Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Hydrocortisone
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Eton Pharmaceuticals’ ET-400 NDA Accepted by FDA
Details : ET-400 is Eton’s proprietary patented formulation of hydrocortisone oral solution. Company has submitted NDA for ET-400 use in endocrine system disorders.
Product Name : ET-400
Product Type : Steroid
Upfront Cash : Inapplicable
July 15, 2024
Lead Product(s) : Hydrocortisone
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Hydrocortisone
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Eton Submits New Drug Application to FDA for ET-400 (Hydrocortisone Oral Solution)
Details : ET-400 is Eton’s proprietary patented formulation of hydrocortisone oral solution. Company has submitted NDA for ET-400 use in endocrine system disorders.
Product Name : ET-400
Product Type : Steroid
Upfront Cash : Inapplicable
April 30, 2024
Lead Product(s) : Hydrocortisone
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Hydrocortisone
Therapeutic Area : Endocrinology
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Antares Pharma Announces Positive Results From Phase I Study For ATRS-1902 For Adrenal Crisis Rescue
Details : 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.
Product Name : ATRS-1902
Product Type : Steroid
Upfront Cash : Inapplicable
November 01, 2022
Lead Product(s) : Hydrocortisone
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Hydrocortisone
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Diurnal Group
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : 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.
Product Name : Efmody
Product Type : Steroid
Upfront Cash : Undisclosed
April 26, 2022
Lead Product(s) : Hydrocortisone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Diurnal Group
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Lead Product(s) : Hydrocortisone
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The submission for the MHRA is based on the data from the Company’s Phase 3 study, an open-label safety extension study of Chronocort® and written formal Scientific Advice received in April 2019 confirming the clinical and regulatory pathway for Chron...
Product Name : Alkindi Sprinkle
Product Type : Steroid
Upfront Cash : Inapplicable
December 01, 2021
Lead Product(s) : Hydrocortisone
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Hydrocortisone
Therapeutic Area : Endocrinology
Study Phase : Approved FDF
Sponsor : Eton Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Agreement
Details : 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 Adrenocortica...
Product Name : Alkindi Sprinkle
Product Type : Steroid
Upfront Cash : Undisclosed
November 15, 2021
Lead Product(s) : Hydrocortisone
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Sponsor : Eton Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Agreement
Lead Product(s) : Hydrocortisone
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : 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.
Product Name : Alkindi Sprinkle
Product Type : Steroid
Upfront Cash : Inapplicable
September 13, 2021
Lead Product(s) : Hydrocortisone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Hydrocortisone
Therapeutic Area : Endocrinology
Study Phase : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Antares Pharma FDA Acceptance of IND Application for ATRS-1902
Details : 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 hydrocorti...
Product Name : ATRS-1902
Product Type : Steroid
Upfront Cash : Inapplicable
July 22, 2021
Lead Product(s) : Hydrocortisone
Therapeutic Area : Endocrinology
Highest Development Status : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Hydrocortisone
Therapeutic Area : Endocrinology
Study Phase : Undisclosed
Sponsor : Crossject
Deal Size : $11.0 million
Deal Type : Licensing Agreement
Details : 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.
Product Name : ZENEO Hydrocortisone
Product Type : Steroid
Upfront Cash : Undisclosed
June 15, 2021
Lead Product(s) : Hydrocortisone
Therapeutic Area : Endocrinology
Highest Development Status : Undisclosed
Sponsor : Crossject
Deal Size : $11.0 million
Deal Type : Licensing Agreement
Lead Product(s) : Hydrocortisone
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Diurnal Group plc - Diurnal receives European Commission approval for Efmody®
Details : 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.
Product Name : Alkindi Sprinkle
Product Type : Steroid
Upfront Cash : Inapplicable
May 28, 2021
Lead Product(s) : Hydrocortisone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable