Vitravene preservative free, Vitravene(fomivirsen)
Vitravene (fomivirsen) is an oligonucleotide pharmaceutical. Fomivirsen was first approved as Vitravene preservative free on 1998-08-26. It is used to treat cytomegalovirus retinitis in the USA. It has been approved in Europe to treat cytomegalovirus retinitis and HIV infections.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| eye diseases | D005128 |
| urogenital diseases | D000091642 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fomivirsen sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VITRAVENE PRESERVATIVE FREE | Novartis | N-020961 DISCN | 1998-08-26 | 1 products |
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Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| cytomegalovirus retinitis | EFO_1001302 | D017726 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1452 | Injection, fomivirsen sodium, intraocular, 1.65 mg |
Clinical
Clinical Trials
62 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | — | 1 | 2 | 4 | 2 | 9 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | 1 | 1 | 2 | 4 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | 2 | 1 | 1 | 4 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | 1 | — | 2 | — | 3 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | 3 | — | 3 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | — | — | 1 | — | 1 |
| Treatment outcome | D016896 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | U07.1 | — | 4 | 4 | — | — | 8 | |
| Depression | D003863 | F33.9 | 1 | — | 1 | — | 3 | 5 | |
| Coronavirus | D017934 | — | 1 | 1 | — | — | 2 | ||
| Separation anxiety | D001010 | EFO_1001916 | — | — | 1 | — | 1 | 2 | |
| Social phobia | D000072861 | EFO_1001917 | F40.1 | — | — | 1 | — | 1 | 2 |
| Severe acute respiratory syndrome-related coronavirus | D045473 | NCBITaxon_227859 | — | — | 1 | — | — | 1 | |
| Dementia | D003704 | F03 | — | — | 1 | — | — | 1 | |
| Psychophysiologic disorders | D011602 | F45.9 | — | — | 1 | — | — | 1 | |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | 1 | — | — | — | 1 |
| Sars-cov-2 | D000086402 | — | 1 | — | — | — | 1 | ||
| Olfaction disorders | D000857 | R43.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 13 | — | — | — | — | 13 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Drug interactions | D004347 | 1 | — | — | — | — | 1 | ||
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | 1 | — | — | — | — | 1 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | — | — | — | — | 1 |
| Weight gain | D015430 | HP_0004324 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cognitive dysfunction | D060825 | G31.84 | — | — | — | — | 2 | 2 | |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | — | — | 1 | 1 |
| Wounds and injuries | D014947 | T14.8 | — | — | — | — | 1 | 1 | |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | — | — | — | 1 | 1 |
| Chronic disease | D002908 | — | — | — | — | 1 | 1 | ||
| Brain injuries | D001930 | S06.9 | — | — | — | — | 1 | 1 | |
| Alcohol-related disorders | D019973 | F10 | — | — | — | — | 1 | 1 | |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | — | — | — | 1 | 1 |
| Suicidal ideation | D059020 | EFO_0004320 | R45.851 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | FOMIVIRSEN |
| INN | fomivirsen |
| Description | Fomivirsen (brand name Vitravene) is an antisense antiviral drug that was used in the treatment of cytomegalovirus retinitis (CMV) in immunocompromised patients, including those with AIDS. It was administered via intraocular injection.
|
| Classification | Oligonucleotide |
| Drug class | antisense oligonucleotides: antivirals; antivirals |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 160369-77-7 |
| RxCUI | 314633 |
| ChEMBL ID | CHEMBL1201688 |
| ChEBI ID | — |
| PubChem CID | 71587550 |
| DrugBank | DB06759 |
| UNII ID | QX5LK7YCHV (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 659 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,231 adverse events reported
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