Reduces transmission Herpes Zoster Pediatric Patients Cold Sores (Herpes Labialis)…. Sold as Valtrex. Every FDA application for this active ingredient: 2 branded and 16 generic.
As of Nov 14, 2026, FDA lists 18 applications for Valacyclovir Hydrochloride (sold as Valtrex), first approved Jun 23, 1995, with 7 new uses approved and 0 published complete response letters.
| Valacyclovir | Part D | $122M | +14% | 1,686,935 |
| Valtrex | Part D | $2.5M | -42% | 1,000 |
| A Clinical Trial of MK-1045 With Zilovertamab Vedotin in Participants With Diffuse Large B-cell Lymphoma (MK-1045-010)Lymphoma, Large B-Cell, Diffuse, Diffuse Large B-Cell Lymphoma · Merck Sharp & Dohme LLC | Phase 2 / Phase 3 | Not yet recruiting | Nov 5, 2026 |
| Study to Compare GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital HerpesHSV-2 Infection · Gilead Sciences | Phase 2 | Not yet recruiting | Nov 3, 2026 |
| Aglatimagene Besadenovec + Prodrug and Pembrolizumab vs Docetaxel for Stage IV Non-Squamous NSCLC Progressing on Pembrolizumab (AURORA)Non-squamous, Non-Small Cell Lung Cancer · Candel Therapeutics, Inc. | Phase 3 | Recruiting | Jun 22, 2026 |
| SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID DysfunctionPost-acute Sequelae of COVID-19, Long COVID · Icahn School of Medicine at Mount Sinai | Phase 2 | Recruiting | May 19, 2026 |
| Efficacy of Electroacupuncture for Acute Herpes Zoster-Associated Pain and Biomarker EvaluationAcute Herpes Zoster · Dexiong Han | Not applicable | Recruiting | Apr 7, 2026 |
| Oral Herpesviruses and Oral Mucositis in Patients Receiving Head and Neck RadiotherapyOral Mucositis, Head and Neck Cancer (H&N) · Instituto Oncoclinicas | Phase 2 | Enrolling by invitation | Jan 23, 2026 |
| Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade GliomaGlioblastoma (GBM), High Grade Gliomas · Trogenix ltd | Phase 1 / Phase 2 | Recruiting | Jan 16, 2026 |
| A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene BesadenovecProstate Cancer Patients Treated by Radiotherapy, Prostate Cancer (Adenocarcinoma) · Candel Therapeutics, Inc. | Phase 2 | Recruiting | Jan 12, 2026 |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
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