Drug Pipeline & Clinical Update - July 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 July 2026 Monthly Drug Update below:

Key New Drug Approvals

Lipfendra® (enlicitide) oral tablet

Approval Date: 07/15/2026

Indication: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH), as an adjunct to diet and exercise

Cost*: ~$3,800 per year

Key Consideration:

• First and only oral proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor approved by the FDA  

• Once-daily oral pill

• Received priority review by the FDA

Press Release: https://www.merck.com/news/mercks-lipfendra-enlicitide-is-the-first-and-only-once-daily-oral-pcsk9-inhibitor-approved-by-the-u-s-fda-to-reduce-ldl-c-in-adults-with-hypercholesterolemia/  

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Jideytro^TM (zidesamtinim) oral tablet

Approval Date: 07/22/2026

Indication: Treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor

Cost*: TBD

Key Consideration:

• Once-daily oral tablet, taken with or without food

• Received orphan drug designation by the FDA  

Press Release: https://www.gsk.com/en-gb/media/press-releases/jideytro-zidesamtinib-approved-in-the-us-for-previously-treated-ros1-positive-non-small-cell-lung-cancer/  

Simtriyo® (centanafadine) extended-release oral capsule

Approval Date: 07/24/2026

Indication: Treatment of attention-deficit hyperactive disorder (ADHD) in patients 6 years of age and older weighing at least 20 kg

Cost*: TBD

Key Consideration:

• Received priority review by the FDA

• First and only norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) approved for treatment of ADHD by the FDA

• Black Box Warning for suicidal ideation and behaviors, and abuse, misuse, and addiction

Press Release: https://www.otsuka-us.com/otsuka-shares-fda-review-update-for-centanafadine  

Notable Expanded Indications

• ‍ Tryngolza® (olezarsen) – expanded to reduce TG and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG: TG greater than or equal to 500 mg/dL)

• Ryaltris® (olopatadine; mometasone) – expanded to treat symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older

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Generic Launches

• Rhofade^TM (oxymetazoline) cream
• Pentasa® (mesalamine) 250 mg oral capsule
• Nuedexta® (dextromethorphan; quinidine) oral capsule

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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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