Drugs / pegaptanib
pegaptanib
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed age-related macular degeneration 2 milestones | |||||
| Filed | EU (EMA) | Macugen | age-related macular degeneration | — | “upon the filing of a new drug application in Europe for Macugen(TM) (pegaptanib sodium injection)” gilead.com ↗ |
| Filed | US (FDA) | Macugen | age-related macular degeneration | — | “filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Macugen™ (pegaptanib sodium injection)” ionis.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Macugen | — | 2006-01-31 | europa.eu ↗ |
| Approved | US (FDA) | MACUGEN | — | 2004-09-17 | fda.gov ↗ |
Trials 32
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01487070 | Apr → Jul 2011 | proliferative diabetic retinopathy | Retina Institute of Hawaii | Completed | No outcome recorded |
| Phase 1 | NCT00056199 | Mar 2003 → Nov 2005 | von Hippel-Lindau disease | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT00358423 | Jul 2006 → Feb 2007 | cystoid macular edema | Johns Hopkins University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT00346983 | Jun 2006 → Apr 2007 | cystoid macular edema | Johns Hopkins University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 26 trials · 1 missed | ||||||
| Phase 2 | NCT01281098 | Mar 2010 → Oct 2012 | proliferative diabetic retinopathy, type 1 diabetes mellitus, type 2 diabetes mellitus | Association for Innovation and Biomedical Research on Light and Image | Completed | No outcome recorded |
| Phase 2 | NCT00531336 | Jul 2006 → Dec 2008 | macular degeneration | The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery | Completed | No outcome recorded |
| Phase 2 | NCT00239928 | Sep 2005 → Nov 2008 | age-related macular degeneration | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00088283 | May 2004 → ? | retinal vein occlusion | Eyetech Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT00087763 | Mar 2004 → May 2006 | macular degeneration | Eyetech Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00040313 | Oct 2002 → Feb 2005 | diabetic macular edema | Eyetech Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/34 trials · 1 met primary | ||||||
| Phase 2/3 | NCT00605280 | Sep 2005 → Nov 2009 | diabetic macular edema | Pfizer | Completed | Met primary |
| Phase 2/3 | NCT00215670 | Nov 2002 → May 2006 | age-related macular degeneration | Eyetech Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/3 | NCT00021736 | Jul 2001 → Jul 2002 | choroidal neovascularization, macular degeneration | Eyetech Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/3 | NCT00321997 | May 2001 → Oct 2007 | age-related macular degeneration | Eyetech Pharmaceuticals | Completed | No outcome recorded |
| Phase 34 trials · 1 met primary | ||||||
| Phase 3 | NCT01189461 | Jan 2011 → Jul 2012 | diabetic macular edema | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01100307 | May 2010 → Aug 2012 | diabetes mellitus, macular retinal edema | Pfizer | Completed | Met primary |
| Phase 3 | NCT00788177 | Nov 2008 → Mar 2012 | age-related macular degeneration | Klinikum Ludwigshafen | Unknown | No outcome recorded |
| Phase 3 | NCT00150202 | Jul 2004 → Oct 2006 | macular degeneration | Pfizer | Completed | No outcome recorded |
| Phase 49 trials | ||||||
| Phase 4 | NCT01175070 | Jan 2011 → Mar 2013 | diabetic macular edema | University of Oxford | Completed | No outcome recorded |
| Phase 4 | NCT01573572 | Apr 2010 → Nov 2019 | age-related macular degeneration, diabetic macular edema, retinal vein occlusion | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 4 | NCT01486238 | Apr 2009 → Jul 2011 | diabetic macular edema | Valley Retina Institute | Completed | No outcome recorded |
| Phase 4 | NCT01486771 | Nov 2007 → Aug 2013 | proliferative diabetic retinopathy | Valley Retina Institute | Unknown | No outcome recorded |
| Phase 4 | NCT00324116 | Jul 2006 → Aug 2008 | macular degeneration | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00327470 | Jul 2006 → Aug 2009 | age-related macular degeneration, choroidal neovascularization | Pfizer | Terminated | No outcome recorded |
| Phase 4 | NCT00354445 | Jun 2006 → ? | age-related macular degeneration | Eyetech Pharmaceuticals | Unknown | No outcome recorded |
| Phase 4 | NCT00312351 | Apr → Nov 2006 | macular degeneration | Eyetech Pharmaceuticals | Terminated | No outcome recorded |
| Phase 4 | NCT00134667 | Mar 2005 → Oct 2008 | age-related macular degeneration | Eyetech Pharmaceuticals | Terminated | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT00790803 | Mar 2009 → Nov 2011 | cystoid macular edema, uveitis | Wake Forest University | Completed | No outcome recorded |
| — | NCT00709657 | Mar 2008 → Jul 2010 | macular degeneration | Medical University of Vienna | Terminated | No outcome recorded |
| — | NCT00272766 | Feb 2006 → May 2007 | choroidal neovascularization, histoplasmosis retinitis | Barnes Retina Institute | Terminated | No outcome recorded |
| — | NCT00088192 | Jul 2004 → ? | macular degeneration | Eyetech Pharmaceuticals | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01487044 | — | diabetic macular edema | Retina Institute of Hawaii | Available | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 3 | NCT00242580 Comparator | Sep 2005 → Jan 2008 | age-related macular degeneration, choroidal neovascularization | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT02321267 Background | Dec 2014 → Dec 2024 | macular degeneration | Kagawa University | Unknown | No outcome recorded |
| Phase 4 | NCT00406107 Comparator | Jan 2006 → Dec 2007 | occlusion of tributary of retinal vein | Palmetto Retina Center, LLC | Completed | No outcome recorded |
| — | NCT01218230 Comparator | Dec 2010 → Jul 2012 | choroidal neovascularization | L.V. Prasad Eye Institute | Withdrawn | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2004-12-20 | Ionis Pharmaceuticals | Regulatory Isis Pharmaceuticals Earns $3 Million Milestone Payment from Eyetech for FDA Marketing Clearance of Macugen(TM) ionis.com ↗
Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced today that it has earned a $3 million milestone from Eyetech Pharmaceuticals, Inc. (Nasdaq: EYET) associated with the marketing clearance of Macugen™ (pegaptanib sodium injection) by the U.S. Food and Drug Administration (FDA). |
| 2004-06-24 | Ionis Pharmaceuticals | Regulatory Isis Pharmaceuticals Earns $1 Million Milestone Payment From Eyetech Related to Filing of Macugen(TM) New Drug Application ionis.com ↗ |
All 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 9 cited values
Every value below carries the sentence it was read from. 40 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | pegaptanib | “intravitreous pegaptanib 0.3 mg or sham injection.” PMID 21896838 ↗ Sep 2011 |
| Known as | EYE001 | “Intravitreal Injections of EYE001 (Anti-VEGF Pegylated Aptamer)” NCT00040313 ↗ |
| Known as | Macugen | “Effect of pegaptanib sodium 0.3 mg intravitreal injections (Macugen) in intraocular pressure: posthoc analysis from V.I.S.I.O.N. study.” PMID 24997182 ↗ Jul 201413“The substances currently in clinical use include ranibizumab (Lucentis®), bevacizumab (Avastin®) and pegaptanib (Macugen®).” NCT00709657 ↗ “Pegaptanib Sodium (Macugen®), Given As Often As Every 6 Weeks for 2 Years” NCT00605280 ↗ “Macugen ™ (pegaptanib sodium injection)” NCT00087763 ↗ “pegaptanib (also called Macugen)” NCT00358423 ↗ “Macugen ® (pegaptanib sodium)” NCT01486771 ↗ “Macugen (Pegaptanib Sodium)” NCT01487070 ↗ “Macugen (pegaptanib sodium)” NCT00134667 ↗ “pegaptanib sodium (Macugen)” NCT00354445 ↗ “Macugen (Pegaptanib Sodium)” NCT01487044 ↗ “pegaptanib sodium (Macugen)” NCT00040313 ↗ |
| Known as | Macugen \[TM\] | “Eligible participants with ischaemic diabetic macular oedema will receive an intravitreal injection of pegaptanib sodium (Macugen \[TM\]) 0.3mg every 6 weeks over a 30 week period.” NCT01175070 ↗ |
| Known as | Pegaptanib Sodium | “Eligible participants with ischaemic diabetic macular oedema will receive an intravitreal injection of pegaptanib sodium (Macugen \[TM\]) 0.3mg every 6 weeks over a 30 week period.” NCT01175070 ↗19“OBJECTIVES: To assess the safety and efficacy of intravitreous pegaptanib sodium for the treatment of macular edema following central retinal vein occlusion (CRVO).” PMID 19365011 ↗ Apr 2009 “An open-label, one-year, noncomparative study to evaluate the safety and tolerability of intravitreal pegaptanib sodium in patients with diabetic macular edema.” PMID 25187694 ↗ Aug 2014 “Pegaptanib sodium is an aptamer designed to bind the VEGF 165 isoform with high affinity.” NCT00531336 ↗ “Intravitreous Injections of Pegaptanib sodium (Anti-VEGF Pegylated Aptamer)” NCT00312351 ↗ “Pegaptanib Sodium (Macugen®), Given As Often As Every 6 Weeks for 2 Years” NCT00605280 ↗ “Macugen ™ (pegaptanib sodium injection)” NCT00087763 ↗ “Macugen ® (pegaptanib sodium)” NCT01486771 ↗ “Macugen (Pegaptanib Sodium)” NCT01487044 ↗ “pegaptanib sodium (Macugen)” NCT00354445 ↗ “pegaptanib sodium (Macugen)” NCT00406107 ↗ |
| Action | Inhibit | “anti-VEGF drug” NCT00021736 ↗ |
| Modality | Aptamer | “EYE001 anti-VEGF aptamer” NCT00021736 ↗ |
| Route | Intravitreal | “Intravitreal Injections of EYE001” NCT00021736 ↗ |
| Target | VEGF | “EYE001 decreases production of VEGF” NCT00056199 ↗ |