XERESE (acyclovir)
Xerese treats recurrent cold sores in adults and children six years of age and older. It is used during the early stages of an outbreak to help patients by shortening the time it takes for lesions to heal and reducing the chance that the sores will become ulcerative. This topical medication combines an antiviral agent with a corticosteroid to manage both the viral infection and the resulting inflammation.
How XERESE Works
This medication works by targeting the herpes virus with acyclovir, which inhibits the DNA polymerase enzyme to stop the virus from replicating. Simultaneously, the hydrocortisone component acts as an anti-inflammatory to reduce swelling and irritation. This dual approach helps limit the progression of the cold sore and speeds up the recovery of the skin.
Details
- Status
- Prescription
- First Approved
- 2009-07-31
- Routes
- TOPICAL
- Dosage Forms
- CREAM
XERESE Approval History
What XERESE Treats
1 indicationsXERESE is approved for 1 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Herpes Labialis
XERESE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to XERESE
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03178149 | 7317-CL-0003 | Ph 1 | recruiting | A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration |
| NCT05589688 ACICLOPTIM | RC31/21/0610 | Ph 1 | recruiting | Individualization of Dosage Regimens in Obese Patients: Application to Acyclovir |
| NCT03368664 LemKids results posted | EFC13429 U1111-1180-6352, 2016-003100-30 | Ph 3 | terminated | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT |
| NCT06134492 HerpMV | ZKSJ0153 BMBF 01KG2301 | Ph 3 | recruiting | Acyclovir in Ventilated Patients With Pneumonia and HSV-1 in BAL |
| NCT02073097 results posted | CASE3413 | Ph 1, Ph 2 | completed | Carfilzomib, Rituximab, and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Lymphoma |
| NCT00495716 results posted | 32545 K23AI071257-01A1 | Ph 4 | terminated | Effect of HSV-2 Suppressive Therapy on Sexual Behavior |
| NCT02977533 | TDU14981 2016-002415-18, U1111-1184-8607 | Ph 1 | completed | A Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis |
| NCT03831165 | 1215208 | Ph 4 | completed | Melatonin Effects on Genital Herpes in Brazilian Women |
| NCT02151240 Focus-101 | cttq-focus-101 | Ph 4 | completed | Efficacy and Safety of Foscarnet Sodium and Sodium Chloride Injection in Patients With Herpes Zoster |
| NCT02583594 SCALA | TDU14260 2015-002550-12, U1111-1171-7939 | Ph 1 | completed | A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis |
| NCT01833143 results posted | 12-222 | Ph 2 | completed | Bortezomib in KRAS-Mutant Non-Small Cell Lung Cancer in Never Smokers or Those With KRAS G12D |
| NCT00942084 results posted | Pro00028772 | Ph 1 | completed | A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo) |
| NCT02047253 results posted | F130725012 (UAB 1336) | Ph 2 | completed | Phase 2 Trial of Carfilzomib for Metastatic Castration-resistant Prostate Cancer Following Treatment |
| NCT00723229 results posted | 34187-B U19AI031448 | Ph 4 | completed | A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation |
| NCT02349828 | NEU-SIUSM-15-001 | Ph 2, Ph 3 | withdrawn | Antiviral Prophylaxis in a Burn Population |
| NCT02282826 | TDU13475 2014-001591-61, U1111-1155-6252 | Ph 1 | completed | A First-in-human, Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis |
| NCT02255734 | YSP-REH3002-01 | Ph 4 | completed | Bioequivalence of Two Formulations of Acyclovir |
| NCT01026454 ACV-VAL results posted | 37162-A | Ph 4 | completed | Valacyclovir vs. Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
XERESE FDA Label Details
Indications & Usage
FDA Label (PDF)XERESE is indicated for the treatment of Herpes Labialis.
Track XERESE with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.