Drug Pipeline & Clinical Update - November 2025

Capital Rx 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 November 2025 Monthly Drug Update below:  

Key New Drug Approvals

Javadin™ (clonidine) oral solution

Approval Date: 10/23/2025

Indication: Treatment of hypertension in adults

Cost*: TBD

Key Consideration:

• First and only ready to use clonidine solution approved by the FDA

• Expected to launch by the end of 2025

Press Release: https://azurity.com/azurity-pharmaceuticals-announces-fda-approval-of-javadin-clonidine-hydrochloride-oral-solution/  

Lynkuet® (elinzanetant) oral capsule

Approval Date: 10/24/2025

Indication: Treatment of moderate to severe vasomotor symptoms due to menopause

Cost*: $625 per month

Key Consideration:

• First and only dual neurokinin (NK) targeted therapy for the treatment of moderate to severe hot flashes due to menopause  

• Recommended dose is 2 capsules (120 mg) orally at bedtime, with or without food

Press Release: https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-inluriyo-imlunestrant-adults-er-her2-esr1  

Kygevvi™ (doxecitine; doxribtimine) oral solution

Approval Date: 11/03/2025

Indication: Treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years

Cost*: TBD

Key Consideration:

• The first and only treatment for individuals living with TK2d

• Received Priority Review and Orphan Drug Designation by the FDA

Press Release: https://www.ucb.com/newsroom/press-releases/article/us-fda-approves-kygevvitm-doxecitine-and-doxribtimine-the-first-and-only-treatment-for-adults-and-children-living-with-thymidine-kinase-2-deficiency-tk2d  

Komzifti™ (ziftomenib) oral capsule

Approval Date: 11/13/2025

Indication: Treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options

Cost*: TBD

Key Consideration:

• First and only once-daily targeted therapy for relapsed or refractory NPM1-mutated AML

• Received Priority Review and Orphan Drug Designation by the FDA

• Contains a Black Box Warning for Differentiation Syndrome

Press Release: https://ir.kuraoncology.com/news-releases/news-release-details/kura-oncology-and-kyowa-kirin-announce-fda-approval-komziftitm

Redemplo® (plozasiran) subcutaneous injection

Approval Date: 11/18/2025

Indication: Reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), as an adjunct to diet

Cost*: $60,000 annually

Key Consideration:

• The first and only FDA-approved drug to be studied in patients with genetically confirmed and clinically diagnosed FCS

• Received Orphan Drug Designation by the FDA

Press Release: https://ir.arrowheadpharma.com/news-releases/news-release-details/arrowhead-pharmaceuticals-announces-fda-approval-redemplor  

Hyrnuo® (sevabertinib) oral tablet

Approval Date: 11/19/2025

Indication: Treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD)

activating mutations, and who have received a prior systemic therapy

Cost*: ~$16,220 per month

Key Consideration:

• Granted accelerated approval based on objective response rate (ORR) and duration of response (DOR)

• Received Priority Review and Orphan Drug Designation by the FDA

Press Release: https://www.bayer.com/en/us/news-stories/hyrnuo  

Notable Expanded Indications

• Revuforj® (revumenib) – expanded to treat relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in patients 1 year of age and older who have no satisfactory alternative treatment options

• Linzess® (linaclotide) – expanded to treat irritable bowel syndrome (IBS) in patients 7 years of age and older

• Caplyta® (lumateperone) – expanded to treat major depressive disorder (MDD) in adults as adjunctive therapy with antidepressants

• Koselugo® (selumetinib) – expanded to treat adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN)

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Generic Launches

• Premarin® (conjugated estrogen) oral tablet

• Ravicti® (glycerol phenylbutyrate) oral liquid

*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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