Announced details
Treatment for pediatric patients with achondroplasia (aged 2–14)
The primary endpoint is the change in annualized height velocity (AHV) after 52 weeks of treatment. The target is an increase of at least +2 cm/year.
The regulatory authority and applicant relationship in connection with the application to initiate the clinical trial. Capital and personnel relationships are Not disclosed.
An incorporated administrative agency responsible for approval reviews of pharmaceuticals, medical devices and other products, safety measures, and relief for health damage. Other information regarding its location, representative, capital and year of establishment is Not disclosed.
Phase 3 clinical trial targeting 16 patients
The impact on full-year results for the fiscal year ending March 2027, including the implementation of this clinical trial, is scheduled to be incorporated into the earnings forecast to be disclosed in the future. The amount of the impact is Not disclosed.
The company does not address Contract Value / Offering price.
18 March 2026 timely disclosure, “Notice Regarding the Application to Initiate a Domestic Phase 3 Clinical Trial of the Achondroplasia Treatment umedaptanib pegol”
| Item | Details |
|---|---|
| Names of Products / Services Covered | umedaptanib pegol (anti-FGF2 aptamer) |
| Counterparty | Pharmaceuticals and Medical Devices Agency (PMDA) |
| Counterparty overview | An incorporated administrative agency responsible for approval reviews of pharmaceuticals, medical devices and other products, safety measures, and relief for health damage. Other information regarding its location, representative, capital and year of establishment is Not disclosed. |
| Relationship with the Company | The regulatory authority and applicant relationship in connection with the application to initiate the clinical trial. Capital and personnel relationships are Not disclosed. |
| Launch date | From a regulatory standpoint, the company is in a position to initiate the clinical trial at any time as of 2 April 2026 (the actual start date is Not disclosed). |
| Applicable area | Treatment for pediatric patients with achondroplasia (aged 2–14) |
| Location scale | Phase 3 clinical trial targeting 16 patients |
| Quantitative Effects | The primary endpoint is the change in annualized height velocity (AHV) after 52 weeks of treatment. The target is an increase of at least +2 cm/year. |
| Impact on Business Performance | The impact on full-year results for the fiscal year ending March 2027, including the implementation of this clinical trial, is scheduled to be incorporated into the earnings forecast to be disclosed in the future. The amount of the impact is Not disclosed. |
| Source | 18 March 2026 timely disclosure, “Notice Regarding the Application to Initiate a Domestic Phase 3 Clinical Trial of the Achondroplasia Treatment umedaptanib pegol” |
Items this document does not state (8)
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.With respect to the application to initiate the clinical trial submitted on 18 March 2026, the prescribed period elapsed and PMDA raised no additional issues.