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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| urogenital diseases | D000091642 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Pifeltro
CombinationsDelstrigo
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 |
|---|---|---|---|---|
| DELSTRIGO | Merck & Co | N-210807 RX | 2018-08-30 | 1 products, RLD, RS |
Doravirine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PIFELTRO | Merck & Co | N-210806 RX | 2018-08-30 | 1 products, RLD, RS |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hiv infections | EFO_0000764 | D015658 | B20 |
| hiv | — | D006678 | — |
| hiv-1 | — | D015497 | — |
| acquired immunodeficiency syndrome | EFO_0000765 | D000163 | B20 |
| hepatitis b | — | D006509 | — |
| chronic hepatitis b | EFO_0004239 | D019694 | B18.1 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DORAVIRINE, PIFELTRO, MSD MERCK CO | |||
| 2025-01-27 | NPP | ||
DORAVIRINE / LAMIVUDINE / TENOFOVIR DISOPROXIL FUMARATE, DELSTRIGO, MSD MERCK CO | |||
| 2025-01-27 | NPP | ||
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 infections | D015658 | EFO_0000764 | B20 | 10 | 10 | 21 | 7 | 9 | 55 |
| Hiv | D006678 | — | — | 3 | 1 | 1 | 8 | 2 | 15 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 5 | 1 | 2 | 1 | 1 | 10 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 5 | 1 | — | 7 |
| Body weight | D001835 | EFO_0004338 | — | — | — | 1 | 3 | 1 | 5 |
| Weight gain | D015430 | HP_0004324 | — | — | — | — | 3 | 1 | 4 |
| Drug interactions | D004347 | — | — | 1 | — | — | 2 | — | 3 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | 1 | — | 2 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | 1 | 1 | — | 2 |
| Body weight changes | D001836 | — | — | — | — | 1 | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Communicable diseases | D003141 | — | — | — | — | 3 | — | — | 3 |
| Hiv-1 | D015497 | — | — | 1 | 1 | 1 | — | — | 3 |
| Immunologic deficiency syndromes | D007153 | HP_0002721 | D84.9 | — | 1 | 1 | — | — | 2 |
| Hiv-2 | D015498 | — | — | — | — | 1 | — | — | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | 1 | — | — | 1 |
| Fasting | D005215 | EFO_0002756 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coinfection | D060085 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 1 | — | — | — | 1 | 2 |
| Heart disease risk factors | D000082742 | — | — | 1 | — | — | — | — | 1 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | 1 | — | — | — | — | 1 |
| Lipid metabolism disorders | D052439 | — | — | 1 | — | — | — | — | 1 |
| Gender dysphoria | D000068116 | — | — | 1 | — | — | — | — | 1 |
| Latent tuberculosis | D055985 | — | Z22.7 | 1 | — | — | — | — | 1 |
| Liver failure | D017093 | HP_0001399 | K72.9 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Pregnancy rate | D018873 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bariatric surgery | D050110 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Doravirine |
| INN | doravirine |
| 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 class | antivirals: 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-ID | 1338225-97-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2364608 |
| ChEBI ID | — |
| PubChem CID | 58460047 |
| DrugBank | DB12301 |
| UNII ID | 913P6LK81M (ChemIDplus, GSRS) |
Target
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Variants
No data
Financial
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Delstrigo – Merck & Co
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Pifeltro – Merck & Co
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
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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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