Xanomeline was first discovered in a therapeutic development collaboration between Eli Lilly & Co. and Novo Nordisk pharmaceutical companies in the early 1990s.[2][3] Eli Lilly led the first clinical development effort of xanomeline through a phase 2 clinical trial to test the hypothesis that it would improve cognition in patients suffering from cognitive decline observed in Alzheimer’s disease [11] and later in a small placebo-controlled study in schizophrenia. Xanomeline’s development was discontinued primarily due to cholinergic side effects observed in clinical studies.[12] Further development was enabled through a novel co-formulation strategy with the peripherally restricted muscarinic antagonist, trospium, to quell the peripheral cholinergic side effects.[5] This new dual drug formulation is currently called KarXT.
Xanomeline is available as Xanomeline oxalate.
There are different suppliers/manufacturers of Xanomeline oxalate like
· Application of the substance / the mixture
Current availability of the product is for research use and Not for human or veterinary diagnostic or therapeutic use.
Apparently, there are some small scale manufacturers, but we need to find out how difficult or easy it is to scale up the production from lab level to commercial level and at what cost it can be scaled up, as the alternate sourcing should commercialy also benefit Karuna.
But it seems that Xanomeline API is presently not being used in any of the commercial drug and hence there will not be any large scale manufacturers and hence we can safely assume that Neuland is at least 2-3 years ahead of any other proposed manufacturer of Xanomeline API.
As already covered by @akash8844 Neuland has done backward integration for production of RSM required for API to ensure high quality and low cost. Infact, it has gone one step further and established 3 domestic secure sources for the RSM’s starting material.
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