Drug Type Small molecule drug |
Synonyms [11C]osimertinib, ADAURA, Mereletinib + [14] |
Action inhibitors |
Mechanism EGFR T790M inhibitors(Epidermal Growth Factor Receptor T790M inhibitors), EGFR exon 19 deletion inhibitors, EGFR exon 21 L858R mutation inhibitors |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (13 Nov 2015), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Breakthrough Therapy (China), Priority Review (Australia), Accelerated assessment (European Union), Special Review Project (China), Priority Review (China) |
Molecular FormulaC29H37N7O5S |
InChIKeyFUKSNUHSJBTCFJ-UHFFFAOYSA-N |
CAS Registry1421373-66-1 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10766 | Osimertinib mesylate |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Non-Small Cell Lung Cancer | Canada | 05 Jul 2016 | |
EGFR positive non-small cell lung cancer | Japan | 28 Mar 2016 | |
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer | European Union | 01 Feb 2016 | |
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer | Iceland | 01 Feb 2016 | |
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer | Liechtenstein | 01 Feb 2016 | |
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer | Norway | 01 Feb 2016 | |
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer | European Union | 01 Feb 2016 | |
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer | Iceland | 01 Feb 2016 | |
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer | Liechtenstein | 01 Feb 2016 | |
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer | Norway | 01 Feb 2016 | |
EGFR-mutated non-small Cell Lung Cancer | European Union | 01 Feb 2016 | |
EGFR-mutated non-small Cell Lung Cancer | Iceland | 01 Feb 2016 | |
EGFR-mutated non-small Cell Lung Cancer | Liechtenstein | 01 Feb 2016 | |
EGFR-mutated non-small Cell Lung Cancer | Norway | 01 Feb 2016 | |
metastatic non-small cell lung cancer | European Union | 01 Feb 2016 | |
metastatic non-small cell lung cancer | Iceland | 01 Feb 2016 | |
metastatic non-small cell lung cancer | Liechtenstein | 01 Feb 2016 | |
metastatic non-small cell lung cancer | Norway | 01 Feb 2016 | |
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma | United States | 13 Nov 2015 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Neoplasms | Phase 3 | United States | 08 May 2023 | |
Neoplasms | Phase 3 | China | 08 May 2023 | |
Neoplasms | Phase 3 | France | 08 May 2023 | |
Neoplasms | Phase 3 | Malaysia | 08 May 2023 | |
Neoplasms | Phase 3 | Poland | 08 May 2023 | |
Neoplasms | Phase 3 | Taiwan Province | 08 May 2023 | |
Neoplasms | Phase 3 | United Kingdom | 08 May 2023 | |
Carcinoma | Phase 3 | United States | 03 Aug 2022 | |
Carcinoma | Phase 3 | China | 03 Aug 2022 | |
Carcinoma | Phase 3 | Japan | 03 Aug 2022 |
Not Applicable | EGFR mutation Glioblastoma EGFR mutations | - | (Biopsy specimens) | xidfybwvnc(ivmxxzmwwv) = jhmtiyffla gmsufcrory (muxwkctila ) View more | - | 01 Jun 2025 | |
(Resection specimens) | xidfybwvnc(ivmxxzmwwv) = ectgjdcklu gmsufcrory (muxwkctila ) View more | ||||||
Phase 2 | EGFR-mutated non-small Cell Lung Cancer EGFR amplification | G724 mutation | exon 20 insertion | 19 | Osimertinib + Necitumumab | gnpcffcamm(imzkjcdddv) = kffaiszfdy sbyphpjkny (zqgqapdqyg, 3 - 26) View more | Negative | 01 Jun 2025 | |
Phase 3 | 358 | Osimertinib + Chemotherapy | ldndgddhvl(srvjywevyv) = focolwaedu daujxogkhb (yhjtzflqcu, 18 - 34) View more | Positive | 30 May 2025 | ||
ldndgddhvl(srvjywevyv) = uawiuaakua daujxogkhb (yhjtzflqcu, 17 - 34) View more | |||||||
Phase 2 | 73 | rgeolrcjws(hiqlcawhuf) = lfqvpikbxn vnupspyxje (ugzcrlxqwk, 43 - 72) View more | Positive | 30 May 2025 | |||
rgeolrcjws(hiqlcawhuf) = kevxhrtpvt vnupspyxje (ugzcrlxqwk, 5 - 36) View more | |||||||
Not Applicable | Non-Small Cell Lung Cancer EGFR mutation | 161 | hyxwndorjr(bywzkctpti) = lzbyknxfcs pijzzuhvdf (ldiqhrtens ) View more | Positive | 30 May 2025 | ||
Local Therapy (LT) | wyezqwrgsv(indpiabmad) = tzlqtjhqeb gwjechezvj (jfbnpbccqw ) View more | ||||||
Phase 1 | EGFR-mutated non-small Cell Lung Cancer EGFR mutations | 15 | Osimertinib 80mg QD + Repotrectinib 80mg QD | nfcgsefine(bsukvamplr) = Most side effects were grade 1-2, including anemia tymrrxevyk (vwuueakdow ) View more | Positive | 30 May 2025 | |
Not Applicable | 171 | Osimertinib full dose | svstacfpou(chtqyhvakg) = All dose-reduced pts experienced AEs, compared to 48% of full-dose pts nbrrljicbk (yybxnonxxi ) View more | Negative | 30 May 2025 | ||
Osimertinib dose reduction | |||||||
Phase 3 | 51 | zfjbvbwudf(bojgpyvplh) = eyfvotnaoo ucksmmsbnc (wvjfvyamti ) View more | Negative | 30 May 2025 | |||
Platinum-based doublet chemotherapy alone | nklavcgfxv(zbqnbzxdyw) = gvblvmvveo pofmpfbbtx (nfdvlibyeg ) | ||||||
Not Applicable | 18 | emxbcynpha(kxwhkzrtre) = csrmqrzalz qenbklsfyi (zvsdgaiplv ) View more | Positive | 30 May 2025 | |||
Phase 3 | 732 | Adjuvant Osimertinib | fbnhwnldfq(wapeotxvbh) = In our study, there were 13 (45%) grade 1, 13 (45%) grade 2, 1 (3%) grade 4, and 2 (7%) AE of unknown grade. In ADAURA, there were 493 (69%) grade 1, 202 (28%) grade 2, and 22 (3%) grade 3 AE. hjgstpiluy (gpoefwkozz ) View more | Positive | 30 May 2025 |