X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
0
Other Suppliers
0
0
USA (Orange Book)
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
0
Details:
Lupkynis (voclosporin) is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action. It is being developed for the treatment of lupus nephritis.
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 13, 2023
Details:
Lupkynis (voclosporin) is an an oral calcineurin inhibitor which is being evaluated in clinical trials for the treatment of patients with Lupus Nephritis.
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2023
Details:
Lupkynis (voclosporin) is a calcineurin-inhibitor of calcineurin. The immunosuppressant activity results in inhibition of lymphocyte proliferation, T-cell cytokine production, and expression of T-cell activation surface antigens. Currently being developed for lupus nephritis.
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2023
Details:
Lupkynis (voclosporin) is a novel, structurally modified calcineurin inhibitor (CNI) with dual mechanism of action, has received swissmedic approval to treat adults with active class III, IV and V lupus nephritis.
Lead Product(s): Voclosporin
Therapeutic Area: Immunology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 02, 2023
Details:
Lupkynis (voclosporin) is a calcineurin-inhibitor of calcineurin. The immunosuppressant activity results in inhibition of lymphocyte proliferation, T-cell cytokine production, and expression of T-cell activation surface antigens. Currently being developed for lupus nephritis.
Lead Product(s): Voclosporin,Mycophenolate Mofetil,Undisclosed
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: PreclinicalProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 11, 2023
Details:
Lupkynis (voclosporin) is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney.
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 05, 2023
Details:
Lupkynis (voclosporin) is a calcineurin-inhibitor of calcineurin. The immunosuppressant activity results in inhibition of lymphocyte proliferation, T-cell cytokine production, and expression of T-cell activation surface antigens. Currently being developed for lupus nephritis.
Lead Product(s): Voclosporin,Mycophenolate Mofetil,Undisclosed
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: PreclinicalProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 24, 2023
Details:
Lupkynis (voclosporin) is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney.
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2022
Details:
LUPKYNIS (voclosporin) is novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney.
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2022
Details:
EC approval is based on positive results, which demonstrated that treatment with voclosporin (lupkynis), in combination with MMF and low-dose corticosteroids, led to statistically superior complete renal response rates at 52 weeks compared to MMF and low-dose corticosteroids.
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 20, 2022
Details:
LUPKYNIS (voclosporin) is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney.
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2022
Details:
LUPKYNIS (voclosporin) is the first FDA-approved oral therapy for lupus nephritis (LN), a condition that causes irreversible kidney damage and increases the risk of kidney failure, cardiac events, and death.
Lead Product(s): Voclosporin
Therapeutic Area: Immunology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 26, 2022
Details:
LUPKYNIS (voclosporin), is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney.
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2022
Details:
At 12 months, 89.6% of the LUPKYNIS® (voclosporin) group and 82.8% of the control group achieved the recommended steroid dose of ≤7.5 mg/day according to the protocol-defined steroid taper (OR 1.83, CI 1.03-3.27, p=0.0396).
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2022
Details:
LUPKYNIS (voclosporin) is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney.
Lead Product(s): Voclosporin,Mycophenolate Mofetil
Therapeutic Area: Immunology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 20, 2022
Details:
LUPKYNIS (voclosporin) is first FDA-approved structurally modified calcineurin inhibitor for treatment of patients with active lupus nephritis, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production.
Lead Product(s): Voclosporin,Mycophenolate Mofetil
Therapeutic Area: Immunology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2022
Details:
Lupkynis (voclosporin), is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney.
Lead Product(s): Voclosporin,Mycophenolate Mofetil
Therapeutic Area: Immunology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 04, 2022
Details:
The interim analysis of AURORA 2 showed that subjects in the LUPKYNIS treatment arm sustained meaningful reductions in proteinuria, with no change in mean estimated glomerular filtration rate (eGFR) at 104 weeks of treatment.
Lead Product(s): Voclosporin,Mycophenolate Mofetil Hydrochloride
Therapeutic Area: Immunology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 20, 2021
Details:
Pooled data from the AURA-LV and AURORA 1 study demonstrate that LUPKYNIS, in combination with mycophenolate mofetil and low-dose corticosteroids, led to treatment benefits across biopsy class subgroups compared with treatment with MMF and low-dose corticosteroids alone.
Lead Product(s): Voclosporin,Mycophenolate Mofetil Hydrochloride
Therapeutic Area: Immunology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2021
Details:
Under the terms of the agreement, Catalent will manufacture LUPKYNIS as a softgel dosage form at its pharmaceutical softgel center of excellence in St. Petersburg, Florida.
Lead Product(s): Voclosporin,Mycophenolate Mofetil
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Aurinia Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement February 18, 2021
Details:
U.S. Food and Drug Administration (FDA) approved the use of Aurinia Pharmaceuticals' LupkynisTM (voclosporin) as the first oral treatment developed specifically for adults with active lupus nephritis (LN) in combination with standard of care.
Lead Product(s): Voclosporin,Mycophenolate Mofetil
Therapeutic Area: Immunology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 22, 2021
Details:
The aim of the collaboration is to develop and commercialize oral voclosporin for the treatment of lupus nephritis (LN) in the European Union (EU), Japan, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, Ukraine and the United Kingdom.
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: $100.0 million Upfront Cash: $50.0 million
Deal Type: Collaboration December 17, 2020
Details:
The dedicated facility will be equipped with state-of-the-art manufacturing equipment to provide cost and production efficiency for the manufacture of voclosporin, while expanding existing capacity and providing supply security to meet future commercial demand.
Lead Product(s): Voclosporin
Therapeutic Area: Immunology Product Name: ISA247
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Aurinia Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration December 15, 2020
Details:
Integrated analysis confirms addition of voclosporin to standard-of-care resulted in faster Renal Response compared to standard-of-care alone in lupus nephritis.
Lead Product(s): Voclosporin
Therapeutic Area: Immunology Product Name: ISA247
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Details:
Phase 2/3 AUDREY™ clinical study evaluating voclosporin ophthalmic solution (VOS) for the potential treatment of dry eye syndrome (DES) did not achieve statistical significance on the primary endpoint of ≥ 10mm improvement in Schirmer Tear Test (STT) at 4 weeks.
Lead Product(s): Voclosporin
Therapeutic Area: Ophthalmology Product Name: ISA247
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2020
Details:
Aurinia Pharmaceuticals has initiated an open-label exploratory trial to analyse the antiviral effects of voclosporin in kidney transplant recipients (KTRs) with Covid-19. Voclosporin is a novel calcineurin inhibitor (CNI) used for treating patients with lupus nephritis.
Lead Product(s): Voclosporin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2020
Details:
Integrated analysis confirms statistically superior efficacy and safety of voclosporin in combination with MMF and steroids over standard-of-care.
Lead Product(s): Voclosporin,Mycophenolate Mofetil
Therapeutic Area: Immunology Product Name: ISA247
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
Last patient study visit has occurred in the Phase 2/3 AUDREY™ clinical study evaluating voclosporin ophthalmic solution (VOS) for the potential treatment of dry eye syndrome (DES).
Lead Product(s): Voclosporin
Therapeutic Area: Ophthalmology Product Name: ISA247
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2020
Details:
The Company intends to use the net proceeds of the Offering for pre-commercialization and launch activities, research and development, as well as working capital and general corporate purposes.
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Jefferies
Deal Size: $200.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering July 27, 2020
Details:
The FDA grants priority review designation to the evaluation of drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment for serious conditions.
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Product Name: ISA247
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2020
Details:
Aurinia has completed enrollment for the Phase 2/3 AUDREY™ clinical trial evaluating voclosporin ophthalmic solution (VOS) for the potential treatment of dry eye syndrome (DES), a chronic disease estimated to affect more than 16 million people in the United States.
Lead Product(s): Voclosporin
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2020
Details:
The data showed that pre-specified confirmed estimated glomerular filtration rate (eGFR) decreases of over 30% were similar in both AURORA trial patient groups, with 10.1% reported in the voclosporin group and 10.2% in the control arm.
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Product Name: ISA247
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2020
Details:
The presented data demonstrated clinically meaningful benefits of voclosporin for trial participants across ethnicities and self-reported race.
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 05, 2020
Details:
Clinical data from its AURORA Phase 3 trial will be highlighted in a late-breaking oral presentation during the National Kidney Foundation 2020 Spring Clinical Meetings.
Lead Product(s): Voclosporin,Mycophenolic Acid,Corticosteroids
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2020
Details:
The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the Agency on an ongoing basis.
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
