Drugs / Voclosporin
Voclosporin
also known as
LX211 · VCS · VOS · ISA-247 · ISATX-247 · LUPKYNIS · QL1074 · voclosporin, ISA247 · +2 more
Other / unclassified targets PPP3CA via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LUPKYNIS | — | 2024-04-29 | fda.gov ↗ |
| Approved | EU (EMA) | Lupkynis | — | 2022-09-15 | europa.eu ↗ |
| Approved | US (FDA) | LUPKYNIS | — | 2021-01-22 | fda.gov ↗ |
Trials 19 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05306379 | Jan → Apr 2022 | — | Aurinia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02949999 | Oct → Dec 2016 | — | Aurinia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00851734 | Feb → Mar 2009 | keratoconjunctivitis | Lux Biosciences, Inc. | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT05306873 | Nov 2022 → Jun 2024 | systemic lupus erythematosus | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 2 | NCT04701528 | Nov 2020 → Mar 2022 | COVID-19, disease related to solid organ transplantation | Leiden University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03597139 | Aug → Nov 2018 | dry eye syndrome | Aurinia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03598036 | Jun 2018 → May 2020 | focal segmental glomerulosclerosis | Aurinia Pharmaceuticals Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT02949973 | Jun 2015 → Dec 2016 | lupus nephritis | Aurinia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02141672 | Jun 2014 → Jul 2016 | lupus nephritis | Aurinia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04147650 | Oct 2019 → Sep 2020 | dry eye syndrome | Aurinia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT05962788 | Mar 2024 → Jul 2025 | lupus nephritis | Aurinia Pharmaceuticals Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT06406205 | Dec 2023 → Jun 2027 expected | lupus nephritis | Qilu Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05288855 | Oct 2023 → Jul 2025 | lupus nephritis | Aurinia Pharmaceuticals Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT03597464 | Sep 2019 → Oct 2021 | lupus nephritis | Aurinia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03021499 | May 2017 → Sep 2019 | lupus nephritis | Aurinia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01586845 | Mar 2013 → Dec 2015 | — | Aurinia Pharmaceuticals Inc. | Withdrawn | No outcome recorded |
| Phase 3 | NCT01243983 | Feb 2011 → Dec 2012 | uveitis | Lux Biosciences, Inc. | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07611214 | Apr 2026 → Mar 2029 expected | lupus nephritis | Aurinia Pharmaceuticals Inc. | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01236287 | — | immunodeficiency disease | Weill Medical College of Cornell University | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00270634 Comparator | Jan 2006 → Jul 2009 | kidney disorder | Aurinia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT00404885 Comparator | Jan 2007 → Nov 2008 | anterior uveitis, panuveitis | Lux Biosciences, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00404612 Comparator | Jan 2007 → Nov 2008 | intermediate uveitis, panuveitis, posterior uveitis | Lux Biosciences, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00404742 Comparator | Jan 2007 → Nov 2008 | intermediate uveitis, panuveitis, posterior uveitis | Lux Biosciences, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00408187 Comparator | Dec 2006 → Dec 2008 | psoriasis | Aurinia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00258713 Comparator | Sep 2005 → Jul 2006 | psoriasis | Aurinia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00244842 Comparator | Dec 2004 → Oct 2005 | psoriasis | Aurinia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07225387 Comparator | Oct 2024 → Jan 2027 expected | lupus nephritis | NephroNet, Inc. | Recruiting | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-11-20 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka launches Lupkynis in Japan® otsuka.co.jp ↗ |
| 2024-09-24 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Receives Approval in Japan for Lupkynis as a Treatment for Lupus Nephritis® otsuka.co.jp ↗ |
| 2022-09-20 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka announces EC approval of Lupkynis® (voclosporin) as first oral treatment for active lupus nephritis otsuka.co.jp ↗ |
| 2022-07-22 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka receives positive CHMP opinion for Lupkynis (voclosporin)for the treatment of active lupus nephritisTM otsuka.co.jp ↗ |
| 2021-06-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Has Filed a Marketing Authorization Application to the European Medicines Agency for Voclosporin for the Treatment of Patients with Lupus Nephritis otsuka.co.jp ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 29 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Voclosporin | “Treatment Arm A: voclosporin 0.4 mg/kg p.o. b.i.d., not to exceed 40 mg p.o. b.i.d.” NCT01243983 ↗ |
| Known as | ISA-247 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314379 ↗ |
| Known as | ISATX-247 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314379 ↗ |
| Known as | LUPKYNIS | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07611214 ↗ |
| Known as | LX211 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00404612 ↗ |
| Known as | QL1074 | “Drug: Voclosporin calcineurin inhibitor Other Names: QL1074” NCT06406205 ↗ |
| Known as | VCS | “Voclosporin (VCS, ISA247) is a novel calcineurin inhibitor being developed for organ transplantation.” PMID 21943027 ↗ Sep 20111“anti-viral effect of voclosporin (VCS) with an extended safety follow-up” NCT04701528 ↗ |
| Known as | voclosporin, ISA247 | “voclosporin, ISA247” NCT01586845 ↗ |
| Known as | Voclosporina | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314379 ↗ |
| Known as | Voclosporine | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314379 ↗ |
| Known as | VOS | “0.05% Voclosporin Ophthalmic Solution (VOS)” NCT04147650 ↗1“Voclosporin ophthalmic solution (VOS)” NCT03597139 ↗ |
| Action | Inhibit | “Voclosporin represents the possibility of a calcineurin inhibitor which is not only as efficacious as cyclosporine A, but also has an improved toxicity profile.” NCT00258713 ↗1“Serine/threonine protein phosphatase 2B catalytic subunit, alpha isoform inhibitor” CHEMBL5314379 ↗ |
| Modality | Other / unclassified | “a novel CNI, voclosporin (VCS)” NCT04701528 ↗ |
| Route | Oral | “voclosporin 0.4, 0.6, 0.8 mg/kg po BID” NCT00270634 ↗ |
| Target | PPP3CA | “Serine/threonine protein phosphatase 2B catalytic subunit, alpha isoform inhibitor” CHEMBL5314379 ↗ |