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Osimertinib Mesylate Tablets

Sun Yat-sen University · Phase 3 active Small molecule

Osimertinib Mesylate Tablets is a EGFR tyrosine kinase inhibitor (third-generation) Small molecule drug developed by Sun Yat-sen University. It is currently in Phase 3 development for Non-small cell lung cancer with EGFR T790M mutation (acquired resistance), Non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations (first-line treatment). Also known as: AZD9291, TAGRISSO.

Osimertinib is a third-generation, irreversible tyrosine kinase inhibitor that selectively targets EGFR mutations, including the T790M resistance mutation, in non-small cell lung cancer.

Osimertinib is a third-generation, irreversible tyrosine kinase inhibitor that selectively targets EGFR mutations, including the T790M resistance mutation, in non-small cell lung cancer. Used for Non-small cell lung cancer with EGFR T790M mutation (acquired resistance), Non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations (first-line treatment).

Likelihood of approval
61.3% 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).
  • Oncology Phase 3 boost +3.0pp
    Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
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 nameOsimertinib Mesylate Tablets
Also known asAZD9291, TAGRISSO
SponsorSun Yat-sen University
Drug classEGFR tyrosine kinase inhibitor (third-generation)
TargetEGFR (epidermal growth factor receptor), particularly mutant forms including T790M
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 3

Mechanism of action

Osimertinib binds irreversibly to mutant EGFR (epidermal growth factor receptor) while showing reduced activity against wild-type EGFR, allowing it to overcome resistance that develops when first- and second-generation EGFR inhibitors select for the T790M mutation. This selective targeting of mutant EGFR leads to sustained inhibition of downstream signaling pathways that drive cancer cell proliferation and survival.

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 Osimertinib Mesylate Tablets

What is Osimertinib Mesylate Tablets?

Osimertinib Mesylate Tablets is a EGFR tyrosine kinase inhibitor (third-generation) drug developed by Sun Yat-sen University, indicated for Non-small cell lung cancer with EGFR T790M mutation (acquired resistance), Non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations (first-line treatment).

How does Osimertinib Mesylate Tablets work?

Osimertinib is a third-generation, irreversible tyrosine kinase inhibitor that selectively targets EGFR mutations, including the T790M resistance mutation, in non-small cell lung cancer.

What is Osimertinib Mesylate Tablets used for?

Osimertinib Mesylate Tablets is indicated for Non-small cell lung cancer with EGFR T790M mutation (acquired resistance), Non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations (first-line treatment).

Who makes Osimertinib Mesylate Tablets?

Osimertinib Mesylate Tablets is developed by Sun Yat-sen University (see full Sun Yat-sen University pipeline at /company/sun-yat-sen-university).

Is Osimertinib Mesylate Tablets also known as anything else?

Osimertinib Mesylate Tablets is also known as AZD9291, TAGRISSO.

What drug class is Osimertinib Mesylate Tablets in?

Osimertinib Mesylate Tablets belongs to the EGFR tyrosine kinase inhibitor (third-generation) class. See all EGFR tyrosine kinase inhibitor (third-generation) drugs at /class/egfr-tyrosine-kinase-inhibitor-third-generation.

What development phase is Osimertinib Mesylate Tablets in?

Osimertinib Mesylate Tablets is in Phase 3.

What are the side effects of Osimertinib Mesylate Tablets?

Common side effects of Osimertinib Mesylate Tablets include Diarrhea, Rash, Dry skin, Nausea, Stomatitis, QT prolongation.

What does Osimertinib Mesylate Tablets target?

Osimertinib Mesylate Tablets targets EGFR (epidermal growth factor receptor), particularly mutant forms including T790M and is a EGFR tyrosine kinase inhibitor (third-generation).

Related

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