Nadofaragene firadenovec

Generic Name
Nadofaragene firadenovec
Brand Names
Adstiladrin
Drug Type
Biotech
Chemical Formula
-
CAS Number
1823059-12-6
Unique Ingredient Identifier
0OOS09O1FH
Background

Nadofaragene firadenovec (nadofaragene firadenovec-vncg) is a recombinant non-replicating adenovirus serotype 5 vector containing a transgene encoding human interferon alfa-2b (IFNα2b). It was approved by the FDA on December 2022 for the treatment of high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcino...

Indication

Nadofaragene firadenovec is indicated for the treatment of adult patients with high-risk Bacillus CalmetteGuérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Associated Conditions
High risk BCG-unresponsive non-muscle invasive bladder cancer
Associated Therapies
-

Low-grade UTUC Treated with Nadofaragene Firadenovec Administered to Renal Pelvis

Phase 1
Not yet recruiting
Conditions
Interventions
First Posted Date
2024-10-31
Last Posted Date
2024-10-31
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
20
Registration Number
NCT06668493

A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer

First Posted Date
2024-08-09
Last Posted Date
2024-11-14
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
150
Registration Number
NCT06545955
Locations
🇺🇸

Ferring Investigational Site, Los Angeles, California, United States

Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer

First Posted Date
2024-07-19
Last Posted Date
2024-11-26
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
454
Registration Number
NCT06510374
Locations
🇺🇸

Ferring Investigational Site, Virginia Beach, Virginia, United States

A Trial to Evaluate Efficacy of Reinduction With Nadofaragene Firadenovec in Subjects With CIS ± High-grade Ta/T1 and no Complete Response to First Nadofaragene Firadenovec Dose.

Phase 4
Withdrawn
Conditions
Interventions
First Posted Date
2024-04-30
Last Posted Date
2024-11-22
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
25
Registration Number
NCT06390111
Locations
🇺🇸

Ferring Investigational Site, Atlanta, Georgia, United States

ADSTILADRIN Early Utilization and Outcomes in the Real World Setting in the United States

Recruiting
Conditions
Interventions
First Posted Date
2023-09-07
Last Posted Date
2024-11-13
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
400
Registration Number
NCT06026332
Locations
🇺🇸

Ferring Investigational Site, Virginia Beach, Virginia, United States

🇺🇸

Ferring Investigation Site, Dallas, Texas, United States

Efficacy & Safety of RAd-IFN Administered with Celecoxib & Gemcitabine in Patients with Malignant Pleural Mesothelioma

First Posted Date
2018-10-18
Last Posted Date
2024-11-08
Lead Sponsor
Ferring Ventures Limited
Target Recruit Count
53
Registration Number
NCT03710876
Locations
🇺🇸

University of California, Los Angeles (UCLA) - Medical Center, Los Angeles, California, United States

🇺🇸

University of California, San Francisco (UCSF), San Francisco, California, United States

🇺🇸

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States

and more 39 locations

Intravesical Administration of rAd-IFN/Syn3 in Patients With BCG-Refractory or Relapsed Bladder Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2012-09-18
Last Posted Date
2017-07-24
Lead Sponsor
FKD Therapies Oy
Target Recruit Count
40
Registration Number
NCT01687244
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