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AlphaRx’s research and development efforts are focused on therapies for life threatening or chronic disease. The company’s product development strategy is to reformulate FDA approved drugs using proprietary, site-specific drug delivery technology to achieve a better efficacy, better safety profile and patient compliance. In addition, the company is developing a number of difficult-to-formulate generic pharmaceutical products.
Although we believe our development strategy of reformulating FDA approved drugs may have less development risks as compared to new chemical entities development, there can be no guarantee that any product candidates can be successfully developed and as such, we constantly evaluate and prioritize our development programs. As a result, new product candidates are constantly added and lower priority development programs may be discontinued or delayed. We believe this product development optimization process is essential for the development of a broad portfolio of short to long-term drug candidates, which will position the company for stable and sustainable growth.
Listed below is the current AlphaRx development pipeline indicating products currently under development. Several of these products have the potential of moving quickly, from FDA Phase I clinical development to registration using the 505b(2) NDA route.
| Indaflex™* |
Osteoarthritis |
Phase II |
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Vansolin™
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Pneumonia (Gram +ve)
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Pre clinical
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Zysolin™
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Pneumonia (Gram -ve)
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Pre IND Tox
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Zysolin™**
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Bio-defense
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Pre clinical
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ARX1088
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Anti-viral
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Pre clinical
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ARX2038
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Lipid Management
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Pre clinical
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ARX8103
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Inflammation
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Pre clinical
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GAI-122***
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Stroke
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IND Tox
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GAI-122***
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Delirium
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IND Tox
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ARX-181
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Oral Chemotherapy
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R&D
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* Licensed to Cypress Bioscience
** Collaborated with US Army
*** Licnesed to Gaia BioPharma
AlphaRx has identified several major pharmaceutical products with combined worldwide sales of over $10 billion, as potential candidates for their proprietary drug delivery systems. AlphaRx is presently focusing on nano-antibiotics which have shown excellent therapeutic activity in the animal model, have multi-billion dollar sales potential and limited market competition.
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