Drugs / Luvometinib

Trials 12 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/23 trials
Phase 1/2 NCT07708285 Jul 2026 → Dec 2028 expected NF2-related schwannomatosis, acoustic neuroma, meningioma Beijing Tiantan Hospital Not yet recruiting No outcome recorded
Phase 1/2 NCT07024394 Jun 2025 → Sep 2029 expected neurofibromatosis type 1, plexiform neurofibroma Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. Not yet recruiting No outcome recorded
Phase 1/2 NCT04954001 Mar 2021 → Feb 2025 overdue neurofibromatosis type 1, plexiform neurofibroma Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. Active not recruiting No outcome recorded
Phase 25 trials
Phase 2 NCT07713745 Jul 2026 → Jun 2036 expected NF2-related schwannomatosis, acoustic neuroma, ependymoma, meningioma Beijing Tiantan Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07562581 Jun 2026 → Jun 2029 expected metastatic neoplasm, non-small cell lung carcinoma Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. Not yet recruiting No outcome recorded
Phase 2 NCT06913725 Feb 2025 → Mar 2026 overdue arteriovenous malformations of the brain Xuanwu Hospital, Beijing Recruiting No outcome recorded
Phase 2 NCT06553365 Aug 2024 → Jul 2026 overdue nerve sheath neoplasm Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting No outcome recorded
Phase 2 NCT05997602 Sep 2023 → May 2025 overdue Langerhans cell histiocytosis Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. Recruiting No outcome recorded
Phase 32 trials
Phase 3 NCT07004075 Jun 2025 → Apr 2027 expected childhood low-grade glioma, diffuse low-grade glioma, MAPK pathway–altered Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT05913037 Jun 2023 → Aug 2025 overdue neurofibromatosis type 1, plexiform neurofibroma Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. Active not recruiting No outcome recorded
Phase not applicable2 trials
NCT07371182 Jun 2026 → Dec 2030 expected Langerhans cell histiocytosis West China Second University Hospital Recruiting No outcome recorded
NCT07431060 Feb 2026 → Dec 2030 expected multisystem langerhans cell histiocytosis West China Second University Hospital Recruiting No outcome recorded

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 12 sources stand behind the page.

FieldValueCited text
Known as Luvometinib ClinicalTrials.gov intervention name — accepted as the source's own label NCT07024394
6

NCT07562581

NCT07431060

NCT07713745

NCT07004075

NCT07371182

NCT07708285

Known as FCN-159 “Luvometinib (also called FCN-159), a new MAPK inhibitor developed by Fosun Pharma in Shanghai, was approved in 2025 for treating adult LCH.” NCT07371182
5

NCT05913037

NCT06913725

NCT05997602

NCT04954001

NCT06553365

Action Inhibit “FCN-159 is a highly active MEK1/2 inhibitor” NCT04954001
Modality Small molecule “Oral selective MEK1/2 inhibitor added to the experimental arm” NCT07431060
Route Oral “FCN-159 is administered orally in once daily schedule for 28 days a cycle.” NCT04954001