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Cortef

Small molecule

NNeurocrine UK Limited

0

Indications

6

Total Trials

0

Active Trials

0

Competitors

53

FDA Applications

NDA/BLA/ANDA regulatory filings

Clinical

Trials by Indication[1]

Congenital Adrenal Hyperplasia3 trials

Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia

Completed·NNeurocrine UK Limited·Phase 1/2·NCT00519818·20 enrolled

Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia

Completed·NNeurocrine UK Limited·Phase 3·NCT05063994·55 enrolled

Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia

Completed·HHaukeland University Hospital·Phase 1/2·NCT02096510·8 enrolled

Adrenal insufficiency2 trials

A Single Centre, Open-label, Randomised, Single Dose, Two Period, Crossover Relative Bioavailability Study of Chronocort® Versus Cortef® Immediate Release Hydrocortisone Tablets in Dexamethasone-suppressed Healthy Adult Male Subjects.

Completed·NNeurocrine UK Limited·Phase 1·NCT03343327·25 enrolled

A Two-part, Single Centre, Open-label, Randomised, Single Dose, Two-period, Crossover, Relative Bioavailability Study of Infacort® Versus Cortef® in Dexamethasone-suppressed Healthy Adult Male and Female Subjects in the Fasted and Fed States.

Completed·NNeurocrine UK Limited·Phase 1·NCT03311932·51 enrolled

Glucocorticoid1 trial

Glucocorticoid Treatment in Addison's Disease

Completed·HHaukeland University Hospital·Phase 2/3·NCT01063569·33 enrolled

Regulatory

FDA Approval Timeline[3]

Dec 15, 1952

CORTEF

NDA NDA008697

Apr 27, 1955

SOLU-CORTEF

NDA NDA009866

Feb 8, 1978

CORTEF

NDA NDA008697

Jun 18, 1979

SOLU-CORTEF

NDA NDA009866

Sep 24, 1979

SOLU-CORTEF

NDA NDA009866

Apr 14, 1980

SOLU-CORTEF

NDA NDA009866

Dec 15, 1981

SOLU-CORTEF

NDA NDA009866

Dec 15, 1981

SOLU-CORTEF

NDA NDA009866

Mar 9, 1983

CORTEF

NDA NDA008697

Jul 24, 1985

SOLU-CORTEF

NDA NDA009866

Jul 2, 1987

SOLU-CORTEF

NDA NDA009866

Jul 23, 1987

SOLU-CORTEF

NDA NDA009866

May 13, 1988

SOLU-CORTEF

NDA NDA009866

Mar 22, 1989

SOLU-CORTEF

NDA NDA009866

Jan 16, 1990

SOLU-CORTEF

NDA NDA009866

Mar 29, 1990

SOLU-CORTEF

NDA NDA009866

Apr 1, 1991

SOLU-CORTEF

NDA NDA009866

Dec 8, 1993

CORTEF

NDA NDA008697

Dec 28, 1993

SOLU-CORTEF

NDA NDA009866

Dec 28, 1993

CORTEF

NDA NDA008697

Mar 25, 1994

SOLU-CORTEF

NDA NDA009866

Sep 15, 1994

SOLU-CORTEF

NDA NDA009866

Dec 6, 1994

SOLU-CORTEF

NDA NDA009866

Nov 25, 1999

SOLU-CORTEF

NDA NDA009866

Apr 4, 2000

SOLU-CORTEF

NDA NDA009866

Mar 16, 2001

CORTEF

NDA NDA008697

Oct 21, 2002

SOLU-CORTEF

NDA NDA009866

Sep 1, 2009

SOLU-CORTEF

NDA NDA009866

Sep 1, 2009

SOLU-CORTEF

NDA NDA009866

Jun 16, 2010

SOLU-CORTEF

NDA NDA009866

Sep 27, 2013

SOLU-CORTEF

NDA NDA009866

Nov 8, 2013

SOLU-CORTEF

NDA NDA009866

Mar 28, 2014

SOLU-CORTEF

NDA NDA009866

Apr 4, 2014

SOLU-CORTEF

NDA NDA009866

Jun 9, 2014

SOLU-CORTEF

NDA NDA009866

Jun 24, 2014

SOLU-CORTEF

NDA NDA009866

Jul 3, 2014

SOLU-CORTEF

NDA NDA009866

Jul 22, 2014

SOLU-CORTEF

NDA NDA009866

Sep 6, 2014

SOLU-CORTEF

NDA NDA009866

Sep 23, 2015

SOLU-CORTEF

NDA NDA009866

Feb 25, 2016

SOLU-CORTEF

NDA NDA009866

Sep 8, 2016

SOLU-CORTEF

NDA NDA009866

Sep 8, 2016

CORTEF

NDA NDA008697

Sep 8, 2016

CORTEF

NDA NDA008697

Sep 8, 2016

SOLU-CORTEF

NDA NDA009866

Nov 21, 2019

CORTEF

NDA NDA008697

Nov 21, 2019

SOLU-CORTEF

NDA NDA009866

May 27, 2021

SOLU-CORTEF

NDA NDA009866

Dec 20, 2023

SOLU-CORTEF

NDA NDA009866

Dec 20, 2023

CORTEF

NDA NDA008697

Jun 5, 2024

CORTEF

NDA NDA008697

Jun 5, 2024

SOLU-CORTEF

NDA NDA009866

Jul 10, 2024

SOLU-CORTEF

NDA NDA009866

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for Cortef. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Cortef compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA009866). U.S. Food & Drug Administration.
[4]
SEC EDGAR — Neurocrine UK Limited company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: NNeurocrine UK Limited

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