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Database","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"FINLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals for MolPort-001-794-637
ODM-208 (or MK-5684) is an investigational oral, non-steroidal and selective inhibitor of the CYP11A1 enzyme discovered and developed by Orion for the treatment of hormone-dependent cancers, such as metastatic castration-resistant prostate cancer.
Efmody® is a modified-release preparation of hydrocortisone that has been specifically designed for the treatment of patients with CAH, a rare condition caused by a genetic deficiency of adrenal enzymes.
The results of the Phase I study met its primary objective showing ATRS-1902 delivered a comparable pharmacokinetic profile and also demonstrated that ATRS-1902 was safe and well-tolerated for the treatment of acute adrenal insufficiency.
Under terms of the agreement, Tolmar’s sales force will promote ALKINDI SPRINKLE® to their pediatric endocrinology targets alongside FENSOLVI®. ALKINDI SPRINKLE® (hydrocortisone) oral granules is FDA-approved as replacement therapy for Adrenocortical Insufficiency (AI).
Efmody® is a preparation of hydrocortisone that has been specifically designed for patients with CAH, a rare condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase.
The active IND enables Antares to initiate a Phase 1 clinical study for ATRS-1902 for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using a novel proprietary auto-injector platform to deliver hydrocortisone.
The ready to use ZENEO® Hydrocortisone will provide a 2-step rescue kit developed for a simple and intuitive autoinjection even by non healthcare professionals.
The $1.25 million milestone payment has been triggered as a result of the recent European Commission’s approval for Efmody® (hydrocortisone modified-release hard capsules) and the attainment by Citrine of certain development milestones in China for Alkindi.
Efmody® is a preparation of hydrocortisone that has been specifically designed for patients with CAH, an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase.
The Phase 3 study results published by the JCEM found that although the standard-deviation-score-focused primary endpoint of the study was missed, Chronocort® improved morning and early afternoon biochemical control for adults with CAH over standard glucocorticoid therapy.
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