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NCE-1 Intelligence & Market Opportunity

Lupkynis

Voclosporin
Immunomodulators
Oral Capsule

Lupus nephritis has historically been treated with broad immunosuppression and steroids, with remission rates that left substantial room for improvement. Lupkynis (voclosporin) arrived as the first FDA-approved oral therapy developed specifically for the condition.

It is a calcineurin inhibitor that reduces the immune-driven kidney inflammation behind proteinuria, while also stabilizing the podocytes that maintain the glomerular filtration barrier. Approved for adults with active lupus nephritis, it is used alongside background immunosuppressive therapy.

Lupkynis remains on the market without generic competition and holds orphan drug designation. As the first oral agent approved in lupus nephritis it is a standard comparator in the space, and worth tracking as competing therapies pursue the same indication.

Approval Date
22-Jan-21
NCE-1 Date
22-Jan-25
NCE Date
22-Jan-26
Commercial snapshot

Market performance & projections

Revenue ($M)
271
CAGR (%)
16.89%
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
351
2027
419
2028
480
2029
506
2030
532
2031
560
2032
595
Molecule profile

Details & specifications

Molecule
Voclosporin
Innovator
AURINIA PHARMA U.S., INC.
Dosage Form
Oral Capsule
Strength
7.9 mg
Therapeutic Category
Immunomodulators
Usage
To treat lupus nephritis
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