Nephrology

Calliditas Therapeutics AB

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SWEDEN Sweden

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First Patient in China Enrolled in Clinical Phase 3 Study NefIgArd with Lead Candidate Nefecon

Lead Product(s): Budesonide

Therapeutic Area: Nephrology Product Name: Nefecon

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 08, 2020

Details:

Following IND approval by the NMPA in December of 2019 and subsequent approval by Human Genetic Resources Administration of China (HGRAC), the first patient in China has now been randomized in the Phase 3 NefIgArd trial.

Goldfinch Bio, Inc

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United States

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Goldfinch Bio Initiates Phase 2 Clinical Trial Evaluating GFB-887 as a Precision Medicine for Patients with Kidney Diseases

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.

Leo Pharma

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DENMARK Denmark

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Leo Pharma Sells Portfolio of Four Products to Cheplapharm

Lead Product(s): Alfacalcidol

Therapeutic Area: Nephrology Product Name: One-Alpha

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Cheplapharm Arzneimittel Gmbh

Deal Size: $355.0 million Upfront Cash: Undisclosed

Deal Type: Divestment August 31, 2020

Details:

The divested portfolio comprises four products within bone disorders/nephrology, dermatology and gynecology: One-Alpha©, Locoid©, Pimafucin©, and Zineryt©.

AstraZeneca PLC

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United Kingdom

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AstraZeneca's Farxiga Improves Survivalinn Kidney Disease Patients Study Shows

Lead Product(s): Dapagliflozin

Therapeutic Area: Nephrology Product Name: Farxiga

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 30, 2020

Details:

Results from the ground-breaking Phase III DAPA-CKD trial showed that AstraZeneca’s Farxiga on top of standard of care reduced the composite measure of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% compared to placebo in CKD patients.

AstraZeneca PLC

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United Kingdom

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Farxiga Phase III DAPA-CKD Trial Paradigm-Shifting Data to Be Presented at ESC 2020

Lead Product(s): Dapagliflozin

Therapeutic Area: Nephrology Product Name: Farxiga

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 27, 2020

Details:

Farxiga shows significant benefit across all primary and secondary endpoints in patients with chronic kidney disease with and without type-2 diabetes .

Akebia Therapeutics

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United States

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Akebia Therapeutics Announces First Commercial Launch of VAFSEO™ (vadadustat tablets)

Lead Product(s): Vadadustat

Therapeutic Area: Nephrology Product Name: Vafseo

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 26, 2020

Details:

Vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is now commercially available in Japan as a treatment for anemia due to chronic kidney disease (CKD) under the trade name VAFSEO™.

Tricida, Inc

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United States

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Tricida sinks as FDA rejection raises prospect of new trial

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.

Chinook Therapeutics

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CANADA Canada

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Chinook Therapeutics Announces $106 Million Private Placement Financing to Advance Precision Medicines for Kidney Disease

Lead Product(s): Atrasentan Hydrochloride

Therapeutic Area: Nephrology Product Name: ABT-627

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: EcoR1 Capital

Deal Size: $106.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement August 18, 2020

Details:

Net proceeds will support company's planned phase 2 and phase 3 trials of atrasentan, an investigational selective endothelin receptor antagonist, in development for the treatment of IgA nephropathy and other primary glomerular diseases including other clinical activities.

DiaMedica Therapeutics

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United States

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DiaMedica Announces Closing of $23 Million Public Offering of Common Shares

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.

Dimerix

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Australia

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DIMERIX’s DMX-200 Posts Strong Results in Kidney Disease Trial

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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Find Nephrology Clinical Drug Pipeline Developments & Deals

Product Type

Development Status

Calliditas Therapeutics AB

First Patient in China Enrolled in Clinical Phase 3 Study NefIgArd with Lead Candidate Nefecon

Goldfinch Bio, Inc

Goldfinch Bio Initiates Phase 2 Clinical Trial Evaluating GFB-887 as a Precision Medicine for Patients with Kidney Diseases

Leo Pharma

Leo Pharma Sells Portfolio of Four Products to Cheplapharm

AstraZeneca PLC

AstraZeneca's Farxiga Improves Survivalinn Kidney Disease Patients Study Shows

AstraZeneca PLC

Farxiga Phase III DAPA-CKD Trial Paradigm-Shifting Data to Be Presented at ESC 2020

Akebia Therapeutics

Akebia Therapeutics Announces First Commercial Launch of VAFSEO™ (vadadustat tablets)

Tricida, Inc

Tricida sinks as FDA rejection raises prospect of new trial

Chinook Therapeutics

Chinook Therapeutics Announces $106 Million Private Placement Financing to Advance Precision Medicines for Kidney Disease

DiaMedica Therapeutics

DiaMedica Announces Closing of $23 Million Public Offering of Common Shares

Dimerix

DIMERIX’s DMX-200 Posts Strong Results in Kidney Disease Trial