alipogene tiparvovec
Trade name: glybera
Alipogene tiparvovec, sold under the brand name Glybera, is a gene therapy treatment designed to reverse lipoprotein lipase deficiency (LPLD), a rare recessive disorder, due to mutations in LPL, which can cause severe pancreatitis. It was recommended for approval by the European Medicines Agency in July 2012, and approved by the European Commission in November of the same year. It was the first marketing authorisation for a gene therapy treatment in either the European Union or the United States. — Wikipedia
Clinical trial activity
3 trials · 6 clinical orgs · 0 marketing orgs
Earliest trial started Aug 1, 2007 (NCT01109498)
Timeline
2000s
- Jan 1, 2007
Earliest Phase 2 Sponsor(trial)
Indications
Mechanism of action
- TriglycerideHYDROLYTIC ENZYME
Triglyceride hydrolytic enzyme
Hydrolyses plasma triglycerides and triglyceride-lipoproteins.
- Lipoprotein lipaseSupplementation
LPL supplementation
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaAlipogene tiparvovec ↗
- ChEMBLCHEMBL2108304 ↗
Also known as
- alipogene tiparvovec
- alipogene tiparvovec
- alipogene tiparvovec
- alipogene tiparvovec
- glybera
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02904772 | Phase 2 | Oct 1, 2016 | Chiesi, UniQure N.V., University of Sherbrooke |
| NCT00891306 | Phase 2/Phase 3 (Phase 3) | Feb 1, 2009 | Amsterdam Molecular Therapeutics, The Clinical Trial Company |
| NCT01109498 | Phase 2/Phase 3 (Phase 3) | Aug 1, 2007 | Amsterdam Molecular Therapeutics, International Antiviral Therapy Evaluation Center (IATEC) |
Organizations
Research & Development (6)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Amsterdam Molecular Therapeutics | For profit | 2 | 2 | 1 | 2007 |
| Chiesi | For profit | 1 | 0 | 1 | 2016 |
| International Antiviral Therapy Evaluation Center (IATEC) | Academic/Hospital | 1 | 0 | 1 | 2007 |
| The Clinical Trial Company | For profit | 1 | 0 | 1 | 2009 |
| UniQure N.V. | For profit | 1 | 1 | 1 | 2016 |
| University of Sherbrooke | Academic/Hospital | 1 | 0 | 1 | 2016 |