Announced details
Acute spinal cord injury
Completed Phase I/II and Phase III trials in Japan in patients with acute spinal cord injury. The IND has taken effect in the United States.
The company submitted an Investigational New Drug (IND) application to the FDA, which reviewed the application.
The U.S. pharmaceutical regulatory authority. Location, representative, stated capital and year established: Not disclosed.
Orphan drug designation
Relevant authorities in Japan, the United States and Europe. Individual institutions: Not disclosed.
The company considers this an important achievement that will expand opportunities to form strategic partnerships with global pharmaceutical companies, pursue joint development and secure development funding, including non-dilutive financing. The specific amount of the impact on business performance is Not disclosed.
The company does not address Contract Value / Offering price.
National Spinal Cord Injury Statistical Center, Traumatic Spinal Cord Injury Facts and Figures at a Glance, 2026
| Item | Details |
|---|---|
| Names of Products / Services Covered | oremepermin alfa (recombinant human HGF protein) |
| Counterparty | U.S. Food and Drug Administration (FDA) |
| Counterparty overview | The U.S. pharmaceutical regulatory authority. Location, representative, stated capital and year established: Not disclosed. |
| Relationship with the Company | The company submitted an Investigational New Drug (IND) application to the FDA, which reviewed the application. |
| Launch date | Preparations are underway to start a Phase III trial in the United States. The specific start date is Not disclosed. |
| Applicable area | Acute spinal cord injury |
| Award/certification name | Orphan drug designation |
| Awarding / certifying body | Relevant authorities in Japan, the United States and Europe. Individual institutions: Not disclosed. |
| Usage history | Completed Phase I/II and Phase III trials in Japan in patients with acute spinal cord injury. The IND has taken effect in the United States. |
| Impact on Business Performance | The company considers this an important achievement that will expand opportunities to form strategic partnerships with global pharmaceutical companies, pursue joint development and secure development funding, including non-dilutive financing. The specific amount of the impact on business performance is Not disclosed. |
| Source | National Spinal Cord Injury Statistical Center, Traumatic Spinal Cord Injury Facts and Figures at a Glance, 2026 |
Items this document does not state (7)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Because the FDA review period has ended and the IND has taken effect. The company plans to advance clinical development in the United States by leveraging safety and efficacy findings and clinical data accumulated in Japan.