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Pifeltro(doravirine)
Delstrigo, Pifeltro (doravirine) is a small molecule pharmaceutical. Doravirine was first approved as Pifeltro on 2018-08-30. It is used to treat hiv-1 in the USA. It has been approved in Europe to treat HIV infections.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
immune system diseasesD007154
Trade Name
FDA
EMA
Pifeltro
Combinations
Delstrigo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Doravirine
Tradename
Company
Number
Date
Products
PIFELTROMerck Sharp & DohmeN-210806 RX2018-08-30
1 products, RLD, RS
Doravirine
+
Lamivudine
+
Tenofovir disoproxil fumarate
Tradename
Company
Number
Date
Products
DELSTRIGOMerck Sharp & DohmeN-210807 RX2018-08-30
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
delstrigoNew Drug Application2021-10-31
pifeltroNew Drug Application2022-12-13
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hiv-1D015497
Agency Specific
FDA
EMA
Expiration
Code
DORAVIRINE, PIFELTRO, MSD MERCK CO
2025-01-27NPP
2023-08-30NCE
DORAVIRINE / LAMIVUDINE / TENOFOVIR DISOPROXIL FUMARATE, DELSTRIGO, MSD MERCK CO
2025-01-27NPP
2023-08-30NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate, Delstrigo, Msd Merck Co
106032822036-11-29DP
108427512036-11-29DP
Doravirine, Pifeltro, Msd Merck Co
84869752031-10-07DS, DPU-2394, U-2395, U-2629, U-2630, U-3307, U-3308
ATC Codes
J: Antiinfectives for systemic use
J05: Antivirals for systemic use
J05A: Direct acting antivirals
J05AG: Non-nucleoside reverse transcriptase inhibitors
J05AG06: Doravirine
J05AR: Antivirals for treatment of hiv infections, combinations
J05AR24: Lamivudine, tenofovir disoproxil and doravirine
HCPCS
No data
Clinical
Clinical Trials
41 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B205655323
HivD006678O98.73519
Weight gainD015430HP_0004324112
Renal insufficiencyD051437HP_0000083N19112
Chronic kidney failureD007676EFO_0003884N18.611
ObesityD009765EFO_0001073E66.911
Hiv-associated lipodystrophy syndromeD039682EFO_100134811
OsteoporosisD010024EFO_0003882M81.011
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv-1D0154971113
Hiv-2D01549811
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Heart disease risk factorsD00008274211
Lipid metabolism disordersD05243911
Gender dysphoriaD000068116F6411
Latent tuberculosisD055985Z22.711
Drug interactionsD00434711
Pregnancy rateD01887311
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TuberculosisD014376EFO_0000774A15-A1911
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDORAVIRINE
INNdoravirine
Description
Doravirine, sold under the brand name Pifeltro, is a non-nucleoside reverse transcriptase inhibitor medication developed by Merck & Co. for use in the treatment of HIV/AIDS.
Classification
Small molecule
Drug classantivirals: non-nucleoside reverse transcriptase inhibitors, not benzoxazinone derivatives
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Cn1c(Cn2ccc(C(F)(F)F)c(Oc3cc(Cl)cc(C#N)c3)c2=O)n[nH]c1=O
Identifiers
PDB
CAS-ID1338225-97-0
RxCUI2055755
ChEMBL IDCHEMBL2364608
ChEBI ID
PubChem CID58460047
DrugBankDB12301
UNII ID913P6LK81M (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 516 documents
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Safety
Black-box Warning
Black-box warning for: Delstrigo
Adverse Events
Top Adverse Reactions
Mock data
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72,033 adverse events reported
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