Ireland
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Priya Life Science Compound trial record
Compound · clinical trials

Crinecerfont clinical trials

Also listed in trial records as NBI-74788, Crenessity
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 4 trials in our USA, Germany, UK, France, Spain, Italy, Belgium, Poland, Canada, Netherlands, Sweden, Austria, Czechia, Portugal and Israel registers that name Crinecerfont as an intervention. Synced 11 Nov 2026
4Current trials
1Recruiting now
2Lead sponsors
15Country registers
At a glance

Crinecerfont is named as an intervention in 4 current clinical trials in our USA, Germany, UK, France, Spain, Italy, Belgium, Poland, Canada, Netherlands, Sweden, Austria, Czechia, Portugal and Israel registers. 1 is recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Neurocrine Biosciences (2). The most-studied condition is Congenital Adrenal Hyperplasia. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.

Where Crinecerfont is approved

All regulators →

Of the three regulators tracked here, the first to approve Crinecerfont was the US, on 13 Dec 2024.

USUnited States (FDA)
13 Dec 2024
Crenessity
NDA218808 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
No new-drug Notice of Compliance since 1994
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Crinecerfont patents and exclusivity

Expiry tracker →

Protections still running for marketed products containing Crinecerfont, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.

US FDA Orange Book Crenessity
  • 5 listed patents; the last listed expires 12 Jan 2043 (US 12582634).
  • Latest patent on the drug substance itself: 12 Jan 2043 (US 12582634).
  • Exclusivity ODE-503: Orphan drug exclusivity: adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years o…, until 13 Dec 2031.
  • Exclusivity NCE: New chemical entity, until 13 Dec 2029.
See the Orange Book listing for NDA 218808
Patents and exclusivities above are pooled across 2 applications for this substance.

Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.

How Crinecerfont works

All drug targets →
  • Corticotropin releasing factor receptor 1 antagonist Antagonist
    Target: CRHR1 corticotropin releasing hormone receptor 1
    ✓ In ChEMBL and the Guide to Pharmacology
Diseases it has been tested for in clinical trials, by furthest phase
  • Anxiety disorderPhase 2
  • Major depressive disorderPhase 2

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL291657, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 3533, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Crinecerfont

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Crinecerfont

ChEMBL
CHEMBL291657
DrugBank
DB18518
PubChem CID
5282340
CAS number
752253-39-7
FDA UNII
MFT24BX55I
Wikidata
Q27088874
Wikipedia
Crinecerfont

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

Trials by status

  • Recruiting125%
  • Active, closed375%

Trials by phase

  • Phase 3250%
  • Phase 2250%
01

Clinical trials of Crinecerfont

4 trials
StudyPhaseStatusLead sponsorRegisters
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Crinecerfont in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Who Are Less Than 4 Years Old
NCT07536269 · Congenital Adrenal Hyperplasia
Phase 2 Recruiting Neurocrine Switzerland GmbH USA
Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia
NCT04490915 · Congenital Adrenal Hyperplasia
Phase 3 Active, closed Neurocrine Biosciences UK, USA, Germany, France, Spain, Italy, Netherlands, Belgium, Sweden, Poland, Austria, Czechia, Portugal, Canada, Israel
Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)
NCT04806451 · Congenital Adrenal Hyperplasia
Phase 3 Active, closed Neurocrine Biosciences UK, USA, Germany, France, Spain, Italy, Belgium, Poland, Canada
Pharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Less Than 2 Years Old
NCT07187375 · ClinicalTrials.gov ↗ · Congenital Adrenal Hyperplasia
Phase 2 Active, closed Neurocrine Switzerland GmbH Germany

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Crinecerfont in the EU trials register (CTIS)

1 trial

Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Crinecerfont. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.

StudyPhaseStatusSponsorCountries
A Phase 3b, Open-Label Study of Crinecerfont to Evaluate Androgen Reduction and Related Outcomes in Adults With Classic Congenital Adrenal Hyperplasia
2025-524282-24-00 · Hormonal diseases
Phase 3 Authorised Neurocrine Biosciences Inc Czechia, Germany, Sweden + 6 more
03

Crinecerfont across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Supply shortages

  • Crinecerfont CapsuleUS (FDA) · Resolved · updated 28 Apr 2026
04

Conditions studied with Crinecerfont

1 condition
Congenital Adrenal Hyperplasia4
05

Sponsors

lead sponsor per trial
Lead sponsorTrials
Neurocrine Biosciences2
Neurocrine Switzerland GmbH2
06

By country register

RegisterTrialsRecruiting
Clinical trials in USA31
Clinical trials in Germany30
Clinical trials in UK20
Clinical trials in France20
Clinical trials in Spain20
Clinical trials in Italy20
Clinical trials in Belgium20
Clinical trials in Poland20
Clinical trials in Canada20
Clinical trials in Netherlands10
Clinical trials in Sweden10
Clinical trials in Austria10
Clinical trials in Czechia10
Clinical trials in Portugal10
Clinical trials in Israel10
EU register (CTIS)1—

A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.

07

Related compounds

08

Questions about Crinecerfont trials

How many clinical trials are testing Crinecerfont?

4 current trials in our USA, Germany, UK, France, Spain, Italy, Belgium, Poland, Canada, Netherlands, Sweden, Austria, Czechia, Portugal and Israel registers name Crinecerfont (also registered as NBI-74788) as a drug or biological intervention, as of the registry sync on 11 November 2026. Completed and withdrawn studies are not counted.

Are Crinecerfont trials recruiting patients?

Yes. 1 of the 4 trials is recruiting: 1 with sites in USA. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Crinecerfont clinical trials?

Neurocrine Biosciences (2) and Neurocrine Switzerland GmbH (2). The number in brackets is how many trials each organisation leads.

Is there a Crinecerfont shortage?

The registers we track list 1 entry for Crinecerfont: US FDA: resolved. Shortages are product- and country-specific; check with a pharmacist.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Crinecerfont works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Crinecerfont works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Crinecerfont (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 11 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.