Doravirine

Summary

Doravirine (CHEMBL2364608) is an approved small molecule (ATC J05AG06); indicated across 4 conditions including hiv infectious disease and viral infectious disease.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: J05AG06
• Indications: 4 conditions
• Clinical trials: 36
• Chemistry: 425.7 Da · C17H11ClF3N5O3

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2364608
Name	Doravirine
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	58460047
ATC	J05AG06
Molecular formula	C17H11ClF3N5O3
Molecular weight	425.7
InChIKey	ZIAOVIPSKUPPQW-UHFFFAOYSA-N

SMILES: CN1C(=NNC1=O)CN2C=CC(=C(C2=O)OC3=CC(=CC(=C3)C#N)Cl)C(F)(F)F

IUPAC name: 3-chloro-5-[[1-[(4-methyl-5-oxo-1H-1,2,4-triazol-3-yl)methyl]-2-oxo-4-(trifluoromethyl)-3-pyridinyl]oxy]benzonitrile

Also known as: Doravirina, Doravirine, Doravirine component of delstrigo, MK-1439, Mk-1439a, Pifeltro, DORAVIRINE, Doravirine; Pifeltro

Patent coverage: 531 distinct patent families (1,367 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 1,315 (96%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 1 (assay-derived). Sample: Voltage-gated inwardly rectifying potassium channel KCNH2.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

4 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
HIV infectious disease	4	MONDO:0005109	EFO:0000180
viral infectious disease	4	MONDO:0005108	EFO:0000763
kidney disorder	1	MONDO:0005240	EFO:0003086

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 36.

Phase distribution

Phase	Trials
PHASE3	8
PHASE1	8
PHASE4	6
PHASE2	6
Not specified	6
PHASE1/PHASE2	1
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05630638	PHASE4	RECRUITING	Doravirine Dose Optimisation in Pregnancy
NCT06602622	PHASE4	RECRUITING	Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI
NCT07357584	PHASE4	NOT_YET_RECRUITING	Efficacy and Safety of Doravirine in the Rapid Initiation
NCT04334551	PHASE4	UNKNOWN	HIV Switch Trial in Experienced Patients With Multiple Class Resistance Including NNRTI Resistance
NCT04636437	PHASE4	COMPLETED	Doravirine for Obese Persons on Integrase Inhibitors and Tenofovir Alafenamide
NCT04689737	PHASE4	COMPLETED	Removal of Doravirine by Hemodialysis in HIV-Infected Patients With End-stage Renal Disease (ESRD)
NCT04892654	PHASE3	RECRUITING	Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch
NCT06203132	PHASE3	RECRUITING	DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection
NCT02275780	PHASE3	COMPLETED	Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018)
NCT02397096	PHASE3	COMPLETED	Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024)
NCT02403674	PHASE3	COMPLETED	Comparison of Doravirine, Tenofovir, Lamivudine (MK-1439A) and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439A-021)
NCT04079452	PHASE3	COMPLETED	Doravirine Concentrations and Antiviral Activity in Cerebrospinal Fluid in HIV-1 Infected Individuals
NCT04429152	PHASE3	UNKNOWN	ADORE: Efficacy of DORavirine in Adults Living With HIV Experiencing Virological Failure on First-line Efavirenz-based Antiretroviral Therapy With NNRTI Resistance
NCT04433780	PHASE3	COMPLETED	DORA: A Doravirine-based First-line Antiretroviral Therapy for Women of Reproductive Potential Living With HIV
NCT04375800	PHASE2	RECRUITING	Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)
NCT01632345	PHASE2	COMPLETED	A Dose-Ranging Study to Compare Doravirine (MK-1439) Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Human Immunodeficiency Virus (HIV)-1 Infected Participants (MK-1439-007)
NCT02629822	PHASE2	COMPLETED	Safety and Efficacy of Doravirine, Tenofovir, Lamivudine (MK-1439A) in Participants Infected With Treatment-Naïve Human Immunodeficiency Virus (HIV) -1 With Transmitted Resistance (MK-1439A-030)
NCT02652260	PHASE2	COMPLETED	Effects of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Participants (MK-1439A-028)
NCT03272347	PHASE2	COMPLETED	Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)
NCT03332095	PHASE1/PHASE2	COMPLETED	Evaluating the Pharmacokinetics, Safety, and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents
NCT04097925	PHASE2	COMPLETED	Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals
NCT01466985	PHASE1	COMPLETED	A Study of Doravirine (MK-1439) in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439-005)
NCT02089659	PHASE1	COMPLETED	A Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Doravirine (MK-1439) (MK-1439-019)
NCT02641067	PHASE1	COMPLETED	A Study Evaluating the Pharmacokinetics of Doravirine (MK-1439) in Participants With Severe Renal Impairment (MK-1439-051)
NCT02715700	PHASE1	COMPLETED	Effects of Doravirine (MK-1439) on Methadone Pharmacokinetics in Methadone-Maintained Participants (MK-1439-045)
NCT03886701	PHASE1	COMPLETED	Doravirine, Rifapentine and Isoniazid Interaction
NCT03894124	PHASE1	COMPLETED	Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers
NCT04283656	PHASE1	COMPLETED	Evaluating Drug Interactions Between Doravirine With Estradiol and Spironolactone in Healthy Transgender Women
NCT04900974	PHASE1	COMPLETED	Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women
NCT04820933	EARLY_PHASE1	COMPLETED	Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV
NCT04495348	Not specified	COMPLETED	Explorations Into the Mechanism for INSTI-associated Weight Gain: a Focus on Energy Balance
NCT04518228	Not specified	COMPLETED	Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum
NCT05202613	Not specified	UNKNOWN	Non-Interventional Observational Retrospective Study to Evaluate Doravirine Based-regimens in HIV Infected Aged Patients (DORAge).
NCT05322083	Not specified	UNKNOWN	HIV A6 Genome In ART Unsuccessful Patients On DOR
NCT05477407	Not specified	COMPLETED	Adipose Tissue After Switch to Doravirine
NCT05761509	Not specified	COMPLETED	Observational Study on Tolerability and Observance of Post-exposure Prophylaxis With Doravirine in HIV Viral Risk

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).