Suven’s CNS molecule enters phase-1 clinical trial

Suven Life Sciences informed that its molecule NCE SUVN-3031 has commenced phase-1 clinical trial in USA


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SUVN-G3031 - a potent, selective, brain penetrant and orally active Histamine H3 antagonist for the treatment of cognitive dysfunction associated with Alzheimer's Disease or Schizophrenia has completed all the pre-clinical, safety and early toxicological studies, GLP toxicological studies and was submitted for Investigational New Drug Application {IND) to conduct phase-1 clinical trial with the indication for Cognition in Alzheimer's Disease under 505(1) of the Federal Food, Drug and Cosmetic Act (FDCA) which was assigned an IND number 123179.

Based on the IND, "A Single Center, Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate the safety, Tolerability, and Pharmacokinetics of SUVN-G3031 after Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects" for Cognition in Alzheimer's Disease is underway in USA.

"We are very pleased that the second compound from our pipeline of molecules in CNS has moved into clinical trial that is being developed for cognitive disorders in Alzheimer's and Schizophrenia with high unmet medical need which has huge market potential globally," said Mr Venkat Jasti, CEO, Suven.

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