Last reviewed 2026-05-24 · How we verify

[11C]osimertinib

AstraZeneca · Phase 1 active Small molecule ✓ Verified May 2026

[11C]osimertinib is a Small molecule drug developed by AstraZeneca. It is currently in Phase 1 development. Also known as: [11C]AZD9291.

[11C]osimertinib is a small molecule inhibitor of the epidermal growth factor receptor (erbB1). It is used to target this receptor, which is involved in the growth and spread of cancer cells.

Likelihood of approval

12.6% 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).
Big-pharma sponsor +3.0pp
AstraZeneca is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

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	[11C]osimertinib
Also known as	[11C]AZD9291
Sponsor	AstraZeneca
Modality	Small molecule
Phase	Phase 1

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:

[11C]osimertinib CI brief — competitive landscape report
[11C]osimertinib updates RSS · CI watch RSS
AstraZeneca portfolio CI

Frequently asked questions about [11C]osimertinib

What is [11C]osimertinib?

[11C]osimertinib is a Small molecule drug developed by AstraZeneca.

Who makes [11C]osimertinib?

[11C]osimertinib is developed by AstraZeneca (see full AstraZeneca pipeline at /company/astrazeneca).

Is [11C]osimertinib also known as anything else?

[11C]osimertinib is also known as [11C]AZD9291.

What development phase is [11C]osimertinib in?

[11C]osimertinib is in Phase 1.

Manufacturer: AstraZeneca — full pipeline
Also known as: [11C]AZD9291

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