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Details:

Filspari (sparsentan) is a once-daily oral medication is designed to selectively target two critical pathways in the disease progression of IgAN (endothelin-1 and angiotensin II). It isapproved for the treatment of IgA Nephropathy.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Product Name: Filspari

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 07, 2024

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Details:

Filspari (sparsentan) is a once-daily oral medication, designed to selectively target two critical pathways in the disease progression of IgAN (endothelin-1 and angiotensin II). It is approved for the treatment of IgA Nephropathy.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Product Name: Filspari

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 11, 2024

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Details:

Filspari (sparsentan) is a once-daily oral medication, designed to selectively target two critical pathways in the disease progression of IgAN (endothelin-1 and angiotensin II). It is approved for the treatment of IgA Nephropathy.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Product Name: Filspari

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: CSL Vifor

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 23, 2024

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Details:

Under the agreement, Renalys will bring Filspari (sparsentan), a dual endothelin angiotensin receptor antagonist for the treatment of IgA nephropathy, to patients in Japan and other countries in Asia.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Product Name: Filspari

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Renalys Pharma

Deal Size: $120.0 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement January 25, 2024

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Details:

Filspari (sparsentan) is a once-daily oral medication is designed to selectively target two critical pathways in the disease progression of IgAN (endothelin-1 and angiotensin II). It isapproved for the treatment of IgA Nephropathy.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Product Name: Filspari

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 25, 2024

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Details:

Filspari (sparsentan) is an endothelin and angiotensin II receptor antagonist indicated to reduce proteinuria in adults with IgAN. It is being investigated for focal segmental glomerulosclerosis.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Product Name: Filspari

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Ligand Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 21, 2023

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Details:

Filspari (sparsentan) is an endothelin and angiotensin II receptor antagonist indicated to reduce proteinuria in adults with IgAN. It is being investigated for focal segmental glomerulosclerosis.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Product Name: Filspari

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: CSL Vifor

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 01, 2023

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Details:

Filspari (sparsentan), a once-daily oral medication is designed to selectively target two critical pathways in the disease progression of IgAN (endothelin-1 and angiotensin II), and is the first and only non-immunosuppressive therapy.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Product Name: Filspari

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Jefferies

Deal Size: $230.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering March 03, 2023

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Details:

Filspari (sparsentan), a once-daily oral medication is designed to selectively target two critical pathways in the disease progression of IgAN (endothelin-1 and angiotensin II), and is the first and only non-immunosuppressive therapy.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Product Name: Filspari

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Jefferies

Deal Size: $200.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering February 28, 2023

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Details:

Filspari (sparsentan) is an endothelin and angiotensin II receptor antagonist indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Product Name: Filspari

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 17, 2023

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Details:

RE-021 (sparsentan), a Dual Endothelin Angiotensin Receptor Antagonist (DEARA), is a novel investigational product candidate selectively targeting the endothelin A receptor (ETAR) and the angiotensin II subtype 1 receptor (AT1R).


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Product Name: RE-021

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 26, 2022

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Details:

Sparsentan, a Dual Endothelin Angiotensin Receptor Antagonist (DEARA), is a novel investigational product candidate selectively targeting the endothelin A receptor (ETAR) and the angiotensin II subtype 1 receptor (AT1R).


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Product Name: RE-021

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 13, 2022

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  • Development Update

Details:

After 36 weeks of treatment, patients receiving RE-021 (sparsentan) achieved a mean reduction in proteinuria from baseline of 49.8 percent, compared to a mean reduction in proteinuria from baseline of 15.1 percent for irbesartan-treated patients.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Product Name: RE-021

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Travere Therapeutics

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 22, 2022

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Details:

RE-021 (sparsentan), a Dual Endothelin Angiotensin Receptor Antagonist (DEARA), is a novel investigational product candidate selectively targeting the endothelin A receptor (ETAR) and the angiotensin II subtype 1 receptor (AT1R).


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Product Name: RE-021

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 03, 2022

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Details:

RE-021 (sparsentan), a dual endothelin angiotensin receptor antagonist (DEARA), and a novel investigational product candidate selectively targeting the endothelin A receptor and the angiotensin II subtype 1 receptor, in IgA nephropathy and focal segmental glomerulosclerosis.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Product Name: RE-021

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 17, 2022

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Details:

The PROTECT Study evaluating RE-021 (sparsentan) in 404 patients with persistent proteinuria, met its pre-specified interim primary efficacy endpoint measuring change in proteinuria compared to the active control irbesartan.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Product Name: RE-021

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 16, 2022

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Details:

NDA submission is supported by positive result from PROTECT Study, evaluating safety and efficacy of sparsentan, a DEAR antagonist in a total of 404 patients with IgAN, as well as data from additional clinical trials and pre-clinical testing of sparsentan.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Product Name: RE-021

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 21, 2022

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Details:

Sparsentan data shown that blockade of both endothelin type A and angiotensin II type 1 pathways in forms of rare chronic kidney disease, reduces proteinuria, protects podocytes and prevents glomerulosclerosis and mesangial cell proliferation.


Lead Product(s): Sparsentan

Therapeutic Area: Immunology Product Name: RE-021

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 02, 2021

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Details:

Under the terms of the agreement, Vifor Pharma will receive exclusive commercialization rights for sparsentan in Europe, Australia and New Zealand and Travere remains responsible for the clinical development of sparsentan and will retain all rights to sparsentan.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Product Name: RE-021

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: CSL Vifor

Deal Size: $190.0 million Upfront Cash: $55.0 million

Deal Type: Collaboration September 16, 2021

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Details:

Preliminary results from the interim analysis suggest that to date in the study, sparsentan has been generally well-tolerated and consistent with the observed safety profile to date.


Lead Product(s): Sparsentan

Therapeutic Area: Immunology Product Name: RE-021

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 16, 2021

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Details:

Preliminary results from the interim analysis suggest that at the time of the interim assessment, sparsentan had been generally well-tolerated and shown a comparable safety profile to irbesartan.


Lead Product(s): Sparsentan

Therapeutic Area: Nephrology Product Name: RE-021

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 25, 2021

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Details:

Sparsentan is an investigational product candidate currently being evaluated for the treatment of IgAN, as well as focal segmental glomerulosclerosis in pivotal Phase 3 clinical trials that are expected to report topline data from interim proteinuria assessments in 2021.


Lead Product(s): Sparsentan

Therapeutic Area: Immunology Product Name: RE-021

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 13, 2021

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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.


Lead Product(s): Sparsentan

Therapeutic Area: Immunology Product Name: RE-021

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 09, 2020

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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).


Lead Product(s): Sparsentan

Therapeutic Area: Immunology Product Name: RE-021

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 21, 2020

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