Thar Pharmaceutical’s lead product, T121, is an oral form of intravenous (IV)-only zoledronic acid. Zoledronic acid (ZA), marketed as Zometa® by Novartis, is a bisphosphonate drug compound used currently in the treatment of multiple myeloma, bone metastases and hypercalcemia of malignancy. Zoledronic Acid is also marketed by Novartis as Reclast® and used for the treatment of osteoporosis.
Thar has developed T121 using its Enhance™ technology platform. T121 has been granted orphan designation in complex regional pain syndrome by the FDA and has been granted composition-of-matter protection IP protection until 2030 with extensions to 2035 pending. Thar is developing T121 in a Phase 3 program for the treatment of complex regional pain syndrome (CRPS) and has a very clear path from the regulatory agencies for its development.
T121 removes the requirement to deliver zoledronic acid through an IV. An oral version of zoledronic acid should improve patient convenience, compliance and comfort.
T109 is in preclinical development and is a fast-acting non-narcotic therapy for acute pain. Originally used for chronic pain, Thar has re-invented this drug for acute pain with targeted applications in back pain, post-operative pain and dysmenorrhea.
Thar Pharmaceuticals has additional IV-to-oral transformation programs ongoing for other cancer products and faster onset product opportunities in development for such indications as pain, erectile dysfunction, anxiety and migraines.
For the company’s own clinical development Thar Pharmaceuticals starts with already approved drugs with known safety, efficacy and market success in order to skip drug discovery and many of the high-risk steps in drug development. An expedited regulatory path may also be available for certain drugs and indications. Furthermore, our EnhanceTM Technology allows us to obtain new composition-of-matter patent life around our products.