Last reviewed 2026-05-14 · How we verify

IMA203 product- flat dose

Immatics US, Inc. · Phase 1 active Biologic

IMA203 product- flat dose is a Biologic drug developed by Immatics US, Inc.. It is currently in Phase 1 development. Also known as: anzutresgene autoleucel, anzu-cel.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	IMA203 product- flat dose
Also known as	anzutresgene autoleucel, anzu-cel
Sponsor	Immatics US, Inc.
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors (PHASE1, PHASE2)

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:

IMA203 product- flat dose CI brief — competitive landscape report
IMA203 product- flat dose updates RSS · CI watch RSS
Immatics US, Inc. portfolio CI

Frequently asked questions about IMA203 product- flat dose

What is IMA203 product- flat dose?

IMA203 product- flat dose is a Biologic drug developed by Immatics US, Inc..

Who makes IMA203 product- flat dose?

IMA203 product- flat dose is developed by Immatics US, Inc. (see full Immatics US, Inc. pipeline at /company/immatics-us-inc).

Is IMA203 product- flat dose also known as anything else?

IMA203 product- flat dose is also known as anzutresgene autoleucel, anzu-cel.

What development phase is IMA203 product- flat dose in?

IMA203 product- flat dose is in Phase 1.

Manufacturer: Immatics US, Inc. — full pipeline
Also known as: anzutresgene autoleucel, anzu-cel

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