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AZD6244 Dosing Period 3

AstraZeneca · Phase 1 active Small molecule

AZD6244 Dosing Period 3 is a MEK inhibitor Small molecule drug developed by AstraZeneca. It is currently in Phase 1 development for Non-small cell lung cancer. Also known as: AZD6244.

MEK inhibitor

MEK inhibitor Used for Non-small cell lung cancer.

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 nameAZD6244 Dosing Period 3
Also known asAZD6244
SponsorAstraZeneca
Drug classMEK inhibitor
TargetMEK1 and MEK2
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 1

Mechanism of action

AZD6244 is a potent and selective inhibitor of MEK1 and MEK2, enzymes that are key regulators of the MAPK/ERK signaling pathway.

Approved indications

Common side effects

Key clinical trials

Primary sources

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

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about AZD6244 Dosing Period 3

What is AZD6244 Dosing Period 3?

AZD6244 Dosing Period 3 is a MEK inhibitor drug developed by AstraZeneca, indicated for Non-small cell lung cancer.

How does AZD6244 Dosing Period 3 work?

MEK inhibitor

What is AZD6244 Dosing Period 3 used for?

AZD6244 Dosing Period 3 is indicated for Non-small cell lung cancer.

Who makes AZD6244 Dosing Period 3?

AZD6244 Dosing Period 3 is developed by AstraZeneca (see full AstraZeneca pipeline at /company/astrazeneca).

Is AZD6244 Dosing Period 3 also known as anything else?

AZD6244 Dosing Period 3 is also known as AZD6244.

What drug class is AZD6244 Dosing Period 3 in?

AZD6244 Dosing Period 3 belongs to the MEK inhibitor class. See all MEK inhibitor drugs at /class/mek-inhibitor.

What development phase is AZD6244 Dosing Period 3 in?

AZD6244 Dosing Period 3 is in Phase 1.

What are the side effects of AZD6244 Dosing Period 3?

Common side effects of AZD6244 Dosing Period 3 include Diarrhea, Nausea, Vomiting.

What does AZD6244 Dosing Period 3 target?

AZD6244 Dosing Period 3 targets MEK1 and MEK2 and is a MEK inhibitor.

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