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Drug ReportsDoravirine
Delstrigo(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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Events Timeline
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3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Primary completion date
Completion date
Results first post date
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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
+
Lamivudine
+
Tenofovir disoproxil fumarate
Tradename
Company
Number
Date
Products
DELSTRIGOMerck & CoN-210807 RX2018-08-30
1 products, RLD, RS
Doravirine
Tradename
Company
Number
Date
Products
PIFELTROMerck & CoN-210806 RX2018-08-30
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
delstrigoNew Drug Application2025-01-28
pifeltroNew Drug Application2024-11-07
Agency Specific
FDA
EMA
Expiration
Code
DORAVIRINE, PIFELTRO, MSD MERCK CO
2025-01-27NPP
DORAVIRINE / LAMIVUDINE / TENOFOVIR DISOPROXIL FUMARATE, DELSTRIGO, MSD MERCK CO
2025-01-27NPP
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
70 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B2085131330
HivD006678O98.721137
Drug interactionsD004347112
Body weightD001835EFO_0004338112
Chronic kidney failureD007676EFO_0003884N18.611
ContraceptionD00326711
Weight gainD01543011
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acquired immunodeficiency syndromeD000163EFO_0000765B204127
InfectionsD007239EFO_0000544145
Hiv-1D0154971113
Communicable diseasesD00314122
Immunologic deficiency syndromesD007153D84.9112
Hiv-2D01549811
ObesityD009765EFO_0001073E66.911
Metabolic syndromeD024821EFO_0000195E88.81011
Body weight changesD00183611
FastingD005215EFO_000275611
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TuberculosisD014376EFO_0000774A15-A19112
Heart disease risk factorsD00008274211
Metabolic diseasesD008659EFO_0000589E88.911
Lipid metabolism disordersD05243911
Latent tuberculosisD055985Z22.711
Renal insufficiencyD051437N1911
Liver failureD017093K72.911
Hepatic insufficiencyD04855011
Pregnancy rateD01887311
Healthy volunteers/patients11
Indications Without Phase
No data
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)Loading
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
RxCUI
ChEMBL IDCHEMBL2364608
ChEBI ID
PubChem CID58460047
DrugBankDB12301
UNII ID913P6LK81M (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Pifeltro Merck & Co
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Delstrigo Merck & Co
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 809 documents
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Safety
Black-box Warning
Black-box warning for: Delstrigo
Adverse Events
Top Adverse Reactions
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535 adverse events reported
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