TheraRadar
Data updated: May 26, 2026

CRENESSITY (crinecerfont)

Corticotropin-releasing Factor Type 1 Receptor Antagonists Trial Activity: Growth 4 active trials
First-in-Class Orphan Drug Breakthrough Therapy Priority Review Fast Track
Endocrine Approved 2024-12-13

CRENESSITY is indicated for the treatment of Congenital Adrenal Hyperplasia.

Source: FDA Label • NEUROCRINE • Corticotropin-releasing Factor Type 1 Receptor Antagonist
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How CRENESSITY Works

Crinecerfont acts as a selective antagonist that blocks the binding of corticotropin-releasing factor (CRF) to type 1 receptors in the pituitary gland. By inhibiting these receptors, the drug suppresses the secretion of adrenocorticotropic hormone (ACTH). This reduction in ACTH levels subsequently decreases the production of ACTH-mediated adrenal androgens.

Source: FDA Label

Development Insights

Neurocrine Biosciences conducting 5 trials (100%)
2 indications explored (Focused)
→ congenital adrenal hyperplasia (4 trials)
→ cah - congenital adrenal hyperplasia (1 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
1
Years on Market

Details

Status
Prescription
First Approved
2024-12-13
Patent Cliff
2043

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE, SOLUTION

Companies

NEUROCRINE
Active Ingredient: CRINECERFONT

CRENESSITY Approval History

2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2024 to 2024
Dec 2024 ORIGINAL Priority
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What CRENESSITY Treats

1 indications

CRENESSITY is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Congenital Adrenal Hyperplasia
Source: FDA Label

CRENESSITY Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

3

Same indication, different mechanism — what else might this patient receive?

DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
AMNEAL
2003 10 indic.
PREDNISONE INTENSOL
Hikma
1985 9 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to CRENESSITY

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CORTEF
HYDROCORTISONE
1 shared
PHARMACIA AND UPJOHN
Shared indications:
Congenital Adrenal Hyperplasia
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
DEXAMETHASONE SODIUM PHOSPHATE
1 shared
AMNEAL
Shared indications:
Congenital Adrenal Hyperplasia
PREDNISONE INTENSOL
PREDNISONE
1 shared
Hikma
Shared indications:
Congenital Adrenal Hyperplasia
📋

Clinical Trial Registry

5 trials
Trial Sponsor ID Phase Status Title
NCT04490915 CAHtalyst results posted NBI-74788-CAH3003 2019-004873-17, 2023-509171-16-00 Ph 3 active not recruiting Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia
NCT07536269 NBI-74788-CAH2032 Ph 2 not yet recruiting Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Crinecerfont in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Who Are Less Than 4 Years Old
NCT07187375 NBI-74788-CAH2011 2024-514127-42-00 Ph 2 recruiting Pharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Less Than 2 Years Old
NCT04806451 results posted NBI-74788-CAH2006 2020-004381-19, 2023-509170-33-00 Ph 3 active not recruiting Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)
NCT04045145 results posted NBI-74788-CAH2008 Ph 2 completed Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 (Crinecerfont) in Pediatric Participants With Congenital Adrenal Hyperplasia
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CRENESSITY FDA Label Details

Indications & Usage

FDA Label (PDF)

CRENESSITY is indicated for the treatment of Congenital Adrenal Hyperplasia.

View full patent landscape →
4 OB patents · 2 families · 142 international docs across 30 countries

CRENESSITY Patents & Exclusivity

Latest Patent: Jan 2043
Exclusivity: Dec 2031

Patents (5 active)

US12582634 Expires Jan 12, 2043
US12128033 Expires Jun 9, 2041
US10905690 Expires Jan 21, 2035
US11311544 Expires Jan 21, 2035
US11730739 Expires Jan 21, 2035

Exclusivity

NCE Until Dec 2029
ODE-503 Until Dec 2031
NCE Until Dec 2029
ODE-503 Until Dec 2031
NCE Until Dec 2029
ODE-503 Until Dec 2031
NCE Until Dec 2029
ODE-503 Until Dec 2031
NCE Until Dec 2029
ODE-503 Until Dec 2031
NCE Until Dec 2029
ODE-503 Until Dec 2031
NCE Until Dec 2029
ODE-503 Until Dec 2031
NCE Until Dec 2029
ODE-503 Until Dec 2031
NCE Until Dec 2029
ODE-503 Until Dec 2031
NCE Until Dec 2029
ODE-503 Until Dec 2031
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for CRENESSITY

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2043
  • • 50 active patents

Trial Analysis

  • • 5 total trials
  • • Stage: Growth

Competitive Landscape

  • • 3 similar drugs
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA218808 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment