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Find Nephrology Drugs in Phase III Clinical Development in UNITED STATES

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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.

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            Lead Product(s): Lanthanum Dioxycarbonate

            Therapeutic Area: Nephrology Product Name: Renazorb

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Unicycive Therapeutics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition December 14, 2020

            Details:

            Under the terms of the asset purchase agreement, Unicycive has acquired global rights for Renazorb and all its trademark and associated patents, and Spectrum has received an equity interest in Unicycive along with milestone and royalty payments.

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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 November 16, 2020

            Details:

            The overall response rate among patients treated with terlipressin, including complete responses and partial responses was 73% and differed between the mild and moderate groups compared to the severe group.

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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 October 29, 2020

            Details:

            Post-hoc, pooled analyses of three Phase 3 trials found HRS-1 patients treated with terlipressin was associated with less RRT up to Day 90 versus placebo.

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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: Kyowa Kirin

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 22, 2020

            Details:

            Five posters continue to support the foundational role tenapanorcould play in the treatment of hyperphosphatemia. Tenapanor is a phosphate absorption inhibitor currently under review by the FDA for the control of serum phosphorus in adult patients with CKD on dialysis.

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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 October 12, 2020

            Details:

            Comprehensive datasets demonstrate tenapanor's ability to control serum phosphorous in patients with chronic kidney disease (CKD) on dialysis.

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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 September 15, 2020

            Details:

            The NDA is supported by three successful Phase 3 trials that evaluated the use of tenapanor, which included two monotherapy trials.

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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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