Development Driven by Unmet Medical Needs

Our Commitment to Unmet Medical Needs–Based Development

SHIONOGI’s development activities are always driven by unmet medical needs.

In disease areas where treatment options are limited, we sincerely listen to the voices of patients and healthcare professionals and select the most appropriate approach from a wide range of modalities—including small molecules, antibodies, peptides, nucleic acids, and vaccines—to deliver solutions that create meaningful value for patients.

Our Commitment in Infectious Diseases and Rare Diseases

Therapeutic Area	Product / Initiative	Overview
Infectious Diseases	Xocova (prevention and pediatric indication expansion)	To address a broad range of needs related to COVID-19, we are advancing development of an oral preventive therapy as well as an expanded treatment indication for children aged 6 to 11. We were the first in the world to demonstrate the preventive effect of an oral antiviral in suppressing the onset of COVID-19.
	Xofluza Granules	Launched in November 2025. A granule formulation for the treatment and prevention of influenza, developed for children and elderly patients who have difficulty taking tablets.
	Cefiderocol / Xeruborbactam (in development)	AMR is a major global public health challenge, often referred to as a “silent pandemic.” SHIONOGI provides cefiderocol and following the addition of Qpex Biopharma to the group in 2023, is advancing development of the next-generation AMR therapy Xeruborbactam.
	Olorofim (invasive aspergillosis)	In collaboration with F2G, we are co-developing an oral antifungal agent with a novel mechanism of action, aiming to provide a new treatment option for patients with resistance to existing therapies or tolerability challenges.
Rare Disease	Pompe disease / S-606001 (in development)	A hereditary disease for which current treatment is limited to enzyme replacement therapy (ERT). Through combination therapy with S-606001 and ERT, as well as the potential for oral treatment, we aim to slow disease progression and reduce the burden of hospital visits.
	Fragile X syndrome (FXS) / Jordan syndrome / Zatolmilast (in development)	Rare diseases for which no approved therapies currently exist. Characterized by developmental delay, intellectual disability, and behavioral abnormalities. In collaboration with international patient advocacy organizations, we are advancing global development, including in Europe, with the goal of improving language function and activities of daily living.
	Dystrophic epidermolysis bullosa / Redasemtide (in development)	Designated as an orphan drug. A severe disease-causing serious damage to the skin and mucous membranes, with approximately 500 to 1,000 patients in Japan. As a regenerative medicine–inducing therapeutic, development is underway with the aim of promoting tissue regeneration through drug administration.