Find Nephrology Drugs in Phase II Clinical Development

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            Lead Product(s): GFB-887

            Therapeutic Area: Nephrology Product Name: GFB-887

            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 08, 2020

            Details:

            TRACTION-2 is a multicenter, double-blind, randomized, placebo controlled Phase 2 trial evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GFB-887 in approximately 125 patients with FSGS or DN.

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            Lead Product(s): DM199

            Therapeutic Area: Nephrology Product Name: DM199

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Guggenheim Securities, LLC

            Deal Size: $20.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering August 06, 2020

            Details:

            Net proceeds to be used in continuing clinical and product development activities, including the addition of a new cohort III to its REDUX study to be comprised of Type II diabetes mellitus patients with CKD, hypertension and albuminuria, and general corporate purposes.

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            Lead Product(s): Propagermanium

            Therapeutic Area: Nephrology Product Name: DMX-200

            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 29, 2020

            Details:

            Primary and secondary endpoints met in the Phase 2a study of DMX-200 in FSGS patients, 86% of patients demonstrated a reduction of proteinuria with DMX-200 versus placebo.

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            Lead Product(s): Ferric oxide adipate

            Therapeutic Area: Nephrology Product Name: PT20

            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 16, 2020

            Details:

            PT20 is a novel iron-based phosphate binder that has the potential to treat patients with hyperphosphatemia (when there is too much phosphorus present in the blood) related to dialysis or non-dialysis dependent chronic kidney disease (CKD).

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            Lead Product(s): KBP-5074

            Therapeutic Area: Nephrology Product Name: KBP-5074

            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 30, 2020

            Details:

            BLOCK-CKD is a Phase 2b, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of KBP-5074, on top of current therapy, in patients with Stage 3B/4 CKD and uncontrolled hypertension.

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            Lead Product(s): KZR-616

            Therapeutic Area: Nephrology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Jefferies

            Deal Size: $46.7 million Upfront Cash: Undisclosed

            Deal Type: Public Offering June 08, 2020

            Details:

            Kezar intends to use the net proceeds from the offering primarily to fund the research and development of its product candidates, acquire or license products or technologies that are complementary to its own.

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            Lead Product(s): CXA-10

            Therapeutic Area: Nephrology 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 03, 2020

            Details:

            FIRSTx is a Phase 2, multicenter, randomized, open-label clinical trial evaluating the safety and efficacy of oral CXA-10 to treat immunosuppression-naïve patients 13 years of age and older with biopsy-confirmed primary FSGS.

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            Lead Product(s): Nimacimab

            Therapeutic Area: Nephrology 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 May 28, 2020

            Details:

            U.S. FDA has approved initiation of a phase 2 clinical study of nimacimab, also known as RYI-018, in patients with one of the following renal diseases: diabetic kidney disease, focal segmental glomerulosclerosis (FSGS), or immunoglobulin A (IgA) nephropathy.

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            Lead Product(s): KBP-5074

            Therapeutic Area: Nephrology 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 May 21, 2020

            Details:

            Single doses of 0.5 mg KBP-5074 were generally well tolerated in patients with severe CKD, with or without hemodialysis . Overall drug exposure was significantly lower in hemodialyzed patients vs. non-hemodialyzed patients.

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            Lead Product(s): KBP-5074

            Therapeutic Area: Nephrology 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 May 20, 2020

            Details:

            BLOCK CKD is a randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy, safety, and pharmacokinetics of KBP-5074 in patients with moderate-to-severe CKD and uncontrolled hypertension.

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