Drugs / Alipogene Tiparvovec

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Withdrawn EU (EMA) Glybera 2017-10-28 europa.eu
Approved EU (EMA) Glybera 2012-10-25 europa.eu

Trials 3 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT02904772 Oct 2016 → Jun 2020 familial lipoprotein lipase deficiency UniQure Biopharma B.V. Withdrawn No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT00891306 Feb 2009 → Aug 2010 familial lipoprotein lipase deficiency Amsterdam Molecular Therapeutics Completed No outcome recorded
Phase 2/3 NCT01109498 Aug 2007 → Jun 2013 familial lipoprotein lipase deficiency Amsterdam Molecular Therapeutics Unknown No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as Alipogene Tiparvovec ClinicalTrials.gov intervention name — accepted as the source's own label NCT01109498
2

NCT02904772

NCT00891306

Known as AAV1-LPLS447X “alipogene tiparvovec (AAV1-LPLS447X) gene” PMID 22717743 Jun 2012
1

“alipogene tiparvovec, AAV1-LPL(S447X)” PMID 22438229 Mar 2012

Known as Alipogen tiparvovec ChEMBL registry synonym — accepted as the source's own label CHEMBL2108304
Known as Glybera ChEMBL registry synonym — accepted as the source's own label CHEMBL2108304
Action Restore “Alipogene tiparvovec corrects or restores lipoprotein lipase (LPL) function long term” NCT00891306
Route Intramuscular “administered as a single set of intramuscular injections” NCT02904772
Target LPL “Alipogene tiparvovec gene therapy ensures that a catabolically beneficial variant of the human LPL gene” NCT00891306