Pifeltro(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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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)
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hiv-1 | — | D015497 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DORAVIRINE, PIFELTRO, MSD MERCK CO | |||
| 2025-01-27 | NPP | ||
| 2023-08-30 | NCE | ||
DORAVIRINE / LAMIVUDINE / TENOFOVIR DISOPROXIL FUMARATE, DELSTRIGO, MSD MERCK CO | |||
| 2025-01-27 | NPP | ||
| 2023-08-30 | NCE | ||
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
41 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 | 5 | 6 | 5 | 5 | 3 | 23 |
| Hiv | D006678 | O98.7 | 3 | — | — | 5 | 1 | 9 | |
| Weight gain | D015430 | HP_0004324 | — | — | — | 1 | 1 | 2 | |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | 1 | — | 2 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | 1 | — | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 1 | — | 1 |
| Hiv-associated lipodystrophy syndrome | D039682 | EFO_1001348 | — | — | — | 1 | — | 1 | |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | — | — | 1 | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart disease risk factors | D000082742 | 1 | — | — | — | — | 1 | ||
| Lipid metabolism disorders | D052439 | 1 | — | — | — | — | 1 | ||
| Gender dysphoria | D000068116 | F64 | 1 | — | — | — | — | 1 | |
| Latent tuberculosis | D055985 | Z22.7 | 1 | — | — | — | — | 1 | |
| Drug interactions | D004347 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | — | — | — | 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 | 2055755 |
| ChEMBL ID | CHEMBL2364608 |
| ChEBI ID | — |
| PubChem CID | 58460047 |
| DrugBank | DB12301 |
| UNII ID | 913P6LK81M (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 516 documents
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Safety
Black-box Warning
Black-box warning for: Delstrigo
Adverse Events
Top Adverse Reactions
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72,033 adverse events reported
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