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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
infectionsD007239
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
PREVYMISMerck Sharp & DohmeN-209939 RX2017-11-08
2 products, RLD, RS
PREVYMISMerck Sharp & DohmeN-209940 RX2017-11-08
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
prevymisNew Drug Application2021-02-01
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
LETERMOVIR, PREVYMIS, MERCK SHARP DOHME
2024-11-08ODE-165
Patent Expiration
Patent
Expires
Flag
FDA Information
Letermovir, Prevymis, Merck Sharp Dohme
106033842033-02-28DP
RE467912024-05-22DS, DP
85132552024-05-22DS, DP
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AX: Other antivirals in atc
— J05AX18: Letermovir
HCPCS
No data
Clinical
Clinical Trials
24 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 infectionsD003586EFO_0001062B25—222—6
NeutropeniaD009503D70———2—2
InfectionsD007239EFO_0000544———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DiseaseD004194EFO_0000408R69——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell chronic lymphocytic leukemiaD015451C91.1—2———2
Sezary syndromeD012751C84.1—1———1
Prolymphocytic leukemia t-cellD015461C91.6—1———1
T-cell lymphoma peripheralD016411C84.9—1———1
Prolymphocytic leukemia b-cellD054403C91.3—1———1
Myelodysplastic syndromesD009190D46—1———1
Myeloid leukemia acuteD015470C92.0—1———1
Non-hodgkin lymphomaD008228C85.9—1———1
Primary myelofibrosisD055728D47.4—1———1
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.0—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
Hematopoietic stem cell transplantationD018380————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLETERMOVIR
INNletermovir
Description
Letermovir (INN; trade 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 classantivirals
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-ID917389-32-3
RxCUI1988648
ChEMBL IDCHEMBL1241951
ChEBI ID—
PubChem CID45138674
DrugBankDB12070
UNII ID1H09Y5WO1F (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Prevymis - Merck Sharp & Dohme
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 866 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5 adverse events reported
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