RAXIBACUMAB · HUMAN GENOME SCIENCES INC.
Raxibacumab is an anthrax protective antigen-directed antibody indicated for the treatment of inhalational anthrax due to Bacillus anthracis in adult and pediatric patients. It is administered in combination with appropriate antibacterial drugs and may also be used for prophylaxis when alternative therapies are not available or appropriate. Because human clinical trials involving intentional exposure to anthrax are unethical, the drug's effectiveness was established using animal models. The medication does not cross the blood-brain barrier and is not indicated for the treatment or prevention of meningitis.
How RAXIBACUMAB Works
Raxibacumab is a monoclonal antibody that specifically binds to the protective antigen (PA) of Bacillus anthracis. By targeting this antigen, the drug neutralizes the toxins produced by the bacteria to prevent their harmful effects. Raxibacumab does not have direct antibacterial activity and must be used in conjunction with antibacterial drugs to address the underlying infection.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-12-14
- Routes
- IV (INFUSION)
- Dosage Forms
- INJECTABLE
RAXIBACUMAB Approval History
What RAXIBACUMAB Treats
1 indicationsRAXIBACUMAB is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Inhalational Anthrax
RAXIBACUMAB Boxed Warning
HYPERSENSITIVITY and ANAPHYLAXIS • Hypersensitivity reactions, including anaphylaxis, have been reported during or after the administration of raxibacumab by intravenous infusion [see Warnings and Precautions ( 5.1 )] . • Administer raxibacumab by intravenous infusion in monitored settings where appropriate equipment, medication (including epinephrine) and personnel trained in the management of hypersensitivity, anaphylaxis, and shock are available [see Warnings and Precautions ( 2.3 , 5.1 )] . ...
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS • Hypersensitivity reactions, including anaphylaxis, have been reported during or after the administration of raxibacumab by intravenous infusion [see Warnings and Precautions ( 5.1 )] . • Administer raxibacumab by intravenous infusion in monitored settings where appropriate equipment, medication (including epinephrine) and personnel trained in the management of hypersensitivity, anaphylaxis, and shock are available [see Warnings and Precautions ( 2.3 , 5.1 )] . WARNING: HYPERSENSITIVITY and ANAPHYLAXIS See full prescribing information for complete boxed warning • Hypersensitivity reactions, including anaphylaxis, have been reported during or after the administration of raxibacumab by intravenous infusion ( 5.1 ). • Administer raxibacumab by intravenous infusion in monitored settings where appropriate equipment, medication (including epinephrine) and personnel trained in the management of hypersensitivity, anaphylaxis, and shock are available ( 2.3 , 5.1 ).
RAXIBACUMAB 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 RAXIBACUMAB
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02339155 results posted | 201436 | Ph 4 | completed | Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed |
| NCT02016963 results posted | HGS1021-C1069 | Ph 2, Ph 3 | completed | An Open-label, Nonrandomized Study to Evaluate the Safety and Immunogenicity of Raxibacumab With Reinjection |
| NCT00639678 results posted | HGS1021-C1063 | Ph 3 | completed | A Study to Evaluate the Safety and Tolerability of Raxibacumab in Healthy Subjects |
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.
RAXIBACUMAB FDA Label Details
Indications & Usage
FDA Label (PDF)Raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. Limitations of Use: • The effectiveness of raxibacumab is based solely on efficacy studies in animal models of inhalational anthrax. • There have been no studies of raxibacumab in the pediatric population. Dosing in pediatric patients was derived using an extrapolation approach. • Raxibacumab does not cros...
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS • Hypersensitivity reactions, including anaphylaxis, have been reported during or after the administration of raxibacumab by intravenous infusion [see Warnings and Precautions ( 5.1 )] . • Administer raxibacumab by intravenous infusion in monitored settings ...
Track RAXIBACUMAB 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.
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