Drugs / Nadofaragene Firadenovec
Nadofaragene Firadenovec
also known as
ADSTILADRIN · nadofaragene firadenovec-vncg · INSTILADRIN · Nadofaragen firadenovec · rAd-IFN · rAd-IFN-2b · rAd-IFNa/Syn3 · rAd-IFNα/Syn3
targets IFNA2
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed urinary tract non-invasive transitional cell neoplasm 1 milestone | |||||
| Filed | Japan (PMDA) | — | urinary tract non-invasive transitional cell neoplasm | 2025-09-11 | “the PMDA has accepted the NDA for nadofaragene firadenovec for review, following submission on August 27 th , 2025.” ferring.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved · conditional | EU (EMA) | Adstiladrin | — | 2026-05-28 | europa.eu ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 | Dec 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 34 trials · 1 met primary | ||||||
| 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 | NCT02773849 | Sep 2016 → May 2019 | superficial urinary bladder carcinoma | Ferring Pharmaceuticals | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT06390111 | Jun 2024 → Jul 2026 | urinary bladder cancer | Ferring Pharmaceuticals | Withdrawn | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT03710876 Comparator | Jan 2019 → Mar 2024 | malignant pleural mesothelioma | Ferring Ventures Limited | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-05-19 | ImmunityBio, Inc. | Results ImmunityBio Presents Favorable Comparative Effectiveness Data in Complete Response Rates of NAI + BCG Versus Nadofaragene and TAR-200 at AUA 2026 immunitybio.com ↗
NAI+BCG treated patients were twice as likely to achieve a complete response (CR) at any point of the study versus nadofaragene firadenovec-vncg in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary disease |
| 2025-09-11 | Ferring Pharmaceuticals | Regulatory Ferring Japan announces PMDA Acceptance of NDA Filing for nadofaragene firadenovec ferring.com ↗
Ferring Pharmaceuticals Co., Ltd. announced that the PMDA has accepted the NDA for nadofaragene firadenovec for review, following submission on August 27 th , 2025. |
| 2025-04-24 | Ferring Pharmaceuticals | Regulatory U.S. FDA approves second drug product manufacturing facility for Adstiladrin® (nadofaragene firadenovec-vncg) ferring.com ↗
Ferring Pharmaceuticals announced today the U.S. Food and Drug Administration (FDA) approved a state-of-the-art drug product manufacturing hub in Parsippany, NJ, for its intravesical non-replicating gene therapy ADSTILADRIN ® (nadofaragene firadenovec-vncg). |
| 2025-04-21 | Ferring Pharmaceuticals | Results Ferring Announces Initial Data from Phase 3 Trial in Japanese Patients Demonstrating 75% Complete Response Rate at 3 Months with (nadofaragene firadenovec) in BCG-unresponsive NMIBC patients ferring.com ↗
The data – presented at the 112 th Annual Meeting of the Japanese Urological Association (JUA 2025) held April 17-19 in Fukuoka, Japan – showed a complete response (CR) rate at three months of 75% (15/20) among Japanese patients with CIS ± high-grade Ta/T1. |
| 2023-11-29 | Ferring Pharmaceuticals | Results New data show durable response following treatment with ADSTILADRIN® (nadofaragene firadenovec-vncg) ferring.com ↗
New data show durable response following treatment with ADSTILADRIN® (nadofaragene firadenovec-vncg) |
| 2022-12-16 | Ferring Pharmaceuticals | Regulatory Ferring Receives Approval from U.S. FDA for Adstiladrin for High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer ferring.com ↗
Ferring Pharmaceuticals today announced the U.S. Food and Drug Administration (FDA) approved Adstiladrin ® (nadofaragene firadenovec-vncg), a novel adenovirus vector-based gene therapy, for the treatment of adult patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. |
All press releases naming this drug 9 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 14 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 | 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 | 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 |
| Route | Other | “Patients received a single intravesical 75 mL dose of nadofaragene firadenovec” PMID 33253641 ↗ Nov 2020 |
| Target | IFNA2 | “Interferon alpha-2 exogenous gene” CHEMBL3990041 ↗ |