SHINKEI THERAPEUTICS GETS FDA CLEARANCE FOR MR-101 TRIAL & COMPLETES PHASE 2 FOR MR-301 IN TRAUMATIC BRAIN INJURY

SHINKEI THERAPEUTICS RECEIVES FDA CLEARANCE TO PROCEED WITH PHASE 1 CLINICAL TRIAL FOR MR-101 AND COMPLETES PHASE 2 CLINICAL TRIAL FOR MR-301 IN SEVERE TBI

PRINCETON, NJ, UNITED STATES, March 9, 2026 /EINPresswire.com/ -- SHINKEI Therapeutics, Inc., a clinical-stage pharmaceutical company dedicated to the development of novel therapeutics for Central Nervous System (CNS) disorders, today announced two significant milestones in its drug development pipeline: (1) the U.S. Food and Drug Administration ("FDA") has cleared the Company's Investigational New Drug ("IND") application for MR-101 to proceed with a Phase 1 clinical trial; and (2) the successful completion of the Phase 2 clinical trial ("SHINKEITBI") for MR-301 in patients with severe Traumatic Brain Injury ("sTBI"), with the Company now preparing for an End-of-Phase 2 ("EOP2") meeting with the FDA.

FDA Clearance of IND for MR-101
SHINKEI Therapeutics announced that the FDA has cleared its IND application for MR-101, a novel formulation candidate being developed for the treatment of Movement Disorders. The IND clearance allows the Company to initiate a Phase 1 clinical study in healthy volunteers to assess the safety, tolerability, and pharmacokinetics of MR-101. SHINKEI intends to leverage the 505(b)(2) regulatory pathway to utilize existing clinical and nonclinical data, thereby accelerating the development timeline.

The Phase 1 study will be conducted in accordance with the protocols reviewed and accepted by the FDA. SHINKEI plans to commence dosing in healthy volunteers in the coming weeks.

Completion of Phase 2 Clinical Trial for MR-301 and Preparation for End-of-Phase 2 FDA Meeting
SHINKEI Therapeutics also announced the successful completion of the SHINKEITBI Phase 2 clinical trial evaluating MR-301 Intravenous (IV) Solution — in patients with severe TBI. The multicenter, randomized, placebo-controlled study enrolled patients across several sites in the United States and was conducted in collaboration with the Duke Clinical Research Institute (DCRI). The trial was registered under NCT identifier: NCT06253923.

Currently, no approved drug therapy exists to treat disorders of consciousness following sTBI, representing a critical unmet clinical need. Every year, 80,000–90,000 individuals in the United States experience the onset of long-term or lifelong disabilities associated with sTBI. MR-301 increases synaptic dopamine levels indirectly via NMDA receptor antagonism, resulting in disinhibition of dopaminergic neurons.

With the Phase 2 study now complete, SHINKEI is actively preparing for its End-of-Phase 2 meeting with the FDA. This meeting will be a critical step in aligning with the Agency on the design and requirements for a Phase 3 pivotal study and establishing a path toward potential regulatory approval via the 505(b)(2) pathway.

About MR-301 / Traumatic Brain Injury (TBI)
Traumatic brain injury (TBI) remains a leading cause of mortality in the United States, accounting for approximately one-third of all injury-related deaths. Even patients who survive TBI may be burdened with long-lasting or permanent disability that significantly impacts their independence and quality of life. Currently, no approved drug therapy exists to treat disorders of consciousness after TBI, representing a significant unmet clinical need.

About MR-101 / Movement Disorders
MR-101 is a novel formulation candidate in SHINKEI's CNS pipeline being developed for movement disorders. Like other SHINKEI product candidates, MR-101 is being advanced using the 505(b)(2) regulatory strategy, which leverages prior clinical and nonclinical data to support an accelerated development and approval pathway.

About SHINKEI Therapeutics
SHINKEI Therapeutics is a clinical-stage pharmaceutical company focused on CNS disorders. The Company's robust and diverse product development pipeline aims to enhance drug administration for new indications, increase convenience, improve patient compliance, and reduce side effects. Using the 505(b)(2) regulatory strategy to repurpose and reformulate existing pharmaceutical products, SHINKEI is positioned to deliver faster and better outcomes for patients with significant unmet medical needs. SHINKEI Therapeutics is headquartered at the Princeton Innovation Center BioLabs, Princeton, New Jersey. For more information, please visit www.SHINKEITherapeutics.com.

For further information, please contact:
GP Singh
SHINKEI Investor Relations
303A College Road East, Princeton, NJ 08540 USA
+1 (855) 574-4653
businessdev@SHINKEITherapeutics.com
www.SHINKEITherapeutics.com

GP Singh
SHINKEI Therapeutics
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