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

Key New Drug Approvals

Desmoda™ (desmopressin) oral solution

Approval Date: 02/25/2026

Indication: Management of central diabetes insipidus as antidiuretic replacement therapy  

Cost*: TBD

Key Consideration:

• First and only FDA-approved desmopressin oral solution
• Commercially launched early March 2026

Press Release: Eton Pharmaceuticals Announces U.S. FDA Approval for DESMODA™ (desmopressin acetate) Oral Solution

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Yuviwel® (navepegritide) subcutaneous injection

Approval Date: 02/27/2026

Indication: Increase linear growth in pediatric patients at least 2 years of age with achondroplasia with open epiphyses  

Cost*: TBD

Key Consideration:

• Received Accelerated Approval, Priority Review, and Orphan Drug Designation by the FDA

• The first and only once weekly injection that provides continuous systemic exposure to C-type natriuretic peptide (CNP) over the course of the weekly dosing interval

Press Release: FDA Approves Once-Weekly YUVIWEL® (navepegritide) for Children with Achondroplasia Aged 2 Years and Older

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Icotyde^TM (icotrokinra) oral tablet

Approval Date: 03/17/2026

Indication: Treatment of moderate-to-severe plaque psoriasis in patients 12 years of age and older who weigh at least 40 kg  

Cost*: TBD

Key Consideration:

• Received Priority Review by the FDA
• The first and only interleukin-23 (IL-23) receptor antagonist that delivers skin clearance in a once-daily oral pill

Press Release: FDA approval of ICOTYDE™ (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide

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Lynavoy (linerixibat) oral tablet

Approval Date: 03/17/2026

Indication: Treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adults

Cost*: TBD

Key Consideration:

• Received Orphan Drug Designation by the FDA

• The first and only FDA-approved treatment for cholestatic pruritus in patients with PBC

Press Release: Lynavoy (linerixibat) approved by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis (PBC)

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Notable Expanded Indications

• Juxtapid® (lomitapide) – expanded to treat homozygous familial hypercholesterolemia (HoFH) in patients 2 years of age and older
• Wegovy® (semaglutide) – expanded to include a 7.2 mg injection dose for chronic weight management in adults with obesity or overweight
• Hernexeos® (zongertinib) – expanded to treat unresectable or metastatic non-sqamous non-small cell lung cancer (NSCLC), whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as first line treatment
• Prezcobix® Ped (darunavir;cobicistat) - expanded to include tablets for oral suspension dosage form to treat HIV-1 infection in patients 3 years of age and older
• Sotyktu^TM (deucravacitinib) – expanded to treat active psoriatic arthritis in adults
• Imcivree® (setmelanotide) – expanded to treat acquired hypothalamic obesity (HO) in patients 4 years of age and older

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Generic Launches

• ‍Nucynta® (tapentadol) oral tablet ‍
• Briviact® (brivaracetam) oral tablet ‍
• Auryxia® (ferric citrate) oral tablet ‍
• Savella® (milnacipran) 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.