Moleac Announces US FDA Approval of IND Application for Phase 1 Study of MLC1501 Programme in Post-Traumatic Brain Injury Recovery
SINGAPORE, May 31, 2021 /PRNewswire/ -- Moleac, a biopharmaceutical company based in Singapore, announced the approval by the U.S. Food and Drug Administration (FDA) of an investigational new drug (IND) application for MLC1501 in traumatic brain injury (TBI).
- SINGAPORE, May 31, 2021 /PRNewswire/ -- Moleac, a biopharmaceutical company based in Singapore, announced the approval by the U.S. Food and Drug Administration (FDA) of an investigational new drug (IND) application for MLC1501 in traumatic brain injury (TBI).
- The approval of this IND comes 3 years after the opening of the first IND by the U.S. FDA for MLC1501 in Post-Stroke Recovery, allowing Moleac to conduct a phase 1 study (safety study) in healthy volunteers which has been successfully completed.
- "This approval represents another milestone for Moleac, supporting our ambition to provide best in class therapeutic options to patients in need.
- In 2018, the U.S. FDA has approved an IND for MLC1501 in post-stroke recovery, the phase 1 was completed in 2020.