Drug Pipeline & Clinical Update - August 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

Gwyn Lo^TM (norelgestromin;ethinyl estradiol) transdermal patch

Approval Date: 07/28/2026

Indication: Prevention of pregnancy in women with a BMI < 30 kg/m² for whom a combined hormonal contraceptive is appropriate  

Cost*: TBD

Key Consideration:

• Once weekly contraceptive patch that offers a low dose of estrogen

• Dosage is norelgestromin 220 mcg/day and ethinyl estradiol 20 mcg/day  

Press Release: https://newsroom.viatris.com/2026-07-29-Viatris-Receives-U-S-FDA-Approval-for-Gwyn-Lo-TM-,-a-Once-Weekly-Contraceptive-Patch  

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Orzeyful^TM (oveporexton) oral tablet

Approval Date: 08/05/2026

Indication: Treatment of narcolepsy type 1 (narcolepsy with cataplexy) in adults

Cost*: $142,000 annually

Key Consideration:

• First in class orexin receptor 2 (OX2R) agonist

• Received priority review and orphan drug designation by the FDA  

Press Release: https://www.takeda.com/en-us/newsroom/news-releases/2026/orzeyful-approved-narcolepsy/  

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Zenbexus^TM (iberdomide) oral capsule

Approval Date: 08/13/2026

Indication: Treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent, in combination with daratumumab and hyaluronidase-fihj and dexamethasone

Cost*: $29,500 per 28-days

Key Consideration:

• First cereblon-modulating protein degrader approved by the FDA

• Received accelerated approval, priority review, and orphan drug designation by the FDA

• Black Box Warning for embryo-fetal toxicity and serious venous and arterial thromboembolism

Press Release: https://news.bms.com/news/corporate-financial/2026/U-S--FDA-Grants-Accelerated-Approval-to-Bristol-Myers-Squibbs-First-CELMoD-Therapy-ZENBEXUS-in-Combination-with-Daratumumab-and-Hyaluronidase-fihj-and-Dexamethasone-ZDd-for-Patients-with-Multiple-Myeloma-as-Early-as-First-Relapse/default.aspx  

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Notable Expanded Indications

• Tivicay® PD (dolutegravir) – expanded to treat HIV-1 infection in patients weighing at least 2 kg, including term neonates

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Generic Launches

• Janumet® XR (sitagliptin; metformin) extended release oral tablet
• Retin-A® Micro Pump (tretinoin) 0.06% topical gel

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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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