Drugs / ME-609
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial · 1 missed | ||||||
| Phase 2 | NCT00736437 | Aug 1999 → Aug 2000 | herpes labialis | Medivir | Completed | Missed primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT00375570 | Oct 2006 → Sep 2007 | herpes labialis | Medivir | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2010-12-08 | Medivir | Results Medivir’s U.S. commercialisation partner Meda presents positive Xerese™ data at ASHP medivir.com ↗
The data showed that Xerese™/ Xerclear® was well tolerated and did not give rise to acyclovir resistant virus. |
| 2009-09-15 | Medivir | Results Medivir has presented Lipsovir® at the ongoing 49th ICAAC meeting in San Francisco, USA medivir.com ↗
The conclusions highlighted in the presentation: ME-609 prevented ulcerated lesions in subjects with recurrent HSL compared to both topical acyclovir and placebo. |
| 2005-12-22 | Medivir | Regulatory Medivir takes its first pharmaceutical project into phase III and sharpens its strategic focus medivir.com ↗
The US Food and Drug Administration (FDA) in an End-of-Phase-II Meeting has recently approved Medivir’s proposal for configuring the pivotal clinical trials to allow drug registration of labial (oral) herpes project ME-609. |
| 2000-12-07 | Medivir | Results Medivir's herpes cream ME-609 shows interesting results in phase II studies medivir.com ↗
Preliminary results from this study, conducted in North America, confirm that ME-609 cream is safe and well-tolerated and may be at least as effective, if not better, than existing products on the market. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2010-12-08 | Medivir | Medivir’s U.S. commercialisation partner Meda presents positive Xerese™ data at ASHP medivir.com ↗ |
| 2009-09-15 | Medivir | Medivir has presented Lipsovir® at the ongoing 49th ICAAC meeting in San Francisco, USA medivir.com ↗ |
| 2005-12-22 | Medivir | Medivir takes its first pharmaceutical project into phase III and sharpens its strategic focus medivir.com ↗ |
| 2004-03-31 | Medivir | EU patent granted on Medivir's herpes project ME-609 medivir.com ↗ |
| 2000-12-07 | Medivir | Medivir's herpes cream ME-609 shows interesting results in phase II studies medivir.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ME-609 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00736437 ↗ |
| Route | Topical | “5-day treatment with 5-time daily topical administration” NCT00375570 ↗ |