Kringle Pharma, Inc.
Oremepermin alfa IND filing in the United States FDA
Submission of IND application to the U.S. FDA for orempermin alfa. Following Phase III in Japan, this milestone is key for global expansion.
Key Figures
- IND filing: submitted (date unknown)
- Designation as drug for intractable diseases: obtained in Japan, the United States, and Europe
- Phase III additional trial ongoing in Japan, vocal cord scar trial enrollment completed
AI要約
Section Heading
Kringle Pharma announced that it has filed an IND application with the U.S. FDA to begin a Phase III clinical trial for orempermin alfa, a recombinant human HGF protein drug targeting acute spinal cord injury. Phase I/II have already been conducted in Japan, and designation as a drug for intractable diseases has been granted in the U.S. and Europe. The IND filing represents a significant step toward global development and is expected to support clinical development funding and strategic partnerships.
Section 2 Heading
The market size for acute spinal cord injury is large with unmet needs; backed by HGF's neuroprotective and axon-regenerating effects, it is expected as a treatment option. The plan is to push for regulatory approval in the United States and accelerate global development.
Kringle Pharma, Inc.
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