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Drug

Nadofaragene firadenovec

Approved · EMA
Late-stage development
Also known as Adstiladrin, RAD-IFN, RAD-IFN-2B, Replication-deficient adenovirus type 5 (ad5) vector encoding the human interferon alpha 2 (ifna2, interferon alpha-2b) gene under the control of the cytomegalovirus (cmv) immediate-early enhancer/promoter+1 more

Adstiladrin, RAD-IFN, RAD-IFN-2B, Replication-deficient adenovirus type 5 (ad5) vector encoding the human interferon alpha 2 (ifna2, interferon alpha-2b) gene under the control of the cytomegalovirus (cmv) immediate-early enhancer/promoter, rAd-IFNa/Syn3.

RxNorm2644436UNII0OOS09O1FH
5
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 4, Multi-center, Open Label 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.

Clinical trial2026-07-31Withdrawn · ClinicalTrials.gov

A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer

Clinical trial2026-07-10Results expected Q2 2028 · ClinicalTrials.gov

A Phase 3, Randomised, Multi-center, Open Label Trial to Evaluate the Safety and Efficacy of Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade Bacillus Calmette-Guerin Therapy (BCG) Unresponsive Non-muscle Invasive Bladder Cancer (NMIBC)

Clinical trial2026-07-08Results expected Q2 2028 · ClinicalTrials.gov

Intravesical Nadofaragene Firadenovec With Neoadjuvant Chemotherapy and Durvalumab in Patients With Muscle Invasive Bladder Cancer (TRIFECTA)

Clinical trial2026-06-08Results expected Q1 2027 · ClinicalTrials.gov

Approval: Adstiladrin (EMA)

Regulatory2026-05-28EMA

COMparative Prospective Assessment Through Clinically Integrated Randomized Trials Evaluating Intravesical Treatments: The COMPARE IT Trial

Clinical trial2026-05-11Results expected Q2 2028 · ClinicalTrials.gov

A Phase 1/2, Single-arm, Open-Label Trial to Evaluate the Safety and Efficacy of Nadofaragene Firadenovec Instilled to the Renal Pelvis in Adult Subjects With Low-grade Upper Tract Urothelial Carcinoma (LG-UTUC)

Clinical trial2026-05-08Results expected Q4 2029 · ClinicalTrials.gov

A Phase 3, Open-Label, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intrapleural Administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in Combination With Celecoxib and Gemcitabine in Patients With Malignant Pleural Mesothelioma

Clinical trial2026-04-21Results posted · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Nadofaragene firadenovec
Aliases & brands
AdstiladrinRAD-IFNRAD-IFN-2BReplication-deficient adenovirus type 5 (ad5) vector encoding the human interferon alpha 2 (ifna2, interferon alpha-2b) gene under the control of the cytomegalovirus (cmv) immediate-early enhancer/promoterrAd-IFNa/Syn3
RxNorm CUI
2644436
UNII
0OOS09O1FH
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2026-05-28
Latest approval
2026-05-28
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2026-05-28Approval
Approval: Adstiladrin (EMA)
Indication: Adstiladrin is indicated as monotherapy for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with… Show full indication

Adstiladrin is indicated as monotherapy for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

7 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
7
registered trials across all phases
LATEST COMPLETION 2026
5
Active studies
5
Recruiting
5
Late-stage (III+)
1
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 7
Phase 1 / 21Phase 21Phase 34Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase 4, Multi-center, Open Label 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.

WithdrawnPH IVFerring Pharmaceuticals2026

A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer

RecruitingPH IIIFerring Pharmaceuticalsn=4542031

A Phase 3, Randomised, Multi-center, Open Label Trial to Evaluate the Safety and Efficacy of Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade Bacillus Calmette-Guerin Therapy (BCG) Unresponsive Non-muscle Invasive Bladder Cancer (NMIBC)

RecruitingPH IIIFerring Pharmaceuticalsn=2502030

COMparative Prospective Assessment Through Clinically Integrated Randomized Trials Evaluating Intravesical Treatments: The COMPARE IT Trial

RecruitingPH IIIMemorial Sloan Kettering Cancer Centern=1252028

A Phase 3, Open-Label, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intrapleural Administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in Combination With Celecoxib and Gemcitabine in Patients With Malignant Pleural Mesothelioma

CompletedPH IIIFerring Ventures Limitedn=532026
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.