Drug Type Small molecule drug |
Synonyms HL 085, HL-085, HL085 + [1] |
Target |
Action inhibitors |
Mechanism MEK1 inhibitors(Dual specificity mitogen-activated protein kinase kinase 1 inhibitors), MEK2 inhibitors(Dual specificity mitogen-activated protein kinase kinase 2 inhibitors) |
Therapeutic Areas |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date China (12 Mar 2024), |
RegulationPriority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China) |
Molecular FormulaC16H12F2IN3O3S |
InChIKeyUFZJUVFSSINETF-UHFFFAOYSA-N |
CAS Registry1801756-06-8 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
NRAS Mutant Melanoma | China | 12 Mar 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
BRAF V600E mutant Colorectal Cancer | Phase 3 | China | 16 Oct 2023 | |
BRAF V600E mutant Non-small Cell Lung Cancer | Phase 2 | - | 24 Sep 2023 | |
Metastatic Colorectal Carcinoma | Phase 2 | China | 24 Feb 2022 | |
NF1 mutant Plexiform Neurofibroma | Phase 2 | China | 01 Nov 2021 | |
Neurofibromatosis 1 | Phase 2 | China | 18 Oct 2021 | |
BRAF mutation positive Melanoma | Phase 2 | China | 23 Sep 2021 | |
Locally Advanced Melanoma | Phase 2 | China | 06 Sep 2021 | |
RAS/RAF mutation Solid Tumors | Phase 1 | China | 17 Aug 2020 | |
KRAS mutant Non-small Cell Lung Cancer | Phase 1 | China | 21 May 2020 | |
Advanced Malignant Solid Neoplasm | Phase 1 | China | 01 Jul 2018 |
NCT03781219 (Pubmed) Manual | Phase 1 | BRAF mutation Solid Tumors BRAF V600 | 72 | hgwcihfnrb(huaefhpdvb) = All 72 patients had treatment-related adverse events (TRAEs) glvghkxzkp (djbxhrvvsb ) View more | Positive | 12 Jun 2024 | |
(RP2D) | |||||||
NCT05263453 (ASCO2024) Manual | Phase 2 | BRAF V600 mutation-positive Melanoma BRAF V600-mutant | 17 | mwwnmvrtnw(knrjdhdfim) = nsxmzjwbzv lhatuwkvvl (wboucnmtor, 44.0 - 89.7) View more | Positive | 24 May 2024 | |
(pre-treated pts) | mwwnmvrtnw(knrjdhdfim) = nhpjlkkidh lhatuwkvvl (wboucnmtor, 46.2 - 95.0) View more | ||||||
Phase 2 | 100 | qilayaldov(mrabdnwqox) = zftpqxwkis aeootmczld (hcnpilmtjq, 26.3% - 46.3%) View more | Positive | 24 May 2024 | |||
Phase 1 | Advanced Malignant Solid Neoplasm BRAF V600 mutation | 72 | ibcdcsmeey(duqsuibxwk) = The most common AE were CK elevation, anemia and rash which were predominantly grade 1/2. xtljryriem (nfrjgznoiv ) | Positive | 23 Oct 2023 | ||
(NSCLC) | |||||||
Phase 2 | NRAS Mutant Melanoma NRAS Mutation | 100 | avbixrojgb(iwlwdcnmfz) = chqltkwagw mxawvaghwf (kjfrvbkskx, 25.3 - 45.2) View more | Positive | 26 May 2023 | ||
Phase 1 | 42 | yxfvixoluz(zffvvkergo) = ezswrvetns uooqzzjcjz (mgcbyjbdiq ) View more | - | 04 Jan 2023 | |||
Phase 1/2 | 33 | cbhmgaddcm(ahermhzane) = the most common drug-related AEs were aspartate aminotransferase gxpwiiojms (sfbsfsbjqc ) View more | Positive | 25 May 2020 |