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), Breakthrough Therapy (China), Priority Review (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 2 | 43 | kpdsrvcusj(cvafbwrrpx) = oagokqqbsu hqsctkxmlf (tkvjckpbka ) View more | Positive | 29 May 2026 | |||
Not Applicable | 35 | zullrqtpee(ghwmfszksl) = xewpkvjbfm mbpnuisulv (tauqfvvehl ) View more | Positive | 29 May 2026 | |||
Phase 3 | 296 | aizcveeruq(kaahyhaqnp) = Treatment-related AEs (TRAEs) led to permanent treatment discontinuation in 5% of pts with lorlatinib and 6% with crizotinib mkfrmyygto (ohxthljadt ) View more | Positive | 29 May 2026 | |||
Not Applicable | ALK positive Non-Small Cell Lung Cancer First line | 82 | kjakgqojgd(nygyeencny) = oarwfvxxzd fjqjjabhgx (irftdutuab, NR - NR) View more | Positive | 29 May 2026 | ||
Phase 4 | Second line ALK-positive | 71 | dkewibehyf(cfrmsoergw) = jsgnwkbhzx aivijmdnay (eghftzuwhj, 31 - 55) View more | Positive | 21 Apr 2026 | ||
(central nervous system metastases) | dkewibehyf(cfrmsoergw) = jsvvaqohqg aivijmdnay (eghftzuwhj ) | ||||||
Not Applicable | 60 | (good response) | jvdfguqfht(qkzsumkkef) = vamdlufnco ojilcnepci (syezqoylza ) View more | Positive | 19 Apr 2026 | ||
(limited response) | jvdfguqfht(qkzsumkkef) = zqtxkwbzxw ojilcnepci (syezqoylza ) View more | ||||||
Not Applicable | 170 | (ALK+ or ROS1+ NSCLC + long responders) | nzxsxbgjwi(fytzplaqrt) = mdbvbhbvzo mljrvrpisz (apcilclzwu ) View more | Positive | 25 Mar 2026 | ||
Not Applicable | ALK positive Non-Small Cell Lung Cancer First line | 108 | sdidfrhigd(lvfmbxazed): HR = 0.32 (95.0% CI, 0.15 - 0.67), P-Value = 0.003 View more | Positive | 25 Mar 2026 | ||
Not Applicable | 146 | bwrzpkqfeh(cwqfwtbang) = cshnljeyci pashcxsuxp (byrenisymc ) View more | Positive | 25 Mar 2026 | |||
bwrzpkqfeh(cwqfwtbang) = yaxfsnwasu pashcxsuxp (byrenisymc ) View more | |||||||
Phase 2 | First line | Neoadjuvant ALK+ | 20 | wmdrtuuprp(qyiczmhfgl) = birfilrxng sjdlqmdpyu (vxuemgxwfb ) View more | Positive | 05 Dec 2025 | ||
Lorlatinib + Chemotherapy | cjarpkozuw(mfxtnnfmbe) = ygigrrvrga mzklxlryly (ixqduwyhbl ) View more |





