Approved & therapeutic
Voclosporin
Lupkynis
Voclosporin is a structurally modified cyclosporine analogue approved in 2021, in combination with background immunosuppression, for adults with active lupus nephritis.
Also known as: ISA247
- Status
- Voclosporin is approved by the U.S. FDA and has official prescribing information.
- Evidence
- Approved labeling. Official prescribing information exists, based on clinical trials in people.
- Half-life
- Approximately 30 hours.
- How it's taken
- Oral capsules twice daily
- Mechanism
- Immune modulation
- Pathways
- Calcineurin
How Voclosporin works
Voclosporin is a calcineurin inhibitor with a modification to the amino acid 1 side chain that increases calcineurin binding potency and alters its metabolite profile. The greater potency allows lower doses, and the more predictable pharmacokinetics permit fixed dosing without the routine therapeutic drug monitoring cyclosporine requires.
What research has looked at
- The AURORA 1 trial showed a higher rate of complete renal response in lupus nephritis when added to mycophenolate and low-dose steroids.
- It has a dual mechanism relevant to this indication: calcineurin inhibition suppresses T cells, and a separate effect stabilises podocytes, directly reducing proteinuria.
- Fixed dosing without routine drug-level monitoring, unlike cyclosporine and tacrolimus.
- It was the first oral therapy specifically approved for lupus nephritis.
Evidence level: Approved labeling. Official prescribing information exists, based on clinical trials in people. These are areas studied or reported, not promised effects.
Reported side effects and risks
- Boxed warning for malignancy and serious infection, as with all calcineurin inhibitors.
- Nephrotoxicity — an inherent tension in a drug given for kidney disease. eGFR must be monitored and the dose reduced or stopped for defined decreases.
- Hypertension, which is common and requires management.
- It is contraindicated with strong CYP3A4 inhibitors and requires dose reduction with moderate inhibitors.
- Long-term data beyond the trial period remain limited, and the durability of the renal response is not fully characterised.
Sources
- FDA approved-drug listing for voclosporin · U.S. Food & Drug Administration
- DailyMed prescribing information for voclosporin · NIH · DailyMed
- PubMed research on voclosporin AURORA lupus nephritis · NIH · National Library of Medicine
- DrugBank record for voclosporin · DrugBank
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Voclosporin FAQ
What is Voclosporin?
Voclosporin is a structurally modified cyclosporine analogue approved in 2021, in combination with background immunosuppression, for adults with active lupus nephritis.
How does Voclosporin work?
Voclosporin is a calcineurin inhibitor with a modification to the amino acid 1 side chain that increases calcineurin binding potency and alters its metabolite profile. The greater potency allows lower doses, and the more predictable pharmacokinetics permit fixed dosing without the routine therapeutic drug monitoring cyclosporine requires.
Is Voclosporin FDA approved?
Yes. Voclosporin is approved by the U.S. FDA and has official prescribing information. Evidence level: approved labeling. Official prescribing information exists, based on clinical trials in people.
What is the half-life of Voclosporin?
Reported half-life: Approximately 30 hours.
How is Voclosporin taken?
Oral capsules twice daily.
What side effects have been reported with Voclosporin?
Reported in the sources: Boxed warning for malignancy and serious infection, as with all calcineurin inhibitors; Nephrotoxicity — an inherent tension in a drug given for kidney disease. eGFR must be monitored and the dose reduced or stopped for defined decreases; Hypertension, which is common and requires management; It is contraindicated with strong CYP3A4 inhibitors and requires dose reduction with moderate inhibitors; Long-term data beyond the trial period remain limited, and the durability of the renal response is not fully characterised.
Educational summary compiled from the sources listed above. Not medical advice. Peptide Vault does not sell, source or recommend any compound. Talk to a qualified clinician before starting or changing anything.