Tolvaptan

The drug industrys efforts to develop a treatment for a rare kidney condition known in shorthand as ADPKD have come in fits and starts.People with ADPKD, or autosomal dominant polycystic kidney disease, can use an Otsuka drug, Jynarque, that U.S. regulators cleared in 2018 to slow the decline in organ function thats brought on by the condition.They have few other good options, however. Sanofi was developing a drug, venglustat, around the same time as Jynarques approval, but stopped clinical testing in 2021 after negative study results.The disease stayed on some drugmakers radars. In April, Novartis agreed to pay $800 million to acquire Regulus Therapeutics and an experimental therapy, farabursen, that the Swiss pharmaceutical company said showed promising clinical efficacy and safety. And a new biotechnology company launching Thursday is trying its hand at developing another.Called Renasant Bio, the company raised $54.5 million in seed financing from blue-chip investors 5AM Ventures, Atlas Venture, OrbiMed and Qiming Venture Partners USA.Renasant is the brainchild of a pair of University of California, San Francisco professors, Jeremy Reiter and Markus Delling, who sent 5AM a cold email in 2022 with a pitch built from their research into the diseases biology. It's now headed up by Emily Conley, a Stanford University scientist who previously led Federation Bio, a gut microbiome biotech, and oversaw business development at the genetic testing company 23AndMe.Renasant draws inspiration from drug development in cystic fibrosis. While cystic fibrosis is a disease of the lungs, both conditions are linked to malformed ion channels. As in cystic fibrosis, where drugs like Vertex Pharmaceuticals Trikafta work by correcting and boosting the activity of those channel proteins, Renasant believes it can develop corrector and potentiator treatments that restore and open up the channels relevant to ADPKD.What a corrector does is it helps that misfolded protein fold properly, said Conley. Once the protein gets into the right shape, then it can go where it needs to go, and then the potentiator holds the channel open.We know what's broken, Conley added. If we can fix it with correctors and potentiators, then we could have this very dramatic effect on patient outcomes.Renasants lead drug candidate, which is currently in preclinical testing, is a small molecule corrector the company hopes can work in patients with any of the wide range of mutations that cause ADPKD. While Renasant envisions this molecule working as a standalone treatment, its also developing a potentiator that could be used in tandem to prevent cysts from forming or growing in the kidney.The company plans to enter clinical testing in the next few years.Overseeing Renasants scientific work is Gus Gustafson, a veteran of large pharmaceutical firms like Johnson & Johnson and Merck & Co. Its board of directors is led by Natalie Holles, the former CEO of Third Harmonic Bio, and includes Charlotte McKee, chief medical officer of cystic fibrosis drugmaker Sionna Therapeutics, as well as venture investors.Renasant has assembled the right team, with years of research experience in polycystic disease that has informed the right scientific approach, Deborah Palestrant, a partner at 5AM, which incubated the biotech, said in a statement.Renasant estimates that some 12 million people have ADPKD worldwide. In addition to Novartis and Regulus, Vertex is also developing a drug for the disease. '

Mumbai: Indian generics drug developer Lupin Limited has launched a generic alternative of kidney blockbuster Jynarque in the US. The launched drug ‘ Tolvaptan ’ is bioequivalent to Otsuka Pharmaceutical ’s blockbuster Jynarque, indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease ( ADPKD ). In the last annual the innovator’s version Jynarque had an estimated annual sale of $1,467 million in the US (close to ₹12,320 crore). "We are pleased to announce the launch of Tolvaptan Tablets in the US to provide ADPKD patients with increased access to high-quality treatment options,” said Vinita Gupta, CEO, Lupin. As per the company it holds the exclusive first-to-file status for this product and will have 180-day generic drug exclusivity. Last month the company had obtained FDA final nod to launch the product and as per the company stock exchange filing the “the product will be manufactured at its Nagpur facility in India.” By Online Bureau ,