Drug Pipeline & Clinical Update - June 2026

Judi Health closely monitors the drug landscape to provide our clients with timely information on newly FDA approved medications and products in the pipeline. Please find the June 2026 Monthly Drug Update below:

Key New Drug Approvals

Xocova® (ensitrelvir) oral tablet

Approval Date: 05/29/2026

Indication: Post-exposure prophylaxis (PEP) of coronavirus disease 2019 (COVID‑19) in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19

Cost*: $1,400 per 5-day treatment course

Key Consideration:

• First post-exposure COVID-19 agent approved in the US  
• Taken as 3 tablets once daily on day 1, followed by 1 tablet daily on days 2-5

Press Release: Shionogi Announces FDA Approval of XOCOVA® (ensitrelvir), the First and Only Oral Option to Help Prevent COVID-19 Following Exposure

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Utebzi (ruxolitinib) oral tablet

Approval Date: 06/17/2026

Indication: Treatment of complicated urinary tract infections (cUTI)

Cost*: TBD

Key Consideration:

• First and only oral carbapenem antibiotic approved in the US  
• Received priority review by the FDA  

Press Release: Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections (cUTIs)

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Notable Expanded Indications

• ‍Welireg® (belzutifan) – expanded to treat adult patients with ccRCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph.‍
• Truqap® (capivasertib) – expanded to treat PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer in combination with abiraterone and prednisone.‍
• Zegalogue® (dasiglucagon) – expanded to treat severe hypoglycemia in adults and pediatric patients with diabetes who weigh at least 20 kg.

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Generic Launches

• Januvia® (sitagliptin) oral tablet
• Janumet® (sitagliptin/metformin) oral tablet
• Opsumit® (macitentan) oral tablet
• Xeljanz® (tofacitinib) oral tablet
• Xeljanz® XR (tofacitinib ER) oral tablet
• Bosulif® (bosutinib) oral tablet
• Edarbi® (azilsartan) oral tablet

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*Cost: actual patient out-of-pocket costs may be lower, as the list price does not reflect insurance coverage, co-pay support for eligible patients, or financial assistance from patient support

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