Overview
Letermovir recieved approval from the FDA on November 8th, 2017 for use in prophylaxis of cytomegalovirus (CMV) infection in allogeneic hematopoietic stem cell transplant patients. It is the first of a new class of CMV anti-infectives called DNA terminase complex inhibitors. Letermovir has recieved both priority and orphan drug status from the FDA. It is currently marketed under the brand name Prevymis.
Indication
Letermovir is indicated for prophylaxis against cytomegalovirus (CMV) infection and disease in adult recipients of an allogeneic hematopoietic stem cell transplant (HSCT) who are CMV-seropositive. It is also indicated for prophylaxis against CMV disease in adult kidney transplant recipients who are at risk (i.e. donor CMV-seropositive/recipient CMV-seronegative).
Associated Conditions
- Cytomegalovirus (CMV) Infections
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/13 | Phase 1 | Not yet recruiting | City of Hope Medical Center | ||
2025/04/09 | Phase 2 | Not yet recruiting | |||
2024/10/15 | Not Applicable | Recruiting | |||
2024/10/04 | Phase 2 | Not yet recruiting | |||
2024/08/28 | Phase 2 | Recruiting | |||
2024/06/11 | Phase 2 | Recruiting | |||
2024/06/10 | Not Applicable | Recruiting | |||
2024/06/04 | N/A | Recruiting | Anhui Provincial Hospital | ||
2024/05/09 | Phase 3 | Recruiting | |||
2024/04/02 | Phase 3 | Not yet recruiting | Hospital do Rim e Hipertensão |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Merck Sharp & Dohme LLC | 0006-3075 | ORAL | 240 mg in 1 1 | 8/2/2023 | |
| Merck Sharp & Dohme LLC | 0006-5004 | INTRAVENOUS | 20 mg in 1 mL | 8/2/2023 | |
| Merck Sharp & Dohme LLC | 0006-5003 | INTRAVENOUS | 20 mg in 1 mL | 8/2/2023 | |
| Merck Sharp & Dohme LLC | 0006-3076 | ORAL | 480 mg in 1 1 | 8/2/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/8/2018 | ||
Authorised | 1/8/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| PREVYMIS CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML | SIN15759P | INFUSION, SOLUTION CONCENTRATE | 20mg/ml | 7/30/2019 | |
| PREVYMIS FILM COATED TABLET 480MG | SIN15758P | TABLET, FILM COATED | 480.0mg | 7/30/2019 | |
| PREVYMIS FILM COATED TABLET 240MG | SIN15757P | TABLET, FILM COATED | 240.0mg | 7/30/2019 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Letermovir Injection | 国药准字HJ20220048 | 化学药品 | 注射剂 | 5/10/2022 | |
| Letermovir Injection | 国药准字HJ20220047 | 化学药品 | 注射剂 | 5/10/2022 | |
| Letermovir Injection | 国药准字H20249025 | 化学药品 | 注射剂 | 10/9/2024 | |
| Letermovir Tablets | 国药准字HJ20210085 | 化学药品 | 片剂 | 12/31/2021 | |
| Letermovir Tablets | 国药准字H20243449 | 化学药品 | 片剂 | 4/7/2024 | |
| Letermovir Tablets | 国药准字HJ20210086 | 化学药品 | 片剂 | 12/31/2021 | |
| Letermovir Tablets | 国药准字H20254189 | 化学药品 | 片剂 | 5/20/2025 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PREVYMIS CONCENTRATE FOR SOLUTION FOR INFUSION 240MG/12ML | N/A | N/A | N/A | 2/27/2019 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PREVYMIS letermovir 480 mg film-coated tablet blister pack | 289797 | Medicine | A | 6/22/2018 | |
| PREVYMIS letermovir 480 mg/24 mL concentrated injection for infusion vial | 289796 | Medicine | A | 6/22/2018 | |
| PREVYMIS letermovir 240 mg film-coated tablet blister pack | 289795 | Medicine | A | 6/22/2018 | |
| PREVYMIS letermovir 240 mg/12 mL concentrated injection for infusion vial | 289794 | Medicine | A | 6/22/2018 |
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