Find Nephrology Drugs in Phase III Clinical Development in UNITED STATES

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            Lead Product(s): Veverimer

            Therapeutic Area: Nephrology Product Name: TRC101

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 24, 2020

            Details:

            Tricida has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for veverimer on August 21, 2020. The NDA was reviewed under the Accelerated Approval Program.

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            Lead Product(s): Terlipressin

            Therapeutic Area: Nephrology Product Name: Teripress

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 15, 2020

            Details:

            Terlipressin is a vasopressin analogue which, in clinical trials, was shown to be effective at HRS-1 reversal, which includes three components: renal function improvement, avoidance of dialysis and short-term survival.

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            Lead Product(s): Tenapanor

            Therapeutic Area: Nephrology Product Name: RDX5791

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 30, 2020

            Details:

            The submission is supported by three successful Phase 3 trials involving over 1,000 patients that evaluated the use of tenapanor for Hyperphosphatemia, a condition which affects approximately 85% of CKD Patients on Dialysis.

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            Lead Product(s): Terlipressin

            Therapeutic Area: Nephrology Product Name: Teripress

            Highest Development Status: Phase III 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:

            The study found that terlipressin was associated with an improvement in kidney function among HRS-1 patients as measured by a reduction in serum creatinine (SCr).

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            Lead Product(s): Terlipressin

            Therapeutic Area: Nephrology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 22, 2020

            Details:

            Terlipressin would be the first FDA-approved treatment option in the United States for adult patients with HRS-1, a life-threatening condition, if approved.

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            Lead Product(s): Terlipressin

            Therapeutic Area: Nephrology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 17, 2020

            Details:

            The terlipressin NDA is based, in part, on results from the Phase 3 CONFIRM trial, and the culmination of a sustained, 17-year effort to develop terlipressin for potential use in the U.S. and Canada.

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            Lead Product(s): Atrasentan Hydrochloride

            Therapeutic Area: Nephrology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Chinook Therapeutics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement January 10, 2020

            Details:

            Chinook Therapeutics in-license of atrasentan provides a unique opportunity for Chinook to add a potential new drug to its precision medicine portfolio for the treatment of rare CKD conditions.