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    Chemistry

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    Also known as: 515814-01-4, Lupkynis, Luveniq, Isatx-247, Voclosporin [usan], Isatx247
    Molecular Formula
    C63H111N11O12
    Molecular Weight
    1214.6  g/mol
    InChI Key
    BICRTLVBTLFLRD-PTWUADNWSA-N
    FDA UNII
    2PN063X6B1
    Voclosporin
    Lupus nephritis (LN) is a type of glomerulonephritis occurring in patients with systemic lupus erythematosus (SLE). LN is a significant cause of renal failure, morbidity, and death in patients with SLE. Within 10 years of being diagnosed with SLE, 5-20% of those suffering from LN develop end-stage kidney disease, a fatal condition. Early and accurate intervention for LN is important in improving clinical outcomes. Voclosporin, marketed as Lupkynis, is a calcineurin-inhibitor immunosuppressant for the treatment of LN. This [cyclosporine] A analog was approved by the FDA on January 22, 2021 following promising results in clinical trials. Early intervention with voclosporin coupled with a kidney response is believed to prevent irreversible damage to the kidney and lead to better long-term clinical outcomes for patients with LN. Voclosporin has demonstrated a more stable pharmacokinetic and pharmacodynamic relationship than cyclosporine, a higher potency than cyclosporine, and an improved metabolic profile when compared to older calcineurin inhibitors.
    Voclosporin is a Calcineurin Inhibitor Immunosuppressant. The mechanism of action of voclosporin is as a Calcineurin Inhibitor, and P-Glycoprotein Inhibitor, and Organic Anion Transporting Polypeptide 1B1 Inhibitor, and Organic Anion Transporting Polypeptide 1B3 Inhibitor.
    1 2D Structure

    Voclosporin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-30-ethyl-33-[(1R,2R,4E)-1-hydroxy-2-methylhepta-4,6-dienyl]-1,4,7,10,12,15,19,25,28-nonamethyl-6,9,18,24-tetrakis(2-methylpropyl)-3,21-di(propan-2-yl)-1,4,7,10,13,16,19,22,25,28,31-undecazacyclotritriacontane-2,5,8,11,14,17,20,23,26,29,32-undecone
    2.1.2 InChI
    InChI=1S/C63H111N11O12/c1-25-27-28-29-41(15)53(76)52-57(80)66-44(26-2)59(82)68(18)34-49(75)69(19)45(30-35(3)4)56(79)67-50(39(11)12)62(85)70(20)46(31-36(5)6)55(78)64-42(16)54(77)65-43(17)58(81)71(21)47(32-37(7)8)60(83)72(22)48(33-38(9)10)61(84)73(23)51(40(13)14)63(86)74(52)24/h25,27-28,35-48,50-53,76H,1,26,29-34H2,2-24H3,(H,64,78)(H,65,77)(H,66,80)(H,67,79)/b28-27+/t41-,42+,43-,44+,45+,46+,47+,48+,50+,51+,52+,53-/m1/s1
    2.1.3 InChI Key
    BICRTLVBTLFLRD-PTWUADNWSA-N
    2.1.4 Canonical SMILES
    CCC1C(=O)N(CC(=O)N(C(C(=O)NC(C(=O)N(C(C(=O)NC(C(=O)NC(C(=O)N(C(C(=O)N(C(C(=O)N(C(C(=O)N(C(C(=O)N1)C(C(C)CC=CC=C)O)C)C(C)C)C)CC(C)C)C)CC(C)C)C)C)C)CC(C)C)C)C(C)C)CC(C)C)C)C
    2.1.5 Isomeric SMILES
    CC[C@H]1C(=O)N(CC(=O)N([C@H](C(=O)N[C@H](C(=O)N([C@H](C(=O)N[C@H](C(=O)N[C@@H](C(=O)N([C@H](C(=O)N([C@H](C(=O)N([C@H](C(=O)N([C@H](C(=O)N1)[C@@H]([C@H](C)C/C=C/C=C)O)C)C(C)C)C)CC(C)C)C)CC(C)C)C)C)C)CC(C)C)C)C(C)C)CC(C)C)C)C
    2.2 Other Identifiers
    2.2.1 UNII
    2PN063X6B1
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Isa 247

    2. Isa(tx)247

    3. Isa-247

    4. Isatx247

    5. Lupkynis

    2.3.2 Depositor-Supplied Synonyms

    1. 515814-01-4

    2. Lupkynis

    3. Luveniq

    4. Isatx-247

    5. Voclosporin [usan]

    6. Isatx247

    7. Isa-247

    8. Isa247

    9. Lx211

    10. Lx-211

    11. R 1524

    12. R-1524

    13. Isa(tx)247

    14. (3s,6s,9s,12r,15s,18s,21s,24s,30s,33s)-30-ethyl-33-[(1r,2r,4e)-1-hydroxy-2-methylhepta-4,6-dienyl]-1,4,7,10,12,15,19,25,28-nonamethyl-6,9,18,24-tetrakis(2-methylpropyl)-3,21-di(propan-2-yl)-1,4,7,10,13,16,19,22,25,28,31-undecazacyclotritriacontane-2,5,8,11,14,17,20,23,26,29,32-undecone

    15. 515814-00-3

    16. 2pn063x6b1

    17. Trans-isa 247

    18. Voclera

    19. Isa 247

    20. (3s,6s,9s,12r,15s,18s,21s,24s,30s,33s)-30-ethyl-33-((1r,2r,e)-1-hydroxy-2-methylhepta-4,6-dien-1-yl)-6,9,18,24-tetraisobutyl-3,21-diisopropyl-1,4,7,10,12,15,19,25,28-nonamethyl-1,4,7,10,13,16,19,22,25,28,31-undecaazacyclotritriacontan-2,5,8,11,14,17,20,23,26,29,32-undecaone

    21. Trans-isa-247

    22. Voclosporin (usan/inn)

    23. Voclosporin [usan:inn]

    24. Isatx 247

    25. Unii-2pn063x6b1

    26. 3odi

    27. Lx-214

    28. Isatx-247; Luveniq

    29. Voclosporin [mi]

    30. Voclosporin [inn]

    31. Voclosporin [mart.]

    32. Voclosporin [who-dd]

    33. E-isa247

    34. Schembl12632344

    35. Gtpl11388

    36. Voclosporin [orange Book]

    37. Chebi:135957

    38. Dtxsid401030488

    39. (e)-isa-247

    40. Ex-a5922

    41. At27977

    42. Db11693

    43. Hy-106638

    44. Cs-0026210

    45. R1524

    46. D09033

    47. Q7939256

    48. Cyclosporin A, 6-((2s,3r,4r)-3-hydroxy-4-methyl-2-(methylamino)-6,8-nonadienoic Acid)-

    49. (3s,6s,9s,12r,15s,18s,21s,24s,30s,33s)-30-ethyl-33-[(1r,2r,4e)-1-hydroxy-2-methylhepta-4,6-dien-1-yl]-1,4,7,10,12,15,19,25,28-nonamethyl-6,9,18,24-tetrakis(2-methylpropyl)-3,21-bis(propan-2-yl)-1,4,7,10,13,16,19,22,25,28,31-undecaazacyclotritriacontan-2,5,8,11,14,17,20,23,26,29,32-undecone

    50. 1,11-anhydro[l-alanyl-d-alanyl-n-methyl-l-leucyl-n-methyl-l-leucyl- N-methyl-l-valyl-[(2s,3r,4r,6e)-3-hydroxy-4-methyl- 2-(methylamino)nona-6,8-dienoyl][(2s)-2-aminobutanoyl]- N-methylglycyl-n-methyl-l-leucyl-l-valyl-n-methyl-l-leucine]

    51. Cyclo (((e,z)-(2s,3r,4r)-3-hydroxy-4-methyl-2-(methylamino)nona-6,8-dienoyl)-l-2-aminobytyrl-n-methyl-glycyl-n-methyl-l-leucyl-l-valyl-n-methyl-l-leucyl-l-alanyl-d-alanyl-n-methyl-l-leucyl-n-methyl-l-leucyl-n-methyl-l-valyl)

    52. Cyclo(l-alanyl-d-alanyl-n-methyl-l-leucyl-n-methyl-l-leucyl-n-methyl-l-valyl- ((2s,3r,4r,6e)-3-hydroxy-4-methyl-2-(methylamino)nona-6,8-dienoyl)-(2s)-2- Aminobutanoyl-n-methylglycyl-n-methyl-l-leucyl-l-valyl-n-methyl-l-leucyl)

    53. Cyclosporin A, 6-((2s,3r,4r,6e)-3-hydroxy-4-methyl-2-(methylamino)-6,8- Nonadienoic Acid)-

    2.4 Create Date
    2006-07-28
    3 Chemical and Physical Properties
    Molecular Weight 1214.6 g/mol
    Molecular Formula C63H111N11O12
    XLogP37.9
    Hydrogen Bond Donor Count5
    Hydrogen Bond Acceptor Count12
    Rotatable Bond Count16
    Exact Mass1213.84136802 g/mol
    Monoisotopic Mass1213.84136802 g/mol
    Topological Polar Surface Area279 Ų
    Heavy Atom Count86
    Formal Charge0
    Complexity2380
    Isotope Atom Count0
    Defined Atom Stereocenter Count12
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Indication

    Voclosporin is used in combination with a background immunosuppressive regimen for the treatment of lupus nephritis. Safety has not been established in combination with cyclophosphamide.

    Treatment of Systemic Lupus Erythematosus (SLE)

    Treatment of non-infectious uveitis

    Lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN).

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Voclosporin inhibits calcineurin, leading to the inhibition of T cell activation by blocking the transcription of early inflammatory cytokines. This reduces inflammation in the kidney, treating lupus nephritis and preventing permanent renal damage.

    5.2 FDA Pharmacological Classification
    5.2.1 Active Moiety
    VOCLOSPORIN
    5.2.2 FDA UNII
    2PN063X6B1
    5.2.3 Pharmacological Classes
    Calcineurin Inhibitors [MoA]; Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]; Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]; P-Glycoprotein Inhibitors [MoA]; Calcineurin Inhibitor Immunosuppressant [EPC]
    5.3 ATC Code

    L04AD03

    L - Antineoplastic and immunomodulating agents

    L04 - Immunosuppressants

    L04A - Immunosuppressants

    L04AD - Calcineurin inhibitors

    L04AD03 - Voclosporin

    5.4 Absorption, Distribution and Excretion

    Absorption

    When administered on an empty stomach, the median Tmax of voclosporin is 1.5 hours, but can range from 1-4 hours. The AUC is estimated at 7693.6 ng/mL*h and the Cmax is estimated at 955.5 ng/mL.

    Route of Elimination

    Voclosporin is eliminated in the urine and feces, with about 88% detected in the feces and about 2% detected in the urine.

    Volume of Distribution

    The apparent volume of distribution of voclosporin is 2,154 L. Voclosporin distributes extensively into red blood cells; distribution between whole blood and plasma is dependent on concentration and temperature.

    Clearance

    The mean apparent steady-state clearance of voclosporin is 63.6 L/h. Hepatic and renal impairment significantly reduce the clearance of voclosporin.

    5.5 Metabolism/Metabolites

    Voclosporin is mainly metabolized by the CYP3A4 hepatic cytochrome enzyme. Pharmacologic activity is mainly attributed to the parent molecule. A major metabolite has been detected in human whole blood, representing 16.7% of total exposure; this metabolite is about 8-fold less potent than the parent drug, voclosporin.

    5.6 Biological Half-Life

    The average terminal half-life of voclosporin is about 30 hours (24.9 to 36.5 hours).

    5.7 Mechanism of Action

    Through the inhibition of calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses, stabilizing podocytes in the kidneys. Voclospoprin is a cyclosporine A analog. It is structurally similar to cyclosporine A (CsA) with the exception of an amino acid modification in one region. This modification changes the binding of voclosporin to calcineurin. Cyclosporine inhibitors reversibly inhibit T-lymphocytes. They also inhibit lymphokine production and release. Cyclosporine A exerts its inhibitory effects on T-lymphocytes by binding to cyclophilin. A cyclophilin-cyclosporine complex is formed, leading to the inhibition of calcium- and calmodulin-dependent serine-threonine phosphatase activity of calcineurin. Along with calcineurin inhibition, the inhibition of many transcription factors necessary for the induction of various cytokine genes such as IL-2, IFN-, IL-4 and GM-CSF occurs. This, in turn, reduces inflammation, treating renal glomerulonephritis associated with systemic lupus erythematosus.

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    Drugs in Development

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    Aurinia Announces Japan Approval of LUPKYNIS® (Voclosporin) to Treat Lupus Nephritis

    Details:

    Lupkynis (voclosporin) is an approved oral calcineurin inhibitor, a small molecule drug candidate, which is indicated for the treatment of patients with Lupus Nephritis.


    Lead Product(s): Voclosporin

    Therapeutic Area: Nephrology Brand Name: Lupkynis

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 24, 2024

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    Lead Product(s) : Voclosporin

    Therapeutic Area : Nephrology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Aurinia Announces Japan Approval of LUPKYNIS® (Voclosporin) to Treat Lupus Nephritis

    Details : Lupkynis (voclosporin) is an approved oral calcineurin inhibitor, a small molecule drug candidate, which is indicated for the treatment of patients with Lupus Nephritis.

    Brand Name : Lupkynis

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 24, 2024

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    FDA Approves Updated LUPKYNIS® Label with Long-Term Data from AURORA Clinical Program

    Details:

    Lupkynis (voclosporin) is a USFDA approved oral calcineurin inhibitor, small molecule drug candidate, which is indicated for the treatment of patients with Lupus Nephritis.


    Lead Product(s): Voclosporin

    Therapeutic Area: Nephrology Brand Name: Lupkynis

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 30, 2024

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    Lead Product(s) : Voclosporin

    Therapeutic Area : Nephrology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    FDA Approves Updated LUPKYNIS® Label with Long-Term Data from AURORA Clinical Program

    Details : Lupkynis (voclosporin) is a USFDA approved oral calcineurin inhibitor, small molecule drug candidate, which is indicated for the treatment of patients with Lupus Nephritis.

    Brand Name : Lupkynis

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    April 30, 2024

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    Aurinia Pharmaceuticals Announces Collaboration Partner Otsuka Filed New Drug Application (NDA) for LUPKYNIS® (Voclosporin) in Japan

    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 Brand Name: Lupkynis

    Study Phase: ApprovedProduct Type: Peptide

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 13, 2023

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    Lead Product(s) : Voclosporin

    Therapeutic Area : Nephrology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Aurinia Pharmaceuticals Announces Collaboration Partner Otsuka Filed New Drug Application (NDA) fo...

    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.

    Brand Name : Lupkynis

    Molecule Type : Peptide

    Upfront Cash : Not Applicable

    November 13, 2023

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    Otsuka Submits New Drug Application in Japan for Voclosporin in the Treatment of Patients with Lupus Nephritis

    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 Brand Name: Lupkynis

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Otsuka Pharmaceutical

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 10, 2023

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    Aurinia Pharmaceuticals

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    Lead Product(s) : Voclosporin

    Therapeutic Area : Nephrology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Otsuka Pharmaceutical

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Otsuka Submits New Drug Application in Japan for Voclosporin in the Treatment of Patients with Lup...

    Details : Lupkynis (voclosporin) is an an oral calcineurin inhibitor which is being evaluated in clinical trials for the treatment of patients with Lupus Nephritis.

    Brand Name : Lupkynis

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 10, 2023

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    Aurinia Pharmaceuticals Announces NICE Recommendation of LUPKYNIS® (Voclosporin) For Adults with Active Lupus Nephritis

    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 Brand Name: Lupkynis

    Study Phase: ApprovedProduct Type: Peptide

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 03, 2023

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    05

    Aurinia Pharmaceuticals

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    Lead Product(s) : Voclosporin

    Therapeutic Area : Nephrology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Aurinia Pharmaceuticals Announces NICE Recommendation of LUPKYNIS® (Voclosporin) For Adults with ...

    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 develope...

    Brand Name : Lupkynis

    Molecule Type : Peptide

    Upfront Cash : Not Applicable

    May 03, 2023

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    Aurinia Pharmaceuticals Announces Swissmedic Approval of LUPKYNIS® (voclosporin)

    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 Brand Name: Lupkynis

    Study Phase: ApprovedProduct Type: Peptide

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 02, 2023

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    06

    Aurinia Pharmaceuticals

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    Lead Product(s) : Voclosporin

    Therapeutic Area : Immunology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Aurinia Pharmaceuticals Announces Swissmedic Approval of LUPKYNIS® (voclosporin)

    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.

    Brand Name : Lupkynis

    Molecule Type : Peptide

    Upfront Cash : Not Applicable

    May 02, 2023

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    Aurinia Pharmaceuticals Announces New and Refined Method of Use Patent for LUPKYNIS® in the Treatment of Lupus Nephritis Issued by United States Patent...

    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 Brand Name: Lupkynis

    Study Phase: PreclinicalProduct Type: Peptide

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 11, 2023

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    07

    Aurinia Pharmaceuticals

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    Lead Product(s) : Voclosporin,Mycophenolate Mofetil,Undisclosed

    Therapeutic Area : Nephrology

    Highest Development Status : Preclinical

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Aurinia Pharmaceuticals Announces New and Refined Method of Use Patent for LUPKYNIS® in the Treat...

    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 develope...

    Brand Name : Lupkynis

    Molecule Type : Peptide

    Upfront Cash : Not Applicable

    April 11, 2023

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    Aurinia Pharmaceuticals Announces Promising Topline Data from Renal Biopsy Sub-study of the AURORA Trial

    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 Brand Name: Lupkynis

    Study Phase: ApprovedProduct Type: Peptide

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 05, 2023

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    08

    Aurinia Pharmaceuticals

    Canada
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    Lead Product(s) : Voclosporin

    Therapeutic Area : Nephrology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Aurinia Pharmaceuticals Announces Promising Topline Data from Renal Biopsy Sub-study of the AURORA...

    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 k...

    Brand Name : Lupkynis

    Molecule Type : Peptide

    Upfront Cash : Not Applicable

    April 05, 2023

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    Aurinia Pharmaceuticals Announces Allowance of a New and Refined Method of Use Patent for Lupkynis® in the Treatment of Lupus Nephritis From the United...

    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 Brand Name: Lupkynis

    Study Phase: PreclinicalProduct Type: Peptide

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 24, 2023

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    09

    Aurinia Pharmaceuticals

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    Lead Product(s) : Voclosporin,Mycophenolate Mofetil,Undisclosed

    Therapeutic Area : Nephrology

    Highest Development Status : Preclinical

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Aurinia Pharmaceuticals Announces Allowance of a New and Refined Method of Use Patent for Lupkynis...

    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 develope...

    Brand Name : Lupkynis

    Molecule Type : Peptide

    Upfront Cash : Not Applicable

    January 24, 2023

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    Aurinia Announces the Great Britain Marketing Authorization of LUPKYNIS® (voclosporin) for the Treatment of Lupus Nephritis

    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 Brand Name: Lupkynis

    Study Phase: ApprovedProduct Type: Peptide

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 30, 2022

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    Aurinia Pharmaceuticals

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    Lead Product(s) : Voclosporin

    Therapeutic Area : Nephrology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Aurinia Announces the Great Britain Marketing Authorization of LUPKYNIS® (voclosporin) for the Tr...

    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 k...

    Brand Name : Lupkynis

    Molecule Type : Peptide

    Upfront Cash : Not Applicable

    November 30, 2022

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    US Patents

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    01

    AURINIA

    VOCLOSPORIN

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    AURINIA

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    Patent Expiration Date : 2025-10-17

    VOCLOSPORIN

    US Patent Number : 7332472

    Drug Substance Claim : Y

    Drug Product Claim : Y

    Application Number : 213716

    Patent Use Code : U-3056

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2025-10-17

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    AURINIA

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    Patent Expiration Date : 2037-12-07

    VOCLOSPORIN

    US Patent Number : 10286036

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 213716

    Patent Use Code : U-3056

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2037-12-07

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    03

    AURINIA

    VOCLOSPORIN

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    AURINIA

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    Patent Expiration Date : 2037-12-07

    VOCLOSPORIN

    US Patent Number : 11622991

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 213716

    Patent Use Code : U-3056

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2037-12-07

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    AURINIA

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      VOCLOSPORIN

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      NCE
      2026-01-22
      213716
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      01

      AURINIA

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      AURINIA

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      VOCLOSPORIN

      Exclusivity Code : NCE

      Exclusivity Expiration Date : 2026-01-22

      Application Number : 213716

      Product Number : 1

      Exclusivity Details :

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