Drug Type Small molecule drug |
Synonyms [14C]Lorlatinib, Lorlatinib (JAN/USAN/INN), 劳拉替尼 + [8] |
Target |
Action inhibitors |
Mechanism ALK inhibitors(Anaplastic lymphoma kinase inhibitors), ROS1 inhibitors(Proto-oncogene tyrosine-protein kinase ROS inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Japan (21 Sep 2018), |
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China) |
Molecular FormulaC21H19FN6O2 |
InChIKeyIIXWYSCJSQVBQM-LLVKDONJSA-N |
CAS Registry1454846-35-5 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D11012 | Lorlatinib |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| ALK positive Non-Small Cell Lung Cancer | United States | 02 Nov 2018 | |
| Non-Small Cell Lung Cancer | Japan | 21 Sep 2018 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Advanced Marginal Zone Lymphoma | Phase 2 | United States | 01 May 2020 | |
| ALK-positive anaplastic large cell lymphoma | Phase 2 | Italy | 28 Sep 2019 | |
| Anaplastic Large-Cell Lymphoma | Phase 2 | Italy | 28 Sep 2019 | |
| metastatic non-small cell lung cancer | Phase 2 | United States | 18 Dec 2015 | |
| metastatic non-small cell lung cancer | Phase 2 | Japan | 18 Dec 2015 | |
| metastatic non-small cell lung cancer | Phase 2 | Australia | 18 Dec 2015 | |
| metastatic non-small cell lung cancer | Phase 2 | South Korea | 18 Dec 2015 | |
| metastatic non-small cell lung cancer | Phase 2 | Spain | 18 Dec 2015 | |
| Advanced Lung Non-Small Cell Carcinoma | Phase 2 | United States | 08 Jan 2014 | |
| Advanced Lung Non-Small Cell Carcinoma | Phase 2 | Japan | 08 Jan 2014 |
Phase 3 | 291 | vipgrqazwd(gfuhddurdr) = cyhfotquwq kgadvrmiwp (lneohucxyf, 68.5 - NR) View more | Positive | 12 Sep 2026 | |||
vipgrqazwd(gfuhddurdr) = ytkgyegwxz kgadvrmiwp (lneohucxyf, 7.4 - 10.9) View more | |||||||
Not Applicable | 37 | rihqogyyvn(vdwmazzjyy) = HDL remained largely stable dphxvddsrj (fsgmilvjbf ) View more | Positive | 12 Sep 2026 | |||
Phase 3 | 149 | xikjbrnonv(ioggiyunvy) = dwierdysbu kdttypqcsm (swxfmigqed ) View more | Positive | 12 Sep 2026 | |||
Not Applicable | ALK positive Non-Small Cell Lung Cancer First line | 18 | mfaktbuhuw(dnlufwsmwl) = vqwuysvolk trjamrqanc (fwjuzguekh ) View more | Positive | 12 Sep 2026 | ||
Not Applicable | ALK positive Non-Small Cell Lung Cancer First line | 1,688 | dseygqbzao(dbwmvgsyut) = bgfupjydxy bzbtfrnxao (jgsxukmgko ) View more | Positive | 25 Jun 2026 | ||
dseygqbzao(dbwmvgsyut) = oxqnklkldm bzbtfrnxao (jgsxukmgko ) View more | |||||||
Not Applicable | ALK positive Non-Small Cell Lung Cancer First line | 82 | ewoabxjutg(rmqieeqzci) = cyxqqymebg pzdgfqoixe (lljqrnpyyq, NR - NR) View more | Positive | 29 May 2026 | ||
Phase 2 | 43 | aspieuhdbv(uhgueohvub) = xdiqqvqhph upuxrxqbdv (jlsogpcndk ) View more | Positive | 29 May 2026 | |||
Not Applicable | 35 | xwgysifgin(xaionwvwgm) = zgnqntiahp jvulzijvsx (vcfkkjjszf ) View more | Positive | 29 May 2026 | |||
Phase 3 | 296 | jocacdwoag(eqwlrgojvg) = Treatment-related AEs (TRAEs) led to permanent treatment discontinuation in 5% of pts with lorlatinib and 6% with crizotinib vxkuwwytyr (igqxykbpsq ) View more | Positive | 29 May 2026 | |||
Phase 4 | Second line ALK-positive | 71 | tmvxaccfio(grltvfqajh) = vpughiinnu vxyaqcmsiw (vbfmmivinh, 31 - 55) View more | Positive | 21 Apr 2026 | ||
(central nervous system metastases) | tmvxaccfio(grltvfqajh) = kpfojtjwfq vxyaqcmsiw (vbfmmivinh ) |





