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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.
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.
A Two-part Open Label, Randomised, Single Dose, Crossover Study in Healthy Volunteers to: (Part A) Compare the Pharmacokinetics of up to 6 Chronocort® Formulations, and (Part B) Determine the Dose Proportionality of a Selected Chronocort® Formulation at Three Dose Levels With an Additional Comparison With the Selected Formulation Dosed on Two Occasions Over a 24 Hour Period
An Open Label, Randomised, Single Dose, 3-period Crossover Study in Healthy Volunteers to: a) Compare the Pharmacokinetics of Chronocort® Formulations Versus Immediate Release Hydrocortisone, and (b) Determine the Dose Proportionality of Chronocort® Formulations
A Phase 1, Randomised, Open-label, 2-cohort, Cross-over Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Native Oral Testosterone Formulation (DITEST) in the Fed and Fasted State and Compared to Testosterone Undecanoate in Adult Men With Primary or Secondary Hypogonadism
An Open-label, Randomized, Titration-blinded, Phase III Study of Efficacy, Safety and Tolerability Of Chronocort® Compared With Standard Glucocorticoid REeplacement Therapy in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
A Double-Blind, Double-Dummy, Two-Way Cross-Over, Randomised, Phase II Study of Efficacy, Safety and Tolerability of Modified-Release Hydrocortisones: Chronocort® Versus Plenadren®, in Adrenal Insufficiency
A Single Centre, Open-label, Randomised, Single Dose, Three-period, Crossover Study to Evaluate the Bioavailability of Infacort Administered as Sprinkles With Soft Food and Yoghurt Compared With Direct Administration to the Back of the Tongue in Dexamethasone-suppressed Healthy Adult Male Subjects
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Cortef — SOLU-CORTEF
Application NDA009866
Cortef — SOLU-CORTEF
Application NDA009866
Cortef — SOLU-CORTEF
Application NDA009866
Cortef — SOLU-CORTEF
Application NDA009866
Cortef — SOLU-CORTEF
Application NDA009866
Cortef — SOLU-CORTEF
Application NDA009866
Cortef — SOLU-CORTEF
Application NDA009866
Cortef — CORTEF
Application NDA008697
Cortef — SOLU-CORTEF
Application NDA009866
Cortef — SOLU-CORTEF
Application NDA009866
Cortef — CORTEF
Application NDA008697
Cortef — SOLU-CORTEF
Application NDA009866
Cortef — CORTEF
Application NDA008697
Cortef — SOLU-CORTEF
Application NDA009866
Cortef — SOLU-CORTEF
Application NDA009866
Cortef — CORTEF
Application NDA008697
Cortef — SOLU-CORTEF
Application NDA009866
Cortef — SOLU-CORTEF
Application NDA009866
Cortef — CORTEF
Application NDA008697
Cortef — SOLU-CORTEF
Application NDA009866
Data sources: ClinicalTrials.gov (NIH) · OpenFDA (FDA) · ChEMBL (EMBL-EBI) · Open Targets (EBI/Sanger) · MedlinePlus (NIH) · PubMed (NIH) · SEC EDGAR (SEC)