Announced details
Treatment of retinitis pigmentosa
Transplantation was performed in 1 subject, the first subject.
SMPA is a U.S. subsidiary of Sumitomo Pharma Co.,Ltd. Sumitomo Pharma, 株式会社RACTHERA, S-RACMO株式会社 and SMPA are collaborating on research and development.
A U.S. subsidiary of Sumitomo Pharma Co.,Ltd. Other details, including its location, representative, capital and year of establishment, are not disclosed.
Orphan Drug Designation (retinitis pigmentosa indication)
U.S. Food and Drug Administration (FDA)
Clinical trial registration number: NCT06891885. Orphan Drug Designation: March 2026. Details of the registration number and validity period are not disclosed.
SMaRT (Suita, Osaka Prefecture)
In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.
ClinicalTrials.gov clinical trial registration number NCT06891885 (number stated in the document)
| Item | Details |
|---|---|
| Names of Products / Services Covered | Allogeneic iPSC-derived retinal sheet (three-dimensional retina) / DSP-3077 |
| Counterparty | Sumitomo Pharma America, Inc.（SMPA） |
| Counterparty overview | A U.S. subsidiary of Sumitomo Pharma Co.,Ltd. Other details, including its location, representative, capital and year of establishment, are not disclosed. |
| Relationship with the Company | SMPA is a U.S. subsidiary of Sumitomo Pharma Co.,Ltd. Sumitomo Pharma, 株式会社RACTHERA, S-RACMO株式会社 and SMPA are collaborating on research and development. |
| Launch date | 13 August 2026: transplantation was performed in the first subject (actual date) |
| Applicable area | Treatment of retinitis pigmentosa |
| Award/certification name | Orphan Drug Designation (retinitis pigmentosa indication) |
| Awarding / certifying body | U.S. Food and Drug Administration (FDA) |
| Registration number and expiry date | Clinical trial registration number: NCT06891885. Orphan Drug Designation: March 2026. Details of the registration number and validity period are not disclosed. |
| Location | SMaRT (Suita, Osaka Prefecture) |
| Usage history | Transplantation was performed in 1 subject, the first subject. |
| Source | ClinicalTrials.gov clinical trial registration number NCT06891885 (number stated in the document) |
Items this document does not state (6)
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 provide patients with retinitis pigmentosa with a new treatment option as soon as possible.