Drug Pipeline & Clinical Update - December 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 December 2025 Monthly Drug Update below:  

Key New Drug Approvals

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Cardamyst™ (etripamil) nasal spray

Approval Date: 12/12/2025 ‍

Indication: Conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults ‍

Cost*: $1,649 per box of 2 nasal spray devices ‍

Key Consideration:

• First and only self-administered nasal spray for adults with PSVT

• Average time to conversion to sinus rhythm is 17 minutes after administration

• Expected to launch in Q1 2026

Press Release: https://investors.milestonepharma.com/news-releases/news-release-details/milestone-receives-fda-approval-cardamysttm-etripamil-first-and  

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Nuzolvence® (zoliflodacin) oral suspension

Approval Date: 12/12/2025

Indication: Treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in patients 12 years of age and older, weighing at least 35 kg

Cost*: TBD

Key Consideration:

• First new antibiotic approved exclusively for gonorrhea treatment in decades

• Belongs to a new class of antibiotics, spiropyrimidinetriones

• Received Priority Review by the FDA

Press Release: https://gardp.org/nuzolvence-zoliflodacin-first-in-class-oral-antibiotic-for-gonorrhoea-receives-u-s-fda-approval/

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Myqorzo™ (aficamten) oral tablet

Approval Date: 12/19/2025

Indication: Treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms in adults

Cost*: ~$104,000 annually

Key Consideration:

• Black Box Warning for causing heart failure due to systolic dysfunction

• Received Orphan Drug Designation by the FDA

Press Release: https://ir.cytokinetics.com/press-releases/press-release-details/2025/Cytokinetics-Announces-FDA-Approval-of-MYQORZO-aficamten-for-the-Treatment-of-Adults-with-Symptomatic-Obstructive-Hypertrophic-Cardiomyopathy-to-Improve-Functional-Capacity-and-Symptoms/default.aspx

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Wegovy® (semaglutide) oral tablet

Approval Date: 12/22/2025

Indication: Reduce excess body weight and maintain weight reduction long term in adults with obesity, or in adults with overweight in the presence of at least one weight-related comorbid condition; reduce the risk of major adverse CV events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV disease and either obesity or overweight

Cost*: TBD

Key Consideration:

• First and only first oral GLP-1 for weight management  

• Expected to launch in January 2026

Press Release: https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916472

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Notable Expanded Indications

• Blujepa (gepotidacin) – expanded to treat uncomplicated urogenital gonorrhea in patients 12 years of age and older weighing at least 45 kg and have limited or no alternative treatment options

• Akeega® (niraparib; abiraterone) – expanded to treat deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC)

• Addyi® (flibanserin) – expanded to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in women up to 65 years of age

• Vraylar® (cariprazine) – expanded to treat schizophrenia in patients 13 years of age and older; acute treatment of manic or mixed episodes associated with bipolar I disorder in patients 10 years of age and older

• Accrufer® (ferric maltol) – expanded to treat iron deficiency in patients 10 years of age and older

• Mounjaro® (tirzepatide) – expanded to improve glycemic control, as an adjunct to diet and exercise, in patients 10 years of age and older with type 2 diabetes mellitus

• Jascayd® (nerandomilast) – expanded to treat progressive pulmonary fibrosis in adults

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Generic Launches

• Adzenys XR-ODT® (amphetamine) oral disintegrating tablet

• Fycompa® (perampanel) oral suspension

• Mavenclad® (cladribine) oral tablet

• Gleostine® (lomustine) 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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