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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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FDA approval date
EMA approval date
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Study first post date
Last update post date
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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 Application2024-11-07
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
68 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_0000764B201010217955
HivD006678——3118215
Acquired immunodeficiency syndromeD000163EFO_0000765B205121110
InfectionsD007239EFO_0000544——151—7
Body weightD001835EFO_0004338———1315
Weight gainD015430HP_0004324————314
Drug interactionsD004347——1——2—3
Renal insufficiencyD051437HP_0000083N191——1—2
ObesityD009765EFO_0001073E66.9——11—2
Body weight changesD001836————11—2
Show 7 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Communicable diseasesD003141————3——3
Hiv-1D015497——111——3
Immunologic deficiency syndromesD007153HP_0002721D84.9—11——2
Hiv-2D015498————1——1
Metabolic syndromeD024821EFO_0000195E88.810——1——1
FastingD005215EFO_0002756———1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CoinfectionD060085———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TuberculosisD014376EFO_0000774A15-A191———12
Heart disease risk factorsD000082742——1————1
Metabolic diseasesD008659EFO_0000589E88.91————1
Lipid metabolism disordersD052439——1————1
Gender dysphoriaD000068116——1————1
Latent tuberculosisD055985—Z22.71————1
Liver failureD017093HP_0001399K72.91————1
Hepatic insufficiencyD048550——1————1
Pregnancy rateD018873——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bariatric surgeryD050110——————11
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
$
€
£
â‚£
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 756 documents
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Safety
Black-box Warning
Black-box warning for: Delstrigo
Adverse Events
Top Adverse Reactions
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491 adverse events reported
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