ZIAGEN (abacavir sulfate)
Ziagen helps patients with human immunodeficiency virus (HIV-1) infection. It is used in combination with other antiretroviral medications to manage the virus. This drug is prescribed as part of a broader treatment plan for individuals living with HIV-1.
How ZIAGEN Works
Ziagen works by inhibiting the HIV-1 reverse transcriptase enzyme. As a nucleoside analogue, it acts as an antiretroviral agent to disrupt the viral replication process. This mechanism helps limit the spread of the virus throughout the body.
Details
- Status
- Prescription
- First Approved
- 1998-12-17
- Routes
- ORAL
- Dosage Forms
- SOLUTION, TABLET
ZIAGEN Approval History
What ZIAGEN Treats
1 indicationsZIAGEN is approved for 1 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Human Immunodeficiency Virus Infection
ZIAGEN Boxed Warning
HYPERSENSITIVITY REACTIONS Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with ZIAGEN (abacavir). Patients who carry the HLA ‑ B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir; although, hypersensitivity reactions have occurred in patients who do not carry the HLA ‑ B*5701 allele [see Warnings and Precautions ( 5.1 )] . ZIAGEN is contraindicated in patients with a prior hypersensitivity reaction to abacavir and ...
WARNING: HYPERSENSITIVITY REACTIONS Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with ZIAGEN (abacavir). Patients who carry the HLA ‑ B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir; although, hypersensitivity reactions have occurred in patients who do not carry the HLA ‑ B*5701 allele [see Warnings and Precautions ( 5.1 )] . ZIAGEN is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA ‑ B*5701-positive patients [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . All patients should be screened for the HLA ‑ B*5701 allele prior to initiating therapy with ZIAGEN or reinitiation of therapy with ZIAGEN, unless patients have a previously documented HLA ‑ B*5701 allele assessment. Discontinue ZIAGEN immediately if a hypersensitivity reaction is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ) ]. Following a hypersensitivity reaction to ZIAGEN, NEVER restart ZIAGEN or any other abacavir-containing product because more severe symptoms, including death can occur within hours. Similar severe reactions have also occurred rarely following the reintroduction of abacavir-containing products in patients who have no history of abacavir hypersensitivity [see Warnings and Precautions ( 5.1 )] . WARNING: HYPERSENSITIVITY REACTIONS See full prescribing information for complete boxed warning. • Serious and sometimes fatal hypersensitivity reactions have occurred with ZIAGEN (abacavir). ( 5.1 ) • Hypersensitivity to ZIAGEN is a multi-organ clinical syndrome. ( 5.1 ) • Patients who carry the HLA-B*5701 allele are at a higher risk of experiencing a hypersensitivity reaction to abacavir. ( 5.1 ) • ZIAGEN is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients. ( 4 ) • Discontinue ZIAGEN as so
ZIAGEN 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.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02101216 | CTIX-14-03 | Ph 1 | completed | Bioequivalence and Pharmacokinetic Study of Prurisol™ and Abacavir Sulfate in Healthy Volunteers |
Active Pipeline
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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.
ZIAGEN FDA Label Details
Indications & Usage
FDA Label (PDF)ZIAGEN is indicated for the treatment of Human Immunodeficiency Virus Infection.
WARNING: HYPERSENSITIVITY REACTIONS Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with ZIAGEN (abacavir). Patients who carry the HLA ‑ B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir; although, hypersensitivity re...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.