Drug Type Small molecule drug |
Synonyms Mel-flufen, Melflufen, Melphalan-prodrug-Oncopeptides + [9] |
Target |
Mechanism DNA inhibitors(DNA inhibitors), DNA alkylating agents |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (26 Feb 2021), |
RegulationOrphan Drug (US), Accelerated Approval (US), Orphan Drug (EU) |
Molecular FormulaC24H31Cl3FN3O3 |
InChIKeyZCMWSKHHXLCVHI-VROPFNGYSA-N |
CAS Registry380449-54-7 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Multiple Myeloma | US | 26 Feb 2021 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Relapse multiple myeloma | Phase 3 | BG | 21 Dec 2020 | |
Relapse multiple myeloma | Phase 3 | CZ | 21 Dec 2020 | |
Relapse multiple myeloma | Phase 3 | GE | 21 Dec 2020 | |
Relapse multiple myeloma | Phase 3 | DE | 21 Dec 2020 | |
Relapse multiple myeloma | Phase 3 | GR | 21 Dec 2020 | |
Relapse multiple myeloma | Phase 3 | NO | 21 Dec 2020 | |
Relapse multiple myeloma | Phase 3 | PL | 21 Dec 2020 | |
Relapse multiple myeloma | Phase 3 | RU | 21 Dec 2020 | |
Relapse multiple myeloma | Phase 3 | RS | 21 Dec 2020 | |
Relapse multiple myeloma | Phase 3 | ES | 21 Dec 2020 |
Phase 3 | del(17p) | TP53 mutation | - | ppftasxfuz(nuahlqgylr) = ftfziruzwk cqcoewhqyv (yqnasxrylf ) View more | Positive | 14 May 2024 | ||
ppftasxfuz(nuahlqgylr) = wdrzsxphbe cqcoewhqyv (yqnasxrylf ) View more | |||||||
Phase 3 | 495 | utnwpryaem(wlqqfjtkdg) = tmwqkbbxbm mkqpksovcr (dsmtnxehwl ) | - | 09 Dec 2023 | |||
utnwpryaem(wlqqfjtkdg) = vacyvwjsjj mkqpksovcr (dsmtnxehwl ) | |||||||
Phase 3 | 54 | hkekbnfliq(wzeucecntt) = kbwmfbpany bfavulwrdh (gpfsjignpo ) View more | Positive | 26 Sep 2023 | |||
Daratumumab | hkekbnfliq(wzeucecntt) = bmtejuiyds bfavulwrdh (gpfsjignpo ) View more | ||||||
Not Applicable | - | Melflufen + Vd | qvkpxoxiqw(ybtnmvitcv) = waevomshww ziqjjhdzuw (cjeaduzglp ) View more | - | 26 Sep 2023 | ||
Melflufen + Dd | qvkpxoxiqw(ybtnmvitcv) = uyurnjtywe ziqjjhdzuw (cjeaduzglp ) View more | ||||||
Phase 3 | 495 | lnfmbefofj(pipxwvwjpz) = oemdnpolpz audjjftfhz (suogxaqvij ) | Positive | 01 Sep 2023 | |||
lnfmbefofj(pipxwvwjpz) = mikcijmwhv audjjftfhz (suogxaqvij ) | |||||||
Phase 2 | 35 | (Cohort 1a, Melflufen 40 mg) | ryyeishfqs(owqprbgkvn) = spqhbxbybg vjqdeyvheu (dymohkzgoq, ckytqjbfzc - jmvpfwmbwr) View more | - | 09 Mar 2023 | ||
(Cohort 1b, Melflufen 30 mg) | ryyeishfqs(owqprbgkvn) = rzcjwkpwbg vjqdeyvheu (dymohkzgoq, fblxqfzepl - pwosypihjw) View more | ||||||
Phase 1/2 | 56 | (Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone) | xebpxymfgv(jnrcgeannq) = pjghcqvxjp zipvfhxaxn (lnpmrplknj, hnqufafrnq - cdafymopnd) View more | - | 19 Dec 2022 | ||
(Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone) | xebpxymfgv(jnrcgeannq) = vjwpfmkhsj zipvfhxaxn (lnpmrplknj, hcbivxwcej - iwzvzqwpyy) View more | ||||||
Phase 3 | 495 | (Arm A: Melflufen+Dexamethasone) | wxiqagzcdl(jbvkclcieh) = fbnekactxw fhamhfsvcz (dquqngpoiy, cdqvklnjah - kpokwlknsg) View more | - | 27 Jul 2022 | ||
(Arm B: Pomalidomide+Dexamethasone) | wxiqagzcdl(jbvkclcieh) = nkchdgyqje fhamhfsvcz (dquqngpoiy, pfsyxixxjc - nqwlmghouz) View more | ||||||
Phase 3 | 495 | augzphypcr(vkmzdajmbr) = zbosyygcof mkufkufqmv (clcfdelvih ) View more | Superior | 01 Feb 2022 | |||
augzphypcr(vkmzdajmbr) = homlvkeaqc mkufkufqmv (clcfdelvih ) View more |