Prevymis(letermovir)
Prevymis (letermovir) is a small molecule pharmaceutical. Letermovir was first approved as Prevymis on 2017-11-08. It has been approved in Europe to treat cytomegalovirus infections.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
Trade Name
FDA
EMA
Prevymis
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Letermovir
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PREVYMIS | Merck & Co | N-209939 RX | 2017-11-08 | 2 products, RLD, RS |
| PREVYMIS | Merck & Co | N-209940 RX | 2017-11-08 | 2 products, RLD, RS |
| PREVYMIS | Merck & Co | N-219104 RX | 2024-08-30 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| prevymis | New Drug Application | 2024-08-30 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LETERMOVIR, PREVYMIS, MERCK SHARP DOHME | |||
| 2030-06-05 | ODE-423 | ||
| 2026-08-02 | D-189 | ||
| 2026-06-05 | I-916 | ||
| 2024-11-08 | ODE-165 | ||
HCPCS
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Clinical
Clinical Trials
42 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cytomegalovirus infections | D003586 | EFO_0001062 | B25 | 1 | 7 | 8 | 3 | 6 | 25 |
| Infections | D007239 | EFO_0000544 | — | — | 6 | 7 | 3 | 3 | 19 |
| Communicable diseases | D003141 | — | — | — | 4 | 6 | 3 | 3 | 16 |
| Neutropenia | D009503 | — | D70 | — | — | — | 2 | — | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematologic neoplasms | D019337 | — | — | — | 2 | 1 | — | 1 | 4 |
| Neoplasms | D009369 | — | C80 | — | 1 | 1 | — | — | 2 |
| Disease | D004194 | EFO_0000408 | R69 | — | — | 1 | — | — | 1 |
| Kidney transplantation | D016030 | — | — | — | — | 1 | — | — | 1 |
| Pancreas transplantation | D016035 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematopoietic stem cell transplantation | D018380 | — | — | — | 3 | — | — | 4 | 7 |
| Leukemia | D007938 | — | C95 | — | 2 | — | — | — | 2 |
| Lymphoma | D008223 | — | C85.9 | — | 2 | — | — | — | 2 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | — | 2 | — | — | — | 2 |
| Viremia | D014766 | — | B34.9 | — | 1 | — | — | 1 | 2 |
| Sezary syndrome | D012751 | — | C84.1 | — | 1 | — | — | — | 1 |
| Prolymphocytic leukemia t-cell | D015461 | — | C91.6 | — | 1 | — | — | — | 1 |
| T-cell lymphoma | D016399 | — | — | — | 1 | — | — | — | 1 |
| Prolymphocytic leukemia | D015463 | — | — | — | 1 | — | — | — | 1 |
| T-cell lymphoma peripheral | D016411 | — | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breakthrough infections | D000093742 | — | — | — | — | — | — | 1 | 1 |
| Latent infection | D000085343 | — | — | — | — | — | — | 1 | 1 |
| Cell- and tissue-based therapy | D064987 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Letermovir |
| INN | letermovir |
| Description | Letermovir (INN; brand name Prevymis) is an antiviral drug for the treatment of cytomegalovirus (CMV) infections. It has been tested in CMV infected patients with allogeneic stem cell transplants and may also be useful for other patients with a compromised immune system such as those with organ transplants or HIV infections. The drug was initially developed by the anti-infective division at Bayer, which became AiCuris Anti-infective Cures AG through a spin-out and progressed the development to end of Phase 2 before the project was sold to Merck & Co for Phase 3 development and approval.
|
| Classification | Small molecule |
| Drug class | antivirals |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COc1cccc(N2CCN(C3=Nc4c(F)cccc4[C@H](CC(=O)O)N3c3cc(C(F)(F)F)ccc3OC)CC2)c1 |
Identifiers
| PDB | — |
| CAS-ID | 917389-32-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1241951 |
| ChEBI ID | — |
| PubChem CID | 45138674 |
| DrugBank | DB12070 |
| UNII ID | 1H09Y5WO1F (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Prevymis – Merck & Co
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 1,218 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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1,103 adverse events reported
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