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Other Disclosures3151VITAL KSK HOLDINGS,INC.Trading & Wholesale

Notice regarding the commencement of a domestic Phase 2 clinical trial of ferric maltol by a consolidated subsidiary, aimed at adding an indication for pulmonary hypertension associated with chronic lung disease

The consolidated subsidiary 株式会社メドリープファーマ has commenced a domestic Phase 2 clinical trial of ferric maltol (ST10) for pulmonary hypertension associated with chronic lung disease. Following a Phase 3 trial, the company plans to prepare for regulatory submission and launch from 2030 onward.

Worth reading
58In focus
0–100. This measures how worthwhile something is to read, not how good or bad the company is.
Direction
Neutral
Direction inferred from the company’s description.
Scale
16
Number of subjects (approximately 16, planned)
Wording
Avoiding a definitive answer
How definitive the wording is.

Announced details

Ferric maltol (development code: ST10)
Applicable field (uses covered by this announcement)

Treatment of pulmonary hypertension associated with chronic lung diseases, including COPD and ILD

Launch date9 November 2026 (date the domestic Phase 2 clinical trial commenced, actual)
What the company reported numerically
Quantitative Effects

The primary endpoint is the change from baseline in the 6-minute walk distance at 12 weeks after administration. Result figures: Not disclosed.

Relationship between the counterparty and the company
VITAL KSK HOLDINGS,INC.3151
Relationship with the Company

株式会社メドリープファーマ is responsible for development. Tatsumi Koichiro (巽浩一郎) has provided comments as a medical expert.

CounterpartyEmeritus Professor, Department of Respiratory Medicine, Chiba University School of Medicine, Tatsumi Koichiro (巽浩一郎) (commenting as a medical expert)

Emeritus Professor, Department of Respiratory Medicine, Chiba University School of Medicine. Other attributes: Not disclosed.

Location (as indicated in this announcement)

Head office of 株式会社メドリープファーマ: 3-3-1 Yaotome, Izumi-ku, Sendai, Miyagi

Impact on Business Performance

The impact on consolidated results for the fiscal year ending March 2027 (fiscal 2026) is minor.

The company does not address Contract Value / Offering price.

Announced details
ItemDetails
Names of Products / Services CoveredFerric maltol (development code: ST10)
CounterpartyEmeritus Professor, Department of Respiratory Medicine, Chiba University School of Medicine, Tatsumi Koichiro (巽浩一郎) (commenting as a medical expert)
Counterparty overviewEmeritus Professor, Department of Respiratory Medicine, Chiba University School of Medicine. Other attributes: Not disclosed.
Relationship with the Company株式会社メドリープファーマ is responsible for development. Tatsumi Koichiro (巽浩一郎) has provided comments as a medical expert.
Launch date9 November 2026 (date the domestic Phase 2 clinical trial commenced, actual)
Applicable areaTreatment of pulmonary hypertension associated with chronic lung diseases, including COPD and ILD
LocationHead office of 株式会社メドリープファーマ: 3-3-1 Yaotome, Izumi-ku, Sendai, Miyagi
Quantitative EffectsThe primary endpoint is the change from baseline in the 6-minute walk distance at 12 weeks after administration. Result figures: Not disclosed.
Impact on Business PerformanceThe impact on consolidated results for the fiscal year ending March 2027 (fiscal 2026) is minor.
Items this document does not state (9)
Contract ValueOffering priceContract DateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocation scaleUsage historySource

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 trial is being conducted as an exploratory study toward a Phase 3 trial, with the aim of adding an indication for pulmonary hypertension associated with chronic lung disease. The company positions this drug as a core pipeline product in the pulmonary hypertension field and aims to strengthen its earnings base and enhance corporate value over the medium to long term.

How to read this page

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Notice regarding the commencement of a domestic Phase 2 clinical trial of ferric maltol by a consolidated subsidiary, aimed at adding an indication for pulmonary hypertension associated with chronic lung disease | VITAL KSK HOLDINGS,INC. (3151) timely disclosure | Komori