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Other Disclosures4569KYORIN Pharmaceutical Co.,Ltd.Pharmaceuticals

Start of a Confirmatory Trial for the Tinnitus Treatment App “KRP-DT123”

Kyorin Pharmaceutical and SUSMED,Inc. will commence a confirmatory clinical trial of “KRP-DT123,” a tinnitus treatment app they are jointly developing, in patients with chronic tinnitus. Following completion of the trial, the companies plan to submit an application for approval in Japan.

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Announced details

KRP-DT123
Applicable field (uses covered by this announcement)

Chronic tinnitus; tinnitus treatment

Launch dateThe confirmatory clinical trial is scheduled to commence, but the specific start date is Not disclosed. An application for approval in Japan is planned following completion of the trial.
What the company reported numerically
Quantitative Effects

Evaluate the app’s efficacy and safety when used for 16 weeks.

Relationship between the counterparty and the company
KYORIN Pharmaceutical Co.,Ltd.4569
Relationship with the Company

The companies are jointly developing a treatment app.

CounterpartySUSMED,Inc.

Head office: Chuo-ku, Tokyo; President and Representative Director: Ueno Taro (上野太郎). SUSMED,Inc. is a research and development-focused company promoting digital healthcare. It develops treatment apps for conditions including insomnia disorder and provides clinical development support systems using blockchain technology.

Impact on Business Performance

The impact on the earnings forecast for the fiscal year ending March 2027 is expected to be minimal.

The company does not address Contract Value / Offering price.

Source (materials cited by the company)

Tinnitus Clinical Practice Guidelines (Japanese Audiological Society)

Web-Based Survey of Tinnitus Care in Japan (Audiology Japan 67:548-557, 2024)

Announced details
ItemDetails
Names of Products / Services CoveredKRP-DT123
CounterpartySUSMED,Inc.
Counterparty overviewHead office: Chuo-ku, Tokyo; President and Representative Director: Ueno Taro (上野太郎). SUSMED,Inc. is a research and development-focused company promoting digital healthcare. It develops treatment apps for conditions including insomnia disorder and provides clinical development support systems using blockchain technology.
Relationship with the CompanyThe companies are jointly developing a treatment app.
Launch dateThe confirmatory clinical trial is scheduled to commence, but the specific start date is Not disclosed. An application for approval in Japan is planned following completion of the trial.
Applicable areaChronic tinnitus; tinnitus treatment
Quantitative EffectsEvaluate the app’s efficacy and safety when used for 16 weeks.
Impact on Business PerformanceThe impact on the earnings forecast for the fiscal year ending March 2027 is expected to be minimal.
SourceTinnitus Clinical Practice Guidelines (Japanese Audiological Society), Web-Based Survey of Tinnitus Care in Japan (Audiology Japan 67:548-557, 2024)
Items this document does not state (9)
Contract ValueOffering priceContract DateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocationLocation scaleUsage history

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 objective is to evaluate the app’s efficacy and safety and provide a new treatment option for patients suffering from tinnitus. The companies will advance research and development by leveraging their respective expertise in disease areas, clinical development and sales capabilities, treatment app development platform, and clinical trial system.

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Start of a Confirmatory Trial for the Tinnitus Treatment App “KRP-DT123” | KYORIN Pharmaceutical Co.,Ltd. (4569) timely disclosure | Komori