Announced details
Domestic Phase III clinical trial for pediatric patients with achondroplasia (ACH) aged 2–14
Orphan drug designation
Ministry of Health, Labour and Welfare
Locations of the clinical trial sites shown on a map (individual locations are not stated in the body of the disclosure)
No impact on full-year earnings for the fiscal year ending March 2027
The company does not address Contract Value / Offering price.
Disclosure dated 18 March 2026, “Notice of Clinical Trial Application for the Domestic Phase III Clinical Trial of the Achondroplasia Treatment umedaptanib pegol,” and disclosure dated 1 July 2026, “Supplementary Explanation Regarding the Study Design and Safety of the Domestic Phase III Clinical Trial of the Achondroplasia Treatment umedaptanib pegol”
| Item | Details |
|---|---|
| Names of Products / Services Covered | umedaptanib pegol (RBM-007, anti-FGF2 aptamer) |
| Applicable area | Domestic Phase III clinical trial for pediatric patients with achondroplasia (ACH) aged 2–14 |
| Award/certification name | Orphan drug designation |
| Awarding / certifying body | Ministry of Health, Labour and Welfare |
| Location | Locations of the clinical trial sites shown on a map (individual locations are not stated in the body of the disclosure) |
| Location scale | A cumulative total of 16 clinical trial sites are able to enroll patients. 6 additional sites were added this time. |
| Impact on Business Performance | No impact on full-year earnings for the fiscal year ending March 2027 |
| Source | Disclosure dated 18 March 2026, “Notice of Clinical Trial Application for the Domestic Phase III Clinical Trial of the Achondroplasia Treatment umedaptanib pegol,” and disclosure dated 1 July 2026, “Supplementary Explanation Regarding the Study Design and Safety of the Domestic Phase III Clinical Trial of the Achondroplasia Treatment umedaptanib pegol” |
Items this document does not state (10)
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.To establish the foundation for the clinical trial structure needed to advance subject enrollment and promote enrollment going forward.