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ASP0113
ASP0113 is a therapeutic vaccine that stimulates the immune system to recognize and eliminate cells infected with cytomegalovirus (CMV).
ASP0113 is a therapeutic vaccine that stimulates the immune system to recognize and eliminate cells infected with cytomegalovirus (CMV). Used for Prevention of cytomegalovirus (CMV) reactivation in CMV-seropositive recipients of hematopoietic stem cell transplantation, Prevention of CMV reactivation in solid organ transplant recipients.
At a glance
| Generic name | ASP0113 |
|---|---|
| Sponsor | Astellas Pharma Global Development, Inc. |
| Drug class | Therapeutic vaccine |
| Target | CMV antigens (IE-1 and pp65) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
ASP0113 is a dendritic cell-targeted vaccine encoding CMV antigens (IE-1 and pp65) designed to enhance CMV-specific T-cell immunity. It works by activating dendritic cells to present CMV antigens, thereby boosting cellular immune responses against CMV-infected cells. This approach aims to prevent CMV reactivation and disease in immunocompromised patients, particularly those undergoing hematopoietic stem cell or solid organ transplantation.
Approved indications
- Prevention of cytomegalovirus (CMV) reactivation in CMV-seropositive recipients of hematopoietic stem cell transplantation
- Prevention of CMV reactivation in solid organ transplant recipients
Common side effects
- Injection site reactions
- Fever
- Fatigue
- Headache
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor (PHASE2)
- A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT) (PHASE3)
- An Evaluation of a Cytomegalovirus (CMV) Vaccine (ASP0113) in CMV-Seropositive and CMV-Seronegative Healthy Subjects and CMV-Seronegative Dialysis Patients (PHASE1)
- A Study to Evaluate Safety and Tolerability of a Therapeutic Vaccine, ASP0113, in Subjects Undergoing Allogeneic Hematopoietic Cell Transplant (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ASP0113 CI brief — competitive landscape report
- ASP0113 updates RSS · CI watch RSS
- Astellas Pharma Global Development, Inc. portfolio CI