# Shionogi Inc. (U.S.)

> Shionogi Inc. is the U.S. pharmaceutical subsidiary of Japan’s Shionogi & Co., Ltd. Its business combines infectious-disease research and commercialization with a growing rare-disease portfolio: Fetroja for certain serious bacterial infections, Xocova for COVID-19 post-exposure prevention, and Radicava ORS for ALS. Hospital sales, licensing partnerships, acquisitions and government preparedness contracts support its work.

- **Founded:** 2008
- **Headquarters:** Florham Park, United States
- **Products:** Fetroja (cefiderocol), Xocova (ensitrelvir), Radicava ORS (edaravone), Methylin (methylphenidate HCl) oral solution, Partner-commercialized discoveries
- **Notable:** Fetroja received initial U.S. approval in 2019 and a hospital-acquired/ventilator-associated pneumonia indication in 2020., Xocova gained U.S. post-exposure prophylaxis approval in 2026., Completed the $2.5 billion Radicava rights acquisition in April 2026, with more than 100 team members joining from Tanabe Pharma America.

## Products & services

- **Fetroja (cefiderocol)** — Intravenous cephalosporin antibiotic approved in the U.S. for adults with certain susceptible Gram-negative complicated urinary tract infections and hospital-acquired or ventilator-associated bacterial pneumonia. Initial FDA approval was in 2019; U.S. launch followed in 2020.
- **Xocova (ensitrelvir)** — Prescription oral antiviral approved in the U.S. in 2026 for COVID-19 post-exposure prophylaxis in adults and adolescents aged 12 or older. The U.S. indication is prevention after exposure, not treatment of established COVID-19.
- **Radicava ORS (edaravone)** — Oral ALS therapy. Shionogi completed acquisition of rights in major countries and regions in April 2026; that is the acquisition date, not the product’s original approval date.
- **Methylin (methylphenidate HCl) oral solution** — Schedule II prescription medicine listed in Shionogi’s current U.S. portfolio; prescribing information includes a boxed warning.
- **Partner-commercialized discoveries** — Shionogi-developed Xofluza is commercialized in the U.S. by Roche; Symproic was out-licensed to BioDelivery Sciences, a Collegium subsidiary. HIV work with ViiV includes dolutegravir and cabotegravir. These are distinct from Shionogi Inc.’s directly marketed U.S. portfolio.

## Achievements

- Fetroja received initial U.S. approval in 2019 and a hospital-acquired/ventilator-associated pneumonia indication in 2020.
- Xocova gained U.S. post-exposure prophylaxis approval in 2026.
- Completed the $2.5 billion Radicava rights acquisition in April 2026, with more than 100 team members joining from Tanabe Pharma America.
- Won a BARDA Project BioShield contract initially funded at $119 million in April 2026.

## Latest updates

- **2026-10** — October 21: announced IDWeek analyses of Fetroja, including a retrospective U.S. subgroup of 266 respiratory-infection patients. Associations should not be read as randomized proof of superiority.
- **2026-10** — October 5: announced an agreement to acquire IntraBio for $2.0 billion upfront, subject to closing conditions; do not describe the transaction as completed.
- **2026-08** — August 28: BARDA exercised a $36.9 million Fetroja procurement option under the April contract.
- **2026-07** — July 28: announced U.S. availability of Xocova following its FDA approval for COVID-19 post-exposure prophylaxis.
- **2026-07** — FDA accepted a pediatric Fetroja supplemental application; announced action date February 23, 2027. Acceptance is not approval.
- **2026-04** — Completed Radicava rights acquisition in major countries and regions; announced $2.5 billion lump-sum payment plus possible future royalties.

## Links

- Website: https://www.shionogi.com/us/en.html
- LinkedIn: https://www.linkedin.com/company/shionogi-inc-/
- Twitter/X: https://twitter.com/SHIONOGI_JP
- YouTube: https://www.youtube.com/channel/UCIBYHy__zKykDWKpJ4HUBog
- Instagram: https://www.instagram.com/shionogi_official/

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Last updated: 2026-10-23