Last reviewed 2026-05-19 · How we verify

NESPECABTAGENE AUTOLEUCEL

Phase 2 active Gene therapy ✓ Verified May 2026 Quality 3/100

NESPECABTAGENE AUTOLEUCEL is a drug. It is currently in Phase 2 development.

NESPECABTAGENE AUTOLEUCEL is a gene therapy modality. It has multiple synonyms, including NESPECABTAGENE AUTOLEUCEL and NESPECABTAGENE AUTOLEUCEL.

Likelihood of approval

14.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Cell / gene therapy complexity -1.0pp
Advanced therapies face additional manufacturing + CMC review hurdles. Offset partially when RMAT-designated.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	NESPECABTAGENE AUTOLEUCEL
Modality	Gene therapy
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

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

NESPECABTAGENE AUTOLEUCEL CI brief — competitive landscape report
NESPECABTAGENE AUTOLEUCEL updates RSS · CI watch RSS

Frequently asked questions about NESPECABTAGENE AUTOLEUCEL

What is NESPECABTAGENE AUTOLEUCEL?

NESPECABTAGENE AUTOLEUCEL is a Gene therapy drug.

What development phase is NESPECABTAGENE AUTOLEUCEL in?

NESPECABTAGENE AUTOLEUCEL is in Phase 2.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing