Maribavir is a small-molecule antiviral active pharmaceutical ingredient (API) belonging to the benzimidazole riboside class of antiviral compounds. It is specifically developed for the treatment of cytomegalovirus (CMV) infection and disease in certain transplant recipients.
Maribavir acts through a mechanism distinct from conventional anti-CMV nucleoside analogues. It inhibits the UL97 protein kinase, an essential CMV enzyme involved in viral replication. This makes maribavir an important antiviral compound for patients with refractory or resistant CMV infection following hematopoietic stem cell or solid organ transplantation.
Maribavir is a synthetic small-molecule antiviral compound with the molecular formula C15H19ClN4O4 and a molecular weight of approximately 376.79 g/mol. Its CAS Number is 176161-24-3.
Maribavir is supplied as a pharmaceutical-grade active ingredient for the development and manufacture of antiviral pharmaceutical formulations.
Maribavir selectively inhibits the UL97 protein kinase of human cytomegalovirus.
UL97 is required for several stages of the CMV replication cycle. Inhibition of this viral kinase interferes with viral DNA replication and other processes required for production of infectious virus. Maribavir therefore provides a mechanism of antiviral action that differs from DNA polymerase inhibitors such as ganciclovir and valganciclovir.
Maribavir is used for the treatment of post-transplant cytomegalovirus infection or disease that is refractory to treatment, with or without genotypic resistance, in appropriate adult patients.
In the United States, maribavir is marketed as Livtencity and is indicated for the treatment of post-transplant CMV infection/disease that is refractory to treatment in adult patients following hematopoietic stem cell transplantation or solid organ transplantation.
Maribavir API can be evaluated using validated analytical procedures for identification, assay, related substances, water content, residual solvents, elemental impurities and other applicable quality attributes.
High-performance liquid chromatography (HPLC) may be used for assay and related-substance determination, while spectroscopic techniques can be applied for identification. Appropriate controls should be established for process-related impurities, degradation products and residual solvents.
Final acceptance criteria should be based on the applicable manufacturer's approved drug-substance specification, Certificate of Analysis and relevant pharmacopoeial and regulatory requirements.
Maribavir should be stored in a tightly closed pharmaceutical-grade container under controlled conditions and protected from excessive heat, moisture and direct light.
Specific storage and transportation requirements should follow the applicable manufacturer's approved specification.
Maribavir API may be supplied for qualified pharmaceutical manufacturing, antiviral formulation development, analytical and research applications, subject to applicable quality and regulatory requirements.
Maribavir API is available for qualified pharmaceutical development and manufacturing requirements. Customers can request product specifications, Certificate of Analysis, analytical documentation, packaging information and commercial details according to their requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 4.0 – 6.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |