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Find Nephrology Drugs in Phase III Clinical Development in UNITED STATES

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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): Sparsentan

            Therapeutic Area: Nephrology Product Name: RE-021

            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 09, 2020

            Details:

            Retrophin will present new data from a post-hoc analysis examining the proportion of patients with focal segmental glomerulosclerosis that achieved complete remission of proteinuria in the Phase 2 DUET Study, at the American Society of Nephrology Kidney Week 2020 Reimagined.

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            Lead Product(s): Sparsentan

            Therapeutic Area: Nephrology Product Name: RE-021

            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 21, 2020

            Details:

            First 280 patients have been enrolled in the pivotal Phase 3 PROTECT Study evaluating the safety and efficacy of sparsentan in IgA nephropathy (IgAN).

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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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            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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