Crenessity

(Crinecerfont)

Phase 3Small molecule

Neurocrine Biosciences

Crenessity is one of 4 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

6 competitors in Congenital Adrenal Hyperplasia

#DrugCompanyPhaseTrials

Lu AF95245

Lundbeck

Phase 2

1 2

Crenessity

Neurocrine Biosciences

Phase 3

5 3

Atumelnant

CCrinetics Pharmaceuticals Inc.

Phase 3

4 4

Actos

Takeda

Preclinical

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

Q1 2028

Phase 2Recruiting

Congenital Adrenal Hyperplasia

NCT07536269

Q4 2029

Phase 2Active, not recruiting

Congenital Adrenal Hyperplasia

NCT07187375

Clinical

Trials by Indication[1]

Congenital Adrenal Hyperplasia5 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

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

Show 2 more trials

A Phase 2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Crinecerfont in Pediatric Participants 3 Months to <4 Years of Age With Classic Congenital Adrenal Hyperplasia

Recruiting·NNeurocrine Switzerland GmbH·Phase 2·NCT07536269·20 enrolled

A Phase 2, Open-Label Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Pharmacodynamics of Crinecerfont in Pediatric Subjects 0 to <2 Years of Age With Congenital Adrenal Hyperplasia

Active, not recruiting· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 2·NCT07187375·7 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 13, 2024

CRENESSITY

NDA NDA218808

Dec 13, 2024

CRENESSITY

NDA NDA218820

Sources

References

[1]
ClinicalTrials.gov — 5 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

Q1 2028

Q4 2029

Trials by Indication[1]

Congenital Adrenal Hyperplasia5 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Related News