Adrenal Insufficiency
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Sign up freeTop drugs studied for this disease
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FDA label_change · 2024-06-11FDA Approved: HYDROCORTISONE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a Supplemental Application for HYDROCORTISONE from Aurobindo Pharma Limited, typically indicating a label change for this gener…
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CLINICAL_TRIALS research · 2024-05-30Clinical Trial Update: Tolerability and Acceptance of Two Oral Hydrocortisone Compounding Formulation for Pediatrics [Phase 4]
A Phase 4 clinical trial update evaluating the tolerability and acceptance of two oral hydrocortisone compounding formulations in children w…
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CLINICAL_TRIALS trial_result · 2024-05-14Clinical Trial Update: Chronocort Versus Plenadren Replacement Therapy in Adults With Adrenal Insufficiency [Phase 2]
Phase 2 trial comparing Chronocort with Plenadren for primary adrenal insufficiency in adults has completed.
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CLINICAL_TRIALS trial_result · 2024-05-08Clinical Trial Update: Rheumatoid Arthritis Adrenal Recovery Study
The University of Edinburgh-based trial on adrenal recovery in rheumatoid arthritis patients has completed. No specific results are provided…
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CLINICAL_TRIALS research · 2024-04-30Clinical Trial Update: Treatment Study in Patients Treated With Both Insulin & Hydrocortisone [NA]
This is a clinical trial status update for a study evaluating treatment in patients treated with both insulin and hydrocortisone, sponsored …
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CLINICAL_TRIALS trial_result · 2024-02-15Clinical Trial Update: Effects of Steroid Replacement Therapy on Metabolic, Cardiovascular and Bone Outcomes in Adrenal Insufficiency [Phase 3]
A Phase 3 clinical trial evaluating the effects of steroid replacement therapy on metabolic, cardiovascular, and bone outcomes in patients w…
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FDA approval · 2024-01-05FDA Approved: DEXAMETHASONE INTENSOL — Supplemental Application (Hikma Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for DEXAMETHASONE INTENSOL from Hikma Pharmaceuticals USA, Inc., a dexamethasone product.
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FDA approval · 2023-12-22FDA Approved: CORTROSYN — Supplemental Application (Amphastar Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Cortrosyn (cosyntropin) from Amphastar Pharmaceuticals, Inc., authorizing changes to the app…
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EMA approval · 2023-10-13EMA Authorised: Plenadren (hydrocortisone) — Takeda Pharmaceuticals International AG Ireland Branch
The EMA authorised Plenadren (hydrocortisone) for adrenal insufficiency, indicating regulatory approval and listing Takeda as the Marketing …
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CLINICAL_TRIALS trial_result · 2023-09-01Clinical Trial Update: Safety and Efficacy of Prednisolone in Adrenal Insufficiency Disease (PRED-AID Study) [Phase 3]
Phase 3 trial update on safety and efficacy of prednisolone in adrenal insufficiency (PRED-AID Study).
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CLINICAL_TRIALS trial_result · 2023-04-10Clinical Trial Update: Effects of High Intensity Statin Therapy on Steroid Hormones and Vitamin D in Type 2 Diabetic Men [Phase 4]
Phase 4 trial evaluating the effects of high-intensity statin therapy on steroid hormones and vitamin D in men with type 2 diabetes and dysl…
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FDA approval · 2022-12-23FDA Approved: ALKINDI SPRINKLE — Supplemental Application (Eton Pharmaceuticals, Inc.)
FDA approved a supplemental application for ALKINDI SPRINKLE (hydrocortisone) from Eton Pharmaceuticals. The approval updates its labeling a…
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CLINICAL_TRIALS trial_result · 2022-07-13Clinical Trial Update: Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone. [Phase 4]
Phase 4 clinical trial examining salivary cortisol measurement in patients with corticotrope deficiency treated with hydrocortisone.
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FDA approval · 2022-05-31FDA Approved: FLUDROCORTISONE ACETATE — Original Application (Novitium Pharma LLC)
FDA approved the original generic application for fludrocortisone acetate (ANDA 215279) from Novitium Pharma LLC. This approval makes a gene…
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FDA approval · 2022-02-03FDA Approved: ALKINDI SPRINKLE — Supplemental Application (Eton Pharmaceuticals, Inc.)
FDA approved a supplemental application for ALKINDI SPRINKLE (hydrocortisone) from Eton Pharmaceuticals. The action represents an approval o…
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FDA approval · 2021-12-14FDA Approved: CORTROSYN — Supplemental Application (Amphastar Pharmaceuticals, Inc.)
The FDA approved Amphastar Pharmaceuticals' supplemental application for Cortrosyn (cosyntropin), a diagnostic agent used to assess adrenal …
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CLINICAL_TRIALS trial_result · 2021-12-09Clinical Trial Update: Is Adrenal Insufficiency Under-diagnosed in Hospitalized Cirrhosis Patients? [Phase 3]
A Phase 3 clinical trial investigated whether adrenal insufficiency is under-diagnosed in hospitalized patients with cirrhosis; results have…
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FDA approval · 2020-09-29FDA Approved: ALKINDI SPRINKLE — Original Application (Eton Pharmaceuticals, Inc.)
FDA approves ALKINDI SPRINKLE (hydrocortisone granules) from an original NDA by Eton Pharmaceuticals, providing hydrocortisone replacement t…
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FDA approval · 2020-09-02FDA Approved: PREDNISONE — Original Application (Strides Pharma Science Limited)
FDA approval of a generic prednisone (PREDNISONE) Original Application by Strides Pharma Science Limited.
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CLINICAL_TRIALS trial_result · 2020-08-12Clinical Trial Update: Determination of Method-specific Normal Cortisol and Adrenal Hormone Responses to the Short Synacthen Test [Phase 4]
Phase 4 trial evaluating method-specific cortisol and adrenal hormone responses to the Short Synacthen Test in healthy individuals and those…
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CLINICAL_TRIALS trial_result · 2019-09-13Clinical Trial Update: Extension Study for Patients Entered Into Study Infacort 003 [Phase 3]
Extension study update for patients enrolled in Infacort 003 (Phase 3) completed with results posted in 2019.
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CLINICAL_TRIALS withdrawal · 2019-05-10Clinical Trial Update: Comparison of Intramuscular and Intravenous ACTH Stimulation Test in Normal Volunteers [Phase 4]
A Phase 4 trial comparing IM and IV ACTH stimulation tests in normal volunteers was withdrawn.
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CLINICAL_TRIALS trial_result · 2019-04-25Clinical Trial Update: Dual RElease Hydrocortisone Versus conventionAl Glucocorticoid replaceMent Therapy in Hypocortisolism (DREAM) [Phase 4]
Phase 4 trial update comparing Dual Release Hydrocortisone to conventional glucocorticoid replacement in hypocortisolism.
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CLINICAL_TRIALS trial_result · 2019-02-21Clinical Trial Update: Effect of Adrenocorticotropic Hormone on Vascular Endothelial Growth Factor Release in Children Study [EARLY_Phase 1]
An early-phase 1 trial evaluated whether adrenocorticotropic hormone (ACTH) affects the release of vascular endothelial growth factor (VEGF)…
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CLINICAL_TRIALS trial_result · 2019-01-18Clinical Trial Update: Cortisol Response to Low Dose Cosyntropin Stimulation Test in the Late Afternoon [NA]
A completed clinical trial update examining cortisol response to a low-dose cosyntropin stimulation test in the late afternoon for adrenal i…