Data updated: May 26, 2026
AVACLYR (acyclovir)
Infectious Disease
Approved 2019-03-29
1
Indication
--
Phase 3 Trials
7
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2019-03-29
- Patent Cliff
- 2026
- Routes
- OPHTHALMIC
- Dosage Forms
- OINTMENT
AVACLYR Approval History
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2019 to 2021
What AVACLYR Treats
1 FDA approvalsOriginally approved for its first indication in 2019 .
- Other (1)
📋
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 |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
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.
AVACLYR FDA Label Details
AVACLYR Patents & Exclusivity
Exclusivity: Mar 2026
Exclusivity
ODE-235
Until Mar 2026
Source: FDA Orange Book
Track AVACLYR 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.