Data updated: May 26, 2026
SITAVIG (acyclovir)
Trial Activity: Declining 3 active trials
Infectious Disease
Approved 2013-04-12
Development Insights
University of Washington conducting 4 trials (21%)
23 indications explored (Broad Platform)
→ genital herpes (4 trials)
→ progressive multiple sclerosis (3 trials)
→ herpes simplex (2 trials)
1
Indication
--
Phase 3 Trials
13
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2013-04-12
- Patent Cliff
- 2030
- Routes
- BUCCAL
- Dosage Forms
- TABLET
SITAVIG Approval History
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2013 to 2019
What SITAVIG Treats
1 FDA approvalsOriginally approved for its first indication in 2013 .
- Other (1)
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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 |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
SITAVIG FDA Label Details
View full patent landscape →
3 OB patents · 2 families ·
50 international docs across 27 countries
Pro Intelligence Preview
Deep insights for SITAVIG
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 3 active patents
Trial Analysis
- • 19 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment