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

Key New Drug Approvals

Aqvesme™ (mitapivat) oral tablet

Approval Date: 12/23/2025

Indication: Treatment of anemia in adults with alpha- or beta-thalassemia

Cost*: $425,000 annually

Key Consideration:

• First and only FDA-approved treatment for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia
• Mitapivat active ingredient marketed under Aqvesme™ brand name in the U.S. for thalassemia indication

Press Release: U.S. FDA Approves Agios’ AQVESME™ (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia

Nereus™ (tradipitant) oral capsule

Approval Date: 12/30/2025

Indication: Prevention of vomiting induced by motion in adults

Cost*: TBD

Key Consideration:

• First FDA approved treatment for motion sickness in over 4 decades
• Recommended dosage is 1-2 capsules orally approximately 60 minutes before an event expected to cause vomiting induced by motion

Press Release: Vanda Pharmaceuticals Announces FDA Approval of NEREUS™ (tradipitant) for the Prevention of Vomiting Induced by Motion: A Historic Scientific Milestone in the Prevention of Motion Sickness

Zycubo® (copper histidinate) subcutaneous injection

Approval Date: 1/12/2026

Indication: Treatment of Menkes disease in pediatric patients

Cost*: TBD

Key Consideration:

• First and only FDA approved treatment for Menkes disease in the U.S.
• Received Priority Review and Orphan Drug Designation by the FDA

Press Release: Sentynl Therapeutics Inc. Announces FDA Approval of ZYCUBO® (copper histidinate)

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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