1. BEGIN File 128, a database containing information about drugs in the pipeline and stages of clinical trials.
2. SELECT the company name (/CO) and the phase of development (/ST) you want.
3. Combine the sets. |
?b 128
File 128:PHARMAPROJECTS 1980-2006/Aug W1
(c) 2006 Informa UK Ltd
Set Items Description
--- ----- -----------
?S ABBOTT/CO
S1 548 ABBOTT/CO
?SELECT PHASE()III/ST
8822 PHASE/ST
1791 III/ST
S2 1791 PHASE()III/ST
?S S1 AND S2
548 S1
1791 S2
S3 42 S1 AND S2 |
5. TYPE the record(s) of your choice in Format 19 to see the complete record and the image.
Information about the drug is listed, including originator, synonyms and drug data. |
?T S3/19/3
3/19/3
DIALOG(R)File 128:PHARMAPROJECTS
(c) 2006 Informa UK Ltd. All rts. reserv.
0036761 ** Image available **
DRUG NAME: zotarolimus
ORIGINATOR: Abbott (USA) [Launched]
LICENSEE: Medtronic (USA) [Launched]
SYNONYMS: ABT-578
Driver
Endeavor
ROTATABLE BONDS: 9
MOL FORMULA: C53H79N5O12
HYDROGEN BOND ACCEPTORS: 15
HYDROGEN BOND DONORS: 2
ALOGP: 8.94 MOL WEIGHT: 978.25 |
Marketing and Clinical Trial information worldwide is also provided, including the status worldwide.
Note: Part of the record is omitted from this display. |
TEXT: Zotarolimus (ABT-578) is a sirolimus(qv)analogue, developed by Abbott as a stent coating for the treatment of restenosis
Marketing
The Endeavor drug-eluting coronary stent containing
zotarolimus is launched in 75 countries including in the EU (2005) (Press release, Medtronic, 31 Jul 2005; Target Daily Online, 20 Dec 2005, W00905764). It is awaiting approval in the US (approval expected in 2007) (Target Daily Online, 11 Oct 2005, W00898470 & 20 Dec 2005, W00905764). It is licensed to Medtronic under a co-exclusive agreement, for use with its drug-eluting Driver and Endeavor stents. As part of the agreement, Medtronic also has rights to a phosphocholine coating technology designed to mimic the outside surface of a red blood cell and thus prevent an immune
response to the stent. Abbott has rights to market several of Medtronic's stent delivery systems. Abbott is also developing its own zotarolimus- eluting stent (ZoMaxx; qv) (Press release, Medtronic, 9 May 2002).
Clinical
Phase III
A randomized, single-blind trial (ENDEAVOR IV) in 1548 restenosis patients in Canada and the US, to evaluate the safety and efficacy of Endeavor formulated with zotarolimus cf TAXUS (qv) was conducted. The primary endpoint was the target vessel failure rate at 9mth and the secondary endpoint was the incidence of major adverse cardiac events at 30 days (Press releases, Medtronic, 31 Aug 2004 & 12 Apr 2005; Direct communication, Medtronic, 7 Feb 2005). In a randomized, double-blind trial in 1197 patients (ENDEAVOR II) in Asia, Canada and Europe, Endeavor formulated with zotarolimus reduced target vessel failure and target lesion revascularization by 47 and 62%, respectively, cf Medtronic's Driver cobalt alloy stent (control). It also gave a 71% reduction in in-stent angiographic binary restenosis and a 50% reduction in the major adverse cardiac event rate, cf control; no late malapposition or late thrombosis were observed beyond 30 days (Press releases, Medtronic, 6 Mar 2005 & 12 Apr 2005). Enrollment is complete in a confirmatory US trial in 436 patients (ENDEAVOR III). The trial will evaluate the safety and efficacy of Endeavor formulated with zotarolimus cf Cypher (sirolimus, stent, J&J; qv). The primary endpoint is late lumen loss at 8mth. Results were expected in 2005 (Press releases, Medtronic, 12 Feb 2004 & 12 Apr 2005).
STATUS: (Active)
World Launched
Australia Phase II Clinical Trial
Austria Launched 2005
Belgium Launched 2005
Canada Phase III Clinical Trial
Denmark Launched 2005
Finland Launched 2005
France Launched 2005
Germany Launched 2005
Greece Launched 2005
Ireland Launched 2005
Italy Launched 2005
Luxembourg Launched 2005
Netherlands Launched 2005
New Zealand Phase II Clinical Trial
Portugal Launched 2005
Spain Launched 2005
Sweden Launched 2005
UK Launched 2005
USA Pre-registration
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