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Other Disclosures4521KAKEN PHARMACEUTICAL CO.,LTD.Pharmaceuticals

Results of the Domestic Phase 3 Confirmatory Study of “KP-001”: Presented at the 22nd Annual Meeting of the Japanese Society for Hemangioma and Vascular Malformations

Results of the domestic Phase 3 confirmatory study of the vascular anomaly treatment drug “KP-001,” which is under development, were presented at an academic meeting. For the primary endpoint, 11 of 36 patients (30.6%) achieved at least a 20% reduction in the target lesion, statistically exceeding the prespecified criterion. Adverse reactions, including liver function test abnormalities, were also observed.

Worth reading
53Recurring
0–100. This measures how worthwhile something is to read, not how good or bad the company is.
Direction
Mixed performance
Direction inferred from the company’s description.
Scale
30.6
% (primary endpoint response rate, 11/36 patients)
Wording
Conditional
How definitive the wording is.

Announced details

KP-001 (generic name: ceraverisib phosphate hydrate)
Applicable field (uses covered by this announcement)

Refractory vascular anomalies (venous malformations, lymphatic malformations, and Klippel–Trenaunay syndrome)

What the company reported numerically
Quantitative Effects

Primary endpoint response rate: 30.6% (11/36 patients), with p<0.001 versus the prespecified null-hypothesis response rate of 6.7%. Changes in pain scores ranged from −10.7±13.34 to −4.4±12.59 mm at 4 to 52 weeks after dosing in the population with baseline pain.

Usage history

36 patients in the domestic Phase 3 confirmatory study (dosed for at least 24 weeks and up to 52 weeks)

Relationship between the counterparty and the company
KAKEN PHARMACEUTICAL CO.,LTD.4521
Relationship with the Company

The venue at which KAKEN PHARMACEUTICAL CO., LTD. presented the results of its domestic Phase 3 confirmatory study.

Counterparty22nd Annual Meeting of the Japanese Society for Hemangioma and Vascular Malformations

An academic meeting held in Morioka, Iwate Prefecture, on 16–17 July 2026.

In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.

Source (materials cited by the company)

22nd Annual Meeting of the Japanese Society for Hemangioma and Vascular Malformations; Information website of the Research Group for Pharmacotherapy of Refractory Hemangiomas and Vascular Malformations

Announced details
ItemDetails
Names of Products / Services CoveredKP-001 (generic name: ceraverisib phosphate hydrate)
Counterparty22nd Annual Meeting of the Japanese Society for Hemangioma and Vascular Malformations
Counterparty overviewAn academic meeting held in Morioka, Iwate Prefecture, on 16–17 July 2026.
Relationship with the CompanyThe venue at which KAKEN PHARMACEUTICAL CO., LTD. presented the results of its domestic Phase 3 confirmatory study.
Applicable areaRefractory vascular anomalies (venous malformations, lymphatic malformations, and Klippel–Trenaunay syndrome)
Quantitative EffectsPrimary endpoint response rate: 30.6% (11/36 patients), with p<0.001 versus the prespecified null-hypothesis response rate of 6.7%. Changes in pain scores ranged from −10.7±13.34 to −4.4±12.59 mm at 4 to 52 weeks after dosing in the population with baseline pain.
Usage history36 patients in the domestic Phase 3 confirmatory study (dosed for at least 24 weeks and up to 52 weeks)
Source22nd Annual Meeting of the Japanese Society for Hemangioma and Vascular Malformations; Information website of the Research Group for Pharmacotherapy of Refractory Hemangiomas and Vascular Malformations
Items this document does not state (10)
Contract ValueOffering priceContract DateLaunch dateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocationLocation scaleImpact on Business Performance

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.

The results of the domestic Phase 3 confirmatory study were presented at the 22nd Annual Meeting of the Japanese Society for Hemangioma and Vascular Malformations.

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Results of the Domestic Phase 3 Confirmatory Study of “KP-001”: Presented at the 22nd Annual Meeting of the Japanese Society for Hemangioma and Vascular Malformations | KAKEN PHARMACEUTICAL CO.,LTD. (4521) timely disclosure | Komori