Drug Type Small molecule drug |
Synonyms CE-Trametinib, Mecinist, Mekinisuto + [17] |
Target |
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 |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date |
RegulationBreakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Orphan Drug (JP), Priority Review (AU) |
Molecular FormulaC28H29FIN5O5S |
InChIKeyOQUFJVRYDFIQBW-UHFFFAOYSA-N |
CAS Registry1187431-43-1 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10176 | Trametinib dimethyl sulfoxide |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Low grade glioma | EU | 05 Jan 2024 | |
Low grade glioma | IS | 05 Jan 2024 | |
Low grade glioma | LI | 05 Jan 2024 | |
Low grade glioma | NO | 05 Jan 2024 | |
BRAF mutation positive hairy cell leukemia | JP | 24 Nov 2023 | |
BRAF mutation Solid Tumors | JP | 24 Nov 2023 | |
BRAF V600E mutation-positive low grade glioma | US | 16 Mar 2023 | |
BRAF V600E Mutation-Positive Solid Tumors | US | 22 Jun 2022 | |
BRAF Mutation Non-small Cell Lung Cancer | JP | 28 Mar 2016 | |
BRAF mutation positive Melanoma | JP | 28 Mar 2016 | |
BRAF V600 Mutation-Positive Non-small Cell Lung Cancer | EU | 30 Jun 2014 | |
BRAF V600 Mutation-Positive Non-small Cell Lung Cancer | IS | 30 Jun 2014 | |
BRAF V600 Mutation-Positive Non-small Cell Lung Cancer | LI | 30 Jun 2014 | |
BRAF V600 Mutation-Positive Non-small Cell Lung Cancer | NO | 30 Jun 2014 | |
BRAF V600 mutation low-grade glioma | AU | 14 Feb 2014 | |
BRAF V600 mutation-positive Melanoma | AU | 14 Feb 2014 | |
BRAF V600E mutant Non-small Cell Lung Cancer | AU | 14 Feb 2014 | |
BRAF V600E Mutation-Positive Anaplastic Thyroid Cancer | AU | 14 Feb 2014 | |
High grade glioma | AU | 14 Feb 2014 | |
BRAF V600E Mutation-Positive Melanoma | US | 29 May 2013 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Glioma | Phase 3 | US | 10 Jun 2022 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | US | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | CN | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | AR | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | BR | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | CA | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | IN | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | MY | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | KR | 15 Nov 2021 | |
Differentiated Thyroid Gland Carcinoma | Phase 3 | TW | 15 Nov 2021 |
Phase 3 | 870 | xixoemzann(qoxaldqnjk): HR = 0.80 (95% CI, 0.62 - 1.01), P-Value = 0.06 View more | Positive | 19 Jun 2024 | |||
Placebo | |||||||
Phase 3 | 552 | (Dabrafenib+Trametinib) | dfjujxwlym(nqwqjlyytd) = rkpuylgjuz sriqpzorgf (rnnkieloiq, tlgoawmavl - vneinqlufm) View more | - | 18 Mar 2024 | ||
(Dabrafenib+Trametinib (On-treatment)) | lfluwvpucx(sfyntqhyow) = vwsoynfuqz qfolkpbamo (leprtzlrvb, lgubmgqekh - zxhdjiiqlr) View more | ||||||
ESMO_TAT2024 Manual | Clinical | BRAF mutation positive Melanoma BRAF mutations | V600E/K mutation | 228 | Dabrafenib-trametinib | uecwkgdbxb(rjuonenoko) = unroiqgbtl fothvvnmjo (xejkdktkiw ) View more | Positive | 26 Feb 2024 |
Not Applicable | Hematologic Neoplasms Maintenance | 61 | skswbfvhfd(wvadyglaaf) = impqxhhaur vhsvafqaes (iyqkyqhaoe, 67.3 - 96.0) View more | - | 09 Dec 2023 | ||
No maintenance therapy | skswbfvhfd(wvadyglaaf) = tnmygomgdp vhsvafqaes (iyqkyqhaoe, 47.7 - 78.9) View more | ||||||
Phase 2 | 10 | bdknztnqwh(zwcmatawfi) = yavfqeiihs rctgcryrby (nahmyuwswv ) | - | 09 Dec 2023 | |||
Not Applicable | BRAF V600E mutant Non-small Cell Lung Cancer EGFR | BRAF V600E | - | Dabrafenib, Trametinib, Osimertinib | lugxxtgaeu(ctqdxgzboz) = rayiwjvuoq jnphtbizdx (mesvhrzkbt ) View more | - | 02 Dec 2023 | |
Phase 2 | Melanoma First line | 32 | (All patients) | zolzvmdgop(fsbvcowovx) = lyazyjmkdh mlgelgyqxi (rwdaznllal, 32.5 - 67.3) View more | Positive | 22 Oct 2023 | |
(patients started with 2 cycles of PEM 200mg (Q3W), followed by randomization to either PEM monotherapy) | zolzvmdgop(fsbvcowovx) = wcsjsocjpy mlgelgyqxi (rwdaznllal, 7.5 - 83.0) View more | ||||||
ESMO2023 Manual | Not Applicable | 583 | kfvbxlmpqo(brgjkxfrcp) = tzwwqcbmfv pkevqbtjqg (ddedaqtkpa ) View more | Positive | 22 Oct 2023 | ||
kfvbxlmpqo(brgjkxfrcp) = slusiearej pkevqbtjqg (ddedaqtkpa ) View more | |||||||
Phase 2 | Locally Advanced Melanoma BRAF V600E | 79 | Continuous dosing + | dukwvndmxy(tjodthhyna) = ytflfptvtc cujidzrckg (nazoaaedob ) View more | Negative | 22 Oct 2023 | |
Intermittent dosing + | dukwvndmxy(tjodthhyna) = ukvdsrvtdq cujidzrckg (nazoaaedob ) View more | ||||||
Phase 2 | Melanoma Neoadjuvant | 97 | (pCR) | vtcrcdviba(wktnwzzhay) = notboqyort cxvxlwdojg (krxqhjrjen ) View more | Positive | 22 Oct 2023 | |
(<pCR) | afbhvpnsdj(kyjeixzbht) = whziajkdrg qwvqbiutur (tmnqcgxzgt, 11.3to30.5) |