About Us » Milestones Achieved
The following milestones in the development of MTR104 have been achieved bringing Meditor closer to drug registration:
- Toxicology package in Germany under cGLP, April 2000.
- Phase I clinical trial in normal healthy volunteers in Germany under cGCP, September 1999 – March 2000.
- Production of drug substance in the US, in full compliance with cGMP, June 2001.
- Phase IV clinical trial in Cardiac Surgery in Eastern Europe on 36 patients, in the spirit of cGCP, August 2001.
- ADME studies in Canada, in compliance with GLP, 2002.
- Production of drug substance in the UK, under cGMP, September 2002.
- Validation of analytical methods completed under cGLP, September 2002.
- IND 66,505 granted by FDA for Cardiac Surgery related hypotension and Intradialytic Hypotension , March 2003.
- Scale-up production of new batch of drug substance in full compliance with cGMP in the US, 2006.
- Development and production of new formulation for immediate release oral tablets for Migraine in full compliance with cGMP in Canada, 2006.
- Protocol for Phase II clinical trial multicenter in Israel, approved by IRB and Israel's Ministry of Health under IND. Study in progress as of June 2006.
- Phase II clinical trial in 40 Migraine patients succesfully completed under cGCP, 2007.
- Phase II clinical trial in the US in 32 Cardiac Surgery patients, approved by WIRB under IND. Study in progress, 2008.
