drug

voclosporin

Marketedupdated 3mo ago

by $AUPH Aurinia Pharmaceuticals Inc.

Approved

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Protein drug with a maximum clinical stage of Approval (across all indications), with an approval for lupus nephritis and immune system disease and 9 investigational indications.

all catalysts(3)

approval · 3

LUPKYNIS (VOCLOSPORIN) — FDA approval

LUPKYNIS (VOCLOSPORIN) — FDA approval

LUPKYNIS (VOCLOSPORIN) — FDA approval

voclosporin

→

Trials studying voclosporin

phase3Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritisterminatedn=9
phase3Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritisterminatedn=4
—LUPKYNIS Drug-use Results Surveyrecruitingn=400
—A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the UScompletedn=229
phase2Anti-Viral Effects of Voclosporin in COVID-19 Positive Kidney Transplant Recipientscompletedn=20
phase3A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritisrecruitingn=270

Patent cliff

source: FDA Orange Book

first barrier falls

Oct 17, 2027

~1.2 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (3)

Dec 7, 2037method-of-use (U-3056)US 10286036
Dec 7, 2037method-of-use (U-3056)US 11622991
Oct 17, 2027compositionUS 73324721.2y

FDA exclusivities (1)

Jan 22, 2026NCENew Chemical Entity (5y)

News(2)

LifeMine raises $263M in mission to improve organ transplant aftercare
Patients who receive an organ transplant must take difficult immuno-suppressive medicines for the rest of their lives. LifeMine Therapeutics wants to offer a safer alternative.
biospace · 9d ago
‘Greg, you’ve got to bring back this platform’: How LifeMine won over Gates and Bezos for $188M series E
A little over a year ago, LifeMine Therapeutics laid off staff and put its fungus-based platform on ice to focus its dwindling resources on its lead asset. Now, the Massachusetts biotech is shaking…
fiercebiotech · 9d ago

brand

Lupkynis

generic

voclosporin

MOA

12.1 Mechanism of Action LUPKYNIS is a calcineurin-inhibitor immunosuppressant. The mechanism of voclosporin suppression of calcineurin has not been fully established. Activation of lymphocytes involves an increase in intracellular calcium concentrations that bind to the calcineurin regulatory site and activate calmodulin binding catalytic subunit and through dephosphorylation activates the transcription factor, Nuclear Factor of Activated T-Cell Cytoplasmic (NFATc). The immunosuppressant activity results in inhibition of lymphocyte proliferation, T-cell cytokine production, and expression of T-cell activation surface antigens. Studies in animal models also support a non-immunological role for calcineurin inhibition in kidney function to stabilize actin cytoskeleton and stress fibers in podocytes leading to increased podocyte integrity in glomeruli.

indication

Lupus Nephritis

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed 29m ago

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drug

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voclosporin

Marketedupdated 3mo ago

by $AUPH Aurinia Pharmaceuticals Inc.

Approved

community read0 votes

🐶 often sniffed alongside

top 3

Protein drug with a maximum clinical stage of Approval (across all indications), with an approval for lupus nephritis and immune system disease and 9 investigational indications.

all catalysts(3)

approval · 3

LUPKYNIS (VOCLOSPORIN) — FDA approval

LUPKYNIS (VOCLOSPORIN) — FDA approval

LUPKYNIS (VOCLOSPORIN) — FDA approval

voclosporin

→

Trials studying voclosporin

phase3Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritisterminatedn=9
phase3Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritisterminatedn=4
—LUPKYNIS Drug-use Results Surveyrecruitingn=400
—A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the UScompletedn=229
phase2Anti-Viral Effects of Voclosporin in COVID-19 Positive Kidney Transplant Recipientscompletedn=20
phase3A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritisrecruitingn=270

Patent cliff

source: FDA Orange Book

first barrier falls

Oct 17, 2027

~1.2 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (3)

Dec 7, 2037method-of-use (U-3056)US 10286036
Dec 7, 2037method-of-use (U-3056)US 11622991
Oct 17, 2027compositionUS 73324721.2y

FDA exclusivities (1)

Jan 22, 2026NCENew Chemical Entity (5y)

News(2)

LifeMine raises $263M in mission to improve organ transplant aftercare
Patients who receive an organ transplant must take difficult immuno-suppressive medicines for the rest of their lives. LifeMine Therapeutics wants to offer a safer alternative.
biospace · 9d ago
‘Greg, you’ve got to bring back this platform’: How LifeMine won over Gates and Bezos for $188M series E
A little over a year ago, LifeMine Therapeutics laid off staff and put its fungus-based platform on ice to focus its dwindling resources on its lead asset. Now, the Massachusetts biotech is shaking…
fiercebiotech · 9d ago

brand

Lupkynis

generic

voclosporin

MOA

indication

Lupus Nephritis

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed 29m ago

Found something off?

comments(0)

5-min edit window · permanent after that

no comments yet — first sniff?

voclosporin

🐶 often sniffed alongside

all catalysts(3)

Trials studying voclosporin

Patent cliff

patents (3)

FDA exclusivities (1)

News(2)

Report a data issue

comments(0)

voclosporin

🐶 often sniffed alongside

all catalysts(3)

Trials studying voclosporin

Patent cliff

patents (3)

FDA exclusivities (1)

News(2)

Report a data issue

comments(0)