Doxil — The First FDA-Approved Nano-Drug: From an Idea to a Product - Harnessing Biomaterials in Nanomedicine: Preparation, Toxicity, and Applications - page 382

The story of Doxil's development carries two important messages.
The first one is that Doxil's successful development opens the way
to major improvement in tumor therapy and especially it served
as a gold standard in the new field referred to as nano-medicine.
The second one is that development of such a complex drug system
requires having a highly multidisciplinary team that can deal in an
integrative way with the many kinds of expertise needed (Gabizon
et al., 1995, 1999; Barenholz, 2003, 2007). Not less important is
the recognition that the understanding and optimal utilization of
physicochemical principles are crucial to the successful development
of such a complex drug product.

12.7 Doxil: Historical Perspectives

Pre-Doxil era (Liver passively targeted by liposomal doxorubicin)
1979 Gabizon and Barenholz start basic research on
liposomal doxorubicin
1984 First clinical trials with liposomal doxorubicin (OLV-
DOX and not Doxil)
1985 LTI licensed the OLV-DOX technology
1987 Clinical trial of OLV-DOX failed
1988 Barenholz developed and Yissum, R & D Company of
the Hebrew University of Jerusalem, Israel, patented
new concept of doxorubicin remote loading, the basis of
Doxil (Barenholz and Haran, 1993, 1994); patents were
licensed to LTI
1989 LTI patented the Stealth concept and registered Stealth ®
1989 Gabizon and LTI start to develop sterically stabilized
(Stealth) liposomes
1989 LTI, Gabizon, and Barenholz start Doxil ® development
1991-1992 Doxil “First in man” clinical trial in Jerusalem
1994 Gabizon and Barenholz major publication on Doxil
clinical trial ( Cancer Research )
1995 (November 17) FDA-approved Doxil
1996 First Doxil sales in USA and Europe
2009 (March) US patent expired