Overview
Maribavir is an inhibitor of the cytomegalovirus (CMV; HHV5) pUL97 kinase which is used to treat CMV infections in patients post-transplantation. Most standard CMV therapies, such as ganciclovir or foscarnet, target CMV DNA polymerase - while generally effective, these medications tend to promote the development of CMV resistance to DNA polymerase-based therapies, and their use is often limited by toxicities like myelosuppression and renal injury. Maribavir is novel in that it instead targets the CMV pUL97 kinase, thereby providing an effective alternative treatment option in cases of resistant infections. Maribavir was approved by the FDA in November 2021, under the name Livtencity (Takeda), for the treatment of resistant CMV infections in post-transplant patients. The drug was also approved by Health Canada in September 2022 and by European Commission in November 2022.
Indication
Maribavir is indicated for the treatment of post-transplant cytomegalovirus (CMV) infection (following hematopoietic stem cell transplant or solid organ transplant) which is refractory to standard treatment with ganciclovir, valganciclovir, cidofovir, or foscarnet. In the US, patients receiving the treatment should weigh more than 35 kg and be at least 12 years old. In Canada and Europe, maribavir is only approved in adults.
Associated Conditions
- Post-transplant Cytomegalovirus (CMV) Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/10 | Phase 2 | Not yet recruiting | |||
2024/08/29 | N/A | Not yet recruiting | |||
2024/08/15 | N/A | Recruiting | |||
2024/06/03 | Phase 3 | Recruiting | |||
2023/09/13 | Phase 4 | Active, not recruiting | |||
2023/06/26 | Phase 1 | Completed | |||
2022/05/19 | Phase 1 | Completed | |||
2022/04/08 | Phase 3 | Active, not recruiting | |||
2021/11/30 | Phase 3 | Completed | |||
2020/08/04 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Takeda Pharmaceuticals America, Inc. | 64764-800 | ORAL | 200 mg in 1 1 | 3/28/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/9/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| LIVTENCITY FILM-COATED TABLET 200MG | SIN17208P | TABLET, FILM COATED | 200mg | 3/18/2025 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Maribavir Tablets | 国药准字HJ20230146 | 化学药品 | 片剂 | 12/19/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| LIVTENCITY TABLETS 200MG | N/A | N/A | N/A | 4/25/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| LIVTENCITY maribavir 200 mg film coated tablet bottle | 380132 | Medicine | A | 10/7/2022 |
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