Drugs / Nadofaragene Firadenovec
Nadofaragene Firadenovec
also known as
SCH 721015 · ADSTILADRIN · nadofaragene firadenovec-vncg · Ad.hIFN-a2b · Ad.hIFN-alpha 2b · Ad.hIFN-α · Ad.IFNalpha · FE 999326 · +6 more
targets IFNA2
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved · conditional | EU (EMA) | Adstiladrin | — | 2026-05-28 | europa.eu ↗ |
Trials 13 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT01162785 | Apr 2011 → Nov 2016 | urinary bladder cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01119664 | Apr 2010 → Oct 2013 | mesothelioma | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 1 | NCT01212367 | Feb 2009 → May 2015 | malignant pleural mesothelioma | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 1 | NCT00536588 | Sep 2006 → Aug 2009 | urinary bladder neoplasm | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06668493 | Jun 2025 → Nov 2029 expected | renal pelvis/ureter urothelial carcinoma | Ferring Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07332351 | Sep 2026 → Jan 2027 expected | infiltrating bladder urothelial carcinoma | University of Washington | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT01687244 | Sep 2012 → Oct 2015 | superficial urinary bladder carcinoma | FKD Therapies Oy | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT06929286 | Apr 2025 → Apr 2028 expected | urinary bladder carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 3 | NCT06510374 | Oct 2024 → Jun 2028 expected | urinary bladder carcinoma | Ferring Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06545955 | Oct 2024 → Jun 2028 expected | bladder carcinoma in situ | Ferring Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT05704244 | Dec 2022 → Nov 2029 expected | urinary bladder cancer | Ferring Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02773849 | Sep 2016 → May 2019 | superficial urinary bladder carcinoma | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06390111 | Jun 2024 → Jul 2026 | urinary bladder cancer | Ferring Pharmaceuticals | Withdrawn | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT03710876 Comparator | Jan 2019 → Mar 2024 | malignant pleural mesothelioma | Ferring Ventures Limited | Completed | No outcome recorded |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | nadofaragene firadenovec | “A treatment option in BCG-unresponsive disease is nadofaragene firadenovec-vncg (Adstiladrin), a nonreplicating adenoviral vector-based gene therapy approved by the US Food and...” PMID 40194933 ↗ Mar 20257“Nadofaragene firadenovec (also known as rAd-IFNa/Syn3) is a replication-deficient recombinant adenovirus that delivers human interferon alfa-2b cDNA into the bladder epithelium” PMID 33253641 ↗ Nov 2020 |
| Known as | Ad.hIFN-a2b | “A Pilot Study of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-Alpha (SCH 721015, Ad.hIFN-a2b) Gene Transfer for Malignant Pleural Mesothelioma” NCT01212367 ↗ |
| Known as | Ad.hIFN-alpha 2b | “The purpose of the new study is to determine the safety of administrating intrapleural SCH 721015 (Ad.hIFN-alpha 2b) in combination with chemotherapy for the management of...” NCT01119664 ↗ |
| Known as | Ad.hIFN-α | “Ad.hIFN-α (SCH 721015, adenoviral-mediated interferon alpha) is a replication-defective recombinant adenoviral vector containing the human interferon-alpha (hIFN-alpha) gene.” NCT01212367 ↗ |
| Known as | Ad.IFNalpha | “The most recent trial of IP Ad.IFNalpha (SCH 721015) at a dose of 3e11 viral particles (vp) given three days apart was safe and well tolerated, and showed high levels of IFN in...” NCT01119664 ↗ |
| Known as | ADSTILADRIN | “A treatment option in BCG-unresponsive disease is nadofaragene firadenovec-vncg (Adstiladrin), a nonreplicating adenoviral vector-based gene therapy approved by the US Food and...” PMID 40194933 ↗ Mar 20252“subjects with NMIBC CIS (± high-grade Ta/T1) who have not responded to their first dose of nadofaragene firadenovec (commercial ADSTILADRIN received before trial entry) will be...” NCT06390111 ↗ “ADSTILADRIN is a non-replicating adenovirus vector harboring the human IFN alpha2b gene.” NCT02773849 ↗ |
| Known as | FE 999326 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05704244 ↗ |
| Known as | INSTILADRIN | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01687244 ↗ |
| Known as | Nadofaragen firadenovec | ChEMBL registry synonym — accepted as the source's own label CHEMBL3990041 ↗ |
| Known as | nadofaragene firadenovec-vncg | “A treatment option in BCG-unresponsive disease is nadofaragene firadenovec-vncg (Adstiladrin), a nonreplicating adenoviral vector-based gene therapy approved by the US Food and...” PMID 40194933 ↗ Mar 20251“Nadofaragene firadenovec-vncg is a nonreplicating adenoviral vector-based gene therapy for bacillus Calmette-Guérin (BCG)-unresponsive carcinoma in situ (CIS) with/without...” PMID 38704840 ↗ May 2024 |
| Known as | rAd-IFN | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03710876 ↗ |
| Known as | rAd-IFN-2b | ChEMBL registry synonym — accepted as the source's own label CHEMBL3990041 ↗ |
| Known as | rAd-IFNa/Syn3 | “Nadofaragene firadenovec (also known as rAd-IFNa/Syn3) is a replication-deficient recombinant adenovirus that delivers human interferon alfa-2b cDNA into the bladder epithelium” PMID 33253641 ↗ Nov 2020 |
| Known as | rAd-IFNα/Syn3 | “We assessed the efficacy and safety of recombinant adenovirus interferon alfa with Syn3 (rAd-IFNα/Syn3), a replication-deficient recombinant adenovirus gene transfer vector,...” PMID 28834453 ↗ Aug 2017 |
| Known as | SCH 721015 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01119664 ↗ |
| Route | Other | “intrapleural SCH 721015 (Ad.hIFN-alpha 2b)” NCT01119664 ↗ |
| Target | IFNA2 | “Interferon alpha-2 exogenous gene” CHEMBL3990041 ↗ |