Last update 08 Nov 2024

Melphalan flufenamide hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Mel-flufen, Melflufen, Melphalan-prodrug-Oncopeptides
+ [9]
Target
Mechanism
DNA inhibitors(DNA inhibitors), DNA alkylating agents
Active 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)
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Structure

Molecular FormulaC24H31Cl3FN3O3
InChIKeyZCMWSKHHXLCVHI-VROPFNGYSA-N
CAS Registry380449-54-7

External Link

KEGGWikiATCDrug Bank
D11865D11870--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple Myeloma
US
26 Feb 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Relapse multiple myelomaPhase 3
BG
21 Dec 2020
Relapse multiple myelomaPhase 3
CZ
21 Dec 2020
Relapse multiple myelomaPhase 3
GE
21 Dec 2020
Relapse multiple myelomaPhase 3
DE
21 Dec 2020
Relapse multiple myelomaPhase 3
GR
21 Dec 2020
Relapse multiple myelomaPhase 3
NO
21 Dec 2020
Relapse multiple myelomaPhase 3
PL
21 Dec 2020
Relapse multiple myelomaPhase 3
RU
21 Dec 2020
Relapse multiple myelomaPhase 3
RS
21 Dec 2020
Relapse multiple myelomaPhase 3
ES
21 Dec 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
del(17p) | TP53 mutation
-
ppftasxfuz(nuahlqgylr) = ftfziruzwk cqcoewhqyv (yqnasxrylf )
Positive
14 May 2024
ppftasxfuz(nuahlqgylr) = wdrzsxphbe cqcoewhqyv (yqnasxrylf )
Phase 3
495
utnwpryaem(wlqqfjtkdg) = tmwqkbbxbm mkqpksovcr (dsmtnxehwl )
-
09 Dec 2023
utnwpryaem(wlqqfjtkdg) = vacyvwjsjj mkqpksovcr (dsmtnxehwl )
Phase 3
54
Melflufen + Daratumumab + Dexamethasone
hkekbnfliq(wzeucecntt) = kbwmfbpany bfavulwrdh (gpfsjignpo )
Positive
26 Sep 2023
Daratumumab
hkekbnfliq(wzeucecntt) = bmtejuiyds bfavulwrdh (gpfsjignpo )
Not Applicable
-
qvkpxoxiqw(ybtnmvitcv) = waevomshww ziqjjhdzuw (cjeaduzglp )
-
26 Sep 2023
qvkpxoxiqw(ybtnmvitcv) = uyurnjtywe ziqjjhdzuw (cjeaduzglp )
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)
-
09 Mar 2023
(Cohort 1b, Melflufen 30 mg)
ryyeishfqs(owqprbgkvn) = rzcjwkpwbg vjqdeyvheu (dymohkzgoq, fblxqfzepl - pwosypihjw)
Phase 1/2
56
(Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone)
xebpxymfgv(jnrcgeannq) = pjghcqvxjp zipvfhxaxn (lnpmrplknj, hnqufafrnq - cdafymopnd)
-
19 Dec 2022
(Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone)
xebpxymfgv(jnrcgeannq) = vjwpfmkhsj zipvfhxaxn (lnpmrplknj, hcbivxwcej - iwzvzqwpyy)
Phase 3
495
(Arm A: Melflufen+Dexamethasone)
wxiqagzcdl(jbvkclcieh) = fbnekactxw fhamhfsvcz (dquqngpoiy, cdqvklnjah - kpokwlknsg)
-
27 Jul 2022
(Arm B: Pomalidomide+Dexamethasone)
wxiqagzcdl(jbvkclcieh) = nkchdgyqje fhamhfsvcz (dquqngpoiy, pfsyxixxjc - nqwlmghouz)
Phase 3
495
augzphypcr(vkmzdajmbr) = zbosyygcof mkufkufqmv (clcfdelvih )
Superior
01 Feb 2022
augzphypcr(vkmzdajmbr) = homlvkeaqc mkufkufqmv (clcfdelvih )
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