Drug Pipeline & Clinical Update - June 2025

Capital Rx's Clinical Team closely monitors the drug landscape to provide our clients with timely information on newly FDA-approved medications, as well as products in the pipeline. Read on to review our June 2025 Monthly Drug Update!

Key New Drug Approvals

Tryptyr® (acoltremon) ophthalmic solution

Approval Date: 5/28/2025

Indication: Treatment of the signs and symptoms of dry eye disease (DED)

Cost*: TBD

Key Consideration:
• First-in-class TRPM8 receptor agonist that rapidly stimulates natural tear production
• Recommended dose is 1 drop in each eye twice daily (approximately 12 hours apart)
• Available in single dose vials

Press Release: https://investor.alcon.com/news-and-events/press-releases/news-details/2025/Alcon-Announces-FDA-Approval-of-TRYPTYR-acoltremon-ophthalmic-solution-0-003-for-the-Treatment-of-the-Signs-and-Symptoms-of-Dry-Eye-Disease/default.aspx

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Khindivi™ (hydrocortisone) solution

‍Approval Date: 5/28/2025

Indication: Corticosteroid replacement therapy in patients 5 years of age and older with adrenocortical insufficiency

Cost*: TBD

Key Consideration:
• First and only FDA approved hydrocortisone oral solution
• Ready to use oral liquid solution that does not require refrigeration, mixing, or shaking
• Dosing is based on Body Surface Area (BSA)

Press Release: https://ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-announces-us-fda-approval-khindivitm

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Widaplik™ (telmisartan; amlodipine; indapamide) tablet

‍Approval Date: 6/5/2025

Indication: Treatment of hypertension

Cost*: TBD

Key Consideration:
• First and only triple combination of an angiotensin II receptor blocker (telmisartan), calcium channel blocker (amlodipine), and thiazide-like diuretic (indapamide)
• First and only triple combination approved for the initial treatment of hypertension
• Black Box Warning for use in pregnancy

Press Release: https://george-medicines.com/george-medicines-announces-fda-approval-of-widaplik-telmisartan-amlodipine-and-indapamide-a-new-single-pill-combination-treatment-for-hypertension-in-adults-including-initial-treatment/

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Ibtrozi™ (taletrectinib) capsule

‍Approval Date: 06/11/2025

Indication: Treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults

Cost*: TBD

Key Consideration:
• Received Priority Review and Orphan Drug Designation by the FDA
• Recommended dose is 600 mg orally once daily on an empty stomach (no food intake at least 2 hours before or 2 hours after taking)

Press Release: https://investors.nuvationbio.com/news/news-details/2025/U-S--Food-and-Drug-Administration-Approves-Nuvation-Bios-IBTROZI-taletrectinib-a-Next-Generation-Oral-Treatment-for-Advanced-ROS1-Positive-Non-Small-Cell-Lung-Cancer/default.aspx

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Andembry® (garadacimab-gxii) subcutaneous injection

Approval Date: 06/16/2025

Indication: Prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older

Cost*: TBD

Key Consideration:
• Once monthly self-administered subcutaneous injection
• First and only FDA approved treatment targeting factor XIIa for prophylactic use for prevention of HAE attacks

Press Release: https://newsroom.csl.com/2025-06-16-U-S-Food-and-Drug-Administration-Approves-CSLs-ANDEMBRY-R-garadacimab-gxii-,-the-Only-Prophylactic-Hereditary-Angioedema-HAE-Treatment-Targeting-Factor-XIIa-with-Once-Monthly-Dosing-for-All-Patients-From-the-Start

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Notable Expanded Indications

• Nubeqa® (darolutamide) – expanded to treat metastatic castration-sensitive prostate cancer (mCSPC)

• Mavyret® (glecaprevir/pibrentasvir) – expanded to treat acute or chronic hepatitis C virus (HCV) infection in patients at least 3 years of age, with or without compensated cirrhosis (Child-Pugh A)

• Talzenna® (talazoparib) – expanded to treat metastatic castration-resistant prostate cancer mCRPC) in combination with Xtandi® (enzalutamide)

• Dupixent® (dupilumab) – expanded to treat bullous pemphigoid in adults

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Generic Launches

• Tasigna® (nilotinib) capsule
• Fycompa® (perampanel) tablet

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Contact Us if you'd like to learn more about Capital Rx's full-service pharmacy benefit management (PBM) solutions and clinical programs.

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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