Drug Pipeline & Clinical Update - October 2025

Capital Rx closely monitors the drug landscape to provide ourclients with timely information on newly FDA approved medications and productsin the pipeline. Please find the October2025 Monthly Drug Update below:

Key New Drug Approvals

1 – Bondlido®(lidocaine) topical system

Approval Date: 09/24/2025

Indication: Relief of pain associated with post-herpeticneuralgia (PHN)

Cost*: TBD

Key Consideration:

• Up to two     patches can be worn for up to 12 hours within a 24-hour period

·       Patchis designed to reduce skin irritation and improve adhesion, even duringexercise.

Press Release: https://www.empr.com/news/bondlido-topical-system-approved-for-postherpetic-neuralgia/

2 – Inluriyo^TM (imlunestrant) oral tablet

Approval Date: 09/25/2025

Indication: Treatment ofER-positive, HER2-negative, ESR1-mutated advanced or metastatic breastcancer in adults whose disease progressed following at least one line ofendocrine therapy

Cost*: $22,500 per 28 days

Key Consideration:

·      Standarddose is 400 mg (2 x 200 mg tablets) once daily on an empty stomach

·      Dosemodifications required for moderate or severe hepatic impairment

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

3 – Palsonify^TM (paltusotine) oral tablet

Approval Date: 09/25/2025

Indication: Treatment of adults with acromegaly who had aninadequate response to surgery and/or for whom surgery is not an option

Cost*: $290,000 annually

Key Consideration:

·      The firstand only once-daily, oral therapy approved by the FDA to treat acromegaly

·      ReceivedOrphan Drug Designation by the FDA

Press Release: https://crinetics.com/crinetics-announces-fda-approval-of-palsonify-paltusotine-for-the-treatment-of-acromegaly-in-adults/

4 – Clotic (clotrimazole) otic solution

Approval Date: 09/26/2025

Indication: Treatment of fungal otitis externa (otomycosis) due to Aspergillusspecies and Candida species in adults

Cost*: TBD

Key Consideration:

·      Firsttargeted treatment for otomycosis in the U.S.

·      Notrecommended for the treatment of otomycosis in patients with perforatedtympanic membranes

·      Available assingle-dose vials

·      ReceivedPriority Review and Orphan Drug Designation by the FDA

Press Release: https://svt.com/en/salvat-receives-fda-approval-for-clotic-an-innovative-treatment-for-otomycosis-with-orphan-drug-designation/

5 – Rhapsido® (remibrutinib) oraltablet

Approval Date: 09/30/2025

Indication: Treatment of chronicspontaneous urticaria (CSU) in adults who remain symptomatic despite H1antihistamine treatment

Cost*: ~$4,500 per month

Key Consideration:

·      The firstand only oral BTK inhibitor approved for CSU

·      Live orlive-attenuated vaccines should be avoiding during treatment with Rhapsido®

·      ReceivedPriority Review by the FDA

Press Release: https://www.novartis.com/us-en/news/media-releases/novartis-receives-fda-approval-rhapsido-remibrutinib-only-oral-targeted-btki-treatment-chronic-spontaneous-urticaria-csu

6 – Jascayd® (nerandomilast) oraltablet

Approval Date: 10/07/2025

Indication: Treatment ofidiopathic pulmonary fibrosis (IPF) in adults

Cost*: ~$16,220 per month

Key Consideration:

·      The first newtreatment approved for IPF in over a decade

·      ReceivedPriority Review and Orphan Drug Designation by the FDA

Press Release: https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/fda-approves-jascayd-nerandomilast-first-new-treatment-ipf-over-decade

Notable Expanded Indications

·       Zoryve® (roflumilast) – expanded to treat mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age (new strength; 0.05% cream)

·       Uzedy® (risperidone) – expanded to treat bipolar I disorder in adults, either as monotherapy or adjunctive therapy to lithium or valproate

·       Olpruva® (sodium phenylbutyrate) –expanded to treat urea cycle disorders (UCDs) in patients at least 1 year of age and weighing at least 7 kg

·       Tezspire® (tezepelumab-ekko)– expanded to treat chronic rhinosinusitis with nasal polyps (CRSwNP) inpatients 12 years of age and older, as add-on maintenance treatment

·       Simponi®(golimumab) – expanded to treat moderate to severe ulcerative colitis (UC) in patientsweighing at least 15 kg

·       Tremfya®(guselkumab) – expanded to treat moderate to severe plaque psoriasis and active psoriatic arthritis in children at least 6 years of age and weighing at least40 kg

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Generic Launches

·       Endometrin® (progesterone) vaginal insert

·       Gralise® (gabapentin (once daily)450mg, 750 mg, 900 mg) 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

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