FE 999326

Ferring Pharmaceuticals · Phase 3 active Small molecule Quality 0/100

FE 999326 is a Small molecule drug developed by Ferring Pharmaceuticals. It is currently in Phase 3 development. Also known as: nadofaragene firadenovec.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

• Baseline phase 3 → approval rate +58.3pp
  Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	FE 999326
Also known as	nadofaragene firadenovec
Sponsor	Ferring Pharmaceuticals
Modality	Small molecule
Phase	Phase 3

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC) (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• FE 999326 CI brief — competitive landscape report
• FE 999326 updates RSS · CI watch RSS
• Ferring Pharmaceuticals portfolio CI

Frequently asked questions about FE 999326

What is FE 999326?

FE 999326 is a Small molecule drug developed by Ferring Pharmaceuticals.

Who makes FE 999326?

FE 999326 is developed by Ferring Pharmaceuticals (see full Ferring Pharmaceuticals pipeline at /company/ferring).

Is FE 999326 also known as anything else?

FE 999326 is also known as nadofaragene firadenovec.

What development phase is FE 999326 in?

FE 999326 is in Phase 3.

Related

• Manufacturer: Ferring Pharmaceuticals — full pipeline
• Also known as: nadofaragene firadenovec