FDA approves application for phase I study of MLC1501 programme in post-traumatic brain injury recovery 

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Moleac has announced the approval of the US Food and Drug Administration (FDA) of an investigational new drug (IND) application for MLC1501 in traumatic brain injury (TBI). 

According to a company press release, Moleac is a biopharmaceutical company based in Singapore, dedicated to finding, developing and commercialising new medicines for the unmet medical needs of patients suffering from central nervous system diseases and injuries, such as stroke, TBI, and dementia.

“This approval represents another milestone for Moleac, supporting our ambition to provide best in class therapeutic options to patients in need. We are confident that MLC1501 will go through several steps to be registered and marketed, making it available to the largest number of stroke and TBI victims in the near future. We would like to thank our colleagues and partners for their support, as this major step forward would have not been possible without their efforts and determination,” David Picard, CEO of Moleac.

The company states that “By succeeding with its drug development, Moleac would make a breakthrough in current treatment options to support patients with their recovery and reducing the overall burden of TBI.”


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