Nadofaragene firadenovec
Adstiladrin (nadofaragene firadenovec) is a gene pharmaceutical. Nadofaragene firadenovec was first approved as Adstiladrin on 2022-12-16.
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Commercial
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FDA
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Adstiladrin
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Nadofaragene firadenovec
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Adstiladrin | nadofaragene firadenovec-vncg | Ferring Pharmaceuticals | N-125700 RX | 2022-12-16 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| adstiladrin | Biologic Licensing Application | 2024-10-30 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
nadofaragene firadenovec, Adstiladrin, Ferring Pharmaceuticals A/S | |||
| 2034-12-16 | Reference product excl. | ||
Patent Expiration
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ATC Codes
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HCPCS
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Clinical
Clinical Trials
18 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | 2 | 3 | 1 | 1 | 8 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | — | — | 1 | 5 | 6 |
| Latent tuberculosis | D055985 | — | Z22.7 | — | — | — | 1 | 4 | 5 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-muscle invasive bladder neoplasms | D000093284 | — | — | — | 1 | 3 | — | — | 4 |
| Malignant mesothelioma | D000086002 | — | — | — | — | 1 | — | — | 1 |
| Mesothelioma | D008654 | — | C45 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 1 | 2 | — | — | — | 2 |
| Leukemia | D007938 | — | C95 | 1 | 1 | — | — | — | 1 |
| Recurrence | D012008 | — | — | 1 | 1 | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | 1 | — | — | — | 1 |
| Lymphoma | D008223 | — | C85.9 | 1 | 1 | — | — | — | 1 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 1 | 1 | — | — | — | 1 |
| Mantle-cell lymphoma | D020522 | — | — | 1 | 1 | — | — | — | 1 |
| B-cell lymphoma | D016393 | — | — | 1 | 1 | — | — | — | 1 |
| Lymphoid leukemia | D007945 | — | C91 | 1 | 1 | — | — | — | 1 |
| Carcinoma in situ | D002278 | — | D09.9 | — | 1 | — | — | — | 1 |
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Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv | D006678 | — | — | — | — | — | — | 1 | 1 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | — | — | — | 1 | 1 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | — | — | — | 1 | 1 |
| Fatty liver | D005234 | EFO_0003934 | — | — | — | — | — | 1 | 1 |
| Exocrine pancreatic insufficiency | D010188 | — | K86.81 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Nadofaragene firadenovec |
| INN | nadofaragene firadenovec |
| Description | Nadofaragene firadenovec, sold under the brand name Adstiladrin, is a gene therapy for the treatment of bladder cancer. It is a non-replicating (cannot multiply in human cells) adenoviral vector-based gene therapy.
|
| Classification | Gene |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3990041 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | 0OOS09O1FH (ChemIDplus, GSRS) |
Target
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Financial
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Trends
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Additional graphs summarizing 224 documents
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Safety
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29 adverse events reported
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