Find Endocrinology Drugs in Phase II Clinical Development in UNITED STATES

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            Lead Product(s): Paltusotine

            Therapeutic Area: Endocrinology Product Name: CRN00808

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 04, 2020

            Details:

            A presentation on the company’s orally administered, small molecule adrenocorticotropic hormone (ACTH) antagonist was selected for a late-breaking session at the virtual European Congress of Endocrinology (eECE).

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            Lead Product(s): MS1819,Porcine enzyme replacement therapy

            Therapeutic Area: Endocrinology Product Name: MS1819

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 11, 2020

            Details:

            In the primary efficacy analysis, patients receiving MS1819 in combination with PERT therapy achieved a clinically meaningful improvement in the coefficient of fat absorption (CFA) at each of the three dose levels, with no adverse safety events reported.

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            Lead Product(s): MS1819,Porcine enzyme replacement therapy

            Therapeutic Area: Endocrinology Product Name: MS1819

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $22.1 million Upfront Cash: Undisclosed

            Deal Type: Private Placement July 20, 2020

            Details:

            Private placement will be used to advance two Phase 2 clinical trials of MS1819 in patients with cystic fibrosis.

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            Lead Product(s): Insulin

            Therapeutic Area: Endocrinology Product Name: ORMD-0801

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 15, 2020

            Details:

            The FDA outlined its expectations for design of the ORMD-0801 Phase 3 trials as well as submission of the Biologics License Application (BLA) that would follow successful trials. Oramed plans to conduct the two Phase 3 trials concurrently.

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            Lead Product(s): Paltusotine

            Therapeutic Area: Endocrinology Product Name: CRN00808

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 08, 2020

            Details:

            The orphan drug designation by the FDA for paltusotine to treat acromegaly validates the encouraging clinical data that has been observed so far in the Phase 2 ACROBAT Edge clinical trial.

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            Lead Product(s): Pramlintide,Insulin

            Therapeutic Area: Endocrinology Product Name: Xerisol

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 18, 2020

            Details:

            XP-3924 resulted in 62% reduction of hyperglycemia after a glucose challenge. XP-3924 showed promising glucose control when compared to both Humulin R and co-administered injections of Humulin R & Symlin and it showed improved glucose control when compared to Humulin R alone.

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            Lead Product(s): Glucagon

            Therapeutic Area: Endocrinology Product Name: Gvoke RTU Micro

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 15, 2020

            Details:

            Xeris Pharmaceuticals announced positive topline results of a Phase 2 study of its developmental Gvoke RTU Micro™ for the prevention of hypoglycemia during and after moderate-to-high intensity aerobic exercise in adults with Type 1 diabetes mellitus who use insulin pumps.

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            Lead Product(s): Insulin

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 15, 2020

            Details:

            Diasome presented new positive data from its Phase 2b OPTI-1 clinical trial in people with type 1 diabetes (T1D) at the American Diabetes Association’s 80th Annual Scientific Sessions.

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            Lead Product(s): TTP399

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 13, 2020

            Details:

            Treatment with TTP399 resulted in significant improvements in HbA1c with reduction in insulin, without increasing risk of hypoglycemia or diabetic ketoacidosis (DKA).

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            Lead Product(s): Paltusotine

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 11, 2020

            Details:

            28 patients have completed the open-label Edge trial measuring IGF-1 levels after 13 weeks of treatment when patients with acromegaly were switched to once daily oral paltusotine from commercially available depot injections of the peptide somatostatin receptor ligands (SRLs).

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