Drugs / Macugen
Macugen
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Macugen | — | 2006-01-31 | europa.eu ↗ |
| Approved | US (FDA) | MACUGEN | — | 2004-09-17 | fda.gov ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT01589718 | Apr 2012 → Mar 2014 | proliferative diabetic retinopathy | Greater Houston Retina Research | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase not applicable1 trial | ||||||
| — | NCT00446381 | Oct 2006 → Sep 2008 | diabetic macular edema, proliferative diabetic retinopathy | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Completed | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2004-12-21 | Ionis Pharmaceuticals | Isis Pharmaceuticals to Receive $24 Million for a Portion of Its Macugen(R) Royalty Rights ionis.com ↗ |
| 2004-12-20 | Ionis Pharmaceuticals | Isis Pharmaceuticals Earns $3 Million Milestone Payment from Eyetech for FDA Marketing Clearance of Macugen(TM) ionis.com ↗ |
| 2004-06-24 | Ionis Pharmaceuticals | Isis Pharmaceuticals Earns $1 Million Milestone Payment From Eyetech Related to Filing of Macugen(TM) New Drug Application ionis.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Macugen | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00446381 ↗ |
| Known as | 0.3mg Pegaptanib Sodium, Macugen | “0.3mg Pegaptanib Sodium, Macugen” NCT01589718 ↗ |
| Known as | pegaptanib | “Macugen (pegaptanib)” NCT00446381 ↗ |
| Action | Inhibit | “inhibits it from binding to its cellular receptors” NCT00446381 ↗ |
| Modality | Aptamer | “anti-VEGF pegylated aptamer” NCT00446381 ↗ |
| Route | Intravitreal | “by intravitreal injection” NCT00446381 ↗ |