739Jan 21, 2035

12128033Jun 9, 2041

12582634Jan 12, 2043

Crenessity

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2029

Trials by Indication[1]

Congenital Adrenal Hyperplasia4 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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