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doravirine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antivirals | 5295 | 1338225-97-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Doravirine is a pyridinone non-nucleoside reverse transcriptase inhibitor of HIV-1 and inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase (RT). Doravirine does not inhibit the human cellular DNA polymerases alpha, beta, and mitochondrial DNA polymerase gamma.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.10 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 0.00 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,AXL,CDK5,CDK9,EIF2AK3,GRK2,MAPK7,PDK1,PDK2,PDK4,PRKDC | 11 | |||
| kinase-selectivity-class | GRK2 | 1 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 14, 2020 | PMDA | MSD K.K. | |
| Aug. 30, 2018 | FDA | MSD MERCK CO | |
| Nov. 22, 2018 | EMA | MERCK SHARP & DOHME B.V. |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Virologic failure | 75.18 | 50.35 | 11 | 172 | 2213 | 90626051 |
| Pathogen resistance | 60.95 | 50.35 | 11 | 172 | 8104 | 90620160 |
| Treatment noncompliance | 55.22 | 50.35 | 14 | 169 | 51713 | 90576551 |
| Viral mutation identified | 52.81 | 50.35 | 8 | 175 | 2017 | 90626247 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Blood HIV RNA increased | 99.05 | 47.14 | 17 | 486 | 1574 | 42619258 |
| CD4 lymphocytes decreased | 57.17 | 47.14 | 11 | 492 | 1910 | 42618922 |
| Drug resistance | 51.05 | 47.14 | 18 | 485 | 34230 | 42586602 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Blood HIV RNA increased | 123.46 | 49.59 | 19 | 523 | 2169 | 110586588 |
| Viral mutation identified | 89.94 | 49.59 | 16 | 526 | 4403 | 110584354 |
| Pathogen resistance | 73.11 | 49.59 | 17 | 525 | 17655 | 110571102 |
| CD4 lymphocytes decreased | 68.71 | 49.59 | 12 | 530 | 2962 | 110585795 |
| Drug resistance | 66.28 | 49.59 | 20 | 522 | 56354 | 110532403 |
| Treatment noncompliance | 57.16 | 49.59 | 19 | 523 | 72971 | 110515786 |
| Virologic failure | 56.42 | 49.59 | 11 | 531 | 4941 | 110583816 |
| Viral load abnormal | 50.05 | 49.59 | 6 | 536 | 102 | 110588655 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J05AG06 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Non-nucleoside reverse transcriptase inhibitors |
| ATC | J05AR24 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations |
| FDA MoA | N0000009948 | Non-Nucleoside Reverse Transcriptase Inhibitors |
| FDA EXT | N0000175460 | Non-Nucleoside Analog |
| FDA EPC | N0000175463 | Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:64946 | anti-HIV agent |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
Related Drugs by ATC class:
J05AG Non-nucleoside reverse transcriptase inhibitors 5 drugs
J05AR Antivirals for treatment of HIV infections, combinations 19 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Human immunodeficiency virus infection | indication | 86406008 | DOID:526 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 9.92 | acidic |
| pKa2 | 5.15 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 100MG | PIFELTRO | MSD MERCK CO | N210806 | Aug. 30, 2018 | RX | TABLET | ORAL | 8486975 | Aug. 30, 2032 | FOR USE IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 AS A REPLACEMENT THERAPY IN VIROLOGICALLY SUPPRESSED ADULTS WITH NO HISTORY OF TREATMENT FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO DORAVIRINE |
| 100MG | PIFELTRO | MSD MERCK CO | N210806 | Aug. 30, 2018 | RX | TABLET | ORAL | 8486975 | Aug. 30, 2032 | FOR USE IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS WITH NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY |
| 100MG | PIFELTRO | MSD MERCK CO | N210806 | Aug. 30, 2018 | RX | TABLET | ORAL | 8486975 | Aug. 30, 2032 | FOR USE IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS TO TREAT HIV-1 INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 35KG WITH NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IF VIROLOGICALLY SUPPRESSED |
| 100MG;300MG;300MG | DELSTRIGO | MSD MERCK CO | N210807 | Aug. 30, 2018 | RX | TABLET | ORAL | 8486975 | Aug. 30, 2032 | FOR THE TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS WITH NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY |
| 100MG;300MG;300MG | DELSTRIGO | MSD MERCK CO | N210807 | Aug. 30, 2018 | RX | TABLET | ORAL | 8486975 | Aug. 30, 2032 | TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS AS A REPLACEMENT THERAPY IN VIROLOGICALLY SUPPRESSED ADULTS WITH NO HISTORY OF TREATMENT FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO THE INDIVIDUAL COMPONENTS OF DELSTRIGO |
| 100MG;300MG;300MG | DELSTRIGO | MSD MERCK CO | N210807 | Aug. 30, 2018 | RX | TABLET | ORAL | 8486975 | Aug. 30, 2032 | TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 35KG WITH NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPPRESSED |
| 100MG;0.25MG | IDVYNSO | MSD | N216964 | April 20, 2026 | RX | TABLET | ORAL | 8486975 | Aug. 30, 2032 | USE OF A COMPLETE TWO-DRUG REGIMEN FOR THE TREATMENT OF HIV-1 INFECTION IN ADULTS TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY-SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 100MG;0.25MG | IDVYNSO | MSD | N216964 | April 20, 2026 | RX | TABLET | ORAL | April 20, 2031 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Reverse transcriptase/RNaseH | Enzyme | INHIBITOR | EC50 | 7.92 | DRUG LABEL | DRUG LABEL | |||
| Reverse transcriptase | Enzyme | IC50 | 7.72 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 913P6LK81M | UNII |
| 4037847 | VANDF |
| C4045491 | UMLSCUI |
| CHEBI:754975 | CHEBI |
| 2KW | PDB_CHEM_ID |
| CHEMBL2364608 | ChEMBL_ID |
| 58460047 | PUBCHEM_CID |
| DB12301 | DRUGBANK_ID |
| D10624 | KEGG_DRUG |
| 9797 | INN_ID |
| C000592662 | MESH_SUPPLEMENTAL_RECORD_UI |
| 12679 | IUPHAR_LIGAND_ID |
| 781493004 | SNOMEDCT_US |
| 781500009 | SNOMEDCT_US |
| 288957 | MMSL |
| 34854 | MMSL |
| d08872 | MMSL |
| 017702 | NDDF |
| 2055755 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| PIFELTRO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0006-3069 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 31 sections |
| DELSTRIGO | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0006-5007 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 32 sections |
| DELSTRIGO | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0006-5007 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 32 sections |
| IDVYNSO | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0006-5092 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 31 sections |
| PIFELTRO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-6268 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 30 sections |