Ranbaxy Laboratories has filed an investigational new drug (IND) application for intravenous (IV) use of its molecule, RBx 7644 (ranbezolid), an extended spectrum oxazolidinone, with the Drugs Controller General of India (DCGI). Ranbaxy had earlier announced the filing of an IND application for this molecule in its oral usage form.
Globally, this will be the second anti-bacterial molecule of the oxazolidinone class of compounds, but it is the first that is going into clinical investigations with an extended spectrum of activity both in solid and injectable forms.
According to Ranbaxy, the development and ultimate availability of oral and IV formulations of ranbezolid would be of great assistance in the treatment of life threatening hospital infections. It would allow medical practitioners to initiate treatment with the IV formulation and, after the patient has stabilised, to switch to oral therapy with the same molecule, thus contributing to early discharge from the hospital.
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During the last two decades, multi-resistant gram positive bacteria have become the dominant cause for hospital infections. The search for new anti-microbial compounds directed at the multiresistant or pan-resistant gram-positive pathogens culminated in the clinical development and FDA approval of linezolid (the first oxazolidinone) in 2000.
Scientists at Ranbaxy have worked towards the discovery and development of an extended spectrum oxazolidinone.
This has resulted in the discovery of RBx 7644 (ranbezolid), which has exhibited excellent activity against significant gram positive pathogens and is markedly active against all anaerobes (gram positive or gram negative).
RBx 7644 (ranbezolid) is also indicative of significant inhibitory activity on slime production and glass adherent bacteria, which has chances of decreasing resistance development. In pre-clinical tests, RBx 7644 (ranbezolid) has shown excellent pharmacokinetic profile with significant safety advantages. In view of the pre-clinical results and the predilection of the target bacteria to cause hospital infections, RBx 7644 (ranbezolid) can be potentially suitable for treatment of hospital acquired infections such as pneumonia, bacteriaemia, post operative wound infection, skin and soft tissue infections, catheter or prosthesis-related prophylaxis or infection caused by gram positive bacteria and anaerobic infections caused by gram positive or gram negative bacteria.
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